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WORLD HEALTH ORGANIZATION
WHO/VDT/85.437
ORGANISATION MONDIALE DE LA SANTE
ORIGINAL:
ENGLISH
SIMPLIFIED APPROACHES FOR
SEXUALLY TRANSMITTED DISEASE (STD) CONTROL
AT THE PRIMARY HEALTH CARE (PHC) LEVEL
Report of a WHO Working Group
Geneva, 24-28 September 1984
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WHO/VDT/85.437
page 2
CONTENTS
Page
List of participants
1.
Introduction
1.1
2.
General principles for STD control at PHC level
2.1
2.2
2.3
2.4
2.5
2.6
3.
. .
Initial steps
Problem identification
Identification of health care practices
Definition of intended users of the protocols
Technical information on etiology, diagnosis and treatment
Protocol design
Testing of protocols
STD management protocols at the PHC level
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
5.
Strategies for STD control
Clinical services • • • • . .........
Support services
Administration
Technical-scientific authority • • • •
Integration of STD control at PHC level
General principles for the design of STD management protocols
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4.
Some current obstacles to STD control at PHC level
Urethral discharge
Vaginal discharge
Pelvic inflammatory disease .
Genital ulcer
Bubo • • . . • ...........
Balanitis and balanoposthitis
Ophthalmia neonatorum . . . .
Swollen scrotum •••••••
Suspected STD
The implementation of STD management protocols
5.1
5.2
5.3
5.4
5.5
5.6
5.7
The setting
The clinician
.
Training
Supervision and guidance
Laboratory support for protocol implementation •
Protocol implementation and STD information needs
Administration and support
6.
Evaluation of STD management protocols
7.
Community participation in STD control efforts
8.
Conclusions
I
WHO/VDT/85.437
page 3
Annex 1
Recommended availability of diagnostic tests by level
of the laboratory system
Annex 2
Monthly clinician notification form
Annex 3
Therapeutic recommendations
Annex 4
Microscopic tests useful at PHC level
Annex 5
Approaches to obtain community support
Annex 6
Recommended reading
WHO/VDT/85.437
page 4
List of Participants
Members
Dr G. Bugingo, Service de Dermatologie, Faculte de Medecine de 1’U.N.R., Butare, Rwanda
Dr Per-Anders MSrdh, Institute of Clinical Bacteriology, University of Uppsala, Sweden
Dr A.Z. Meheus, Associated Professor of Epidemiology and Social Medicine, University of
Antwerp, Wilrijk, Belgium (Chairman)
Dr I. De Schampheleire, Projet Pikine, Dakar, Senegal
Dr Amnuay Traisupa, Director, Venereal Disease Division, Bangkok, Thailand
Dr F. Zacarias, Division of Sexually Transmitted Diseases, Center for Prevention Services
Centers for Disease Control, Atlanta, Georgia, USA (Rapporteur)
Secretariat
Dr G.M. Antal, Medical Officer, Bacterial and Venereal Infections, Division of
Communicable Diseases, WHO, Geneva (Secretary)
Dr G.Y. Causse, Chief Medical Officer, Bacterial and Venereal Infections, Division
of Communicable Diseases, WHO, Geneva
Dr D. Flahault, Chief Medical Officer, Health Team Development, Division of Health
Manpower Development, WHO, Geneva
Dr L. Houang, Chief Medical Officer, Health Laboratory Technology, Division of
Diagnostic, Therapeutic and Rehabilitative Technology, WHO, Geneva
4i
WHO/VDT/85.437
page 5
Simplified Approaches for
Sexually Transmitted Disease (STD) Control
at the Primary Health Care (PHC) Level
Report of a WHO Working Group
A Working Group on Simplified Approaches for Sexually Transmitted Disease (STD)
Control at the Primary Health Care (PHC) Level met in Geneva from 24 to 28 September
1984. Dr G.Y. Causse, Chief Medical Officer, Bacterial and Venereal Infections, Division
of Communicable Diseases, WHO, opened the meeting.
1.
INTRODUCTION
A major objective of any national STD control programme is the prevention of the
devastating consequences of sexually transmitted diseases. Seirious complications of STD,
such as pelvic inflammatory disease leading to ectopic pregnancy and infertility;
urethral stricture; congenital syphilis, and ophthalmia neonatorum, arise particularly in
situations where infected individuals are not identified and/or are treated
inappropriately in the course of their disease. This underlines the need to increase the
competence of health services close to the community to deal more effectively with the
STD problem.
Within this context and the objectives of the strategy of "Health for All by the Year
2000", WHO has given priority to the development of methods and technologies to enable
health care units with minimal or no laboratory diagnostic support to provide effective
treatment to STD cases and their contacts. In such a "simplified STD control approach"
simple patient management instructions in the form of flow charts will be provided to
physicians, practitioners and other community health workers to guide them in the
appropriate management of patients with suspected sexually transmitted diseases and their
sex partners.
In order to bring about a significant reduction in disease transmission and the
development of sequelae, these clinical activities will have to be supplemented by other
STD control strategies (e.g., screening for asymptomatic cases, promotion of changes in
health and illness behaviour, etc.) and should receive the support of the community.
The purposes of this document are:
1)
2)
to outline general principles for STD control at the PHC level, and
to offer guidance in the design, implementation and evaluation of patient
management protocols covering a wide range of STD-associated syndromes.
As such, this document is directed to professionals responsible for improving STD
control in a defined geographic area.
The Group realizes that the increasing complexity of the STD field and the continuing
changes in our understanding of the microbiology, epidemiology, diagnosis and management
of STDs pose a formidable challenge and defy efforts for designing all-inclusive
approaches and procedures applicable to all settings. However, with proper adaptation,
this document will prove useful to clinicians and health administrators charged with the
integration of STD control activities into the existing PHC structure.
For its discussions, the Group reviewed the topics covered in WHO Technical Report
Series Nos. 616, 660, and 674 (see Annex 6), and was assisted by WHO staff with expertise
in laboratory technology and health manpower development at the PHC level.
WHO/VDT/85.437
page 6
Finally, various WHO meetings (1-5) had recently addressed in detail some of these
issues. Relevant conclusions and recommendations of those Groups have been freely
quoted, used and adapted, to fit into the present document.
1.1
Some current obstacles to STD control at PHC level
Many developing countries facing health problems which result in high mortality and
morbidity have very limited resources in trained manpower, laboratory facilities and
funds to solve them. Frequently, health centres have to satisfy the needs and demands of
80 to 90% of the population living in rural and peri-urban areas. Under the best
conditions, the health centres (or their equivalent) are staffed with medical and/or
auxiliary workers and act as the first referral services for primary care within the
community. These facilities are expected to deliver integrated community health care
including curative and preventive services. Generally, approximately 10% or more of
their daily work load is related to sexually transmitted diseases or their
complications. However, diagnostic facilities in the health services are often either
very limited (microscope only) or non-existent. Furthermore, even in places with access
to better laboratory facilities, the delays in reporting of test results and the
limitations inherent in the techniques used for STD detection may hinder timely treatment
of infectious cases. Long patient waiting time, scarcity of drugs, and poor service are
often encountered in the clinics.
As a result, a varying but usually large proportion of STD patients resort to
self-treatment or are managed by traditional healers, drug vendors, pharmacists, and
other self-styled practitioners outside the official STD and public health services.
Those patients who can bear the expense, seek care from private physicians who, in
general, seldom provide partner management, and rarely report STD cases or follow
official STD treatment guidelines.
In some countries where prostitution is believed to be a significant factor in the
transmission of these diseases, "control programmes" tend to devote their resources
almost exclusively to providing some sort of preventive STD diagnosis and treatment to
these women. Unfortunately, these programmes often are of poor technical quality, reach
only a small proportion (probably less than 20%) of the total prostitute propulation and
in general have failed to produce a demonstrable impact on STD morbidity in the
community. In addition, prostitute control programmes often interfere with the
introduction of other STD control measures. Health policy makers are frequently
satisfied that by implementing "prostitute control" enough is being done and additional
resources need not be devoted to STD problems in the community.
Antimicrobial resistance of STD organisms has become a major problem in most
developing areas and has rendered some of the low cost drug regimens useless.
1) "Current Treatments in the Control of Sexually Transmitted Diseases." Report of a
WHO Consultative Group (16-19 Nov. 1982). Unpublished WHO document WHO/VDT/83.433.
2) "Control of Sexually Transmitted Diseases." (WHO, Geneva 1985).
3) "Prevention and Treatment of Conjunctivitis in the Newborn at the Primary Level."
Report of a meeting (29 Nov-2 Dec, 1983). Unpublished WHO document PBL/84.4.
4) "Prevention of Infertility at the Primary Health Care Level." Report of a WHO
meeting (12-16 December, 1983). Unpublished WHO document MCH/84.4.
5) WHO Expert Committee on Venereal Diseases and Treponematoses, Geneva, 1-7
November 1983, in press.
WHO/VDT/85.437
page 7
Adoption of drug regimens or health policies found appropriate elsewhere has lead to
serious consequences in some settings (e.g., inadequate treatment of PPNG infections, or
increased frequency of gonococcal ophthalmia neonatorum following abandonment of silver
nitrate prophylaxis).
For all the above reasons, it is important that those patients already seeking care
for an STD-related problem, as well as their sexual contacts be identified, properly
managed, and be referred, if necessary, to the next higher level.
The Group believes that the design, implementation, and evaluation of patient
management protocols will not only contribute to these ends but will have additional
value as a means of assessing and improving other STD control components and activities.
Although most of this discussion relates to conditions present in developing
countries, it is by no means restricted by geography. For small segments of the
population in industrialized nations (migrant workers, minorities, etc.) some of the
problems discussed above are relevant. Similarly, a medical practitioner seeing a
patient with STD in an industrialized country may face the same clinical judgement
dilemma and lack of immediate laboratory resources confronting a health worker in a
peri-urban setting in Asia, Africa or Latin America.
2.
GENERAL PRINCIPLES FOR STD CONTROL AT THE PHC LEVEL
The main aims of STD control are;
a)
b)
to interrupt the transmission of disease, and
to prevent the development of complications and their consequences.
This is accomplished by:
a)
b)
c)
d)
e)
Reducing disease exposure by educating individuals at risk to avoid sexual
intercourse with persons who have a high probability of being infected.
Preventing infection by promoting the use of condoms or other prophylactic
barriers.
Detecting and curing disease by implementing disease detection activities,
providing effective and efficient diagnostic and treatment facilities, and
promoting health-seeking behaviour.
Limiting complications of infection by providing early and appropriate treatment
for both symptomatic and asymptomatic infected patients and their contacts; and
Limiting disease transmission within the community with the above efforts
Strategies for STD control
2.1
These efforts are translated into the following main STD control strategies:
2.1.1
Disease detection
This strategy is accomplished by applying the following three tools:
a)
b)
c)
screening: Ascertainment of probability of disease in populations or
individuals not directly seeking health care; e.g., serological screening for
syphilis (VDRL) in selected groups in the community.
case finding: Use of clinical and/or laboratory tests to detect an infection in
individuals seeking health care for other reason; e.g., VDRL to detect syphilis
in patients admitted to hospitals; and
diagnosis: Application of clinical and laboratory procedures to detect the
cause of specific disease in individuals presumed ill; e.g., VDRL in an
individual with lesions suggesting secondary syphilis.
WHO/VDT/85.437
page 8
2.1.2
Treatment
Treatment is the application of drugs, surgical procedures and other interventions to
cure or ameliorate the patient’s health problem, STD treatment usually refers to the
application of antimicrobial regimens, The selection of an appropriate drug is
determined by:
a)
b)
c)
d)
2.1.3
_______
efficacy; Ability to cure the disease. When coexisting infections are common,
preference is given to drug regimens which can cure more than one of the STD
infections likely to be present.
acceptability: Lack of toxicity or side effects and ease of patient compliance.
convenience: For the health worker administering the drug and the patient
receiving it, and
cost and availability of the drug.
Health education
This strategy consists of
a)
b)
activities which increase individual and community awareness and knowledge of
STD, and
efforts which produce positive changes in their attitudes and health and illness
behaviours in STD and their prevention.
In patients attending health services, patient counselling is one of the mainstays of
proper management and aims to increase a patient’s compliance with the clinician’s advice
and instructions on treatment, avoidance of re-exposure, and active collaboration with
sexual partner referral.
