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

BACKGROUND: As oral pre-exposure prophylaxis (PrEP) becomes the standard of prevention globally, its potential effect on HIV incidence in clinical trials of new prevention interventions is unknown, particularly for trials among women. In a trial measuring HIV incidence in African women, oral PrEP wa...

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Autores principales: Donnell, Deborah, Beesham, Ivana, Welch, Julia D, Heffron, Renee, Pleaner, Melanie, Kidoguchi, Lara, Palanee-Phillips, Thesla, Ahmed, Khatija, Baron, Deborah, Bukusi, Elizabeth A, Louw, Cheryl, Mastro, Timothy D, Smit, Jennifer, Batting, Joanne R, Malahleha, Mookho, Bailey, Veronique C, Beksinska, Mags, Rees, Helen, Baeten, Jared M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8340029/
https://www.ncbi.nlm.nih.gov/pubmed/34126052
http://dx.doi.org/10.1016/S2352-3018(21)00048-5
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author Donnell, Deborah
Beesham, Ivana
Welch, Julia D
Heffron, Renee
Pleaner, Melanie
Kidoguchi, Lara
Palanee-Phillips, Thesla
Ahmed, Khatija
Baron, Deborah
Bukusi, Elizabeth A
Louw, Cheryl
Mastro, Timothy D
Smit, Jennifer
Batting, Joanne R
Malahleha, Mookho
Bailey, Veronique C
Beksinska, Mags
Rees, Helen
Baeten, Jared M
author_facet Donnell, Deborah
Beesham, Ivana
Welch, Julia D
Heffron, Renee
Pleaner, Melanie
Kidoguchi, Lara
Palanee-Phillips, Thesla
Ahmed, Khatija
Baron, Deborah
Bukusi, Elizabeth A
Louw, Cheryl
Mastro, Timothy D
Smit, Jennifer
Batting, Joanne R
Malahleha, Mookho
Bailey, Veronique C
Beksinska, Mags
Rees, Helen
Baeten, Jared M
author_sort Donnell, Deborah
collection PubMed
description BACKGROUND: As oral pre-exposure prophylaxis (PrEP) becomes the standard of prevention globally, its potential effect on HIV incidence in clinical trials of new prevention interventions is unknown, particularly for trials among women. In a trial measuring HIV incidence in African women, oral PrEP was incorporated into the standard of prevention in the trial's last year. We assessed the effect of on-site access to PrEP on HIV incidence in this natural experiment. METHODS: We did a nested interrupted time-series study using data from the ECHO trial. At 12 sites in four countries (Eswatini, Kenya, South Africa, and Zambia), women (aged 16–35 years) were randomly assigned to receive one of three contraceptives between Dec 14, 2015, and Sept 12, 2017, and followed up quarterly for up to 18 months to determine the effect of contraceptive method on HIV acquisition. Women were eligible if they wanted long-acting contraception, were medically qualified to receive study contraceptives, and had not used any of the study contraceptives in the past 6 months. The present analyses are limited to nine South African sites where on-site access to oral PrEP was implemented between March 13 and June 12, 2018. Using an interrupted time-series design, we compared HIV incidence before versus after PrEP access, limited to quarterly study visits at which on-site PrEP access was available to at least some participants and, in a sensitivity analysis, to the 180 days before and after access. The outcome was incident HIV infection, detected using two rapid HIV tests done in parallel for each participant at every scheduled follow-up visit. This study is registered on ClinicalTrials.gov, NCT02550067. FINDINGS: 2124 women were followed up after on-site PrEP access began, of whom 543 (26%) reported PrEP use. A total of 12 HIV seroconversions were observed in 556 person-years (incidence 2·16%) after on-site PrEP access, compared with 133 HIV seroconversions in 2860 person-years (4·65%) before PrEP access (adjusted incidence rate ratio [IRR] 0·45, 95% CI 0·25–0·82, p=0·0085). Similar results were also observed when limiting the analysis to 180 days before versus after PrEP access. A total of 46 HIV seroconversions were observed in 919 person-years within 180 days before PrEP access, compared with 11 seroconversions in 481 person-years in the 180 days following PrEP access (incidence 5·00 vs 2·29 per 100 person-years; IRR 0·43, 95% CI 0·22–0·88, p=0·012). INTERPRETATION: On-site access to PrEP as part of standard of prevention in a clinical trial among women in South Africa was associated with halving HIV incidence, when approximately a quarter of women started PrEP. Providing access to on-site PrEP could decrease incidence in HIV prevention trials. These data are also among the first to show in any setting that access to PrEP is associated with decreased HIV acquisition among South African women. FUNDING: Bill & Melinda Gates Foundation, United States Agency for International Development, President's Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency, South African Medical Research Council, and United Nations Population Fund.
