Observational studies suggest an increased risk of HIV acquisition among women using DMPA contraception.
Within the context of a South African program to increase women’s access to the IUD, we conducted a pragmatic, open-label, parallel-arm RCT of the IUD versus IPC at two South African hospitals.
HIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomization to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 participants received DMPA, 96 received injectable norethisterone enanthate, 14 received the IUD, and one received oral contraception. In the IUD group, 609 received the IUD, 20 received IPC, and 5 had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 women in the IPC arm and 22/634 women in the IUD arm.
This sub-study confirms the feasibility of randomized trial methodology to address this question. Larger RCTs are needed to determine the relative risks of various contraceptive methods on HIV acquisition with greater precision.