2.1.4
Management of sexual contacts
This activity may be a direct result of patient counselling which may include
motivating the patient to assume an active role in bringing contacts for evaluation and
treatment or it may be implemented as an active search for STD contacts by health
personnel. The appropriate management of STD patients must include the application of
full treatment regimens to all known contacts; particularly the regular sex partner
(husband/wife), in addition to the source of infection and those contacts at high risk of
having been infected.
2.2
Clinical services
The clinical services are usually provided at a clinic, hospital, private office,
health post, drugstore, or any other facility ensuring some privacy for the
*
patient-clinician encounter, It is within this context that most of the strategies
outlined above are implemented, Thus the clinician tries to provide adequate management
by:
a)
b)
c)
d)
e)
detecting or ruling out disease;
giving treatment, if necessary;
counselling the patient regarding disease prevention;
advising the patient on treatment compliance, and
ensuring that the patient’s contact(s) are evaluated and treated.
A In this document the term ’’clinician" will be used to designate any person
actually diagnosing and treating patients (i.e., health worker, pharmacist, midwife,
etc.) and not only physicians.
WHO/VDT/85.437
page 9
The clinician must realize that treatment of a case is only a part of proper STD
management and control. The identification and treatment of sexual contacts, which are
often asymptomatic, are important in limiting disease transmission in the community, and
in preventing reinfection and the development of complications.
Support components (see 5.)
2.3
In order to provide proper STD management, it is necessary to have support services:
2.3.1
Professional and technical training, to ensure that health personnel have the
necessary knowledge/skills and the proper attitude and behaviour to work in STD control.
2.3.2
Laboratory services - Laboratory support is a highly desirable objective for
improving both patient management and the quality of epidemiological data.
Unfortunately, these services are seldom available at the peripheral level.
2.3.3
Information systems - Information systems consist of the information flow
between the peripheral, intermediate and central levels and permit epidemiological
surveillance and the planning and evaluation of control activities. Adequate information
systems should include data gathering, collation, analysis and feedback.
Administration
2.4
An administrative system is necessary to support and supervise STD control activities
and strategies. A person or a cadre of persons with managerial and policy-making
abilities should be part of the STD control programme. These administrators need not be
STD specialists or even health workers and often will have responsibilities which extend
beyond STD control and include other PHC services (e.g., immunizations, oral care, family
planning). Some designated person must be administratively responsible for:
a)
b)
c)
planning, directing and organizing activities;
procuring and administering resources, including drugs and other supplies; and
evaluating the results of STD control activities.
Technical-scientific authority
2.5
Each country and/or region usually has individuals with knowledge and skills
necessary to establish a viable STD control programme. Unfortunately, this national or
regional expertise is often not recognized or used sufficiently by health authorities.
Whenever possible, these experts should be organized as a group representing the various
disciplines (i.e., microbiology, laboratory science, epidemiology, behavioural science,
clinical medicine, health administration, etc.) and institutions (i.e., academic and
professional organizations, Social Security Institutes, Army, Labour or private
organizations, etc.) necessary for STD control. In some countries, the formation of such
a group of experts, aided by community leaders and other ’'movers" from public and private
organizations, has resulted in the creation or improvement of a national "STD centre of
excellence" which then becomes the technical-scientific and policy-making focus for STD
control. This centre has the ability to:
a)
b)
c)
d)
e)
provide professional and technical training;
act as a reference laboratory;
conduct operational research activities (especially the very necessary
evaluation of appropriate diagnostic tests and treatments);
conduct epidemiological surveillance activities; and
guide supervision, evaluation and policy-making activities.
WHO/VDT/85.437
page 10
2.6
Integration of STD control at the PHC leve1
Categorical STD control programmes and special STD clinics are expensive and
effective but they reach only small segments of the population. Scarcity of categorical
resources and predicted worldwide increases in the sexually active population at risk
provide a fertile ground for STD dissemination; therefore, the deteriorating public
health problems posed by sexually transmitted diseases will have to be addressed within
the framework of the existing PHC services. The strategies and components for STD
control outlined above need not be implemented as a "special" or categorical programme.
However, the Group felt very strongly that a categorical technical-scientific and
supervisory focus should be maintained at the central level in all countries. Inserting
an STD control element into the activities of the PHC service is a difficult but
worthwhile task that will permit:
a)
b)
broadening the basis of STD control activities, and
increasing the contribution of the primary health care level to STD prevention
and control.
The first consideration for integration is the recognition that the problem can be
managed by non-specialists, if "categorical" multi-disciplinary expertise on STD control
is available to provide technical and scientific support to programme activities. The
second consideration is that this expertise should be translated into practical and
useful guidelines for simplified approaches for STD control at the primary health care
level, such as patient and contact management protocols.
3.
GENERAL PRINCIPLES FOR THE DESIGN OF STD MANAGEMENT PROTOCOLS
The management protocol is a flowchart outlining the actions that the clinician
should undertake to manage a patient’s problem according to the epidemiological,
clinical, and therapeutic information available.
3.1
Initial steps
Whenever possible, the person responsible for primary health care or STD control
should seek the assistance of two or more interested and capable professionals with
knowledge of STD including their clinical management to integrate a working group, to
provide technical information, and to help design and write the protocol(s).
3.2
Problem identification
The STD health problem(s) selected should have medical and public health importance
in terms of frequency of presentation, burden to health services, seriousness of
consequences (if undetected and untreated in time), and vulnerability to control (i.e.,
it should be amenable to successful medical intervention). The presenting symptoms and
signs (clinical syndrome) of the STD problem should be identifiable by paramedical
personnel without extensive clinical training and with minimal or no laboratory support.
3.3
Assessment of health care practices and policies in the community
It may be helpful to obtain data on current treatment, as well as local preferences
for ensuring patient compliance by asking practitioners how the genitourinary problem
selected is being managed locally. The characteristics of the community and health
system that may influence (negatively or positively) protocol implementation should be
considered at this stage (e.g.» acceptance of nonmedical personnel, utilization of local
clinics, ability to pay for medical services or supplies, etc.).
k
WHO/VDT/85.437
page 11
Definition of intended users of the protocols
3.4
It is also important to establish who will be the user of the protocols since the
amount of information and the complexity of the protocols may vary accordingly (e.g.,
between a general practitioner with access to laboratory tests in an urban setting and a
rural village worker in a remote community). Some countries may even want to make the
protocols available to _______
de facto "STD healers" (e.g.» drug vendors). This is not a
government endorsement of their activities but a realistic recognition of the fact that
they provide most STD care in a community, often inadequately.
Technical information on etiology, diagnosis and treatment
3.5
The working group should make the best possible educated guesses when no information
can be obtained or very little is known about the etiologies of common syndromes in a
certain geographic area. Ideally and as part of the design of the protocol(s), the
working group should review relevant information on STD morbidity when available (medical
literature, statistical data, hospital and outpatient records, etc.). In some instances
it will be necessary or desirable to conduct limited clinical microbiological studies to
further define the etiologies producing a certain syndrome as well as the response of
these organisms to various treatment regimens. When pertinent, the group should also
collect and review information on laboratory tests for diagnosis (sensitivity,
specificity, cost, etc.) and treatment (efficacy, cost, convenience, acceptability,
availability, antimicrobial resistance, etc.). Ad hoc operational research studies on
test evaluation and clinical trials (controlled and uncontrolled) may sometimes be
needed. Information from neighbouring countries and adjacent areas may occasionally
prove useful.
Protocol design
3.6
Before developing a protocol, a clear statement of the signs and symptoms which
constitute the syndrome under consideration ("case definition") should be made for
operational purposes (e.g. the clinical syndrome "urethritis" may be defined as urethral
discharge with or without dysuria and frequency). To be useful, a protocol should be:
a)
b)
c)
d)
e)
f)
g)
3.7
sensitive, i.e. correctly identify patients with a particular STD problem;
specific, i.e. identify those patients requiring other forms of management or
having other conditions;
feasible, i.e. be prone to implementation based on manpower and resources;
practical, i.e. follow the logic actions and procedures of the clinician who
will implement it;
cost-effective, i.e. obtain intended results at acceptable cost;
relevant, i.e. appropriate to the health problems, the setting, the patient and
the practitioner; and
adaptable, i.e. amenable to changes in setting and time. Ideally, patient
management protocols should be different for each level of competence and
designed in such a way that they are also helpful and acceptable to private
clinicians.
Testing of the protocol
Once the protocol is designed, it is highly desirable to test and evaluate its
performance in a small demonstration or pilot project before extending its implementation
to all PHC services. Many times, changes in design and corrections in recommended
treatment regimens will be done at this stage. It is important to remember that the
local disease patterns and resources may vary widely and sometimes will require different
area-specific management protocols within the same country. In other cases, similarities
between countries may permit the design and implementation of protocols which are equally
effective over a wide area.
WHO/VDT/85.437
page 12
4.
STD MANAGEMENT PROTOCOLS AT THE PHC LEVEL
The following section deals with some of the more common and easily distinguishable
STD-associated clinical syndromes seen at the PHC level and gives examples of protocols
for adaptation to the local circumstances. The health problems addressed are:
Urethral discharge (4.1)
Vaginal discharge (4.2)
Pelvic inflammatory disease (4.3)
Genital ulcer (4.4)
Bubo (4.5)
Balanitis (4.6)
Ophthalmia neonatorum (conjunctivitis of the newborn) (4.7)
Swollen scrotum (4.8)
Suspected STD (4.9).
These syndromes can be further refined by the use of simple microscopic tests
(Annex 4) which could also allow the application of more specific and less costly
treatment sequences.
4.1
Urethral Discharge
4.1.1
Definition.
Presence of secretion in the anterior urethra, sometimes accompanied by dysuria or
urethral discomfort.
4.1.2
Background information
Importance. Urethral discharge is the most common presenting complaint of STD in
male patients. Untreated urethritis may lead to complications, such as epididymitis, male
infertility and urethral stricture.
Etiology. In males with history of sexual exposure, urethral discharge is usually
produced by Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum, and
rarely, by other STD agents (e.g. T. vaginalis). For practical purposes STD-related
urethritis is subdivided into gonococcal urethritis, produced by N. gonorrhoeae and
nongonococcal urethritis (NGU), which is usually caused by C. trachomatis or
U. urealyticum. Non-infectious traumatic urethritis caused by excessive manipulation of
the penis may be seen in some patients.
In primary health care settings in developing countries, the vast majority of
urethritis is caused by gonococci; some of these patients also have a concomitant
infection by C. trachomatis. Nongonococcal urethritis is the form found most frequently
in industrialized countries and in pretreated urethritis patients in developing
countries. 0. trachomatis can be isolated in approximately 50% of males with
nongonococcal urethritis and in up to 1/3 of patients with concomitant gonococcal
infections. Chlamydial infection is therefore the most common cause of urethral
discharge in those settings.
Treatment. The choice of an appropriate regimen is crucial (see Annex 3). In
countries where gonococci are still sensitive to tetracyclines and erythromycin, the NGU
treatment schedules for chlamydial infections are effective in also curing gonorrhoea.
Owing to varying resistance patterns, the choice of an appropriate treatment for
gonorrhoea may be difficult. National or local health authorities need to consider the
following before recommending any therapeutic regimen:.
prevalence of beta-lactamase producing gonococci in the area and the level of
chromosomal sensitivity to penicillin and other antimicrobials.
WHO/VDT/85.437
page 13
recommendations by WHO scientific groups and other institutions, Recommendations
from neighbouring countries or regions should also be considered,
results of local clinical trials with recommended schedules.
Recommendations for the treatment of uncomplicated urogenital gonococcal infections
are given in Annex 3. In general, a single dose regimen is preferred at PHC level.
4.1.3
Subjective complaints
Most patients complain of "pus dripping from penis", and/or "burning or pain on
urination".
4.1.4
Objective findings
______________
In uncircumcised males it is important to check that the
Physical examination.
secretion is coming from the urethral meatus and not from the glans (e.g. in balanitis
(4.6), genital ulcer (4.4), or phimosis). The discharge may range from "abundant and
purulent" to “scarce and mucoid". It may be necessary to "milk" the urethra in order to
see the discharge.
Laboratory tests. Microscopic examination of a smear of urethral discharge stained
with methylene blue (MB) or Gram stain (Annex 4) can be used immediately to detect
gonococcal urethritis (characteristic intracellular diplococci) or NGU (pus cells without
intracellular diplococci). If properly performed, the sensitivity and specificity of the
Gram or MB stain are above 95% for gonococcal urethritis. Patients with concomitant
gonococcal and chlamydial infections will not be identified by this method.
