Evidence map›Paper›PMID 30180860›Full record

Trial reportImplementation science : IS2018

Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya.

Kenneth K Mugwanya, Elizabeth Irungu, Elizabeth Bukusi, Nelly R Mugo, Josephine Odoyo, Elizabeth Wamoni, Kenneth Ngure, Jennifer F Morton, Kathryn Peebles, Sarah Masyuko and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Implementation science : IS, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03052010 (Delivery of Integrated PrEP and ART for Couples in Kenya), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
–field-weighted citation impact
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.

NCT03052010 phase4completednot on this map

Delivery of Integrated PrEP and ART for Couples in Kenya

TypeinterventionalSponsorUniversity of WashingtonRan2017 to 2021Enrolled4,898ConditionsHIV-1-infectionArmsIntegrated PrEP as a bridge to ART HIV-1 prevention strategy, PrEP, ART
3 · Its place in the literature

Who cites it

29 citing papers in PubMed.

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  17. Implementing PrEP Services in Diverse Health Care Settings.Journal of acquired immune deficiency syndromes (1999) · 2022
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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

17 authors.

Kenneth K MugwanyaDepartment of Global Health, University of Washington, 325 Ninth Avenue, #HMC 359927, Seattle, WA, 98104, USA. mugwanya@uw.edu.ORCID 0000-0001-5208-7468
Elizabeth IrunguKenya Medical Research Institute, Nairobi, Kenya.
Elizabeth BukusiKenya Medical Research Institute, Nairobi, Kenya.
Nelly R MugoDepartment of Global Health, University of Washington, 325 Ninth Avenue, #HMC 359927, Seattle, WA, 98104, USA.
Josephine OdoyoKenya Medical Research Institute, Nairobi, Kenya.
Elizabeth WamoniKenya Medical Research Institute, Nairobi, Kenya.
Kenneth NgureJomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Jennifer F MortonDepartment of Global Health, University of Washington, 325 Ninth Avenue, #HMC 359927, Seattle, WA, 98104, USA.
Kathryn PeeblesDepartment of Global Health, University of Washington, 325 Ninth Avenue, #HMC 359927, Seattle, WA, 98104, USA.
Sarah MasyukoNational AIDS and STI Control Program Ministry of Health, Nairobi, Kenya.
Gena BarnabeeDepartment of Global Health, University of Washington, 325 Ninth Avenue, #HMC 359927, Seattle, WA, 98104, USA.
Deborah DonnellDepartment of Global Health, University of Washington, 325 Ninth Avenue, #HMC 359927, Seattle, WA, 98104, USA.
Ruanne BarnabasDepartments of Global Health and Medicine, University of Washington, Seattle, USA.
Jessica HabererMassachusetts General Hospital, Boston, USA.
Gabrielle O'MalleyDepartment of Global Health, University of Washington, 325 Ninth Avenue, #HMC 359927, Seattle, WA, 98104, USA.
Jared M BaetenDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, USA.
Partners Scale Up Team

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
Optimizing Antiretroviral-Based HIV Prevention for HIV Serodiscordant CouplesR01MH095507 · NIMH · UNIVERSITY OF WASHINGTON · PI BAETEN, JARED · 2011 to 2020
$6.1M
Promoting Diversity, Equity, and Inclusivity in Research Training to Optimize HIV Prevention and TreatmentD43TW009580 · FIC · UNIVERSITY OF WASHINGTON · PI CAREY FARQUHAR, John Kinuthia · 2013 to 2026
$4.8M
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
Bill and Melinda Gates Foundation OPP1056051FIC NIH HHS D43 TW009580National Institute of Mental Health (US) K99MH118134NIAID NIH HHS P30 AI027757NIMH NIH HHS K99 MH118134NIMH NIH HHS R00 MH118134NIMH NIH HHS R01 MH095507
6 · The paper itself

Abstract

backgroundAntiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings.

methodsThe Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods. DISCUSSION: Cost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration.

trial registrationRegistered with ClinicalTrials.gov on February 14, 2017: NCT03052010 .

Indexed as

Pre-Exposure ProphylaxisAnti-HIV AgentsHIV InfectionsHumansKenyaProspective StudiesPublic HealthAnti-HIV Agents

Identifiers

PMID30180860
PMCPMC6123996

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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.