Trial reportJournal of the International AIDS Society2020
Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial.
Trial report in Journal of the International AIDS Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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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.
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Who cites it
17 citing papers in PubMed, 25 citations in OpenAlex.
- Incidence of Herpes Simplex Virus Type 2 Infection Among African Women Using Depot Medroxyprogesterone Acetate, a Copper Intrauterine Device, or a Levonorgestrel Implant for Contraception: A Nested Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Daily Oral Pre-exposure Prophylaxis (PrEP) Continuation Among Women from Durban, South Africa, Who Initiated PrEP as Standard of Care for HIV Prevention in a Clinical Trial.AIDS and behavior · 2022Trial
- High HIV incidence among young women in South Africa: Data from a large prospective study.PloS one · 2022Trial
- Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study.The lancet. HIV · 2021Trial
- Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial.Journal of the International AIDS Society · 2020Trial
- Article
- Factors associated with women's preference for an over-encapsulated Dual Prevention Pill: Findings from two clinical crossover trials among women in South Africa and Zimbabwe.Research square · 2025Article
- Disclosure of oral pre-exposure prophylaxis use for HIV prevention among women enrolled in a contraceptive study: qualitative findings from Durban, South Africa.Frontiers in global women's health · 2024Article
- Preparing for long-acting PrEP delivery: building on lessons from oral PrEP.Journal of the International AIDS Society · 2023Article
- Integrating pre-exposure prophylaxis of HIV infection into family planning services: a scoping review.BMJ sexual & reproductive health · 2023Article
- Post-trial access to and use of pre-exposure prophylaxis in Durban, South Africa.BMC public health · 2023Article
- Knowledge, Attitudes, and Practices of Sex Workers of Three South African Towns towards Female Condom Use and Contraceptives.Healthcare (Basel, Switzerland) · 2023Article
- The impact of prevention-effective PrEP use on HIV incidence: a mathematical modelling study.Journal of the International AIDS Society · 2022Article
- Adoption of guidelines on and use of oral pre-exposure prophylaxis: a global summary and forecasting study.The lancet. HIV · 2021Article
- Exploring the Use of Oral Pre-exposure Prophylaxis (PrEP) Among Women from Durban, South Africa as Part of the HIV Prevention Package in a Clinical Trial.AIDS and behavior · 2021Article
- The demographic features and outcome indicators of the Barbados HIV Pre-exposure Prophylaxis Program, 2018-2019.Revista panamericana de salud publica = Pan American journal of public health · 2021Article
- A survey-based exploratory study of factors influencing women's intentions to utilise pre-exposure prophylaxis in the Eastern Cape Province, South Africa: sociodemographic characteristics, HIV risk behaviours and transactional sex.Therapeutic advances in infectious diseaseArticle
Corrections and comments
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Authors and funding
19 authors at 6 institutions in 3 countries.
Funding
Abstract
introductionGlobal guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.
methodsECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression.
resultsPrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit.
conclusionsThere is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.
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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.