In some PHC settings, cultures for isolation of N, gonorrhoeae are available but the
result of this test will not be known for two or more days and is, therefore, not helpful
in guiding the initial management decision. Cultures are, however, important when
isolation of the gonococcus is required (e.g. screening for beta-lactamase production, or
antimicrobial susceptibility at a reference laboratory).
Cultures for C. trachomatis, U. urealyticum, and other STD agents are usually not
available at the PHC level, but, when available, will not aid in the initial decision to
treat the patient.
Newer non-culture tests for C trachomatis (e.g. ELISA, monoclonal antibody) and for
N, gonorrhoeae (e.g. ELISA, transformation test) are being evaluated, These technologies
are still expensive and insufficiently tested for widespread application.
4.1.5
Noteworthy information
Gonococcal urethritis tends to produce more severe symptoms and has a shorter
incubation period (2-3 days) than NGU (around one week). Consequently, some clinicians
in high gonococcal prevalence areas rely on the characteristics of the urethral discharge
to differentiate between gonorrhoea (abundant, purulent secretion) and NGU (scanty
secretion, usually mucoid or serous). However, these physical signs are not sufficiently
discriminatory to predict the etiology of the urethral discharge in a given patient. The
clinician must be aware of the possibility of concomitant (gonococcal and chlamydial)
infection in the patient, and of the presence of resistant gonococcal strains (e.g. PPNG)
in the community.
4.1.6
Management plan
Sexual contacts should be treated with full treatment regimens, the same as the
patient. In a male with urethral discharge in the absence of laboratory support,
PROTOCOL 1A or IB should be used. If microscopy is available to examine a stained smear
of the urethral discharge, the management protocol can be made more specific (PROTOCOL 2).
WHO/VDT/85.437
page 14
PROTOCOL 1
(Urethral Discharge)
A. In settings in which urethral discharge is mainly due to gonococcal infection (e.g.
above 80%)
Urethral Discharge
Gonorrhoea treatment
(also to contacts)
follow-up between 3 and 7 days
cure
Urethral discharge persists
NGU treatment (also to contacts)
follow-up after 7 days
cure
Urethral discharge persists
Refer
If a urethral discharge is seen on clinical examination, the standard gonorrhoea
regimen is administered. The patient is instructed to return between 3 and 7 days after
the gonorrhoea treatment if he still has symptoms. If upon return a urethral discharge
can be verified, the standard NGU (chlamydia) regimen is administered. If the urethral
discharge still persists 7 days after completion of treatment, the patient should be
referred to a higher level.
WHO/VDT/85.437
page 15
B.
In settings in which urethral discharge is due to gonococcal infection in less than
80%.
Urethral Discharge
Gonorrhoea and NGU treatment
(also to contacts)
Follow-up after 7 days
Cure
Urethral discharge persists
Refer
If a urethral discharge is seen on clinical examination, both the standard gonorrhoea
plus the standard NGU regimen are administered. (In areas where tetracyclines or
erythromycin are appropriate for treatment of gonorrhoea, only one regimen needs to be
used for both gonorrhoea and NGU). The patient is instructed to return 7 days after
completion of treatment if not cured. If the urethral discharge still persists, the
patient has to be referred to a higher level
WHO/VDT/85.437
page 16
In a male with urethral discharge when microscopic examination is available,
use PROTOCOL 2.
PROTOCOL 2 (Urethral Discharge)
Urethral Discharge
Methylene Blue (MB) or Gram Stain (GS)
I
I
Intracellular
diplococci (ICDC)
Polymorphonuclear
leukocytes (PMN’S)
No ICDC
No PMN's
Gonorrhoea treatment
(also to contacts)
NGU treatment
(also to contacts)
No drug treatment.
Advise to return for
re-evaluation if
"discharge" persists
follow-up between 3-7 days
Follow-up after 7 days
cure
cure
UD persists
r
NGU treatment
(also to contacts)
V
Urethral discharge persists
Refer
follow-up at 7 days
I ~~ I
cure
Urethral discharge persists
Refer
If a urethral discharge is seen on physical examination a smear of the
discharge should be examined after staining with methylene blue or Gram stain.
Based on results of the smear three possibilities exist:
Intracellular diplococci (ICDC) are seen; the patient is given standard
gonorrhoea treatment and followed-up if not cured.
No intracellular diplococci are seen but polymorphonuclear leucocytes are
present; the patient is given NGU standard treatment and followed-up if not
cured.
No polymorphonuclear leucocytes are seen on the smear; no drug treatment is
given and the patient is asked to return for re-evaluation if the discharge
persists.
WHO/VDT/85.437
page 17
4.2
Vaginal Discharge
4.2.1
Definition
STD-related vaginal discharge is defined as a change in colour, odour and/or an
increase in the amount of vaginal secretion attributable to vaginal or cervical
infection. Vaginal discharge may be accompanied by pruritus, genital swelling, dysuria,
or lower abdominal or back pain (see also pelvic inflammatory disease, 4.3).
4.2.2
Background information
Importance. Vaginal discharge is probably the most common gynaecological complaint.
In addition to patient discomfort, a vaginal discharge may indicate the presence of STD
or other problem which may lead to serious consequences (e.g. PID, see 4.3).
Etiology. The main infectious causes of a STD-related discharge are N. gonorrhoeae,
iC. trachomatis, and Herpes simplex virus for cervicitis, and T, vaginalis, C, albicans,
and a combination of Gardnerella vaginalis and anaerobes ("bacterial vaginosis") for
vaginitis.
In most countries the prevalence of trichomonas and Candida infections are very
similar (30-40% of women seeking care), but the prevalence of gonorrhoea and chlamydial
infection vary according to the setting. As in the case of urethritis in males,
concomitant infection by N. gonorrhoeae and C. trachomatis occurs commonly (1/2 of cases
in some series).
Treatment. Considerations for selecting treatment include pregnancy status, patient
discomfort, and the most likely etiology. The regular sex partner should be included in
the management of all cases except in candidiasis and bacterial vaginosis. Suspicion of
gonococcal or chlamydial etiologies warrant immediate treatment of the patient and her
contact.
4.2.3
Subjective complaints
The individual patient’s and the community’s perception of what constitutes "vaginal
discharge" may also vary. In general, most women with this syndrome will complain of
soiling of undergarments, excess of secretion, change in colour and/or odour, itching,
dysuria, dyspareunia, redness of vulva, and sometimes lower abdominal pain (see 4.3).
Pregnancy should be checked for by asking the patient about the presence or absence of
menses.
4.2.4
Objective findings
Clinical examination. A proper gynaecological examination may not be possible when
facilities (table, gloves, speculum, etc.) are not available or when the patient refuses
to be examined or for cultural or religious reasons. In those cases the patient’s
complaints may be the only basis for management (see PROTOCOL 1).
If a clinical examination can be done the following situations may arise:
A.
Table for examination, but no gloves or speculum. Some clinical manoeuvres
should be undertaken including inspection of vulva and introitus looking for
discharge, skin aspect, erosions, presence of ulcer (if ulcer is present, see
4.4, genital ulcer) and palpation of the lower abdomen. If palpation is
painful, refer to 4.3, pelvic inflammatory disease.
WHO/VDT/85.437
page 18
B.
Table and speculum, but no gloves. Inspection of genitalia and palpation of
lower abdomen are possible. After introducing the speculum, the aspect of the
cervix, the characteristics of the discharge and the apparent origin of the
secretion (vaginal, endocervical) may provide some helpful information for
management•
C.
Table and gloves, but no speculum. Inspection of vulva will be possible and a
bimanual pelvic examination may aid in ruling out pregnancy, If mobilization of
cervix elicits pain (see 4.3 pelvic inflammatory disease).
D.
Table, speculum, and gloves. All three clinical manoeuvres; inspection of
vulva, visualisation of cervical orifice and discharge using the speculum, and
bimanual examination should be done.
Laboratory tests. Although desirable, culture facilities are usually not available
at PHC level. In some facilities microscope, a wetmount examination for trichomoniasis
and candidiasis, and "vaginosis" (KOH test, ratio of pus cells to epithelial cells and
presence of "clue" cells) may be useful (see Annex 4). If planning to use Gram stain for
diagnosis, the quality and validity of this method should be tested under local
circumstances. In general, the Gram stain procedure for gonococcal infection is not a
helpful diagnostic method in female patients.
4.2.5
Noteworthy information
Some vaginal discharges due to gonococcal or chlamydial infection, if left untreated,
can lead to pelvic inflammatory diseases, infertility and other complications (e.g.,
chronic pain, ectopic pregnancy). If patient has lower abdominal pain, refer to PID
protocol (4.3). Occasionally, information of a recent STD problem in the male partner
may be available and may aid in patient management (e.g. patient is a contact of a
urethritis case).
Pregnant women should not receive tetracycline; infants born to women with untreated
gonorrhoea or chlamydial infection may develop ophthalmia neonatorum if no eye
prophylaxis was given at birth (see 4.7).
4.2.6
Management plan
Always investigate if the patient is the contact of a known case (e.g., a male with
urethritis), and use this information to guide the management of the suspected STD (see
4.9).
Depending on the information available, the following protocols are suggested:
WHO/VDT/85.437
page 19
PROTOCOL 1 (no clinical examination nor
laboratory tests can be done)
Vaginal discharge with no lower abdominal pain
Trichomoniasis treatment* to patient and contacts (add gonorrhoea treatment if pre
valence is thought to exceed 5-10%
in female patients with vaginal
discharge)
follow-up after 7 days
Discharge persists
Candidiasis treatment only to patient (plus gonorrhoeae treatment of patient
and contacts, if not given previously)
follow-up after 7 days
Discharge persists
Refer
* This treatment is also efficacious for most patients with bacterial
vaginosis
WHO/VDT/85.437
page 20
PR0T0C01 2 (Clinical examination with visualization of cervix
but no microscopy)
If vaginal discharge is accompanied by lower abdominal pain or pain on mobilization
of cervix, use pelvic inflammatory disease protocol (4.3,).
Vaginal Discharge
Frothy, malodorous,
fishy smell
White, curdlike
Trichomoniasis treatment*
(also to contacts)
Candidiasis treatment
(only patient)
Discharge coming from the cervix
or other vaginal discharges
Follow urethral discharge
PROTOCOLS 1A or IB
follow-up after 7 days
Discharge persists
Trichomoniasis treatment
(also to contacts)
Follow-up after 7 days
Chlamydial and gonorrhoea treatment
(also to contacts)
Follow-up after 7 days
Symptoms persist
Refer
*
This treatment is also efficacious for most patients with bacterial vaginosis
WHO/VDT/85.437
page 21
PROTOCOL 3 (Clinical examination and microscopy - wet mount - done)
Vaginal Discharge
Yeast positive,
Trichomonas negative
Trichomonas positive
and/or clue cells
Trichomonas negative,
Yeast negative
Candidiasis treatment
(only patient)
Trichomonas treatment*
(also to contacts)
Follow urethral
discharge PROTOCOL
1A or IB
Add gonorrhoeae treatment if prevalence
is thought to exceed 5-10% in patients
with this syndrome
follow-up after 7 days
Symptoms persist, vaginal discharge,
trichomonas and yeast negative
Chlamydia treatment
(and gonorrhoea if not treated before)
(also to contacts)
follow-up after 7 days
Symptoms persist, trichomonas negative, yeast negative
Refer
* Clue cells without polymorphonuclear leukocytes in the absence of
trichomonas suggest bacterial vaginosis which requires no partner treatment
WHO/VDT/85.437
page 22
4.3
Pelvic Inflammatory Disease (PIP)
4.3.1
Definition
Pelvic inflammatory disease is a general name for pelvic infections in women (e.g.,
salpingitis, endometritis, parametritis, oophoritis, pelvic peritonitis) caused by
microorganisms which generally ascend from the lower genital tract and invade the
endometrium, the Fallopian tubes, the ovaries and the peritoneum.
4.3.2
Background information
Importance. STD-related pelvic infections are a major cause of infertility,
recurrent infection, ectopic pregnancy, and chronic pain. PID is a common reason for
admission to gynaecological wards and emergency rooms. Complications, such as
tubo-ovarian abscess, require major surgical procedures and may cause death. Common STD
pathogens producing PID are N. gonorrhoeae, C. trachomatis, and perhaps M. hominis.
Facultative and strictly anaerobic bacteria are also found frequently, especially in
clinically severe, suppurative infections. In addition to STD-related PID, post-partum
and post-abortion ascending infections also occur and are usually related to lack of
hygiene and poor obstetrical care. The presence of intrauterine devices favours the
development of PID, particularly in the month following insertion.
