Abstract
BackgroundA 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 Findings1573 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/SignificanceWomen 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.
Highlights
In many developed and developing countries, HIV prevention trials are usually undertaken among vulnerable, disadvantaged communities at high-risk of HIV and sexually transmitted infections (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]
We present data on cohort retention, factors associated with loss to follow-up, and HIV, STI and pregnancy incidence over 12 months of follow-up among initially HIV sero-negative, non-pregnant women who would be eligible for future phase III HIV prevention trials
General characteristics of the study population Participatory community mapping conducted in March 2002 showed that there were around 2494 women working in 953 food and recreational facilities in ten administrative wards in Mwanza City[37]
Summary
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]. 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 operate at unusual hours or at weekends in order to encourage potential participants to attend[4,12,26] In addition to these considerations, researchers planning vaginal microbicide trials need to take into account pregnancy rates and the prevalence and nature of intravaginal hygiene practices in any proposed study population. 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
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
