No sex for science? Formative research on the acceptability and feasibility of a true contraceptive efficacy clinical trial.

BACKGROUND: Recruitment challenges and restrictions on intercourse frequency and timing have stymied previous attempts to implement true contraceptive efficacy clinical trials. STUDY DESIGN: Qualitative research was conducted in Madagascar, South Africa, and the United States to explore the acceptability of three potential true contraceptive efficacy study designs and the feasibility of recruitment for such trials, including characteristics of potential participants who may be willing to join. RESULTS: Participants preferred the study design with the least restrictive sex criteria: participants have sex with assigned contraceptive method/no method on days around ovulation and use condoms on other days. Participants suggested that condom adherence would be low. Differences were noted across sites on whether female participants should be actively seeking pregnancy or not actively seeking pregnancy but willing to accept a pregnancy. Recruitment of participants was expected to be difficult. CONCLUSIONS: Data suggest that a true contraceptive efficacy clinical trial may not be feasible at this time in these settings.

Randomised controlled trial of alternative male and female condom promotion strategies targeting sex workers in Madagascar.

OBJECTIVES: To assess whether individual clinic-based counselling as a supplement to peer education for male and female condom promotion leads to greater use of protection and lower STI prevalence among sex workers in Madagascar already exposed to intensive male condom promotion. METHODS: In two public dispensaries in Madagascar, a total of 901 sex workers were randomly allocated between two alternative male and female condom promotion INTERVENTIONS: peer education only, or peer education supplemented with individual clinic-based counselling. Participants were followed for 12 months. Every 2 months they made clinic visits, where they were interviewed on condom use. Peer educators counselled all participants on condom use as they accompanied their assigned participants to study visits. Participants assigned to receive the supplemental intervention were counselled by a trained clinician following study interviews. Participants were tested and treated for chlamydia, gonorrhoea and trichomoniasis every 6 months. We used logistic regression to assess whether the more intensive intervention was associated with reduced STI prevalence. Use of protection with clients and non-paying partners was assessed by study arm, site, and visit. RESULTS: There was no statistically significant association between study arm and aggregated STI prevalence. No substantial differences in levels of reported protection were noted between study groups. CONCLUSIONS: This study found little evidence for gains from more thorough clinical counselling on male and female condom use. These findings suggest that less clinically intensive interventions such as peer education could be suitable for male and female condom promotion in populations already exposed to barrier method promotion.