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We examined the continuation of community-organized and financed emergency transport systems implemented by the Community-Based Reproductive Health Project (CBRHP) from 1998 to 2000 in two rural districts in Tanzania. The CBRHP was a multipronged program, one component of which focused on affordable transport to health facilities from the villages. In 2006-2007, we assessed the existence and continuation of community-supported emergency transport systems. A total of 249 persons in 29 villages were surveyed, and qualitative data were collected to identify features of community-supported transport systems that have continued. Twelve villages reported having an emergency transport system for obstetrical/medical emergencies to a dispensary/district hospital. Six systems continue to be community supported and have been functioning since CBRHP activities ended in 2000. In these six villages, the modes of transport include tricycles with platforms, canoes, oxcarts, and stretchers. A total of 272 people have used the emergency transport system since its implementation; 47% were pregnant women experiencing obstetrical difficulties. In 2006, 35% (29/84) of users were women with obstetrical difficulties. The community-supported transport systems provide a critical service to villagers in rural areas who experience health emergencies that necessitate facility level care and while some communities continue to maintain support for these systems, other do not. Future research should focus on examining long-term sustainability of community level efforts aimed at increasing access to health care facilities and explore reasons for community level decisions to continue or discontinue activities over time, to fully understand the process of sustainability. (Contains 2 tables and 1 figure.)

Background: HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods: A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locallyappropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs) conducted immediately after their 4, 24 and 52 week follow-up visits. Results: 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews). In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions: Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings. [ABSTRACT FROM AUTHOR]

Objective: This study was performed to analyze the associations between cervical human papillomavirus (HPV) infection and human immunodeficiency virus (HIV) acquisition, using cervical samples from previous studies in Tanzania and Uganda.Methods: A total of 161 adult women who acquired HIV infection during follow-up and 464 individually matched HIV-seronegative controls were selected from 5 cohorts of women working in bars and recreational facilities. Stored cervical samples were tested for 37 HPV genotypes, using a polymerase chain reaction assay (Roche Linear Array genotyping assay). Multivariate matched analysis using conditional logistic regression was performed to evaluate HPV infection, persistence, and clearance as predictors of HIV acquisition.Results: HIV seroconverters were significantly more likely than controls to frequently drink alcohol and to be infected with Chlamydia trachomatis, Neisseria gonorrhoeae, or herpes simplex virus type 2. There was no evidence of an association between HIV acquisition and any detectable HPV at the visit prior to HIV seroconversion (adjusted odds ratio, 1.02; 95% confidence interval, .66-1.57) or between HIV acquisition and persistent HPV infection (defined as 2 positive HPV genotype-specific test results at least 6 months apart), cleared HPV infection (defined as a positive HPV test result followed by negative HPV genotype-specific test result), or newly acquired HPV infection, compared with HPV-negative women.Conclusions: There was no evidence of association between HPV infection status and subsequent HIV acquisition. These results stand in contrast to other observational studies. [ABSTRACT FROM AUTHOR]

Intravaginal and menstrual practices may potentially influence results of trials of microbicides for HIV prevention through effects on the vaginal environment and on adherence to microbicide and placebo products. As part of the feasibility study for the Microbicides Development Programme Phase 3 trial of a vaginal microbicide in Mwanza, a variety of quantitative and qualitative methods were used to describe these practices, associations with behaviour and underlying social norms among women working in food and recreational facilities. Intravaginal cleansing by inserting fingers and either water alone or soap and water was thought necessary to remove 'uchafu' (dirt), referring to vaginal secretions, including menstrual blood and post-coital discharge. Vaginal cleansing was carried out within 2 hours after 45% of sex acts. Sexual enhancement practices were less common. Intravaginal and menstrual practices and associated behaviours and demographic factors should be measured and monitored throughout microbicide trials to enable analyses of their impacts on microbicide effectiveness. [ABSTRACT FROM AUTHOR]

