Young women want choice of PrEP modalities, indicates study in Africa

After spending six months using the dapivirine vaginal ring and six months taking daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP), most young women in a study conducted in Africa elected to continue using the ring, while a substantial minority opted to keep taking oral medications.

About This Study

“Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial” was published online on Oct. 25, 2023, in The Lancet HIV. The lead authors are Gonasagrie Nair, MBChB, of the Centre for Medical Ethics and Law at Stellenbosch University in South Africa, and Connie Celum, M.D., of the Departments of Global Health, of Medicine, and of Epidemiology at the University of Washington in Seattle, Washington.

A related commentary, “PrEParing for choice in a new era of HIV prevention” by Lauren A. Graybill, Ph.D., and Benjamin H. Chi, M.D., M.Sc., both of the Department of Epidemiology at the Gillings School of Global Public Health of the University of North Carolina at Chapel Hill, was published in the same issue.

Key Research Findings

This crossover trial compared the monthly dapivirine vaginal ring and TDF/FTC for PrEP in 247 women 16-21-years-old in southern Africa. Participants were randomized 1:1 to either modality for six months, switched to the other modality for another six months, and then given a choice for the final six-month period. There was 94% retention in the study at 72 weeks.

Drug concentrations measured adherence, with high adherence observed during 57% of visits on either modality. All four seroconversions were associated with low/no adherence. There were 54 ≥ grade 2 adverse events (AEs) on oral PrEP and five AEs on the ring, with no product-related serious AEs. Minor changes in creatinine clearance occurred in both groups.

During the final study period, 65% of participants initially chose the ring, 30% preferred the pills, and 5% decided against PrEP, with 13% of participants switching products over the course of those final six months. Choosing the ring was associated with reporting vaginal sex before study enrollment and choosing oral PrEP was associated with high adherence while on that prevention modality.

Discussion Highlights and Implications for Practice

Study limitations reported by the researchers included less frequent clinic visits during the COVID-19 pandemic and lack of a washout between the two randomization periods.

“HIV prevention coverage is likely to be higher if a choice of PrEP options is offered to meet the needs and preferences of users,” the study authors concluded. However, providers must not try to direct their patients toward a specific modality, the commentary authors cautioned. To that end, decision support tools need to be refined for patient-centered care and adapted to new modalities.

By Barbara Jungwirth