4.3.3
Subjective complaints
Mild to severe lower abdominal pain (LAP), which usually worsens before menses and
which is sometimes associated with fever and/or symptoms discussed under vaginal
discharge (see 4.2), should make the clinician suspicious of PID. Inquire about any
previous attacks of this condition and rule out pregnancy and abortion.
4.3.4
Objective findings
Physical examination.
a)
b)
c)
d)
e)
f)
g)
Should exclude medical-surgical emergencies.
Check for:
Suprapubic tenderness
Vaginal discharge (see 4.2)
Ulceration (also in ext. genitalia) (see 4.4)
Presence of IUD
Open cervix, tissue seen or felt (abortion)
Bimanual examination for unilateral and bilateral adnexal tenderness
Temperature 38°C.
Physical examination should also include the inspection of the external genitalia for
ulcerations (see 4.4).
Laboratory tests. Direct microscopy (wet mount) of a vaginal specimen: Presence of
pus cells outnumbering epithelial cells suggests lower genital tract infection.
4.3.5
Noteworthy information
If lower abdominal pain is present surgical emergencies (gastro-intestinal,
abdominal, appendicitis, obstetrical, gynaecological, such as extra-uterine pregnancy,
etc.) and complications of puerperium should be ruled out. A diagnosis of PID should
lead to antibiotic treatment of patient and partners of at least 10 days duration. Lower
genital tract infections (cervicitis included) require antibiotic treatment of patient
and contacts for 7 days.
4.3.6
Management plan
Depending on the clinical facility and the ability to examine the patient, the
following PID protocols are suggested:
WHO/VDT/85.437
page 23
PROTOCOL 1 (Only interrogation and external
palpation of patient are possible)
Lower Abdominal pain
Abdominal tenderness
with guarding or rebound
tenderness
>► yes
► Refer to where facilities
for surgery exist
No
Last menstrual period overdue
yes
Refer
No
Fever^38°C
■►yes
► Treat patient and partner with
single dose for gonorrhoea
and tetracycline plus
metronidazole* for 10 days
No
Symptoms persist
Refer
Vaginal discharge, dysuria
yes
► Treat patient and partner with
single dose for gonorrhoea
plus tetracycline for 10 days
and single dose regimen
for trichomoniasis
No
Symptoms persist
after 7 days
Advise patient to return
for re-evaluation, if the pain
persists
*
Metronidazole not required for contact treatment
Refer
WHO/VDT/85.437
page 24
PROTOCOL 2 (When gynecological examination is done)
Lower Abdominal Pain (without bowel symptoms (diarrhoea) or urinary symptoms)
Abdominal.tenderness + guarding
yes
Refer
yes
Refer
No
Last menstrual period overdue
No
t
Recent pregnancy or abortion -
^►yes
Treat, if feasible,
by evacuation/
curettage
■►yes
Treat patient and partner
with single dose for
gonorrhoea plus tetracycline
for 10 days. Consider removing
IUD (see Annex 3)
► Otherwise
refer
No
♦
Intrauterine device (IUD)
Fever 38°C
yes
► Treat patient and partner
with single dose for gonor
rhoea plus tetracyline
for 10 days
No
t
Painful pelvic examination
(uterine mobilisation)
>yes
Treat patient and partner with
single dose for gonorrhoea
and tetracycline plus metro
nidazole* for 10 days
If symptoms persist —► Refer
No
i
Pelvic mass ----
f
yes
Refer
No
t
Vaginal discharge
► yes
► Follow vaginal discharge
PROTOCOL
No
i
Advise patient to return for
re-evaluation, if the pain persists
* Metronidazole not required for contact treatment
WHO/VDT/85.437
page 25
4.4.
Genital Ulcer
4.4.1
Definition
Loss of continuity of skin producing one or more ulcerative lesions in the
genitalia. Genital ulcers may be painful or painless and are frequently accompanied by
inguinal lymphadenopathy.
4.4.2
Background information
Importance. Genital ulcerations are a common cause of consultation in tropical
countries. Depending on etiology, this syndrome may cause serious complications (i.e.
late symptomatic syphilis, mutilating lesions of the genitalia, etc.).
Etiology. Common STD agents producing genital ulcers are Treponema pallidum,
Haemophilus ducreyi, Calymmatobacterium granulomatis, C. trachomatis (serovars LI - L3),
and herpes simplex viruses. Ulcers due to trauma can become secondarily infected by
other bacteria.
The relative frequency of the different STD agents causing genital ulcers varies
according to the setting. In studies in East and Southern Africa H. ducreyi infection
(chancroid) accounted for 40-60% of all cases; T. pallidum (syphilis) for 9-17%;
C. trachomatis (LGV) for 0-12%; and herpes simplex viruses for 4-11%, and donovanosis for
0-1%. In Thailand, chancroid outnumbers syphilis (30:1) as a cause of genital ulcer
disease. STDs which are frequently accompanied by buboes include syphilis, chancroid,
lymphogranuloma venereum and genital herpes.
Treatment.
Annex 3.
4.4.3
Treatment schedules for diseases causing genital ulcer(s) are given in
Subjective complaints.
Patients usually complain of a sore or sores of the genitalia, Uncircumcised males
may complain of penile discharge or inability to retract the prepuce, Females may
complain of a burning sensation on urination if ulcers are situated in the vulva.
4.4.4
Objective findings
Physical
______________
examination, The number and characteristics of the lesions should be
noted, Examination of females may be difficult to perform in some settings but should be
done whenever possible. Presence of inguinal lymphadenopathy (bubo) should be noted.
Laboratory tests. Generally, diagnostic tests for this syndrome are not useful for
initial treatment decision at the peripheral level. When available, Giemsa stain for
C. granulomatis (donovanosis), darkfield microscopy for syphilis, serological tests for
syphilis (STS), or cultures (H. ducreyi) may provide additional information which may
lead to a more disease-specific treatment approach at the initial or follow-up visit.
4.4.5
Noteworthy information
Painless, indurated lesions are attributed to syphilis (wear gloves for palpation);
painful, easily bleeding sores are attributed to chancroid; the presence of vesicular
lesions or superficial erosions indicates probable herpetic infection. However, genital
ulcers often do not correspond to textbook descriptions and in areas where chancroid and
syphilis are frequent etiologies of genital ulcers, the clinical diagnosis is not
sufficiently discriminatory. Since double infections are not uncommon, the initial
management could be directed at both diseases. Crucial for the development of management
instructions is to know the importance of each etiology in the genital ulcer problem in
the area.
WHO/VDT/85.437
page 26
4.4.6
Management plan
Management is based on the clinical examination and should always include sexual
partners who must receive the same treatment as the index case.
In areas where laboratory support is not available, the following protocol is proposed
If no genital ulcer is seen but vesicular lesions are present, the patient is advised to
keep the lesions clean and dry. If a genital ulcer is present, treatment for syphilis as
well as chancroid are given at the initial visit. If no improvement is noted at
follow-up, the patient is referred.
PROTOCOL (Genital Ulcer)
A.
Without laboratory facilities
Vesicular lesions
only
Genital Ulcer
HSV management
Syphilis and chancroid
treatment (also to contact)
follow-up after 7 days
Stable or worse
Improved
Refer
B.
With laboratory facilities
If darkfield microscopy is available at the initial visit and the examination is
positive, treat for syphilis; if the examination is negative, treat for chancroid.
Note on buboes
A bubo is frequently associated with the genital ulcer(s) and although the ulcer
heals under treatment, the bubo can progress to fluctuation and rupture. Fluctuant
buboes should be aspirated through healthy adjacent normal skin (should not be incised
for drainage).
WHO/VDT/85.437
page 27
4.5
Bubo
4.5.1
Definition
Bubo is an enlargement of lymph glands in the groin area.
4.5.2
Background information
Importance. A bubo as the sole manifestation of an STD is not frequent,
cases the bubo is combined with genital ulcer (see 4.4).
In most
Etiology. Patients with lymphogranuloma venereum caused by Chlamydia trachomatis
(serovars L1-L3) often present with a bubo and without any genital ulcer, In other STDs,
the bubo is nearly always accompanied by ulcerative lesions. Other infections can
produce inguinal adenopathy (e.g., infection of lower limbs).
4.5.3
Subjective complaints
The patient consults for pain and swelling in the groin. The bubo can be painless.
It is important to know the duration of the problem, and a history of preceding genital
ulceration.
4.5.4
Objective findings
The prepuce should be retracted to detect ulcers, The bubo can be unilateral or
bilateral. The palpation reveals pain or fluctuation.
4.5.5
Noteworthy information
Management of patients with buboes is important because inadequate treatment can lead
to rupture with chronic fistulization, scarring, etc.
4.5.6
Management plan
PROTOCOL, If genital ulcers are present, the genital ulcer protocol (see 4.4) must
be applied. In a patient with inguinal bubo without accompanying genital ulcer, give
tetracycline hydrochloride 500 mg x 4 daily for 2 weeks. Fluctuating buboes require
aspiration. If the bubo persists, the patient has to be referred to the next higher
level. The same treatment should be applied to sexual partners.
4.6 Balanitis and balanoposthitis
4.6.1
Definition
Inflammation of the glans (balanitis) and/or the prepuce (posthitis) of the penis may
occur simultaneously. A mild to profuse superficial secretion may be present and should
be distinguished from urethral discharge (see 4.1) by direct inspection.
4.6.2
Background information
Importance. An uncommon cause of consultation which can, however, produce
considerable discomfort (irritation, itching, etc.).
Etiology: Lack of good hygiene is a predisposing factor especially in uncircumcised
males. Micro-organisms commonly causing balanitis are staphylococcus, streptococcus, and
Candida albicans. In most cases the partner shows no subjective nor objective signs of
infection but some contacts may have Candida lesions in the genitalia or pathological
vaginal discharge.
WHO/VDT/85.437
page 28
4.6.3
Subjective complaints
The patient usually complains of "swollen member", itching at the glans penis,
discharge or phimosis.
4.6.4
Objective findings
Physical examination, Redness of the glans and the penis; erosions and sometimes
white secretions. The skin may show desquamation and erythema.
Laboratory tests. Wet mount with KOH will show fungal pseudohyphae or spores between
epithelial cells in cases of candidiasis.
4.6.5
Noteworthy information
The most common cause of severe balanitis is Candida albicans, Some pathological
conditions predispose to candidiasis, for example, diabetes, Spread of infection from a
female partner is common.
4.6.6
Management plan
Clinical examination and laboratory findings (when available) will guide treatment.
If ulcers are present refer to genital ulcer PROTOCOL (see 4.4)
WHO/VDT/85.437
page 29
PROTOCOL (Balanitis)
Itching, discharge on glans penis
Prepuce retractable
No
■►Use genital ulcer PROTOCOL
(see 4.4)
Yes
Ulcer present
Discharge from urethra
Use urethral discharge PROTOCOL
(see 4.1)
Erythema, erosions, but no ulcers
Local hygiene; painting of area with
aqueous solution of Gentian violet 0.5%,
or application of nystatin ointment
(when available)
(Treat female partner for candidiasis)
WHO/VDT/85.437
page 30
4.7 Ophthalmia neonatorum
4.7.1
Definition
Infection with discharge from the conjunctivae of the newborn (in one or both eyes)
in the first month of life.
4.7.2
Background information
Importance.Ophthalmia neonatorum can lead to blindness especially when caused by
_____
gonococcal infection.
Etiology.
Sexually transmitted micro-organisms to be considered as common causes of
ophthalmia neonatorum are N. gonorrhoeae and C. trachomatis. Other common causes of
ophthalmia neonatorum include Staphylococcus aureus, Streptococcus pneumoniae,
Haemophilus sp. and Pseudomonas spp. Except for the latter, they usually do not endanger
sight•
If silver nitrate 1% eye drops have been instilled at birth as a prophylaxis against
ophthalmia neonatorum, a chemical conjunctivitis frequently develops within 24 hours. It
subsides without treatment. The relative frequency of gonococcal and non-gonococcal
ophthalmia neonatorum depends on the prevalence of the infection in pregnant women and on
the eventual use of eye prophylaxis.
In developed countries, C. trachomatis is a more frequent cause of ophthalmia
neonatorum than N. gonorrhoeae:
1Z to 15Z of cases coming for care are caused by
N. gonorrhoeae and 25Z to 50Z by C, trachomatis. The remaining 35-65Z are due to other
causes or are of unknown cause. In developing countries, N. gonorrhoeae still accounts
for about 20Z to 75Z of cases, and 0. trachomatis causes 15Z to 35Z.
