Integrating oral PrEP delivery among African women in a large HIV endpoint‐driven clinical trial

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.

Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study

“…In the ECHO trial, women who initiated PrEP had characteristics correlated with increased risk, such as never married, having multiple partners, and testing positive for curable sexually transmitted infections. 16 A limitation of our study is that access to PrEP was confounded with calendar time; thus we cannot rule out the possibility of falling HIV incidence as partly explained as a cohort effect. In addition to selecting follow-up time to reduce the potential for confounding, we evaluated trends for reducing incidence in calendar time, study time, and enrolment cohort independent of PrEP access.…”

“…At the nine South African sites, ECHO expanded PrEP access by implementing on-site access to daily tenofovir disoproxil fumarate and emtricitabine, following community consultation, regulatory body notification, staff training, and operational readiness preparation. 16 The change to PrEP provided on-site by study staff began at all nine sites in the last year of the study, between March and June, 2018, and the risk of HIV acquisition continued to be assessed. This natural experiment offered an opportunity to assess whether on-site access to PrEP at the South African clinical sites reduced HIV incidence.…”

Adoption of guidelines on and use of oral pre-exposure prophylaxis: a global summary and forecasting study

“…Although the target of 3 million PrEP users by 2020 will be missed, PrEP use is likely to continue to rise at an accelerated pace with continuing adoption and implementation of PrEP policies by countries. The integration of PrEP services, including long-acting methods, with other health services, such as sexual and reproductive health services, 31 , 32 might improve uptake and adherence and can further increase the efficiency of service delivery. With greater implementation of PrEP services, increasing awareness, demand, and uptake, a range of method options, and simplified delivery, public health programmes have better opportunities to reach individuals who could benefit from PrEP, prevent new HIV infections, and make substantial progress towards the UN declaration of ending AIDS by 2030.…”

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

“…The ECHO trial was ongoing at the time of the SAMRC recommendation and shifted from offering PrEP via referral to off-site facilities where available, to on-site provision at the SA study sites, in addition to referral. The integration of PrEP delivery into the ECHO trial has been described previously [ 14 ]. Here, we present data on the uptake of PrEP, reasons for initiating and discontinuing PrEP, side effects experienced, perceived HIV risk, self-reported adherence to PrEP, disclosure of PrEP use and post-trial access to PrEP among women at one study site in Durban, SA.…”