Background Evidence from observational studies suggests an increased risk of HIV acquisition among women using depot medroxyprogesterone acetate (DMPA) contraception.
Methods Within the context of a South African programme to increase women's access to the intrauterine contraceptive device (IUD), we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial (RCT) of the IUD versus injectable progestogen contraception (IPC) at two South African hospitals. The primary outcome was pregnancy; secondary outcomes included HIV acquisition. Consenting women attending termination of pregnancy services were randomised after pregnancy termination between July 2009 and November 2012. Condoms were promoted for the prevention of sexually transmitted infections. Voluntary HIV testing was offered at baseline and at 12 or more months later. Findings on HIV acquisition are reported in this article.
Results HIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomisation to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 (83%) of participants received DMPA, 96 (15%) received injectable norethisterone enanthate, 14 (2%) received the IUD and one received oral contraception. In the IUD group 609 (96%) received the IUD, 20 (3%) received IPC and 5 (1%) had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 (3.0%) women in the IPC arm and 22/634 (3.5%) women in the IUD arm (IPC vs IUD, risk ratio 0.88; 95% confidence interval 0.48–1.59; p=0.7).
Conclusions This sub-study was underpowered to rule out moderate differences in HIV risk, but confirms the feasibility of randomised 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.
Trial registration number Pan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).
- hormonal contraception
- DMPA, IUD, HIV, medroxyprogesterone acetate, randomised
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Contributors GJH contributed to study design, data analysis, and the drafting and revision of the report. MS contributed to study design, project management, and data collection. TAL contributed to data analysis and interpretation, and drafting and revision of the report. MT contributed to the drafting and revision of the report. EB contributed to study design. All authors reviewed and approved the final manuscript.
Funding Contraceptive care was provided by the routine clinical services and research costs were internally funded by the Effective Care Research Unit, East London, South Africa.
Competing interests GJH and MS are members of the Evidence for Contraceptive health and HIV Outcomes (ECHO) consortium that is undertaking a multicentre randomised trial of contraceptive methods and HIV acquisition.
Patient consent Obtained.
Ethics approval University of the Witwatersrand Committee for Research on Human Subjects, South Africa.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The authors support data sharing. Additional data on side effects of the contraceptive methods assessed in this study are still to be published.
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