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

the ECHO Trial Consortium

doi:10.1002/jia2.25491

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

the ECHO Trial Consortium

Mailman School of Public Health

Research output: Contribution to journal › Article › peer-review

16 Citations (Scopus)

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.

Original language	English
Article number	e25491
Journal	Journal of the International AIDS Society
Volume	23
Issue number	5
DOIs	https://doi.org/10.1002/jia2.25491
Publication status	Published - May 1 2020

Bibliographical note

Publisher Copyright:
© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.

Funding

The ECHO Trial was funded by Bill & Melinda Gates Foundation, US Agency for International Development and the President’s Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council and UN Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development. IB received funding from the South African Medical Research Council under the SAMRC Clinician Researcher MD PhD Development Programme. The content is the sole responsibility of the authors and does not necessarily represent the official views of the study funders. The ECHO Trial was funded by Bill & Melinda Gates Foundation, US Agency for International Development and the President?s Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council and UN Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development. IB received funding from the South African Medical Research Council under the SAMRC Clinician Researcher MD PhD Development Programme. The content is the sole responsibility of the authors and does not necessarily represent the official views of the study funders. We are grateful to all the women who participated in the ECHO Trial and to the members of the study team and community advisory boards who advocated for PrEP provision. The ECHO Trial was funded by Bill & Melinda Gates Foundation, US Agency for International Development and the President?s Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council and UN Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development. IB received funding from the South African Medical Research Council under the SAMRC Clinician Researcher MD PhD Development Programme. The content is the sole responsibility of the authors and does not necessarily represent the official views of the study funders.

Funders	Funder number
US Agency for International Development
National Institute of Allergy and Infectious Diseases	UM1AI069463
United States Agency for International Development
Bill and Melinda Gates Foundation
Styrelsen för Internationellt Utvecklingssamarbete
U.S. President’s Emergency Plan for AIDS Relief
South African Medical Research Council

ASJC Scopus Subject Areas

Public Health, Environmental and Occupational Health
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1002/jia2.25491

Cite this

@article{7b0d489b8e5c4015a0f89e8ea42e65ab,

title = "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.",

author = "{the ECHO Trial Consortium} and Ivana Beesham and Welch, {Julia D.} and Renee Heffron and Melanie Pleaner and Lara Kidoguchi and Thesla Palanee-Phillips and Khatija Ahmed and Deborah Baron and Bukusi, {Elizabeth A.} and Cheryl Louw and Mastro, {Timothy D.} and Jennifer Smit and Batting, {Joanne R.} and Mookho Malahleha and Bailey, {Veronique C.} and Mags Beksinska and Deborah Donnell and Baeten, {Jared M.} and James Kiarie and Mugo, {Nelly R.} and Helen Rees and Jessica Justman and Zelda Nhlabatsi and Maricianah Onono and Bekker, {Linda Gail} and Gonasagrie Nair and Hofmeyr, {G. Justus} and Mandisa Singata-Madliki and Jennifer Smit and Sydney Sibiya and Jeffrey Stringer and Gichangi, {Peter B.} and Heller, {Kate B.} and Nomthandazo Mbandazayo and Morrison, {Charles S.} and Kavita Nanda and Scoville, {Caitlin W.} and Kathleen Shears and Steyn, {Petrus S.} and Douglas Taylor and Thomas, {Katherine K.} and Selepe, {Raesibe Agnes Pearl} and {Phiri Kasaro}, Margaret",

note = "Publisher Copyright: {\textcopyright} 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.",

year = "2020",

month = may,

day = "1",

doi = "10.1002/jia2.25491",

language = "English",

volume = "23",

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TY - JOUR

T1 - Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial

AU - the ECHO Trial Consortium

AU - Beesham, Ivana

AU - Welch, Julia D.

AU - Heffron, Renee

AU - Pleaner, Melanie

AU - Kidoguchi, Lara

AU - Palanee-Phillips, Thesla

AU - Ahmed, Khatija

AU - Baron, Deborah

AU - Bukusi, Elizabeth A.

AU - Louw, Cheryl

AU - Mastro, Timothy D.

AU - Smit, Jennifer

AU - Batting, Joanne R.

AU - Malahleha, Mookho

AU - Bailey, Veronique C.

AU - Beksinska, Mags

AU - Donnell, Deborah

AU - Baeten, Jared M.

AU - Kiarie, James

AU - Mugo, Nelly R.

AU - Rees, Helen

AU - Justman, Jessica

AU - Nhlabatsi, Zelda

AU - Onono, Maricianah

AU - Bekker, Linda Gail

AU - Nair, Gonasagrie

AU - Hofmeyr, G. Justus

AU - Singata-Madliki, Mandisa

AU - Smit, Jennifer

AU - Sibiya, Sydney

AU - Stringer, Jeffrey

AU - Gichangi, Peter B.

AU - Heller, Kate B.

AU - Mbandazayo, Nomthandazo

AU - Morrison, Charles S.

AU - Nanda, Kavita

AU - Scoville, Caitlin W.

AU - Shears, Kathleen

AU - Steyn, Petrus S.

AU - Taylor, Douglas

AU - Thomas, Katherine K.

AU - Selepe, Raesibe Agnes Pearl

AU - Phiri Kasaro, Margaret

PY - 2020/5/1

Y1 - 2020/5/1

N2 - 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.

AB - 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.

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

Abstract

Bibliographical note

Funding

ASJC Scopus Subject Areas

UN SDGs

Access to Document

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Cite this