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This report covers the FHI AIDS Control and Prevention (AIDSCAP) Project (1991-1997). Volume 1 covers regional program overviews, technical strategies, and program support strategies.
Volume 1 |
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In Haiti, local providers were impressed by studies showing how ineffective the current STI management practices were when compared with the gold standard laboratory test. The process of developing guidelines began in 1992 with a study in primary care centers in Cité Soleil showing that 90 percent of clinicians treated urethritis with penicillin or ampicillin, antibiotics to which at least 60 percent of gonococcal strains were resistant. The clinicians also failed to treat chlamydial infection, refer sexual partners of STI patients, and screen pregnant woman for syphilis. Because of limited laboratory facilities, the STI management guidelines were based on the syndromic approach. There was initial resistance to this approach, which included treating chlamydial infection when patients sought treatment for urethritis and cervical infections. The process that followed facilitated the providers' acceptance of this new approach to STI case management. Studies that tested the WHO syndromic management guidelines in local situations were completed in 1993. The study findings, along with the findings about STI management practices, were shared with local health professionals and program managers, who subsequently reached a consensus about national guidelines. This was followed by provider training. An evaluation conducted 2 1/2 years later showed significant improvement in providers' management of STI cases. |
STI Communication
Community STI control demands a multilevel community and clinic communication program. HIV programs have concentrated on raising awareness and knowledge about HIV and decreasing the stigmatization of those infected. As a result, the level of knowledge about HIV is high in most developing countries. The same cannot be said for STIs. A lack of understanding of the modes of transmission, symptoms, treatment, and complications of STIs still exists. Ideally, services should be improved before there is an increased demand for STI control, and the increased demand will be the result of a community's response to a well-crafted communication campaign about STIs.
One hypothesis for the decrease in HIV incidence after improved STI treatment was offered in the Mwanza, Tanzania, intervention trial is that there was a decrease in the duration of infection in patients with STIs. This finding makes it incumbent on STI programs to emphasize that early treatment is critical not only in preventing complications and infection of others but also in decreasing the likelihood of acquiring HIV.
Targeted Intervention Research
The AIDSCAP Project developed the TIR methodology to study community perceptions, beliefs, and practices about STIs as the basis for developing messages and more effective service delivery approaches. The findings of these studies on community perceptions of STIs proved valuable in determining the types of messages and education needed to improve STI control in communities.
The need for these studies resulted from AIDSCAP's recognition that the primary source of treatment for community members with STI symptoms is not established medical facilities. Instead, most people with STI symptoms, especially men, treat themselves with drugs purchased from patent medicine dealers or pharmacies or acquired from friends; many go to traditional healers. Furthermore, the relationship between patient and provider at the clinics is often not good, as TIR studies revealed, because patients experience a lack of privacy, a judgmental attitude from providers, long lines, and ineffective or no antibiotics.
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Key informant: "I know that a lot of us [older people] will go directly to a pharmacist that we know well. At the health center, the wait is very long and there are many people; there isn't any soutoura." (Soutoura can be translated as "discretion" or "respect of privacy.")
(From the Targeted Intervention Research Study in Senegal) |
Alternatives to Clinic-Based Care
TIR results and experience in many countries with limited resources and infrastructures for STI care suggest that alternative non-clinic-based approaches should be considered to help address the critical STI control problems in resource-poor countries.
Many aspects of the STI control model of specialized treatment and referral centers developed in industrialized countries may not be appropriate, feasible, or transferable to resource-poor settings. In these settings it is common for STIs to be treated by primary health care workers who have received little or no training in STI management. Therefore, STI control must compete for resources with other important and less stigmatized health problems.
The quality of STI care is often in questioned as well. The results of AIDSCAP-sponsored prevalence and antibiotic susceptibility studies showed that the drugs prescribed by health providers are often ineffective. These studies attributed drug ineffectiveness to a lack of laboratory data, a lack of available antibiotics, and the absence of national guidelines based on data.
Individuals tend to receive ineffective antibiotics whether they receive care from established clinics, self-medication, or the informal sector (i.e., pharmacies or retired or off-duty health personnel); therefore, an approach to make effective drugs more available should improve the control of STIs.
Two approaches to addressing this problem -- training pharmacy workers in syndromic management and promotion of prepackaged therapy and prevention for urethritis -- have been field-tested by AIDSCAP.
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In Ethiopia, 61 percent of the men and 41 percent of the women interviewed had sought treatment at a pharmacy or from a local injector or traditional healer before consulting at a health center. In Cameroon, as many as 50 percent of male patients with a history of acute urethritis in the previous 12 months decided not to seek care in the formal health sector; they self-medicated instead. The reasons for their actions were long lines at clinics, the cost of lab tests, and long waits for test results and prescriptions, as well as the cost and ineffectiveness of the drugs prescribed. (Trebucq 1994). |
Training Pharmacy Workers
The training of pharmacy workers is particularly relevant in settings where the health infrastructure is weak and where pharmacy personnel are often the only accessible recourse for medical advice and treatment. Enlisting pharmacy workers in STI management acknowledges the significant though informal role this sector plays in providing STI treatment, patient education (prevention education, instructions on medication use, and partner treatment), and condom promotion and distribution.