Epidemiology. In developing countries in Africa, the incidence of gonococcal
ophthalmia neonatorum is estimated between 5 and 50 per 1000 live births; incidence of
chlamydial neonatal conjunctivitis is probably comparable. In developed countries,
incidence rates for gonococcal ophthalmia neonatorum range between 0.1 and 0.6 per 1000
live births and between 5 and 60 for chlamydial neonatal conjunctivitis. If the mother
is infected at birth the risk of transmission of infection from her cervix to the eyes of
the neonate is approximately 30Z for N. gonorrhoeae and for C. trachomatis.
4.7.3
Subjective complaints
The mother presents her newborn baby because of redness and swelling of palpebrae or
"sticky eyes", or because of purulent discharge from the eye(s).
4.7.4
a)
b)
c)
d)
Objective findings
Discharge which may be purulent;
Redness and swelling of conjunctivae;
Oedema and redness of palpebrae;
One eye or both eyes affected.
Laboratory. Gram stain or methylene blue stain for intracellular diplococci. A
_________
Giemsa stain of conjunctival epithelial cells allows the recognition of
intra-cytoplasmtic inclusions of C. trachomatis, but this is a difficult technique to be
applied at PHC level. Other laboratory tests are discussed in the laboratory section of
this report (see Annex 4).
WHO/VDT/85.437
page 31
4.7.5
Noteworthy information
The more severe the conjunctivitis, especially if symptoms of ophthalmia neonatorum
develop in the first week of life, the higher the probability that the ophthalmia
neonatorum is gonococcal and that it may produce complications.
The conjunctivitis is also a marker of a more generalized neonatal infection,* for
this reason, systemic treatment should be combined with topical treatment. In cases of
gonococcal ophthalmia neonatorum, the gonococcus can be recovered from the nasopharynx or
the rectum of the newborn in 25-50% of cases. Transmission of C. trachomatis at birth
can produce not only chlamydial neonatal conjunctivitis but also acute respiratory
infection in an infant of 1 to 3 months of age.
4.7.6
Management plan
If only clinical assessment is possible, all ophthalmia neonatorum should be managed
as gonococcal (apply PROTOCOL 1). If a stained smear (methylene blue, Gram) is
performed, the ophthalmia neonatorum can be classified as gonococcal or nongonococcal
based on the result (PROTOCOL 2). The mother and her regular sex partner(s) should also
be treated with standard regimens, Even if the ophthalmia neonatorum is unilateral, both
eyes should be treated.
PROTOCOL 1
Wipe the eyes with a clean cloth and saline or cooled, boiled water
plus
tetracycline ointment 1% on the conjunctivae every hour for 24 hours, afterwards 4 to
8 times a day for ten days,
plus
a systemic antibiotic: cefotaxime 100 mg/kg single dose im
or
kanamycin A 25 mg/kg single dose im
in areas of low prevalence of PPNG, penicillin still can be used:
aqueous crystalline penicillin G, 50.000 units/kg im per day, divided in 2 doses,
during 3 days.
If no improvement is noted after 2 full days of systemic treatment
REFER.
PROTOCOL 2
stain of conjunctival pus
Intracellular
diplococci (ICDC)
I
Tetracycline 1% ointment
for 10 days
plus
Cefotaxime 100 mg/kg in single dose
or
Kanamycin 25 mg/kg in single dose
or
in low PPNG prevalence areas, crystalline
penicillin G 50.000 U/kg daily
in 2 injections for 3 days
Polymorphonuclear
leukocytes. No ICDC
♦
Tetracycline 1% ointment
for 10 days
plus
Erythromycin syrup
50 mg/kg/day divided in
2 doses for 14 days by mouth
WHO/VDT/85.437
page 32
Management of mother.
Treat for gonorrhoea and/or chlamydial (NGU) infection.
Management of father.
Treat as urethritis, even if asymptomatic.
Prophylaxis of ophthalmia neonatorum at PHO level. A policy of neonatal eye
prophylaxis should be implemented at PHO level: cleaning of the eyes immediately after
birth plus instillation of 1% silver nitrate eye drops or 1% tetracycline ointment.
4.8
Swollen scrotum
4.8.1
Definition
Increase in volume of the scrotal sac, accompanied by oedema and erythema, sometimes
associated with pain, urethral discharge or urinary tract symptoms (e.g. frequency,
dysuria).
4.8.2
Background information
Importance, STD-related epididymitis and orchitis not treated appropriately may lead
to infertility, Acute onset of unilateral swollen scrotum may be due to trauma or
testicular torsion requiring immediate referral.
Causative sexually transmitted agents are C. trachomatis, N, gonorrhoeae,
Etiology.
and very rarely T. pallidum. M. tuberculosis is relatively frequent in some developing
countries; Brucella spp. and S. pneumoniae are rare causes. Gram-negative bacilli
(especially of the family of Enterobacteriaceae and Pseudomonas aeruginosa) are common
causes of this syndrome in patients with complicated urinary tract infections. Mumps
virus is an etiological agent in postpuberal males. All these agents produce infection
of the epididymis (epididymitis) or the testis (orchitis). A swollen scrotum can also be
due to the torsion of a testicle in young males or trauma, testicular tumor, vascular
abnormality, or inguinal hernia, which are important etiologies to rule out in all
patients. Epididymitis is almost always unilateral and usually relatively acute in onset.
Epididymitis is a rather common disease (634 000 cases in 1977 in the US), although
prevalence figures from most countries are not available.
4.8.3
Subjective complaints
The patient presents with a painful or painless swollen scrotum. In the STD-related
syndrome (epididymitis) a recent history of urethral discharge can be elicited or
urethral discharge can be seen on physical examination. Sudden onset chronicity, trauma,
characteristics of the pain or history of recurrent urinary tract infection may help
pinpoint other etiologies in some cases (e.g. tuberculosis, cancer, testicular torsion,
etc.) •
4.8.4
Objective findings
This disease is usually unilateral. The scrotum may appear
Physical examination.
red and oedematous and is tender to palpation. Evidence of urethral discharge should be
sought.
Laboratory tests. When feasible the study of urinary sediment of first voided urine
for white blood cells (WBC’s) and bacteria, may be helpful to identify a subacute
urethritis.
WHO/VDT/85.437
page 33
4.8.5
Noteworthy information
The most important concern is to rule out and refer immediately surgical emergencies
and severe cases. Sudden onset and rapid progression of unilateral scrotal swelling in a
young patient may be indicative of testicular torsion requiring specialized care.
4.8.6
Management plan
Epididymitis should be managed with antibiotics, symptomatic treatment, and
supportive measures. Because of the high frequency of underlying urethral infection,
urethral discharge treatment is indicated (see 4.1).
PROTOCOL (Swollen scrotum, no laboratory)
Swollen scrotum
No
Refer immediately
Yes
No
Urethral
discharge
Urethral
discharge
Yes
Give urethral discharge
treatment to patient and
contacts for gonorrhoeae
(single .dose) plus tetracy
cline for 10 days. Scrotal
elevation, cold compresses
and bed rest should also be
prescribed
If no improvement occurs
in three days,
I
Refer
No
Refer at later
date (as non
emergency)
’v
A
WHO/VDT/85.437
page 34
4.9
'■
\
Suspected Sexually transmitted disease
Often patients may seek advice as they believe to have been exposed to a
sexually transmitted disease.
PROTOCOL (suspected STD)
Is patient a contact of a
known ’’STD’’ case? —-
Treat as case
■►Yes
No
Symptoms of STD or
STD-related findings
on physical examination
Yes
Use appropriate protocol
No
Laboratory support
available
Yes
► Use appropriate test(s)
(VDRL, culture, smear)
No
Advise patient to return if
having symptoms; reassurance
WHO/VDT/85.437
page 35
5.
THE IMPLEMENTATION OF STD MANAGEMENT PROTOCOLS
Protocol implementation includes: a) training or retraining of health care
providers; b) ensuring availability of resources (personnel, drugs and other supplies);
c) gathering data to assess protocol effectiveness and to allow modification or
adaptation when necessary.
5.1
The setting
The protocol should bes as specific as possible to the setting where it will be
used. This is not to say that a "borrowed"
"borrowed” protocol from another country is useless. In
settings with similar epidemiological, cultural and health system characteristics (e.g.,
some East African neighbouring countries), a patient management protocol designed for one
country may assist in providing appropriate management in another. The key words are
adaptation, based on local capabilities and circumstances, and evaluation of its
effectiveness under field conditions (see 6.).
5.2
The clinician
Depending on the area, the health worker implementing a patient management protocol
may be a physician with several years of formal training or a village health assistant
who can only read and write. In either case, the clinician is the most important
component for successful protocol implementation and should become the starting point of
the health information system (see 5.4).
One person should be responsible for "carrying the patient through the protocol".
In other words, the clinician charged with implementing the protocol should ensure that
the observations and actions required by the protocol are accomplished. It is likely
that in most settings the clinician implementing STD management protocols will also
perform other tasks and functions, including the application of non—STD protocols. The
responsibilities and functions that the worker is expected to perform should be clearly
stated.
5.3
Training
Training, either as an initial procedure or an ongoing process of continuing
education, should be relevant to the STD health problem and appropriate to the setting
and health worker applying the protocol. The clinician should know that the protocol is
a problem-solving guide but he should also understand the rationale behind the algorithm
approach, i.e., why he should do what the protocol establishes.
The contents and duration of the training activity will vary according to the
complexity of the protocols and the skills required for their implementation.
Accordingly, the teaching method may range from a face-to-face short discussion of the
protocol with an experienced physician to formal training sessions of several days
duration required by health auxiliaries.
Similarly, the teaching materials may vary from a sheet of paper outlining the
protocol to documents, instruments (e.g., microscope, vaginal speculum), supplies (e.g.,
dyes for staining, syringes, etc.), audiovisual devices, and the use of supervised
practical training.
Rather than using a didactic approach in which the trainee is given a lecture about
the protocol, a dialogue providing opportunities for the trainee to explain the steps
outlined in the protocol should be encouraged. The most appropriate trainer may well be
an experienced clinician or supervisor who is familiar with the protocol.
WHO/VDT/85.437
page 36
The location for the training activity should be as similar as possible to the
environment where the clinician will practice (or even the same facility). Occasionally,
and especially in the case of inexperienced personnel or clinicians working in clinics
where few STD patients attend, it may be necessary to provide practical training in a
larger clinic with sufficient numbers of STD patients, It is possible, however, that in
some instances the training will be a self-teaching exercise, In other words, a
clinician will ’’learn by doing" when applying the protocol.
5.4
Supervision and guidance
The supervisory activities will depend on the managerial and administrative setup of
the health system where the clinician is practicing. In general, supervision will be
closely linked with the evaluation of the protocol’s usefulness (see below), and the
clinician’s performance may be assessed primarily by his adherence to a useful protocol.
In the case of noncompliance or difficulties experienced in the application of the
protocol, a satisfactory explanation of the deviation should be sought.
In addition to direct observation of the clinician’s performance by a supervisor
(when feasible), other mechanisms, such as patient outcome evaluations (including
referrals to the next level), drug and supply utilization, patient and community
satisfaction, etc., should be explored. The Importance of even a rudimentary record
keeping system can not be overemphasized; thus, the periodic review of patient records
may substitute for direct clinician supervision in remote and smaller communities.
5.5
Laboratory support for protocol implementation
Laboratory services are an integral part of all disease control programmes and the
availability of laboratory tests improves considerably the quality of patient care and
public health practice. Unfortunately, at the most peripheral levels, laboratory support
is practically non-existent and diagnosis is usually made on clinical and/or
epidemiological grounds alone. Annex 1 lists the recommended availability of diagnostic
tests for STDs by level within the laboratory system, Laboratory services development
should be encouraged if at all possible.
5.5.1
Uses of laboratory tests
As a general rule it is preferable to be without laboratory support than to be
misled by the results of poorly performed tests. On the other hand, laboratory tests may
facilitate the selection of a more specific treatment approach which may be considerably
less costly than a sequential treatment or the use of a broad spectrum treatment of the
clinical syndrome designed to cover a variety of etiologies. The most important
characteristic and justification for the use of a laboratory test is its ability to
provide information to assist in patient management. Sometimes, this information may
guide the immediate therapeutic decision of the clinician, thus providing a
"prescriptive" diagnosis (e.g., to give gonorrhoea treatment to a patient with urethral
discharge showing characteristic intracellular diplococci on microscopic examination).
