PMID- 31272495 OWN - NLM STAT- MEDLINE DCOM- 20200224 LR - 20210610 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 20 IP - 1 DP - 2019 Jul 4 TI - HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya. PG - 396 LID - 10.1186/s13063-019-3521-2 [doi] LID - 396 AB - 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. FAU - Ortblad, Katrina F AU - Ortblad KF AUID- ORCID: 0000-0002-5675-8836 AD - Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. katort@uw.edu. FAU - Kearney, John E AU - Kearney JE AD - Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. FAU - Mugwanya, Kenneth AU - Mugwanya K AD - Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. FAU - Irungu, Elizabeth M AU - Irungu EM AD - Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. FAU - Haberer, Jessica E AU - Haberer JE AD - Massachusetts General Hospital, Boston, USA. AD - Harvard Medical School, Boston, USA. FAU - Barnabas, Ruanne V AU - Barnabas RV AD - Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. AD - Department of Medicine, University of Washington, Seattle, USA. FAU - Donnell, Deborah AU - Donnell D AD - Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. AD - Fred Hutchinson Cancer Research Center, Seattle, USA. FAU - Mugo, Nelly Rwamba AU - Mugo NR AD - Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. AD - Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya. FAU - Baeten, Jared M AU - Baeten JM AD - Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. AD - Department of Medicine, University of Washington, Seattle, USA. AD - Department of Epidemiology, University of Washington, Seattle, USA. FAU - Ngure, Kenneth AU - Ngure K AD - Department of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya. LA - eng SI - ClinicalTrials.gov/NCT03593629 GR - K24 MH114732/MH/NIMH NIH HHS/United States GR - K99 MH118134/MH/NIMH NIH HHS/United States GR - P30 AI027757/AI/NIAID NIH HHS/United States GR - R01MH113572/MH/NIMH NIH HHS/United States GR - R00 MH118134/MH/NIMH NIH HHS/United States GR - R01 MH113572/MH/NIMH NIH HHS/United States PT - Clinical Trial Protocol PT - Journal Article DEP - 20190704 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Anti-HIV Agents) RN - 0 (HIV Antibodies) SB - IM MH - Anti-HIV Agents/*administration & dosage/adverse effects MH - Female MH - HIV Antibodies/*blood MH - HIV Infections/diagnosis/*prevention & control/transmission/virology MH - HIV-1/*immunology MH - Humans MH - Kenya MH - Male MH - Pre-Exposure Prophylaxis/*methods MH - Predictive Value of Tests MH - Randomized Controlled Trials as Topic MH - Risk Assessment MH - Risk Factors MH - Saliva/*virology MH - Self Care/adverse effects/*methods MH - *Serologic Tests MH - Sexual Partners MH - Time Factors MH - Treatment Outcome PMC - PMC6610957 OTO - NOTNLM OT - Delivery models OT - HIV-1 self-testing OT - HIV-1 serodiscordant couples OT - HIV-1 testing OT - Kenya OT - PrEP OT - Randomized trial OT - Young women COIS- The authors declare that they have no competing interests. EDAT- 2019/07/06 06:00 MHDA- 2020/02/25 06:00 PMCR- 2019/07/04 CRDT- 2019/07/06 06:00 PHST- 2019/05/17 00:00 [received] PHST- 2019/06/11 00:00 [accepted] PHST- 2019/07/06 06:00 [entrez] PHST- 2019/07/06 06:00 [pubmed] PHST- 2020/02/25 06:00 [medline] PHST- 2019/07/04 00:00 [pmc-release] AID - 10.1186/s13063-019-3521-2 [pii] AID - 3521 [pii] AID - 10.1186/s13063-019-3521-2 [doi] PST - epublish SO - Trials. 2019 Jul 4;20(1):396. doi: 10.1186/s13063-019-3521-2.