Background: A feasibility study was conducted to investigate whether an occupational at-risk cohort of women in Mwanza, Tanzania are a suitable study population for future phase III vaginal microbicide trials. Methodology/Principal Findings: 1573 women aged 16-54 y working in traditional and modern bars, restaurants, hotels, guesthouses or as local food-handlers were enrolled at community-based reproductive health clinics, provided specimens for HIV/STI and pregnancy testing, and asked to attend three-monthly clinical follow-up visits for 12-months. HIV positive and negative women were eligible to enter the feasibility study and to receive free reproductive health services at any time. HIV prevalence at baseline was 26.5% (417/1573). HIV incidence among 1156 sero-negative women attending at baseline was 2.9/100PYs. Among 1020 HIV sero-negative, non-pregnant women, HIV incidence was 2.0/100PYs, HSV-2 incidence 12.7/100PYs and pregnancy rate 17.8/100PYs. Retention at three-months was 76.3% (778/1020). Among 771 HIV seronegative, non-pregnant women attending at three-months, subsequent follow-up at 6, 9 and 12-months was 83.7%, 79.6%, and 72.1% respectively. Older women, those who had not moved home or changed their place of work in the last year, and women working in traditional bars or as local food handlers had the highest re-attendance. Conclusions/Significance: Women working in food outlets and recreational facilities in Tanzania and other parts of Africa may be a suitable study population for microbicide and other HIV prevention trials. Effective locally-appropriate strategies to address high pregnancy rates and early losses to follow-up are essential to minimise risk to clinical trials in these settings. [ABSTRACT FROM AUTHOR]

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Objectives: To compare coital diaries and face-to-face interviews (FFIs) in measuring sexual behaviour among women at high risk of HIV. To assess the effect of differing levels of support from researchers on reporting in coital diaries and FFIs.Methods: Three groups of 50 women were randomly selected from a cohort of food and recreational facility workers participating in a microbicide trial feasibility study and received differing levels of researcher support. Minimum support involved delivering and collecting coital diaries weekly; medium support included a weekly FFI and discussion of concerns; intensive support also included an unscheduled mid-week visit when diaries were checked and concerns addressed. All respondents participated in an exit FFI, including questions on sexual behaviour over the four-week study period and study acceptability.Results: Sexual behaviours were generally reported more frequently in coital diaries than weekly or exit interviews. Vaginal and anal sex, male and female condom use, vaginal cleaning and lubrication, sex during menstruation and sex with irregular and regular partners were reported more frequently in coital diaries than exit interviews. In coital diaries, level of support was associated with reporting of vaginal sex and cleaning. In exit interviews, support level was associated with reporting of vaginal sex, vaginal cleaning and sex with regular, irregular and commercial partners. Women with minimum support reported least satisfaction with the research process. Women with intensive support were most likely to report that they informed someone about their study participation and that they completed diaries daily.Conclusion: Compared with FFIs, coital diaries resulted in higher reporting of socially stigmatised activities, and sexual behaviour reporting varied less by level of support. More researcher support enhanced study acceptability. [ABSTRACT FROM AUTHOR]

The article reports on a study that determined baseline characteristics of a group of women working in Mwanza City, Tanzania for a microbicide development program. It involved 1,573 women tested for HIV, sexually transmitted infections (STI) and pregnancy, and were made to attend a clinical follow-up after three months. It was found that 25.5 percent had HIV, 9.7 percent were pregnant and 74.6 percent had herpes type-2, among others, at the initial visit. Clinical reattendance (74.1 percent) were associated with location permanence, and found that HIV-negative women were more likely to return. The article suggested that improved participant understanding of the study and effective tracking could help reduce losses in follow-up studies.