In other instances, the laboratory test will help correct an improper management (e.g.,
in cases of misdiagnosis), or permit patient follow-up (e.g., by monitoring cure).
Finally, the laboratory test may serve "statistical" purposes for epidemiology and
planning, (e.g., permitting a better classification of disease problems in the community)
or serve as a basis for further testing or research (e.g., isolation of organisms for
antimicrobial susceptibility testing).
5.5.2
Laboratory tests for simplified STD management protocols
In the STD management protocols presented in section 4, only the laboratory tests
providing information useful for immediate decision-making were included since the
patient will usually require treatment at the first visit. In many settings, the use of
tests providing results which are not immediately available (e.g. culture, serology) but
are useful for patient follow-up, may be advisable.
WHO/VDT/85.437
page 37
5.6
Protocol implementation and STD information needs
The two main objectives of STD information systems are:
a)
b)
to provide epidemiological data to help define the magnitude and trends of the
STD problem and its distribution in time, place, and persons; and
to generate managerial data to measure activities and the effect of these
activities on programme performance and results.
The quantity and quality of data will vary according to the specific health system
and its resources. The output of useful and timely information without overburdening
already busy practitioners is difficult but necessary in all settings.
The implementation of simplified STD management protocols may result in an
improvement of epidemiological and managerial STD information if simple clinician
notification forms are designed and used appropriately. An example of such a form
appears as Annex 2. If the relative frequencies of the etiologies which contribute to a
given clinical syndrome are known it may be possible to translate the reports originating
from the primary health care level into causes of morbidity.
5.7
Administration and support
The written management protocol is only the first step to successful patient care
and the PHC administrator or person responsible for STD control and/or primary health
care should ensure that supplies and support services necessary to implement the protocol
are available to the clinician or can be easily obtained by the patient. Drugs are
essential. If not available, there is no use for management protocols. Recommended
regimens for STD management appear as Annex 3. Annex 4 includes simple laboratory tests
useful at the PHC level. The minimum equipment needed is a properly maintained and
functioning microscope as well as a few laboratory reagents. When available, this
laboratory support will provide an invaluable aid to patient and contact management.
Priorities for availability of laboratory tests at the peripheral level are: wet mount,
stained smear examination, and a serologiocal test for syphilis (e.g., VDRL, RPR).
6.
EVALUATION OF STD MANAGEMENT PROTOCOLS
A good protocol guides the clinician in solving the patient’s problem and in
interrupting disease transmission in the community. Clinician notification forms, and
patient "record" reviews and direct supervision to assess adherence to the protocol are
useful indicators of protocol usage and its usefulness to the clinician. Consequently,
protocol evaluation must comprise: a) a measurement of protocol usage, and b) the
assessment of results. The minimum data required for protocol evaluation include:
a)
b)
c)
d)
Numbers of patients presenting with suspected or definite STD problems;
Numbers of patients who were "carried through the protocol";
Results of these actions (cure, Improvement, referral, failure, contacts found,
etc.);
If desired or possible, costs associated with the protocol’s implementation.
Changes in the prevalence of different STD, changes in antimicrobial susceptibility
of STD organisms, and other factors, may render today’s ’’perfect" protocol obsolete, For
this reason, those designing and using a protocol must devise a system to monitor the
protocol’s effectiveness and to detect its obsolescence in a timely manner. The "red
flag" indication that a protocol is no longer useful should be established in terms easy
to understand and follow (e.g., "20% or more of patients failing treatment or requiring
referral" or "three or more consecutive patients whose problem is not solved with a
particular protocol"). The protocol, however, may be appropriate and other factors, such
as lack of treatment compliance, reinfection, etc., may explain an apparent failure in
the protocol. Supervision, data review, and/or limited operational research studies may
help to clarify this situation.
WHO/VDT/85.437
page 38
Finally, evaluations of the impact of appropriate STD protocol implementation on
long-term consequences and complications of STD are highly desirable but probably only
possible as special research efforts in very few settings.
7.
COMMUNITY PARTICIPATION IN STD CONTROL EFFORTS
The ’’uncontrolled" status of STD in most countries is often blamed on the population
at risk engaging in unsafe sexual behaviour, contacts never found or examined,
practitioners failing to report STD cases, patients not complying with treatment
regimens, health authorities not providing necessary resources, etc. Some of these
problems, which at first appear unsolvable, may be overcome at the peripheral level, by
using innovative approaches involving community participation in PHC and STD control.
People do care about their health. Furthermore, people are willing to contribute
financially in order to receive good treatment. In one particular setting, for example,
joint government-community financing and management were established to provide health
care when the community recognized that governmental institutions were financially unable
to obtain enough essential drugs for health care in the community, Some suggestions for
outreach and health promotion approaches to obtain community support for PHC and STD
control are included as Annex 5.
8.
CONCLUSIONS
Demographic and epidemiological trends seem to indicate that the STD problem will
increase in magnitude and severity during the next decades, However, in most countries,
efforts to counteract this unfortunate trend can and should be initiated now.
Improvement of patient and contact management through design and implementation of
simplified approaches, such as management protocols at the primary health care level,
should be the first step. Outreach activities such as health promotion will ensure that
communities are a part of the solution and not a part of the problem.
WHO/VDT/85.437
page 39
ANNEX 1
Recommended availability of diagnostic tests by level of the
laboratory system
Etiological
Agent
Laboratory
Test
Peripheral
Smear (Gram or methylene blue
stain)
Culture
B-lactamase
Antimicrobial susceptibility
+
Darkfield microscopy
RPR card test
VDRL, quantitative
TPHA, MHA-TP, AMHA-TP
FTA-ABS
Specific IgM assays
+/+/+/-
3) Chlamydia trachomatis
Smear (Giemsa)-(eye only)
CFT (LGV only)
Direct FA
Culture
Micro-IF antibody
+
4) Haemophilus ducreyi
Culture
B-lactamase
Antimicrobial susceptibility
5) Calymmatobacterium
Granulomatis
Smear (Wright-Giemsa)
Hi stopathology
6) Candida spp
1) Neisseria gonorrhoeae
2) Treponema pallidum
Level
Intermediate
Central
+
+
+
+/+/-
+
+
+
+
+
+/-
+
+
+
+
+
+
+/+
+/+/+/-
+
+
+
+
+
+
+/-
+
+
+
+/-
+
+/-
+
+
KOH wet mount
Culture
Speciation
+
+
+
+/-
+
+
7) Trichomonas vaginalis
Saline wet mount
Culture
+
+
+/-
+
+
9) Herpes simplex Virus
Smear (Pap or Tzanck)
Direct FA
Culture
Neutralizing antibody
+/+/+/-
+
+
+
+
9) Bacteria producing
vaginosis
Saline wet mount,
"Sniff test"
+
+
+
+
WHO/VDT/85.437
page 40
ANNEX 2
Monthly clinician notification form*
Clinician
Month
Year
Location
Syndrome
No. of patients treated
No of patients referred
Genital Ulcer
Men;
Women:
Men:
Women:
Bubo
Men:
Women:
Men;
Women:
Suspected STD
Men;
Women:
Men;
Women:
Urethral discharge
Balanitis
Swollen scrotum
Vaginal discharge
Pelvic Inflammatory
Disease
Conjunctivitis in
Newborn
* More comprehensive forms including data on "Total seen", "Total managed with
protocol", "Total not returning to complete protocol", "Total referred", etc. could be
designed. Depending on the facility and the clinicians, in some areas, individual
patient records containing additional data (age, pregnancy status, etc.) may be available.
WHO/VDT/85.437
page 41
ANNEX 3
Therapeutic recommendations*
GONOCOCCAL INFECTIONS
Uncomplicated urogenital infection
GROUP A
The following regimens remain useful in areas in which gonococci are known to have
maintained chromosomal sensitivity to antimicrobials and in which beta-lactamaseproducing gonococci comprise less than 5% of isolates. (However, patients who are likely
to have acquired their gonococcal infections in areas of high resistance should be
treated with regimens from GROUP B.)
Amoxycillin, 3.0 g with 1.0 g of probenecid by mouth
or
Ampicillin, 3.5 g with 1.0 g of probenecid by mouth
or
Aqueous procaine penicillin G, 4.8 million units by intramuscular injection, with
1.0 g of probenecid by mouth
or
Aqueous crystalline penicillin G, 5 million units by intramuscular injection, with
1.0 g of probenecid by mouth
or
Tetracycline hydrochloride, 500 mg by mouth, 4 times daily for 7 days
or
Doxycycline, 100 mg by mouth, twice daily for 7 days.
GROUP B
In areas where chromosomal gonococcal resistance has reduced the efficacy of
antimicrobial agents such as penicillin G, tetracycline, and trimethoprim/
sulfamethoxazole to cure rates below 95% (including areas where beta-lactamase-producing
gonococci are significantly prevalent), the following single session regimens remain
effective in at least 95% of cases. These regimens may be used also in pregnancy
although their safety may not have been established.
Cefotaxime, 1.0 g by intramuscular injection with 1.0 g of probenecid by mouth
or
Cefoxitin, 2.0 g by intramuscular injection with 1.0 g of probenecid by mouth
or
Ceftriaxone, 250 mg by intramuscular injection
or
Spectinomycin, 2.0 g by intramuscular injection.
* Adapted from a WHO Consultative Group Report on Current Treatments in the Control
of Sexually Transmitted Diseases: Unpublished WHO Document WHO/VDT/83.433.
WHO/VDT/85.437
page 42
GROUP C
The following regimens show considerable geographic variation in their efficacy,
sometimes curing less than 95% of infections. They are active against
beta-lactamase-producing gonococci and are often less costly and more widely available
(than group B drugs), but are not recommended during pregnancy.
Kanamycin A, 2.0 g by intramuscular injection
or
Thiamphenicol, 2.5 g by mouth
or
Trimethoprim (80 mg)/sulfamethoxazole (400 mg) or a comparable sulfonamide
component, 10 tablets by mouth, daily for 3 days.
C. TRACHOMATIS INFECTIONS AND NONGONOCOCCAL URETHRITIS
Uncomplicated urethral, endocervical or rectal infections in adults
Drug regimens of choice
Tetracycline hydrochloride, 500 mg by mouth, 4 times daily for 7 days
or
Doxycycline, 100 mg by mouth, twice daily for 7 days.
Alternative regimens (for patients in whom tetracyclines are contraindicated - pregnancy or not tolerated)
Erythromycin, 500 mg by mouth, 4 times for 7 days.
Management of sexual partners
All persons exposed to C. trachomatis infection should be examined for STD and
promptly treated for exposure to C. trachomatis with one of the above regimens.
Urogenital infections during pregnancy
Treatment should be given to pregnant women who have 0. trachomatis infections or,
to pregnant women whose sexual partners have non-gonococcal urethritis.
Suggested treatment: Erythromycin, 500 mg by mouth, 4 times daily on an empty
stomach for 7 days. For women who cannot tolerate this regimen, a decreased dose of 250
mg by mouth, 4 times daily should be used for 14 days.
EARLY SYPHILIS
Recommended regimens
Benzathine benzyl penicillin G, 2.4 million units in a single session by
intramuscular injection
or
Aqueous procaine penicillin G, 600 000 units daily by intramuscular injection for 10
consecutive days.
Penicillin-allergic patients
Tetracycline hydrochloride, 500 mg by mouth, 4 times daily for 15 days
or
Erythromycin, 500b mg by mouth, 4 times daily for 15 days.
WHO/VDT/85.437
page 43
CHANCROID (H. DUCREYI INFECTION)
Recommended regimens
Trimethoprim (80 mg)/sulfamethoxazole (400 mg) or a comparable sulfonamide
component, 2 tablets by mouth twice daily for 5 days,
or
Erythromycin, 500 mg orally 3 times daily for 7 days.
Limited data also suggest adequate cure rates with single dose regimens consisting
of: spectinomycin: 2 g by intramuscular injection; or ceftriaxone: 250 mg by
intramuscular injection; or trimethoprim (80 mg)/sulfametrole (400 mg), 8 tablets by
mouth; or thiamphenicol, 2.5 g by mouth for two consecutive days.
LYMPHOGRANULOMA VENEREUM
Drug regimen of choice
Tetracycline hydrochloride, 500 mg by mouth, 4 times daily for 2 weeks.
Alternative regimens
The following drugs are active against LGV serotypes in vitro but have not been
evaluated extensively in culture-confirmed cases:
Doxycycline, 100 mg by mouth, twice daily for 2 weeks
or
Erythromycin, 500 mg by mouth, 4 times daily for 2 weeks
or
Sulfamethoxazole, 1.0 g by mouth, twice daily for 2 weeks,
be used in equivalent dosage.
