Evidence map›Paper›PMID 31272495›Full record

ArticleTrials2019

HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya.

Katrina F Ortblad, John E Kearney, Kenneth Mugwanya, Elizabeth M Irungu, Jessica E Haberer, Ruanne V Barnabas, Deborah Donnell, Nelly Rwamba Mugo, Jared M Baeten, Kenneth Ngure

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03593629 (HIV Self-Testing to Improve the Efficiency of PrEP Delivery), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03593629 nacompletednot on this map

HIV Self-Testing to Improve the Efficiency of PrEP Delivery

TypeinterventionalSponsorUniversity of WashingtonRan2018 to 2021Enrolled790ConditionsHIV-1-infectionArms6-month PrEP + blood-based HIV self-test, 6-month PrEP + oral fluid HIV self-test
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 24 citations in OpenAlex.

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  6. Scaling Up HIV Self-Testing and Linkage to Care Among Women Who Exchange Sex and/or Use Drugs in Kazakhstan.AIDS education and prevention : official publication of the International Society for AIDS Education · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 2 countries.

Katrina F OrtbladDepartment of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. katort@uw.edu.ORCID http://orcid.org/0000-0002-5675-8836
John E KearneyDepartment of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.
Kenneth MugwanyaDepartment of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.
Elizabeth M IrunguDepartment of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.
Jessica E HabererMassachusetts General Hospital, Boston, USA.
Ruanne V BarnabasDepartment of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.
Deborah DonnellDepartment of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.
Nelly Rwamba MugoDepartment of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.
Jared M BaetenDepartment of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.
Kenneth NgureDepartment of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
University of Washington · USHarvard University · USJomo Kenyatta University of Agriculture and Technology · KE

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
Integrated PrEP and ART delivered in Ugandan public health clinics to improve HIV and ART outcomes for HIV serodiscordant couplesR01MH110296 · NIMH · UNIVERSITY OF WASHINGTON · PI HEFFRON, RENEE A. · 2017 to 2021
$3.2M
HIV self-testing to improve the efficiency of PrEP deliveryR01MH113572 · NIMH · UNIVERSITY OF WASHINGTON · PI MUGO, NELLY RWAMBA, NGURE, KENNETH · 2018 to 2021
$2.2M
Optimizing mHealth for adherence monitoring and interventionK24MH114732 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI HABERER, JESSICA ELIZABETH · 2017 to 2021
$800k
A differentiated care model to improve the efficiency of PrEP delivery in KenyaR00MH118134 · NIMH · UNIVERSITY OF WASHINGTON · PI MUGWANYA, KENNETH KIGGUNDU · 2019 to 2021
$743k
A differentiated care model to improve the efficiency of PrEP delivery in KenyaK99MH118134 · NIMH · UNIVERSITY OF WASHINGTON · PI MUGWANYA, KENNETH KIGGUNDU · 2018 to 2018
$123k
NIAID NIH HHS P30 AI027757NIMH NIH HHS K24 MH114732NIMH NIH HHS K99 MH118134NIMH NIH HHS R00 MH118134NIMH NIH HHS R01 MH113572NIMH NIH HHS R01MH113572
6 · The paper itself

Abstract

backgroundThe 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.

methodsThe 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 registrationClinicalTrials.gov, NCT03593629 . Retrospectively registered on 20 July 2018.

Indexed as

Serologic TestsAnti-HIV AgentsEquivalence Trials as TopicFemaleHIV-1HIV AntibodiesHIV InfectionsHumansKenyaMalePredictive Value of TestsPre-Exposure ProphylaxisRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsSalivaAnti-HIV AgentsHIV AntibodiesDelivery modelsHIV-1 self-testingHIV-1 serodiscordant couplesHIV-1 testingKenyaPrEPRandomized trialYoung women

Identifiers

PMID31272495
PMCPMC6610957
OpenAlexW2954548944

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.