Community perspectives on care options for HIV prevention trial participants.

There is on-going global debate and policy-setting concerning researchers' obligations to meet the health needs of people participating in HIV prevention trials in resource-poor settings. The perspectives of local community stakeholders on this issue are poorly understood as most of what is presented on behalf of communities where research takes place is anecdotal commentary. Using qualitative methods (130 in-depth interviews and 20 focus groups) we assessed perceived fairness of different strategies to meet the health needs of women who become HIV-infected during a hypothetical vaginal microbicide trial. Respondents included HIV prevention research participants, community stakeholders and health-care service providers in ten sites in seven countries (South Africa, Malawi, Tanzania, Zimbabwe, Zambia, India, US). Many respondents perceived referrals to be a potentially fair way to address care and treatment needs but concerns were also voiced about the adequacy of local health-care options and the ability of trial participants to access options. Most respondents viewed the provision of antiretroviral treatment by researchers to HIV-infected trial participants as unfair if treatment was not sustained beyond the end of the trial. The results underscore the importance of effectively linking trial participants to sustainable, community-based treatment and care.

The validity of self-reported likelihood of HIV infection among the general population in rural Malawi.

BACKGROUND: Understanding HIV risk perception is important for designing appropriate strategies for HIV/AIDS prevention, because these interventions often rely on behaviour modification. A key component of HIV risk perception is the individual's own assessment of HIV status, and the extent to which this assessment is correct. However, this issue has received limited attention. OBJECTIVES: To examine the validity of self-reported likelihood of current HIV infection among the general population in rural Malawi. METHODS: As part of a panel household survey, data on behaviour and biomarkers were collected for a population-based sample of approximately 3000 respondents in rural Malawi aged > or = 15 years. Information on self-assessed likelihood of currently having HIV was collected by survey interview. Saliva was obtained from all consenting respondents to assess actual HIV status. RESULTS: Of 2299 survey respondents who assessed their likelihood of being infected with HIV at the time of the survey, 71% were accurate. Most incorrect assessments (88%) were due to respondents overestimating (rather than underestimating) their likelihood of being infected with HIV. Women were less likely than men to correctly assess their HIV status. The two most important predictors of false-positive responses were marital status and self-reported health. CONCLUSIONS: Self-reports of HIV infection were generally valid. Most invalid self-reports were due to overestimating the risk of having HIV. The implications of this finding are highlighted, as they pertain to the design of HIV prevention interventions and the expansion of HIV counselling, testing and treatment programmes in developing countries.

Genotypic analysis of the protease and reverse transcriptase of HIV type 1 subtype C isolates from antiretroviral drug-naive adults in Malawi.

The protease (PR) and reverse transcriptase (RT) regions of HIV-1 isolates from 21 antiretroviral (ARV)-naive Malawian adults were sequenced and analyzed to determine the prevalence of drug resistance-associated mutations in this population. Phylogenetic analysis confirmed that all isolates grouped with HIV-1 subtype C, the predominant subtype in Malawi. No major mutations associated with resistance to PR inhibitors (PIs), nucleoside RT inhibitors (NRTIs), or nonnucleoside RT inhibitors (NNRTIs) were found. In contrast, accessory mutations were found in the protease region at positions 10, 20, 36, 63, 77, and 93, and in the RT region at positions 118, 211, and 214. Further studies will be needed to determine the clinical impact of these polymorphisms on viral susceptibility to existing antiretroviral drugs.

A cost comparison of approaches to sexually transmitted disease treatment in Malawi.

Since syndromic management of STDs requires treatment with at least two antibiotics per patient, one of the concerns raised by adoption of the syndromic approach is the cost of drugs, especially for developing countries with limited drug budgets. The objective of the current study is to compare the cost-effectiveness of syndromic management to current national practice for the management of STDs in Malawi. The actual cost of observed antibiotic treatment for 144 patients receiving same day treatment for two STD syndromes in Malawi was determined using prices from the Malawi government supply catalogue. This was then compared to the calculated cost of treatment had the same patients been managed syndromically according to national guidelines. The cost of drug treatment under current practice was similar to the cost of syndromic treatment. However, at least one-third of observed patients did not receive effective treatment for either likely cause of their STD syndrome and wastage accounted for 54% of total observed drug cost. Overall, syndromic management of STDs in Malawi would result in more effective treatment of STDs at no additional cost. Since the indirect costs of low treatment efficacy were not taken into account in this analysis, a net saving is likely to be realized with the adoption of syndromic management.

Quality of case management of sexually transmitted diseases: comparison of the methods for assessing the performance of providers.

This article examines the reliability and validity of direct observation of patient-provider encounters, interviews with providers, and use of patients simulating sexually transmitted diseases (STD) as methods for assessing the quality of STD case management in developing countries. Data were collected during an STD health facility survey in Malawi; the performance of 49 providers was observed, and the providers were also interviewed; 20 of them were visited by a simulated patient complaining of urethral discharge. Agreement (based on the kappa statistic) was generally poor between direct observation and provider-interview data, and also between direct observation and simulated-patient data. In contrast, percentage agreements between direct observation and simulated-patient data were often high. Multiple observations on providers indicated that a provider's behaviour is not consistent across several patients. Simulated-patient data are probably the best in reflecting normal performance, but their feasibility for routine quality assessment is limited because the provider's behaviour is not consistent and would require multiple data points. Direct observation data are the best option for assessing quality if the results are assumed to reflect better than normal levels of quality of care. Data from interviews with providers should be viewed with caution, because they may reflect provider knowledge and not necessarily performance.

PIP: The quality of health care delivery in developing countries has been assessed by many studies using the following methods: direct observation of patient-provider encounters, review of records, exit interviews with clients, interviews with providers, and inventories of facilities, drugs, and supplies. This paper assesses the reliability and validity of the following methods used in a nationwide survey of STD case management conducted in health facilities in Malawi in 1994: the direct observation of provider-patient encounters, interviews with providers, and the use of people who pretend to be patients. The performance of 49 providers was observed. All of the providers were also interviewed and 20 were visited by a simulated patient complaining of urethral discharge. Multiple observations of providers indicated that any given provider does not behave in the same manner with all patients. Simulated-patient data can probably give the most accurate view of a provider's typical performance, but the approach has only limited use in routine quality assessment because the inconsistent nature of providers' behavior would require multiple data points per provider. Direct observation data are the best when measuring quality if the results are thought to be of higher quality than normal care. Data from interviews with providers should be carefully interpreted since they may reflect only provider knowledge and not his or her actual performance.

Sexually transmitted diseases: a survey of case management in Malawi.

A national survey of sexually transmitted disease (STD) case management was carried out at 39 health care facilities in Malawi in 1994. Fifty-four health care providers were observed managing 150 patients presenting with selected STD syndromes and 103 providers were interviewed. STD case management was assessed by calculation of WHO/GPA prevention indicators (PIs) from observation data. The overall rate for PI-6, which measures correct assessment and treatment of STD patients was 11% (81% for history taking, 46% in physical examination, and 13% correct antibiotic treatment according to national guidelines). The score for PI-7, which measures overall patient counselling was 29% (65% for partner notification and 40% for condom advice). Although Haemophilus ducreyi is at least as common as Treponema pallidum as the causative agent for genital ulcers, only 16% of patients with genital ulcers were treated effectively for chancroid vs 56% for syphilis. Female patients received less comprehensive care than male STD patients. Only 20% of STD patients were offered condoms. Overall, the survey results support the policy decision to adopt syndromic management of STDs, and provide baseline information for planning and evaluation of a national control programme.