Other sulfonamides can
Lesion management
Fluctuant lymph nodes should be aspirated as needed through healthy adjacent normal
skin. Incision and drainage or excision of nodes will delay healing and are
contraindicated.
Late sequelae such as stricture and/or fistula may require surgical intervention.
DONOVANOSIS (GRANULOMA INGUINALE)
Treatment of choice
Trimethoprim (80 mg)/sulfamethoxazole (400 mg) or a comparable sulfonamide
component, 2 tablets twice daily by mouth for 14 days.
Alternative regimens (regional variation in efficacy)
Tetracycline hydrochloride, 500 mg 4 times daily by mouth for 14 days
or
Chloramphenicol, 500 mg by mouth 4 times daily plus gentamicin 1 mg/kg by
intramuscular injection 3 times daily for 3 weeks.
GENITAL HERPES SIMPLEX VIRUS INFECTIONS
Lesions should be kept clean by washing affected sites with soap and water, followed
by careful drying.
WHO/VDT/85.437
page 44
TRICHOMONAS VAGINALIS INFECTIONS
Recommended regimen
Metronidazole, 2,0 g in a single oral dose.
Management of sexual partners
Male sexual partners of women with trichomoniasis should be treated with
metronidazole 2.0 g in a single oral dose.
Trichomoniasis in pregnancy
Metronidazole is contraindicated in the first trimester of pregnancy and should be
avoided throughout pregnancy. Clotrimazole 100 mg, intravaginally, at bedtime for 7 days
may produce symptomatic improvement and some cures. Other local treatments may be used
for symptomatic relief but have low cure rates. In lactating women breast feeding should
be interrupted for at least 24 hours after single dose therapy.
GENITAL CANDIDIASIS
Examples of effective regimens - Vaginitis
Clotrimazole, 100 mg intravaginally daily for 7 days
or
Miconazole, 100 mg intravaginally daily for 7 days
or
Nystatin, 100 000-1 000 000 units (depending on geographical area) intravaginally
daily for 14 days.
Simultaneous oral therapy with nystatin, attempting to eradicate gut infections,
does not reduce the frequency of recurrence.
Balanitis
days.
Topical application of imidazole or polyene creams or lotions twice daily for 7
Optimal regimens have not been determined.
BACTERIAL VAGINOSIS (NONSPECIFIC VAGINITIS)
This syndrome consists of non-irritating, malodorous, thin, greyish-white vaginal
discharge; elevated vaginal pH (greater than 4.5); and the elaboration of malodorous
amines from discharge fluid after alkalinization with KOH. Microscopic examination of a
wet mount of vaginal fluid typically reveals the presence of small coccobacillary
organisms associated with epithelial cells (so-called "clue cells").
Drug regimen of choice
Metronidazole, 500 mg by mouth twice daily for 7 days.
Alternative regimen
Metronidazole, 2.0 g in a single oral dose is efficacious for most patients.
Pregnancy
Metronidazole is not recommended during the first trimester of pregnancy and should
be avoided throughout pregnancy. Ampicillin, 500 mg by mouth, 4 times dally for 7 days
may be used, but is less effective than metronidazole.
WHO/VDT/85.437
page 45
EPIDIDYMITIS
Drug regimens of choice
Single dose therapy for uncomplicated gonorrhoea
plus either
Tetracycline hydrochloride, 500 mg by mouth, 4 times daily for 10 days
or
Doxycycline, 100 mg by mouth twice daily for 10 days.
Alternative regimens
Patients who cannot tolerate tetracycline should receive a single dose therapy for
uncomplicated gonorrhoea
plus
Erythromycin, 500 mg by mouth 4 times daily for 10 days.
Adjuncts to therapy
Bed rest and scrotal elevation until fever and local inflammation have subsided.
Management of sexual partners
Sexual partners of patients with sexually transmitted acute epididymo-orchitis
should be examined for STD and promptly treated with one of the regimen above.
Follow-up
Failure to improve within 3 days requires re-evaluation of diagnosis/therapy and
consideration of hospitalization. Persistent swelling for longer than 1 month should
lead to evaluation for tumour or tuberculosis.
ACUTE PELVIC INFLAMMATORY DISEASE (ENDOMETRITIS; SALPINGITIS, PARAMETRITIS)
Ambulatory treatment
For patients who must be treated on an ambulatory basis, one of the following
regimens may be used:
Single dose therapy for uncomplicated urogenital gonorrhoea
plus
Doxycycline, 100 mg twice daily or Tetracycline hydrochloride, 500 mg 4 times daily
by mouth for 10 days
plus
Metronidazole, 1.0 g by mouth twice daily for 10 days.
This regimen provides excellent activity against chlamydiae and probably provides
good coverage for N, gonorrhoeae or facultative anaerobes. The use of a cephalosporin as
the initial gonorrhoeal therapy would increase activity against facultative anaerobes.
Thiamphenicol, 2.5 g by mouth followed by 500 mg orally 4 times daily for 10 days.
This regimen provides excellent activity against N. gonorrhoeae and facultative
anaerobes, but its effectiveness against C. trachomatis is unknown.
Intrauterine device (IUD)
The IUD is a risk factor for the development of PID. Although the exact effect of
removing an IUD on the response of actue salpingitis to antimicrobial therapy and on the
risk of recurrent salpingitis is unknown, removal of the IUD is recommended soon after
antimicrobial therapy has been initiated. When an IUD is removed, contraceptive
counselling is necessary.
WHO/VDT/85.437
page 46
ANNEX 4
Microscopic tests useful at PHC level*
The same specimen (from urethral discharge, vaginal-cervical discharge, etc.) can be
used for several tests.
A.
Direct microscopy without staining (Wet mount)
Main uses: vaginal discharge (for diagnosis of trichomoniasis, and bacterial vaginosis);
occasionally, in urethral discharge (trichomoniasis).
Specimen collection in women
A sample of vaginal secretion is obtained from the posterior fornix with, if
possible, a cotton-tipped swab, The sample is then immediately transferred onto a glass
slide.
Urethral samples in men
The chances of demonstrating T. vaginalis are optimized if the patient is examined
early in the morning before voiding or if he has at least not voided in the two hours
preceding sampling. If discharge is present, this may be collected on a sterile
bacteriological loop or swab. Otherwise, scrapings can be obtained from the anterior
urethra with a loop.
Preparation of a wet mount
The sample is placed immediately onto a glass slide and diluted with a drop of
normal saline (Section A). A coverslip is applied on top, and the preparation examined
immediately under low power (40 x 10) with reduced illumination.
The morphological details may be enhanced by staining the wet mount with a very
dilute (approximately 1:10000) solution of buffered methylene blue. Use of more
concentrated stain solution is liable to prove counterproductive by depriving the
trichomonads of their motility, an important factor in microscopic identification.
However, T. vaginalis is usually easily identifiable without resorting to such
complexities.
Microscopic appearance
Trichomoniasis
The striking and diagnostic feature of trichomoniasis in microscopic examination is
the characteristic jerky motility exhibited by the organism. T. vaginalis is a clear,
pear-shaped organism about the size of a pus cell, with four anterior flagellae and an
axostyle that traverses the body to end in a spine (Section B). The organisms will soon
lose their jerky movement, and their undulating membranes may become visible, especially
under higher magnification.
Bacterial vaginosis
This is defined as "a replacement of the lactobacilli of the vagina by
characteristic groups of bacteria accompanied by changed properties of vaginal fluid •
*Tests included are only those not requiring special laboratory skills (i.e. those
which can easily be performed by the clinician) but the availability of reagin tests for
syphilis is desirable.
WHO/VDT/85.437
page 47
The typical fishy odour will be enhanced by the addition of 1 or 2 drops of 10-20% KOH to
the vaginal discharge specimen ("Sniff test"). The features of bacterial vaginosis seen
on wet mount examination are illustrated in Appendix B.
Other findings in vaginosis are:
a)
b)
c)
The leukocyte count is normal or only slightly elevated, i.e. the number of
epithelial cells per microscopic field exceeds the number of leukocytes. (This
compares with the massive elevation of the leukocyte count seen in
trichomoniasis).
A reduction in the numbers of lactobacilli of DUderlein is generally noted.
The presence of clue cells: these are cornified squamous epithelial cells,
covered by bacilli (making the cell outline indistinct) producing a distinctive
granular cytoplasmic appearance.
Other infections
Other pathogens, e.g. Candida albicans may occasionally be seen,
is not the best method for detection of candidiasis (see below).
B.
However, wet mount
Direct microscopy with staining
Main uses:
discharge;
Vaginal discharge (especially discharge due to cervical infection); urethral
ophthalmia neonatorum; balanitis (for diagnosis of candidiasis).
Specimen collection
Specimens are collected for direct examination from the cervix in females;
urethra in males; from the conjunctivae in cases of conjuctivitis.
from the
Urethral samples in men
A sample from the anterior urethral mucosa is obtained by using a sterile (cool)
bacteriological loop or, alternatively, a cotton wool or calcium alginate sampling swab,
moistened with saline if available to facilitate its introduction, is passed
approximately one to two cm into the urethra and gently rotated.
Cervical samples in women
A sample is obtained by passing a sterile curette, loop or swab into the cervical
canal. The sampling instrument is then rotated and moved from side to side for 10 to 30
seconds before withdrawal. Ideally, during this procedure the cervix should be
visualized by a speculum (which, if used must be sterilized) with the woman in the
lithotomy position. If possible excess cervical mucus should be removed (e.g. with a
cotton ball held in ring forceps) before sampling. Sampling from the vagina, including
the posterior fornix, should be used only if hysterectomy has been performed. Where the
hymen is intact, material is obtained from the vaginal orifice.
Sampling from the eye
Pus is collected from the conjunctiva with a sterile bacteriological loop or swab.
Sampling from glans penis
Use a sterile cotton-tipped swab to collect discharge from the coronal sulcus in men
(to detect candidiasis).
t
WHO/VDT/85.437
page 48
Preparation of smears
The specimen is transferred immediately onto a glass slide where a thin and even
smear is made by rolling the swab. The smear is air-dried and fixed either by heat (by
holding the slide, film upwards, in a flame until just too hot to be borne on the back of
the hand) or by a 5-minute immersion in methanol (94%).
Two simple staining procedures. Gram’s method (Section C) and methylene blue
(Section D), are suitable. The latter should be preferred on the grounds that it renders
bacteria more easily recognisable in clinical material, and for use at the peripheral
level; it also carries the additional advantage of being a less time-consuming
procedure. However, the requirement that the solution must be stored at 4 C may preclude
its use in some settings. (The Gram stain has, of course, the advantage that the
Gram-staining characteristics of the bacteria can be ascertained).
Microscopic examination
Gonorrhoea
Slides are examined under oil immersion. Gonococci are Gram-negative kidney or
coffee bean-shaped diplococci, 0.6 to 0.8 um in size (Section B). Although the presence
of these diplococci within polymorphonuclear leukocytes is strongly suggestive of
gonorrhoea, absence of this feature does not necessarily exclude the disease.
Nongonococcal urethritis (and cervicitis)
During examination of the slide, attention should be paid to the presence of any
other pathological features, e.g., the number of polymorphonuclear leukocytes per field
in relation to the number of epithelial elements; whether lactobacilli or coccoid
bacteria predominate, the occurence of clue cells (see above); the presence of yeast,
fungi, trichomonads, etc. A characteristic feature of nongonococcal urethritis (usually
caused by Chlamydia trachomatis) is the presence of pus cells without bacteria.
Candidiasis and fungal infections
0. albicans appears as an oval budding, yeast-like fungus. Despite a lack of
experimental substantiation, it is widely held that the presence of pseudohyphae is an
indication of tissue invasion. The number of organisms seen does not correlate well with
the severity of symptoms. A wet mount preparation treated with 1 or 2 drops of 10-20%
KOH and heated (but not boiled) and Gram staining appear approximately equally
sensitive. The presence of pseudohyphae suggests that fungus seen is unlikely to be one
of the less pathogenic yeasts which do not form pseudohyphae. However, reliable
speciation by direct microscopy is usually not possible.
SECTION A
(a)
(b)
NORMAL SALINE
Normal saline is a 0.85% solution of sodium chloride (NaCl) in water.
Dissolve 8.5 g NaCl in approximately 900 ml water (preferably distilled).
Make up the volume to 1 litre by adding more water.
