Are Women Who Work in Bars, Guesthouses and Similar Facilities a Suitable Study Population for Vaginal Microbicide Trials in Africa?

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.

The Epidemiology of HIV and HSV-2 Infections among Women Participating in Microbicide and Vaccine Feasibility Studies in Northern Tanzania

“…While the prevalence of HIV was somewhat lower than in earlier studies conducted in similar cohorts [5], [7], [15]–[17], it remained higher than that reported among women in the general population [3]. Women working in these settings are known to be involved in complex sexual networks including multiple partners and exchange of sex for gifts or money [15], [17].…”

“…Score based on the number of positive answers: 0–1 = non-drinker or no problem drinking, 2 = possible problem drinking, ≥3 = probable problem drinking. [5] Based on responses to 10 AUDIT questions. Scores based on responses to each question: 0–7 non-drinker or low-risk, ≥8 harmful or hazardous drinking.…”

“…[4] Estimated RRs adjusted for town, age, education and marital status (the adjusted results for these variables are shown in bold). [5] Other hormonal contraceptives grouped with pill, due to low numbers. [6] Results for syphilis, T. vaginalis (diagnosed by 72-hour culture) and bacterial vaginosis (diagnosed by Nugent criteria) not available for vaccines-preparedness cohort.…”

Caring for sex workers

“…[127][128][129] Unfortunately, sex worker pregnancies are often unintended, and in some countries this leads to unsafe abortions. 17 24 25 35 38 39 127-135 This often reflects a reliance on condoms alone to prevent pregnancy.…”

Emergent HIV technology: urban Tanzanian women's narratives of medical research, microbicides and sexuality

“…They were asked to attend the study clinics on a monthly basis for 12 months to return used gel applicators, collect new gel applicators and condoms, and undergo clinical examinations, HIV tests, and provide information about their sexual lives and other health-related information. Three key messages were reiterated at each clinic visit: that the gel may not prevent HIV; that condoms, when used correctly and consistently, are the most effective form of HIV prevention; and that the participant must stop using the gel if pregnant (see Vallely et al 2010). By the end of the trial, 2183 had women been screened at the Mwanza site and of these 1146 (48%) women participated in the clinical trial.…”