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Introduction of PrEP reduces infections in women

The introduction of PrEP into a large study that was designed to find out if contraceptives increased the risk of HIV in women allowed for a “natural experiment” to see if it reduced HIV incidence in trial participants, the 23rd International AIDS Conference (AIDS 2020: Virtual) heard.

Professor Deborah Donnell of the Fred Hutchinson Cancer Research Centre of the University of Washington told attendees that the introduction of PrEP into the ECHO Study cut HIV incidence in participants by 55%. This is particularly impressive because this 55% reduction was seen in all study participants – whether or not they took PrEP themselves.

ECHO randomised 7,829 women in Eswatini, Kenya, South Africa and Zambia to use either a copper intrauterine device, a levonorgestrel implant, or injections of depot medroxyprogesterone acetate (DMPA) as contraceptives and to see if any of them raised the risk of acquring HIV, as had been speculated in the case of DMPA. As reported in June 2019, the study found no indication of raised HIV risk.

ECHO started in December 2015 and ended in October 2018. In November 2017, a stakeholder consultation in Cape Town recommended that PrEP be made available to trial participants. All the sites in South Africa provided PrEP on-site between March and June 2018. Study participants in other countries were referred to other clinics for PrEP and are not included in this analysis.

Three-quarters of ECHO participants (5670 women) were enrolled in South Africa. Of these, some had already finished the study, but 2043 had some time in the study after the introduction of PrEP. Of these, 543 (26.6%) initiated PrEP.

Abstract
Introduction: Global 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.
Methods: ECHO 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.
Results: PrEP 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.
Conclusions: There 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.

Authors
Ivana Beesham, Julia D Welch, Renee Heffron, Melanie Pleaner, Lara Kidoguchi, Thesla Palanee‐Phillips, Khatija Ahmed, Deborah Baron, Elizabeth A Bukusi, Cheryl Louw, Timothy D Mastro, Jennifer Smit, Joanne R Batting, Mookho Malahleha, Veronique C Bailey, Mags Beksinska, Deborah Donnell, Jared M Baeten

Abstract
International AIDS Conference (AIDS 2020: Virtual), abstract OAC0105, 2020

[link url="https://www.aidsmap.com/news/jul-2020/second-study-finds-introducing-prep-africa-considerably-reduces-hiv-infections-women"]Full Aidsmap report[/link]

[link url="https://onlinelibrary.wiley.com/doi/full/10.1002/jia2.25491"]Journal of the International Aids Society abstract[/link]

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