Background: Women enrolled in microbicide and pre-exposure prophylaxis (PrEP) HIV prevention trials are not allowed to continue use of study products when pregnant because of fetal safety concerns. High pregnancy rates among women in trials can undermine statistical measures of safety and effectiveness.
Methods: Women enrolled in a PrEP trial in Ghana, Nigeria, and Cameroon had an overall pregnancy rate of 52 per 100 person-years of observation. In-depth interviews were conducted with 67 women who were asked to describe any changes made in their pregnancy prevention practices after enrolling in the trial.
Results: Most women (n = 44, 65%) reported changing pregnancy prevention practices after enrolling in the trial. Twice as many reported using condoms for pregnancy prevention after enrollment (n = 56, 84%) than before (n = 27, 40%). Cluster analysis identified site-specific patterns. Nigerian women tended to report using condoms for dual protection before and after trial enrollment. Cameroonian women tended to rely on natural methods before and after trial enrollment. Ghanaian women tended to switch from hormonal methods to condoms.
Conclusions: The role of condoms in HIV prevention trials must not be diminished. Their use-effectiveness for contraception is likely too low for microbicide and PrEP trial needs, however. HIV prevention trials with women should be appropriately staffed to provide effective contraceptive counseling and, if needed, direct provision of contraceptives. This must be done without undermining women's reproductive rights.