Evidence map›Paper›PMID 36332953›Full record

ArticleBMJ open2022

MPrEP+ study protocol: a prospective cohort study assessing the feasibility and acceptability of an HIV pre-exposure prophylaxis (PrEP) strategy for male clients of female sex workers in Kisumu, Kenya.

Joanne Mantell, Julie Franks, Allison Zerbe, Matthew R Lamb, Domonique M Reed, Dan Omollo, Maria Lahuerta, Doris Naitore, Wafaa M El-Sadr, Kawango Agot

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

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04898699 (IPrEP), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 55% 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.

NCT04898699 early_phase1completednot on this map

IPrEP: A Combination HIV Prevention Strategy for Young Women at Risk for HIV in Kisumu, Kenya IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya

TypeinterventionalSponsorColumbia UniversityRan2021 to 2022Enrolled120ConditionsHIVArmsUrSure Rapid Urine Tenofovir Test, OraQuick Rapid HIV Self-test kit, Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®], 2-way text message reminders, HIV risk-reduction counseling
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
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.

Joanne MantellHIV Center for Clinical and Behavioral Studies, Gender, Sexuality and Health Area, New York State Psychiatric Institute, New York City, New York, USA jem57@cumc.columbia.edu.
Julie FranksMailman School of Public Health, ICAP at Columbia University, New York City, New York, USA.
Allison ZerbeMailman School of Public Health, ICAP at Columbia University, New York City, New York, USA.ORCID 0000-0002-3372-6882
Matthew R LambMailman School of Public Health, ICAP at Columbia University, New York City, New York, USA.
Domonique M ReedMailman School of Public Health, ICAP at Columbia University, New York City, New York, USA.
Dan OmolloImpact Research And Development Organisation, Kisumu, Kenya.
Maria LahuertaMailman School of Public Health, ICAP at Columbia University, New York City, New York, USA.
Doris NaitoreMailman School of Public Health, ICAP at Columbia University, New York City, New York, USA.
Wafaa M El-SadrMailman School of Public Health, ICAP at Columbia University, New York City, New York, USA.
Kawango AgotImpact Research And Development Organisation, Kisumu, Kenya.
ICAP Global HealthImpact Research and Development Organization · KEColumbia University Irving Medical Center · US

Funding

The Statistics, Data Science, and Data Management (SDM) CoreP30MH043520 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI Claude Ann Mellins · 2003 to 2026
$48.2M
Global HIV Implementation Science Research Training Grant RenewalT32AI114398 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Yael R Hirsch-Moverman · 2014 to 2026
$4.1M
NIAID NIH HHS T32 AI114398NIMH NIH HHS P30 MH043520
6 · The paper itself

Abstract

introductionMale clients (MCs) are integral to sex work-driven HIV transmission dynamics as sexual partners of female sex worker (FSW). MCs contribute disproportionately to incident HIV globally and in sub-Saharan Africa, with 27% of new infections attributed to MCs of FSW and other partners of key populations. Gaps in coverage of HIV testing and prevention services for men, including MCs, are well-documented, yet research and innovative interventions to improve MC uptake of effective prevention services, including pre-exposure prophylaxis (PrEP), are scarce. METHODS AND ANALYSIS: MPrEP+ is a cohort study designed to assess the feasibility and acceptability of a PrEP-focused HIV prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with three adherence self-management interventions: (1) use of a validated point-of-care urine drug-level assay with real-time feedback and tailored self-management counselling; (2) frequent HIV self-testing; and (3) weekly one-way text messaging. This package of interventions is being delivered to 120 MCs enrolled in the study in Kisumu, Kenya over a 6-month period. The primary outcome is PrEP adherence at 6 months as measured by PrEP drug levels. Bivariate and multivariable regression models will be used to identify predictors of PrEP adherence. We will also explore associations of sociodemographic characteristics and PrEP beliefs with PrEP adherence. ETHICS AND DISSEMINATION: The study was approved by the Columbia University Irving Medical Center Institutional Review Board and the Maseno University Ethical Review Committee. Study enrolment was initiated in November 2021 with participant follow-up planned through August 2022. Study results will be submitted for publication in peer-reviewed journals. Summaries and infographics of study findings will be developed and distributed to MC, FSW and stakeholders working in HIV prevention and support for people who sell and buy sex, including Kenya's Ministry of Health. TRIAL REGISTRATION NUMBER: NCT04898699; Registered on 24 May 2021.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisSex WorkersEmtricitabineFeasibility StudiesFemaleHumansKenyaMaleProspective StudiesAnti-HIV AgentsEmtricitabineHIV & AIDSinternational health servicespublic health

Identifiers

PMID36332953
PMCPMC9639093
OpenAlexW4308196203

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.