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spelling pubmed-83400292021-08-23 Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study Donnell, Deborah Beesham, Ivana Welch, Julia D Heffron, Renee Pleaner, Melanie Kidoguchi, Lara Palanee-Phillips, Thesla Ahmed, Khatija Baron, Deborah Bukusi, Elizabeth A Louw, Cheryl Mastro, Timothy D Smit, Jennifer Batting, Joanne R Malahleha, Mookho Bailey, Veronique C Beksinska, Mags Rees, Helen Baeten, Jared M Lancet HIV Articles BACKGROUND: As oral pre-exposure prophylaxis (PrEP) becomes the standard of prevention globally, its potential effect on HIV incidence in clinical trials of new prevention interventions is unknown, particularly for trials among women. In a trial measuring HIV incidence in African women, oral PrEP was incorporated into the standard of prevention in the trial's last year. We assessed the effect of on-site access to PrEP on HIV incidence in this natural experiment. METHODS: We did a nested interrupted time-series study using data from the ECHO trial. At 12 sites in four countries (Eswatini, Kenya, South Africa, and Zambia), women (aged 16–35 years) were randomly assigned to receive one of three contraceptives between Dec 14, 2015, and Sept 12, 2017, and followed up quarterly for up to 18 months to determine the effect of contraceptive method on HIV acquisition. Women were eligible if they wanted long-acting contraception, were medically qualified to receive study contraceptives, and had not used any of the study contraceptives in the past 6 months. The present analyses are limited to nine South African sites where on-site access to oral PrEP was implemented between March 13 and June 12, 2018. Using an interrupted time-series design, we compared HIV incidence before versus after PrEP access, limited to quarterly study visits at which on-site PrEP access was available to at least some participants and, in a sensitivity analysis, to the 180 days before and after access. The outcome was incident HIV infection, detected using two rapid HIV tests done in parallel for each participant at every scheduled follow-up visit. This study is registered on ClinicalTrials.gov, NCT02550067. FINDINGS: 2124 women were followed up after on-site PrEP access began, of whom 543 (26%) reported PrEP use. A total of 12 HIV seroconversions were observed in 556 person-years (incidence 2·16%) after on-site PrEP access, compared with 133 HIV seroconversions in 2860 person-years (4·65%) before PrEP access (adjusted incidence rate ratio [IRR] 0·45, 95% CI 0·25–0·82, p=0·0085). Similar results were also observed when limiting the analysis to 180 days before versus after PrEP access. A total of 46 HIV seroconversions were observed in 919 person-years within 180 days before PrEP access, compared with 11 seroconversions in 481 person-years in the 180 days following PrEP access (incidence 5·00 vs 2·29 per 100 person-years; IRR 0·43, 95% CI 0·22–0·88, p=0·012). INTERPRETATION: On-site access to PrEP as part of standard of prevention in a clinical trial among women in South Africa was associated with halving HIV incidence, when approximately a quarter of women started PrEP. Providing access to on-site PrEP could decrease incidence in HIV prevention trials. These data are also among the first to show in any setting that access to PrEP is associated with decreased HIV acquisition among South African women. FUNDING: Bill & Melinda Gates Foundation, United States Agency for International Development, President's Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency, South African Medical Research Council, and United Nations Population Fund. Elsevier B.V 2021-06-11 /pmc/articles/PMC8340029/ /pubmed/34126052 http://dx.doi.org/10.1016/S2352-3018(21)00048-5 Text en © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Articles
Donnell, Deborah
Beesham, Ivana
Welch, Julia D
Heffron, Renee
Pleaner, Melanie
Kidoguchi, Lara
Palanee-Phillips, Thesla
Ahmed, Khatija
Baron, Deborah
Bukusi, Elizabeth A
Louw, Cheryl
Mastro, Timothy D
Smit, Jennifer
Batting, Joanne R
Malahleha, Mookho
Bailey, Veronique C
Beksinska, Mags
Rees, Helen
Baeten, Jared M
Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study
title Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study
title_full Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study
title_fullStr Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study
title_full_unstemmed Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study
title_short Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study
title_sort incorporating oral prep into standard prevention services for south african women: a nested interrupted time-series study
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8340029/
https://www.ncbi.nlm.nih.gov/pubmed/34126052
http://dx.doi.org/10.1016/S2352-3018(21)00048-5
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