Are Women Who Work in Bars, Guesthouses and Similar Facilities a Suitable Study Population for Vaginal Microbicide Trials in Africa? Andrew Vallely 1,2 *, Ian R. Hambleton 1,3,4 , Stella Kasindi 2 , Louise Knight 1,3 , Suzanna C. Francis 1 , Tobias Chirwa 1,3 , Dean Everett 1,3 , Charles Shagi 2 , Claire Cook 1,3 , Celia Barberousse 1,3 , Deborah Watson- Jones 1,2 , John Changalucha 3 , David Ross 1 , Richard J. Hayes 1 for the Microbicides Development Programme 1 London School of Hygiene and Tropical Medicine, London, United Kingdom, 2 African Medical and Research Foundation, Mwanza, Tanzania, 3 National Institute for Medical Research, Mwanza, Tanzania, 4 Tropical Medicine Research Institute, The University of the West Indies, Bridgetown, Barbados, West Indies Abstract 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 sero- negative, 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. Citation: Vallely A, Hambleton IR, Kasindi S, Knight L, Francis SC, et al. (2010) Are Women Who Work in Bars, Guesthouses and Similar Facilities a Suitable Study Population for Vaginal Microbicide Trials in Africa? PLoS ONE 5(5): e10661. doi:10.1371/journal.pone.0010661 Editor: Landon Myer, University of Cape Town, South Africa Received January 14, 2010; Accepted April 20, 2010; Published May 14, 2010 Copyright: ß 2010 Vallely et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: The Department for International Development and the Medical Research Council, United Kingdom. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no competing interests exist. * E-mail: a.vallely@uq.edu.au Introduction In many developed and developing countries, HIV prevention trials are usually undertaken among vulnerable, disadvantaged communities at high-risk of HIV and STIs, where HIV incidence rates make randomised controlled clinical trials feasible[1,2] but where poverty and social exclusion mean ethical considerations are paramount[3,4]. Such populations may include female sex workers, injecting drug users, men who have sex with men, prison inmates and the homeless[5,6,7,8,9,10,11,12,13,14]. There are considerable ethical and logistical challenges to consider when planning HIV prevention trials in such populations, for example, the need to develop effective locally-appropriate informed consent procedures[4,15,16,17,18,19], of ensuring that trial participation does not exacerbate stigma, vulnerability or social harm[20,21,22]; and to ensure that appropriate locally- agreed standards of clinical care are made available to trial participants, particularly those who seroconvert during the trial or who are HIV positive at screening[23,24,25]. Recruiting and retaining participants from high-risk cohorts is often problematic. In many settings it is difficult to access and meaningfully engage with vulnerable groups in the communi- ty[11,12]. Providing accurate information about trial objectives and procedures; dispelling fears around disclosure and confiden- tiality; and reducing distrust and suspicion between potential participants and external researchers may therefore be difficult, and may hinder trial enrolment. High mobility is common in many vulnerable groups, which makes tracing those who default from follow-up difficult, necessitating the use of community fieldworkers or peer educators[26]. Volunteers from vulnerable groups may be reluctant to attend established health services due to travel and opportunity costs and the way in which they are treated by health centre staff so that it is often necessary to establish community-based study clinics, which may need to PLoS ONE | www.plosone.org 1 May 2010 | Volume 5 | Issue 5 | e10661