Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews.

Objective: We investigated whether participants in a phase II randomized clinical trial of a candidate vaginal microbicide ever intentionally misled interviewers.

Study Design And Setting: We used audio computer-assisted self-interviews (ACASI) to ask the South African women (n=132) participating in the trial about the accuracy of self-reported data collected during face-to-face interviews. The trial protocol recommended that women use their assigned gel (active microbicide or placebo) with condoms during each vaginal sex act.

Microbicide trials for preventing HIV/AIDS in South Africa: phase II trial partricipants' experiences and psychological needs.

The Microbicide Division of the Department of Medical Microbiology at MEDUNSA, South Africa, recently completed a phase II expanded safety trial of the candidate microbicide Carraguard. A microbicide is a vaginal product that women might use, if proven safe and effective, to protect themselves from HIV and possibly other sexually transmitted infections (STIs). The study participants were from Ga-Rankuwa and its neighbouring areas, an historically disadvantaged residential township near Pretoria.

Phase III microbicide trial methodology: opinions of experienced expanded safety trial participants in South Africa.

In preparation for effectiveness trials of candidate vaginal microbicides, scientists are debating trial design and implementation challenges, including choice of control arm(s), product-sharing across arms, and visit schedules. This study involved a survey of South African women participating in an expanded safety trial of the candidate microbicide Carraguard gel. The first 100 consenting women who attended the study clinics in Ga-Rankuwa and Gugulethu (total N = 200) were interviewed; all women had been using a study gel for at least 6 months at the time of the interview.