Trial reportJournal of acquired immune deficiency syndromes (1999)2024
DELIVER: A Safety Study of a Dapivirine Vaginal Ring and Oral PrEP for the Prevention of HIV During Pregnancy.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Oral pre-exposure prophylaxis initiation, continuation and adherence among pregnant and postpartum women receiving antenatal and postnatal care: a systematic review.Journal of the International AIDS Society · 2025Pooled it
- Vaginal Microbiota and Cytokines Among Pregnant and Breastfeeding Women in Clinical Trials of the Dapivirine Vaginal Ring and Oral Tenofovir Disoproxil Fumarate/Emtricitabine.Open forum infectious diseases · 2026Trial
- Trial
- Just4Us: Acceptability and Feasibility of a Woman-Focused Pre-exposure Prophylaxis (PrEP) Randomized Controlled Trial Intervention.Archives of sexual behavior · 2026Article
- Maternal and pregnancy outcomes in women offered daily oral preexposure prophylaxis during pregnancy and postpartum.AIDS (London, England) · 2026Article
- Advancing ethical biomedical HIV prevention research for pregnant and lactating people.AIDS (London, England) · 2026Article
- Estimated adherence to the Dapivirine Vaginal Ring and its associated factors among African women: A systematic review and meta-analysis.PLOS global public health · 2026Article
- A rapid qualitative analysis of health care worker and community focus groups on determinants and implementation strategies for long-acting PrEP in antenatal and postpartum settings in Kenya.Discover health systems · 2026Article
- Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group.Frontiers in public health · 2026Article
- Barriers, beliefs, and biomedical prevention: a qualitative study of PrEP among justice-involved peripregnant women who use drugs.Health & justice · 2025Article
- Multisector global collaboration to advance the inclusion of pregnant and lactating people in HIV prevention research.AIDS (London, England) · 2025Article
- Article
- Postpartum women's prospective acceptability of long-acting HIV prevention approaches in Kenya: a qualitative study.BMC health services research · 2025Article
- Long-acting pre-exposure prophylaxis preferences among pregnant and postpartum women in Kenya: results from a discrete choice experiment.AJOG global reports · 2025Article
- Antiretroviral Use for HIV Prevention During Pregnancy: The Need to Strengthen Regulatory and Surveillance Systems in Africa.Drug safety · 2025Article
- Understanding PrEP misconceptions and their impact on PrEP initiation and use among pregnant and lactating women in Malawi.PLOS global public health · 2025Article
- Southern African HIV Clinicians Society guideline on pre-exposure prophylaxis to prevent HIV.Southern African journal of HIV medicine · 2025Article
- Preventing perinatal HIV acquisition; current gaps and future perspectives.Current opinion in HIV and AIDS · 2024Review
- Acceptability of the Dapivirine Vaginal Ring and Daily Oral Pre-exposure Prophylaxis (PrEP) during Pregnancy in Malawi, South Africa, Uganda, and Zimbabwe.AIDS and behavior · 2024Article
- Perinatal outcomes associated with pre-exposure prophylaxis for HIV prevention during pregnancy: a systematic review and meta-analysis.EClinicalMedicine · 2024Article
Corrections and comments
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Authors and funding
14 authors at 11 institutions in 5 countries.
Funding
Abstract
backgroundPregnancy represents a period of high HIV acquisition risk. Safety data for the monthly dapivirine vaginal ring (DVR) during pregnancy are limited. Here, we report data from the first 2 cohorts of pregnant participants in MTN-042/DELIVER, a phase 3b, randomized, open-label safety trial of DVR and oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). MTN-042 is being conducted in 3 cohorts beginning with later gestational ages when risks of drug exposure are less.
methodsEligible pregnant individuals aged 18-40 years in Malawi, South Africa, Uganda, and Zimbabwe were randomized 2:1 to monthly DVR or daily TDF/FTC. Participants in cohort 1 initiated product use between 36 weeks 0 days (36 0/7 weeks) and 37 6/7 weeks gestation; participants in cohort 2 initiated product use between 30 0/7 and 35 6/7 weeks gestation. All participants continued product use until delivery or 41 6/7 weeks gestation. Pregnancy outcomes and complications were assessed and summarized using descriptive statistics and compared with local background rates obtained through a separate chart review.
resultsOne-hundred and fifty participants were enrolled into cohort 1 with 101 randomized to DVR and 49 to TDF/FTC. One-hundred and fifty-seven participants were enrolled into cohort 2 with 106 randomized to DVR and 51 to TDF/FTC. In both cohorts, pregnancy complications were rare and similar to local background rates.
conclusionIn this first study of a long-acting HIV prevention agent in pregnancy, adverse pregnancy outcomes and complications were uncommon when DVR and TDF/FTC were used in the third trimester of pregnancy, suggesting a favorable safety profile for both prevention products.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.