Are previous enrollees in a feasibility study a suitable study population from which to recruit for an HIV prevention trial?
Objectives: To explore the association between enrolment in a feasibility study and risk of HIV infection during an HIV prevention trial. Methods: Between August 2002 and October 2003 we conducted a study to assess the feasibility of implementing a vaginal microbicide study among recreational workers in Mwanza, Tanzania. In February 06 we began enrolment into a randomized, placebo-controlled vaginal microbicide study to assess the safety and efficacy of PRO 2000/5 vaginal microbicide gel for HIV prevention, recruiting from the same target population. Willingness to receive HIV test results was an inclusion criterion in the clinical trial but not in the feasibility study. Results: Baseline HIV prevalence among women screened into the clinical trial was 18.6% compared to 25.5% at enrolment into the feasibility study. 512/1573 (32.5%) enrolled in the feasibility study were unwilling to know their HIV status. Of women screened for enrolment into the randomized clinical trial, 183/1520 (12.0%) had previously participated in the feasibility study. Women previously enrolled in the feasibility study were older (median age 35 vs. 30 years, p
Moffat, C. Are previous enrollees in a feasibility study a suitable study population from which to recruit for an HIV prevention trial? Presented at Microbicides 2008, New Delhi, India, 24-27 February 2008. (2008)