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. RESULTS: Nearly four-fifths of participants (n=104, 79%) reported that they had misinformed trial interviewers at least once. Motivations included politeness (n=45, 34% of ACASI participants) to avoid criticism or seek praise (n=32, 24%), and embarrassment (n=24, 18%). Participants acknowledged misreporting eligibility characteristics to enroll (11%) and, during follow-up, exaggerating their enthusiasm for the study gel (13%), applicator (13%), and the effect of the gel on sexual pleasure (13%). In general, women who were untruthful had actually used the gel with condoms less and used the gel alone more than they had reported during the trial. Women overwhelmingly found the computer survey easy. CONCLUSION: Researchers cannot assume that participants always tell the truth about sensitive behaviors in face-to-face interviews. ACASI was efficient and acceptable in this population.

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. The study found that many participants thought that including a condoms-only arm would result in increased product-sharing, male partner resistance to trial participation and decreased enrollment; no clear patterns emerged regarding the potential effect on condom use and cohort retention. The majority of women preferred a monthly visit schedule, would be willing to use a product for 2 years, and thought that their product use would not decrease over time. Thus flexibility in trial design and implementation strategies is needed until evidence-based decisions can be made. When including a condoms-only arm, extra efforts should be made to explain the importance of all study arms to potential participants and to measure adherence and product-sharing.