This approach, however, does not overcome the problem of patients purchasing partial prescriptions because of lack of funds. Furthermore, it is often difficult in a public business setting to guarantee confidentiality and the privacy necessary for gaining customer trust. Public health authorities and members of the medical profession usually do not object to enlisting pharmacy personnel in patient education, but often oppose training these individuals in STI syndromic management. These officials and practitioners must be engaged as partners in the intervention from the onset.
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In Nepal, where the medical infrastructure is limited, pharmacy personnel were taught to dispense antibiotics using the syndromic approach and to provide clients with preventive education and condoms. A baseline evaluation using a mystery shopper with urethritis symptoms found that 81 percent of the drugstore personnel suggested medications to treat the STI symptoms. Of these individuals, only 0.8 percent suggested effective medication to treat urethritis, 14 percent advised condom use, and 5 percent advised partner treatment. After the training, 45 percent suggested effective urethritis medication, 23 percent advised condom use, and 21 percent advised partner treatment. |
Prepackaged STI Therapy
The advantage of attending a clinic for treatment compared to direct purchase of a prescription is minimal because the diagnosis of many STI syndromes is straightforward, especially in diagnosing urethritis in men. The prepackaging of antibiotics for urethritis, along with prevention materials (condoms, partner referral cards, instructions) and educational materials, could well be an appropriate strategy to address the problem of improved STI management through a social marketing approach.
Social norm change, in the form of improved STI management practices by providers and improved treatment-seeking by those with STIs, can be stimulated through prepackaged STI therapy. The package and its contents can shape provider and patient perceptions of STI care by emphasizing the following facts: (1) STIs must be prevented; (2) STIs must be treated quickly with specific drugs; (3) partners must be treated; and (4) condoms must be used to prevent STIs. The use of prepackaged therapy can also reinforce the use of syndromic management by providers and patients.
AIDSCAP/FHI piloted a prepackaged therapy project -- Mstop -- in Cameroon. Ten months after the project started, only 1,421 kits had been sold. Reasons for low sales included lack of access to the kit and the failure of physicians and nurses to prescribe it. Evidence of this failure came from mystery patients. Only 27 percent of the trained health care providers actually prescribed Mstop to mystery patients who visited the providers. The other providers requested lab tests first or prescribed other antibiotics that were either prescribed incorrectly or needlessly.
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Situation: High incidence of urethritis in young men, high levels of self-treatment, widespread use of inappropriate and ineffective drugs by physicians and pharmacies, and widespread undermedication through partial prescription filling. Objective: Make effective STI drugs both available and affordable in primary health care facilities and private pharmacies, improve compliance with drug treatment, increase knowledge of STIs in male STI patients, train health care providers in syndromic management of urethritis, and improve partner notification by using attractive referral cards. Treatment and prevention kit: Included antibiotics for the two major causes of male urethritis, STI education leaflet, eight condoms, and two partner referral cards; obtained by prescription only at U.S.$17; and piloted in a few health care facilities and three pharmacies in Douala and Yaoundé, Cameroon. Results: Only 1,421 kits were sold in 10 months; only 50 percent of the providers gave prevention advice. Follow-up patients who used the kit showed high levels of satisfaction: 98 percent took the two tablets for gonococcal infection, 83 percent took the 10 days of medication for chlamydial infection, 84 percent used condoms while on treatment, and 44 percent used their partner referral cards. |
Lessons from Mstop
Assessment of the following options for prepackaged therapy is critical prior to launching a prepackaged therapy initiative: placing the product only in pharmacies with or without the requirement of a prescription; making the product available in STI, maternal and child health/family planning, primary care, or other clinical sites with or without a prescription; and making the product available by prescription only.
The feasibility of these approaches depends on the health infrastructure in the country; current response to demands for diagnosis and treatment; sufficiency of the current system or the need for an alternative one; availability and acceptability of STI services to the general public; availability of drugs; current use of alternative sources of care; use of social marketing approaches in other areas such as family planning, midwifery, and condoms; current dispensing practices; the policy environment; availability of STI data; and the receptivity of local collaborators.
- Provider acceptance of syndromic management increases the chances of provider support for prepackaged therapy. Ministry of Health support is essential. Cameroon's drug registration laws were a major issue, and the promotion of Mstop available without a prescription was disturbing to the medical community.
