P53.03
Background: Women's vulnerability to HIV-1 remains high in sub-Saharan Africa where transmission occurs mainly through heterosexual sex. Antiretroviral prophylaxis, is a promising biomedical HIV-1 prevention strategy.
Methods: ASPIRE - A Study to Prevent Infection with a Ring for Extended Use - is a phase III, randomized, double-blind, placebo-controlled trial testing the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection. Initiated in August 2012, HIV-1 sero-negative women between 18–45 years are being recruited from 15 trial sites in Malawi (MW), South Africa(SA), Uganda(UG), and Zimbabwe(ZIM). Eligible participants must be sexually active, have normal serum chemistry and hematology profiles, gynecologic examinations, not be pregnant nor planning to fall pregnant for the duration of participation. Post enrolment, participants attend monthly visits for HIV-1 counseling and testing, provision of a HIV-1 risk-reduction care package, adherence counseling, and provision of a new vaginal ring, to be worn continuously for the following month.
Results: As of March 2014, enrolment is ongoing with 2303 HIV-1 negative women enrolled in a screen:enrol ratio of 2.1:1. The median age is 26 years with 39% <25 years and 14% >35 years. Overall, 100% reported having a primary partner in the 3 months prior to enrolment and 18% reported≥1 other partner. Eight percent of SA participants report being married, with 84% in ZIM, 82% in MW and 66% in UG. Forty percent report no condom use with the last sex act prior to enrolment. Chlamydia and gonorrhoeae prevalence is 14% and 4% respectively. Baseline contraceptive use reflects a wide method mix: 41% injectable depot medroxyprogesterone acetate, 19% contraceptive implants, 14% injectable Norethisterone enanthate, 13% intrauterine devices, and 11% oral contraceptive pills.
Conclusions: African seronegative women at risk of HIV−1 infection can be successfully enrolled into a trial of dapvirine vaginal ring for HIV-1 prevention.
