Background: Female sex workers (FSWs) at substantial risk of HIV are potentially a suitable group for HIV prevention\ntrials including vaccine trials. Few HIV vaccine preparatory studies have been conducted among FSWs in Sub-Saharan\nAfrica (SSA); data are therefore limited on acceptability of vaccine trial procedures. We determined vaccination\ncompletion and one-year retention among FSWs in Kampala, Uganda.\nMethods: We conducted a prospective study that simulated a vaccine efficacy trial among HIV negative FSWs (18-49\nyears). Hepatitis B vaccine (Engerix B) was used to mimic an HIV vaccine product. Volunteers received 1ml intramuscular\ninjection at 0, 1 and 6months, and made additional visits (3 days post-vaccination and months 3, 9 and 12). They were\ncensored at that visit if diagnosed as HIV positive or pregnant. We collected socio-demographic, behavioral and clinical\ndata at baseline, 6 and 12 months and fitted Poisson regression models with robust standard error to find factors\nassociated with vaccination completion and retention.\nResults: We enrolled 290 volunteers (median age 27 years) of whom 230 reached a study end-point as follows: 7\nbecame HIV infected, 11 became pregnant and 212 completed both the vaccination schedule and 12-month visit\ngiving a retention of 77.9% (212/272). Vaccination completion was 82.4%.\nNon-retention at 1 year was more likely among those reporting symptoms of genital ulcer disease (GUD) in the past 3\nmonths (IRR 1.90; 95% CI 1.09-3.32) and those < 35 years; (IRR 6.59; 95% CI 2.11-20.57). Non-completion of the\nvaccination schedule was associated with being < 35 years (IRR 13.10; 95% CI 1.89-90.92, reporting GUD symptoms (IRR\n3.02; 95% CI 1.71-5.33) and reporting consistent condom use with new sexual partners (IRR 2.57; 95% CI 1.10-6.07).\nConclusions: FSWs are at substantial risk of HIV infection and yet willing to participate in HIV vaccine and prevention\nresearch; young FSWs should be empowered, and those reporting GUD symptoms need close follow up to improve\nparticipation in future HIV vaccine trials.
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