- Although the Cameroon project did not achieve the anticipated level of success, the rationale for marketing syndrome-selective kits for STI treatment and prevention remains valid. The final consensus on this approach should be reserved until after it has been thoroughly tested. The concept of packaging effective drugs (ideally single-dose drugs) and prevention material for managing STI syndromes could be modified for specific country situations. Some examples include the following:
- A syndromic package of generic drugs and prevention materials could be sold in public sector clinics as part of a cost-recovery scheme. If sales were limited in the public sector clinics where drugs are often supplied free of charge or for a nominal cost, the pharmaceutical industry might be less resistant.
- A syndromic management kit of effective drugs and prevention materials could be marketed to health care providers through the usual and accepted routes of current pharmaceutical marketing, thus ensuring consistently effective treatment for STI syndromes and reinforcing the syndromic management approach.
- A syndromic management kit could be marketed to pharmacists to be made available by prescription. Drugs that are single-dose and orally administered are preferable because injections would require a return trip to a health care facility. This approach would reinforce syndromic management by health care providers.
- A syndromic management kit could be marketed to the public as an over-the-counter product available without prescription. This approach would be appropriate only for male urethritis, since genital ulcer disease requires an injection and vaginal discharge in women is a nonspecific symptom. This avenue deserves careful study before it can be promoted.
Challenges for the Future
Additional Strategies
The syndromic approach to STI management is not the complete solution for controlling STI. Syndromic management -- the recognition of a group of clinical findings and patient symptoms -- was developed as a tool that would allow health care workers to effectively manage patients with symptoms without sophisticated laboratory tests, without specialized skills, and within the time frame of a single clinic visit. It works well for urethral discharge in men, genital ulcer disease in both men and women, and pelvic inflammatory disease in women, but is less than optimal for managing vaginal discharge.
Additional components to a comprehensive STI control strategy include the following:
- Targeting services to high-risk populations, which is especially important because resources are often limited.
- Implementing comprehensive syphilis screening and treatment programs in antenatal clinics and referring and treating partners of seroreactive women.
- Developing rapid, inexpensive diagnostics for gonococcal and chlamydial infection to improve the management of symptomatic women and to identify asymptomatic infection.
Improving STI Care for Women
STI prevention and management can be integrated into maternal and child health/family planning settings even though the case management methods available and the existing health infrastructures have limitations. All clinics should be able to provide prevention services whereby health care providers are able to (1) counsel for the reduction of high-risk behavior, including condom demonstration; (2) recognize and refer women with findings suggestive of an STI found on routine examinations; (3) refer symptomatic women; and (4) discuss STI prevention and contraceptive options.
Better health care for women can also be achieved through syndromic management of symptomatic women and women with clinical findings of STIs; linkages with clinics treating female partners of symptomatic men; screening and treatment of syphilis; and presumptive treatment in high-prevalence settings.
In addition, if laboratory services are available, specific testing for STIs can be done. Clearly, the integration of STI services into reproductive health settings is a challenge that will require a significant amount of operations research.
Innovative Approaches
The critical constraints in resources and infrastructure that are typical of most developing country settings make improved and creative approaches to STI control an urgent need. Periodic empirical treatment of selected STIs among high-risk populations (often referred to as mass treatment) is a potential strategy to achieve a rapid decrease in a community's reservoir of STIs. This approach offers the advantages of achieving a decline in STIs more quickly than sexual behavior changes alone and providing treatment for asymptomatic individuals who would not otherwise seek it. Several potential risks associated with this approach include (1) the antibiotic resistance of STI pathogens and other important pathogens in the community; (2) the disruption of an individual's normal flora and subsequent natural resistance; and (3) an increase in high-risk sexual behavior. Careful research is needed to evaluate this approach. It will also be important to implement and carefully evaluate prepackaged STI therapy and prevention kits and STI prevention marketing.
Antibiotic Resistance
One of the major problems encountered in the management of STIs is resistance against antibiotics, especially for gonococcal infections. Since resistance patterns against antibiotics may differ substantially by region and by country, the adaptation of STI guidelines for country and regional use is hampered by a lack of reliable and representative data on gonococcal antimicrobial resistance. Furthermore, high-level quinolone resistance has been identified in Asia, and it is only a matter of time before quinolone-resistant strains become a global problem.
The establishment of a global network of laboratories using a common methodology for regional and global gonococcal surveillance would greatly facilitate guideline development and updating. In addition, the quality of locally made antibiotics -- both the concentration of active ingredient and the bioavailability -- should be monitored routinely to ensure that these antibiotics are not contributing to the emergence of gonococcal antimicrobial resistance, especially in Southeast Asia. The availability of effective antibiotics remains a constant challenge.
STI Communication
STI messages must address more than treatment issues. They should promote behavioral risk recognition, partner referral, condom use and other preventive measures, symptom recognition, and treatment-seeking behavior. Furthermore, cost-effective methods should be developed for provider training and supportive supervision to create truly national STI control programs with strong communication components.