17HO/VDT/85.437
page 49
SECTION B
1.1
ILLUSTRATIONS
FEATURES SEEN ON WET SMEAR EXAMINATION
"Ripe" vaginal epithelial cells
Polygonal cells with small
nuclei.
: -r
"Unripe" vaginal epithelial
Round cells with relatively large
nuclei.
Polymorphonuclear leukocytes
Irregular, multi-lobular
nuclei.
Erythrocytes
Appear as two concentric rings.
Greenish-yellow in colour with
no nuclei.
WHO/VDT/85.437
page 50
Spermatozoa
Glue cell
The adherent cocci give the cell a
characteristic granular appearance,
and can also make the cell outline
rather indistinct.
A
)'e
■
) '1
Vaginal epithelial cell with
adherent curved rods
The number of bacteria attached to
individual cells varies greatly.
Cells usually have less adherent
bacteria than shown here.
Trichomonads
Trichomonads are easily identified
by their characteristic motility.
WHO/VDT/85.437
page 51
Candida albicans
The fungal elements are rendered
more visible by mixing with KOH.
Pseudohyphae and blastospores
are seen.
>
1
1
'
J
. *
*
»
♦
Normal wet smear
*
*
«
A.
The normal coccoid and lactobacillary flora is seen.
Leukocytes are sparse.
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The field is dominated by leuko
cytes. This picture is seen in
gonococcal, chlamydial and
trichomonal infections and may
be an indication for cervical
sampling for Neisseria gonorrhoeae
and Chlamydia trachomatis.
3 .
%
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a '
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/V (
WHO/VDT/85.437
page 52
Gardnerella vaginalis •• associated
bacterial vaginosis
»
The bacterial flora is dominated by
cocci, which can adhere to epithelial
cells to form clue cells. Few
leukocytes are seen.
*
X
*
Mobiluncus - associated bacterial
vaginosis
»
»
9
The bacterial flora is dominated by
curved rods and cocci. Some curved
rods adhere to epithelial cells.
Again, few leukocytes are seen.
*
♦
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♦
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X
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STAINED SMEAR IN GONORRHOEAE
1.2
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c.
Numerous leukocytes are seen. The characteristic kidney or coffee-bean
shaped diplococci are present within leukocytes and epithelial cells
and also extra-cellularly.
WHO/VDT/85.437
page 53
SECTION C - GRAM’S STAIN
Preparation of reagents
a
In preparation of the reagents, the use of distilled water is preferred. If
unavailable, tap water, if possible, cleaned and purified, e.g., by filtration, will have
to be used.
Crystal violet
a)
b)
Dissolve 2 g crystal violet in 20 ml 96% ethanol.
Then add 80 ml 1% ammonium oxalate.
Iodine solution
a) Dissolve 2 g iodine crystals in 10 ml 1 N NaOH solution.
b) Make up to 100 ml with distilled water.
Decolorizing solution
Acetone per analysis.
Counterstain solution
a)
b)
c)
d)
e)
f)
Dissolve 0.3 g basic fuchsin in 10 ml 96% ethanol.
Dissolve 5 g phenol in 95 ml distilled water.
Mix the two solutions (a) and (b) gradually, under vigorous stirrings.
Add 950 ml distilled water.
Allow the mixture to stand for 2 to 3 days.
If possible, filter (0.22 urn) before use.
Method
a)
b)
c)
d)
e)
f)
g)
Heat-fixed specimens must be allowed to coof before commencing staining.
Flood the slide with crystal violet for one minute, then rinse with water,
preferably under a running tap.
Cover the slide with iodine solution for 2 minutes, then rinse with water.
Before the smear has dried completely, decolorize with acetone until no more
colour comes off (this is the critical step in the staining procedure, therefore
only one slide at a time should be decolorized).
Wash the slide thoroughly with water.
Flood the slide with counterstain for 30 seconds, then wash it in water again.
Allow the slide to dry, before examination under the microscope. Drying may be
hastened by pressing a blotting paper against the slide taking care not to rub
off the stain.
WHO/VDT/85.437
page 54
SECTION D - METHYLENE BLUE STAINING
Preparation of stain
In preparation of the stain, use of distilled water is preferred. If this is
unavailable, tap water, if possible, cleaned and purified, e.g., by filtration, will have
to be used.
a)
b)
c)
d)
Dissolve 450 mg methylene blue in 30 ml ethanol (99.9%).
Dissolve 10 mg KOH in 100 ml distilled water.
Mix the two solutions and sterilize, if possible, by filtration (0.22 urn).
The solution must be kept in darkness at 4°C until use.
Method
a)
b)
c)
Cover the air-dried and fixed smear with stain for one minute.
Wash the slide in water, preferably under a running tap.
Allow the slide to dry and examine it under the microscope.
WHO/VDT/85.437
page 55
ANNEX 5
Approaches to obtain community support
1.
Raising the community's awareness of the STD problem
a)
Informing the community (through health education) about;
mechnism of transmission of STD to sex partners
Impact of STD on maternal and infant health and on human reproduction and
fertility
effective and ineffective treatment
difference in cost between treatment of a complicated case and of a
non-complicated case.
b) Collecting general data about sexual practices and behaviour in the population
which increased risk of STD.
c)
Communicating results of data obtained to the community.
An informed public will cooperate actively with the control programme only if the
seriousness of the consequences of STD have been clearly understood, identified and
assimilated by the community.
2.
Community participation
Because of the demographic explosion and the rapid rise in needs and demands for
health services, many governments are no longer able to accomplish their tasks. In view
of the limited budget of the Ministry of Public Health and the lack of qualified health
workers in developing countries, community participation is mandatory.
a)
Financial participation
in rural areas, 2 types are suggested:
1) patients pay a standard fee-for-service.
2) production units and social services are integrated into village cooperatives
which operate a system of self-finance.
in urban areas:
The collective system through cooperatives (a2) is difficult to implement in urban
areas and patients usually pay a standard fee-for-service.
People prefer the system of individual financial contribution to obtain
comprehensive health services instead of "free clinics" providing prescriptions for drug
purchase at private pharmacies.
This primary health insurance is an important Instrument for economic and social
development.
b)
Community health workers
The community can select the most appropriate persons for training as community
health workers. These health workers would assist the professional health workers
(record keeping, distribution of drugs. Injections, sexual contact referral) or do
themselves the tasks in the absence of better qualified personnel.
WHO/VDT/85.437
page 56
3)
Community organization: health committees
To enhance communication between the community and the health
personnel/administrative authorities, some kind of community organization is necessary.
The health committee is the fundamental structure for community participation, Each
health unit (health post, health centre, maternity unit) should have the support by a
health committee. The committee is chosen by a general assembly of village
representatives in rural areas; in urban areas, it is selected by representatives of
different blocks located in catchment areas of the health unit. The committee should
have a president, a secretary, a treasurer and eventually an ad hoc sub-committee.
All the committees of a given administrative area may be grouped into an association
for health promotion. Tasks of this association are:
a)
b)
c)
d)
to regulate the election procedure and the activities of the committees in
collaboration with the medical authorities,
to coordinate similar activities in different health committees,
to supply drugs in collaboration with the medical authorities,
to supervise the committees (financial evaluation).
The utilization of financial resources (patient fees) is done by the health
committee in collaboration with the nurse of the health unit (= co-management), It is
important to determine levels for different types of expenditures: i.e. 60% of the
receipts would go for the purchase of drugs, 10% for small medical material, 15% for
payment of community health workers, etc. All current expenses are paid by check.
co-signed by the committee’s president and treasurer, The checkbook stays in the nurses’
hands.
Through community participation, a regular supply and distribution of drugs at a low
cost is assured. The following sources of supplies may be feasible.
a)
b)
c)
government medical stores
pharmaceutical companies in the country
pharmaceutical companies abroad: imported drugs have to be exempt of import
taxes (to be negotiated with the Health Ministry and Ministry of Finance).
The association of health committees should set up a central community store to
organize the supplies of drugs, vaccines, disposable medical supplies for all health
units of the administrative area. This community store purchases bulk supplies,
maintains the inventory, and is responsible for distribution (everything is paid by
check).
The association of health committees can establish committees for specific health
problems (e.g., a committee for STD). The members of this committee are volunteers from
individual health committees and are particularly interested in the subject of STD. This
special STD committee can be "the go-between” of the community and the general clinic or
specialized centre of STD (depending on the setting).
k
WHO/VDT/85.437
page 57
ANNEX 6
Recommended Reading
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of a WHO Scientific Group. Technical Report Series No. 616, WHO, Geneva, 1978
4
Report
World Health Organization. Nongonococcal urethritis and other selected sexually
transmitted diseases of public health importance. Report of a WHO Scientific Group,
Technical Report Series No. 660, WHO, Geneva, 1981
World Health Organization. Treponemal infections. Report of a WHO Scientific
Group, Technical Report Series No. 674, WHO, Geneva, 1982
Jancloes M., Seek B. & Kebe M., Autofinancement et autogestion des soins de sante
primaires; une experience au Senegal. Rev. Int. Educ. Sante, 23, 117-123, 1980.
Meheus A. & Plot P., Lutte centre les MTS dans les pays en developpement. Ann. Soc.
Beige Med. trop., 63, 281-311, 1983.
Ministere de la Sante publique - Senegal. Participation des populations a I’effort
de sante publique: principes et directives methodologiques, 1980.
Essex B.J. Approach to rapid problem solving in clinical medicine.
34-36, 1975.
Cumper G. The costs of primary health care.
Brit Med J, 3,
Tropical Doctor, 14, 19-22, 1984.
Fendall N.R.E. Training and management for primary health care.
B209, 97-109, 1980.
Proc R Soc Lond,
Arya O.P. & Bennett F.J. Role of the medical auxiliary in the control of sexually
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Essex B. A new approach to decision making in primary health care.
B209, 89-96, 1980.
Proc R Soc Lond,
Arya O.P. & Lawson J.B. Sexually transmitted diseases in the tropics.
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Stocking B. & Smith C.E.G. National policies and national experts,
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Basic
Reisman A. & Duran L. Designing primary health care teams for developing countries.
Publ Hlth Rep, 98, 184-189, 1983.
McCord C. & Kielmann A.A. A successful programme for medical auxiliaries treating
childhood diarrhoea and pneumonia. Tropical Doctor, 8, 220-225, 1978.
Nchinda T.C. The propharmacy as a means of meeting chronic drug shortages in rural
health centres in rural African communities. Tropical Doctor, 8, 225-228, 1978.
Pillsbury B.L.K. Policy and evaluation perspectives on traditional health
practitioners in national health care systems. Soc Sci Med, 16, 1825-1834, 1982.
Bestane W.J. A gonorreia e outras uretrites na cidade de Santos, Estado de Sao
Paulo. Rev Ass Med Brasil, 24, 133-138, 1978.
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Rein M.F. Therapeutic decisions in the treatment of sexually transmitted diseases:
an overview. Sex Transm Dis, 8, 93-99, 1981.
Rhodes A., McCue J., Komaroff A.L. & Pass T.M. Protocol management of male
genitourinary infections. J Amer Vener Dis Assoc, 2, 23-30, 1976.
Meheus A. Chapter 81. Practical approaches in developing nations. In: Sexually
Transmitted Dieases, Holmes K.K., MSrdh P.H., Sparling P.F., Wiesner P.J. (eds). McGraw
Hill Book Company, New York, 1984.
World Health Organization. Training and utilization of auxiliary personnel for
rural health teams in developing countries. Tech Rep Series No. 633, 1979, WHO, Geneva.
World Health Organization. The traditional birth attendant in seven countries:
case studies in utilization and training. Mangay-Maglacas A, Pizurki H. (eds). Publ
Hlth Papers No. 75, 1981, WHO, Geneva.
World Health Organization. The primary health worker, Working guide, guidelines
for training, guidelines for adaptation. 1980, WHO, Geneva.
World Health Organization. Control of sexually transmitted diseases,
scientific working group. WHO, Geneva, 1985.
Report of a
Ofosu-Amaah V. National experience in the use of community health workers,
offset publication No. 71, WHO, Geneva.
WHO
Kirkpatrick D.L. How to improve performance through appraisal and coaching.
New York, N.Y., 1982.
AMACOM,
World Health Organization.
Unpublished document. LAB/79.1.
Laboratory services at primary health care level.
World Health Organization. Manual on methods for the diagnosis of gonorrhoea in
general laboratories. Unpublished document LAB/80.2.
World Health Organization. Protocol for clinical and laboratory studies of genital
ulcer disease. Unpublished document INT/VDT/83.406.
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