Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial
Abstract Background Oral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse p...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07734-x |
| _version_ | 1797636724431519744 |
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| author | Njeri Wairimu Rachel C. Malen Adriana M. Reedy Peter Mogere Irene Njeru Carlos Culquichicón Maureen McGowan Fei Gao Jared M. Baeten Kenneth Ngure Katrina F. Ortblad |
| author_facet | Njeri Wairimu Rachel C. Malen Adriana M. Reedy Peter Mogere Irene Njeru Carlos Culquichicón Maureen McGowan Fei Gao Jared M. Baeten Kenneth Ngure Katrina F. Ortblad |
| author_sort | Njeri Wairimu |
| collection | DOAJ |
| description | Abstract Background Oral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women. Methods The Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16–24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16–24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants’ perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention’s fidelity and cost. Discussion Evidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings. Trial registration ClinicalTrials.gov NCT04982250. Registered on July 29, 2021. |
| first_indexed | 2024-03-11T12:38:13Z |
| format | Article |
| id | doaj.art-fa6394237ee849ed828946eeb7c2821b |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-11T12:38:13Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-fa6394237ee849ed828946eeb7c2821b2023-11-05T12:28:56ZengBMCTrials1745-62152023-11-0124111210.1186/s13063-023-07734-xPeer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trialNjeri Wairimu0Rachel C. Malen1Adriana M. Reedy2Peter Mogere3Irene Njeru4Carlos Culquichicón5Maureen McGowan6Fei Gao7Jared M. Baeten8Kenneth Ngure9Katrina F. Ortblad10Partners in Health and Research Development, Center for Clinical Research, Kenya Medical Research InstitutePublic Health Sciences Division, Fred Hutchinson Cancer CenterPublic Health Sciences Division, Fred Hutchinson Cancer CenterPartners in Health and Research Development, Center for Clinical Research, Kenya Medical Research InstitutePartners in Health and Research Development, Center for Clinical Research, Kenya Medical Research InstitutePublic Health Sciences Division, Fred Hutchinson Cancer CenterHeidelberg Institute of Global Health, Heidelberg UniversityPublic Health Sciences Division, Fred Hutchinson Cancer CenterDepartment of Global Health, University of WashingtonSchool of Public Health, Jomo Kenyatta University of Agriculture and TechnologyPublic Health Sciences Division, Fred Hutchinson Cancer CenterAbstract Background Oral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women. Methods The Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16–24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16–24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants’ perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention’s fidelity and cost. Discussion Evidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings. Trial registration ClinicalTrials.gov NCT04982250. Registered on July 29, 2021.https://doi.org/10.1186/s13063-023-07734-xHIV preventionPre-exposure prophylaxis (PrEP)Adolescent girls and young women (AGYW)Peer referralSelf-testingKenya |
| spellingShingle | Njeri Wairimu Rachel C. Malen Adriana M. Reedy Peter Mogere Irene Njeru Carlos Culquichicón Maureen McGowan Fei Gao Jared M. Baeten Kenneth Ngure Katrina F. Ortblad Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial Trials HIV prevention Pre-exposure prophylaxis (PrEP) Adolescent girls and young women (AGYW) Peer referral Self-testing Kenya |
| title | Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial |
| title_full | Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial |
| title_fullStr | Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial |
| title_full_unstemmed | Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial |
| title_short | Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial |
| title_sort | peer prep referral hiv self test delivery for prep initiation among young kenyan women study protocol for a hybrid cluster randomized controlled trial |
| topic | HIV prevention Pre-exposure prophylaxis (PrEP) Adolescent girls and young women (AGYW) Peer referral Self-testing Kenya |
| url | https://doi.org/10.1186/s13063-023-07734-x |
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