Background: During a microbicide trial feasibility study among women at high-risk of HIV and sexually transmitted infections in Mwanza, northern Tanzania we used participatory research tools to facilitate open dialogue and partnership between researchers and study participants. Methods: A community-based sexual and reproductive health service was established in ten city wards. Wards were divided into seventy-eight geographical clusters, representatives at cluster and ward level elected and a city-level Community Advisory Committee (CAC) with representatives from each ward established. Workshops and community meetings at ward and city-level were conducted to explore project-related concerns using tools adapted from participatory learning and action techniques such as listing, scoring, ranking, chapatti diagrams and pair-wise matrices. Results: Key issues identified included beliefs that blood specimens were being sold for witchcraft purposes; worries about specula not being clean; inadequacy of transport allowances; and delays in reporting laboratory test results to participants. To date, the project has responded by inviting members of the CAC to visit the laboratory to observe how blood and genital specimens are prepared; demonstrated the use of the autoclave to community representatives; raised reimbursement levels; introduced HIV rapid testing in the clinic; and streamlined laboratory reporting procedures. Conclusion: Participatory techniques were instrumental in promoting meaningful dialogue between the research team, study participants and community representatives in Mwanza, allowing researchers and community representatives to gain a shared understanding of project-related priority areas for intervention. [ABSTRACT FROM AUTHOR]

The article focuses on the article "Evaluating the Capacity of Theories of Justice to Serve As a Justice Framework for International Clinical Research" by Bridgett Pratt, Deborah Zion and Bebe Loff, which was concerned with whether health research should contribute to justice in global health. In the article the authors offer their opinions on several points which are raised in Pratt et al.'s article and on microbicides development research in Tanzania.

The article offers a comparison of sexual behavior data collected using coital diary (CD) and clinic-based interview in Mwanza, Tanzania. The survey shows that sex acts recorded in CD are greater compared with the clinic face-to-face interview (Clinic FFI). It notes that 84% of women report using gel for each sex act and vaginal washing.

The suitability and accuracy of using simple human immunodeficiency virus (HIV) rapid (SR) tests in community-based clinics in northwest Tanzania were determined to assess eligibility for participation in clinical trials. The HIV rapid and ELISA test results for 789 women aged 16 to 54 who were screened for two clinical trials of HIV prevention were compared. Women were offered voluntary HIV counseling and testing (VCT) at screening; those who accepted were tested with the Abbott Determine and Trinity Biotech Capillus SR tests in parallel. The results were confirmed by two parallel HIV enzyme-linked immunosorbent assay (ELISA) tests (Abbott Murex HIV Ag/Ab combination and Vironostika Uniform II HIV Ag/Ab) to determine eligibility. Positive samples for any of the four assays were confirmed by a line immunoassay and p24 testing. The parallel SR tests had high concordance (96.2%) with the parallel ELISA algorithm. The sensitivities of the SR tests were 98.6% for Capillus (95% confidence interval [CI], 95.1 to 99.8%), 99.3% for Determine (95% CI, 96.2 to 100%), and 98.6% for the parallel SR (95% CI, 95.1 to 99.8%). The specificities were 99.7% for Capillus (95% CI, 98.9 to 100%), 99.7% for Determine (95% CI, 98.9 to 100%), and 100% for the parallel SR (95% CI, 99.4 to 100%). SR tests are suitable for use in community-based clinical research settings to assess eligibility both for trial participation and for the provision of on-site VCT services.

Actively engaging communities in effective partnerships for the design and implementation of HIV prevention research is vital to the successful conduct of ethically robust, locally-appropriate clinical trials in developing countries. This is especially true in vulnerable at-risk sub-populations, where definitions of "community", "participation" and "representation" can be difficult to apply. This study was conducted to investigate the feasibility of a participatory model of community liaison among an occupational cohort of women at high-risk of HIV and sexually-transmitted infections in Mwanza City, northwest Tanzania in preparation for a Phase III vaginal microbicide trial. This approach was rooted in participatory action-orientated research and used tools adapted from participatory learning and action techniques. During the feasibility study, a mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses was established in 10 city wards. Participatory mapping was carried out by project fieldworkers and wards divided into 78 geographical clusters of facilities in consultation with community members and study participants. Representatives at cluster and ward level were elected in a process facilitated by the site Community Liaison Officer and a site-level Community Advisory Committee established. A logical framework was used to guide the implementation, monitoring and evaluation of the community liaison system (CLS) within the broader feasibility study. The CLS was essential to the successful conduct of the feasibility study and has now been consolidated and expanded as part of the on-going MDP301 Phase III microbicide trial in Mwanza. The participatory model presented in this paper is likely to be generalisable to other vulnerable, stigmatised, at-risk study populations in resource-limited settings.