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HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya
BACKGROUND: The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610957/ https://www.ncbi.nlm.nih.gov/pubmed/31272495 http://dx.doi.org/10.1186/s13063-019-3521-2 |
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author | Ortblad, Katrina F. Kearney, John E. Mugwanya, Kenneth Irungu, Elizabeth M. Haberer, Jessica E. Barnabas, Ruanne V. Donnell, Deborah Mugo, Nelly Rwamba Baeten, Jared M. Ngure, Kenneth |
author_facet | Ortblad, Katrina F. Kearney, John E. Mugwanya, Kenneth Irungu, Elizabeth M. Haberer, Jessica E. Barnabas, Ruanne V. Donnell, Deborah Mugo, Nelly Rwamba Baeten, Jared M. Ngure, Kenneth |
author_sort | Ortblad, Katrina F. |
collection | PubMed |
description | BACKGROUND: The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya. METHODS: The JiPime-JiPrEP (Kiswahili for ‘Test Yourself, PrEP Yourself’) study is a three-arm randomized trial taking place in Thika, Kenya. Participants (n = 495) are eligible for enrollment if they are at least 18 years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men (n = 165) and women (n = 165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n = 165) who are at HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for the objective measurement of PrEP adherence at baseline, 6 months, and 12 months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6 months and secondarily at 12 months. DISCUSSION: The findings from this trial can help to understand how HIVST—a new HIV-1 testing technology—can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03593629. Retrospectively registered on 20 July 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3521-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6610957 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-66109572019-07-16 HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya Ortblad, Katrina F. Kearney, John E. Mugwanya, Kenneth Irungu, Elizabeth M. Haberer, Jessica E. Barnabas, Ruanne V. Donnell, Deborah Mugo, Nelly Rwamba Baeten, Jared M. Ngure, Kenneth Trials Study Protocol BACKGROUND: The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya. METHODS: The JiPime-JiPrEP (Kiswahili for ‘Test Yourself, PrEP Yourself’) study is a three-arm randomized trial taking place in Thika, Kenya. Participants (n = 495) are eligible for enrollment if they are at least 18 years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men (n = 165) and women (n = 165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n = 165) who are at HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for the objective measurement of PrEP adherence at baseline, 6 months, and 12 months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6 months and secondarily at 12 months. DISCUSSION: The findings from this trial can help to understand how HIVST—a new HIV-1 testing technology—can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03593629. Retrospectively registered on 20 July 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3521-2) contains supplementary material, which is available to authorized users. BioMed Central 2019-07-04 /pmc/articles/PMC6610957/ /pubmed/31272495 http://dx.doi.org/10.1186/s13063-019-3521-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Ortblad, Katrina F. Kearney, John E. Mugwanya, Kenneth Irungu, Elizabeth M. Haberer, Jessica E. Barnabas, Ruanne V. Donnell, Deborah Mugo, Nelly Rwamba Baeten, Jared M. Ngure, Kenneth HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya |
title | HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya |
title_full | HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya |
title_fullStr | HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya |
title_full_unstemmed | HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya |
title_short | HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya |
title_sort | hiv-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in kenya |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610957/ https://www.ncbi.nlm.nih.gov/pubmed/31272495 http://dx.doi.org/10.1186/s13063-019-3521-2 |
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