Acceptability of the Dapivirine Vaginal Ring and Oral Truvada Among African Users in Late-Stage of Pregnancy

AIDS Behav. 2024 Mar;28(3):963-973. doi: 10.1007/s10461-023-04203-z. Epub 2023 Nov 7.

Abstract

The Microbicide Trials Network 042 study (MTN-042/DELIVER) is a two-arm, randomized, open-label Phase 3b trial that is evaluating the safety, adherence, and acceptability of the monthly ring and daily oral PrEP among HIV-uninfected pregnant people in four African countries. This analysis focuses on acceptability data captured qualitatively from a subset (n = 48) of the 150 people in the first cohort of the trial who were enrolled in late-stage pregnancy at 36 to 38 weeks gestational age and followed until after delivery. Single IDIs were conducted by trained interviewers at each clinic site using a semi-structured guide. Data excerpts of key codes pertaining to acceptability, pregnancy, and maternal health were summarized, reviewed and interpreted by multinational analyst teams. Although the product use period was relatively short, the data suggested several acceptability findings that may directly translate to longer durations of product use in pregnancy. The first was the overarching maternal sentiment that being able to protect both oneself and their baby was highly valued. The second was the importance of counseling support from providers not only because participants used methods that might generate side effects, but because pregnancy itself is a period with its own set of side effects. The third was that, similar to non-pregnant participants in other trials, here study products were generally liked and described as easy to use. Concerns about ring and oral PrEP use could be addressed with provider counseling and support and should form an essential component rollout among pregnant people.

Keywords: Dapivirine ring; HIV prevention; Malawi; Oral PrEP; Pregnant women; South Africa; Uganda; Zimbabwe.

MeSH terms

  • Africa / epidemiology
  • Anti-HIV Agents* / therapeutic use
  • Clinical Trials, Phase III as Topic
  • Contraceptive Devices, Female*
  • Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Female
  • HIV Infections* / prevention & control
  • Humans
  • Pregnancy
  • Pyrimidines*
  • Randomized Controlled Trials as Topic

Substances

  • Anti-HIV Agents
  • Dapivirine
  • Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Pyrimidines