Acceptability research across diverse settings through all stages of microbicide research, development, and post-licensure dissemination can help maximize acceptability and use.

PRO 2000 Gel was safe and well tolerated in sexually active HIV-uninfected and sexually abstinent HIV-infected women, enabling the product to be considered for evaluation in efficacy trials.

Background Limited data exists on effect of tenofovir (TDF) when used for Pre exposure prophylaxis (PrEP) on bone mineral density (BMD) in HIV negative women. We evaluated the effect of daily oral TDF and emtricitabine/TDF (FTC/TDF) compared to placebo on BMD among women enrolled in an HIV-1 PrEP trial. Methods HIV-uninfected women in Uganda and Zimbabwe had BMD measurements of lumbar spine (LS) and total hip (TH) via dual energy x-ray absorptiometry (DXA) at baseline and every 24 weeks for 48 weeks of active treatment and for 48 weeks after discontinuation of study medication. Plasma tenofovir levels were assessed every 12 weeks for the first 48 weeks. Results Of 518 women enrolled, 432 had DXA results at baseline and week 48. In the primary analysis, no significant differences in percent BMD change in hip or spine between arms observed, likely due to low product adherence. Among the subset with tenofovir detection in 75–100% of plasma samples, the mean percent BMD change from baseline to week 48 in the LS was 1.4% lower for TDF or FTC/TDF recipients than for placebo (p=0.002) and TH BMD was 0.9% lower (p=0.018). BMD changes from end of active treatment to 48 weeks were significantly greater in the active arm participants compared to placebo participants with a net difference of approximately +0.9% at the LS (p=0.007) and +0.7% (p=0.003) at the TH. Conclusion TDF-containing oral PrEP resulted in small but significant reversible decreases in hip and spine BMD among young African women.