OA09.01
Background: HIV-1 prevalence in Uganda remains among the highest in the world, and recent surveillance data have not seen a significant drop in HIV-1 incidence. The VOICE study evaluated safety and effectiveness of daily use of female-controlled ARV-based oral and topical vaginal HIV prophylaxis. Despite being at risk of HIV-1 acquisition, and having limited prevention tools, many women declined to join the study. We describe the underlying factors that hindered at-risk women from joining VOICE.
Methods: Women aged 18–45 in high-risk communities identified by the Uganda HIV/AIDS sero-Behavioral Survey 2004–05 were sensitized about the VOICE study. Prospective participants' questions and concerns were addressed, and those willing to be screened on site were systematically pre-screened using an IRB-approved checklist with multiple risk questions. Presumptively eligible women were given appointments and reminded by telephone calls.
Results: From November 2009 to December 2011, among the 3,217 women sensitized in the community, only 25% (n=820) were interested and pre-screened. Of those expected to turn up, only 43% (n=356) showed for appointments. Among those who did not turn up (n=464), 78% (n=362) did not know or were not sure of their partners HIV status and feared finding out their HIV status; 58% (n=269) were not living with their partner(s) and could not choose from which partner to obtain permission; and 30% (n=139) had no income and feared losing financial support from their partners. Other factors included fear of side effects, myths and misconceptions about clinical research. Others needed more time to think about participation, and the rest promised to come for screening but later changed their minds.
Conclusions: Women are challenged by the fear of knowing their HIV status, exacerbated by lack of independence to make decisions about study participation. There is more need to sensitize communities about HIV prevention research, participant challenges and involving male partners in research.
