Evidence map›Paper›PMID 38935796›Full record

ArticlePloS one2024

Demonstrating service delivery models for effective initiation and retention on pre-exposure prophylaxis (PrEP) among female bar workers in Dar es Salaam, Tanzania: A double randomized intervention study protocol.

Joy J Chebet, Winfrida Onesmo Akyoo, Hannah Goymann, Guy Harling, Dale A Barnhart, Idda H Mosha, Doreen Donald Kamori, Monica Gandhi, Theodora Mbunda, Judith Kipeleka and 4 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Frontiers in public health · 2025
    Article
  3. 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

14 authors.

Joy J ChebetDepartment of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, The University of Arizona, Tucson, Arizona, United States of America.
Winfrida Onesmo AkyooDepartment of Behavioural Sciences, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania.ORCID 0000-0001-7984-2953
Hannah GoymannHeidelberg Institute of Global Health, Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.
Guy HarlingInstitute for Global Health, University College London, London, United Kingdom.
Dale A BarnhartDepartment of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.
Idda H MoshaDepartment of Behavioural Sciences, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania.
Doreen Donald KamoriDepartment of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania.
Monica GandhiDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco (UCSF), San Francisco, California, United States of America.
Theodora MbundaManagement and Development for Health, Dar es Salaam, Tanzania.
Judith KipelekaManagement and Development for Health, Dar es Salaam, Tanzania.
David SandoManagement and Development for Health, Dar es Salaam, Tanzania.
Donna SpiegelmanDepartment of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.
Rose MpembeniDepartment of Epidemiology and Biostatistics, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania.
Till BärnighausenHeidelberg Institute of Global Health, Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.

Funding

Comprehensive Translational Science Analytics Tools for the Global Health AgendaDP1ES025459 · NIEHS · YALE UNIVERSITY · PI SPIEGELMAN, DONNA L · 2014 to 2018
$4.1M
New Methods for the design and evaluation of large HIV prevention interventionsR01AI112339 · NIAID · YALE UNIVERSITY · PI SPIEGELMAN, DONNA L · 2014 to 2017
$2.7M
NIAID NIH HHS R01 AI112339NIEHS NIH HHS DP1 ES025459
6 · The paper itself

Abstract

backgroundPre-Exposure Prophylaxis (PrEP) has demonstrated efficacy in preventing HIV infection. Female Bar Workers (FBWs) often act as informal sex workers, placing them at risk of HIV infection. Despite expressing interest in PrEP, FBWs face barriers to accessing public-sector clinics where PrEP is delivered. We developed a study to compare the effectiveness of workplace-based PrEP provision to standard-of-care facility-based provision for PrEP initiation, retention and adherence among FBWs.

methodsIn this double-randomized intervention study, FBWs aged 15 years and above will be screened, consented and initiated on PrEP (emtricitabine/tenofovir disoproxil), and followed for six months. Participants will be randomized at the bar level and offered PrEP at their workplace or at a health facility. Those who are initiated will be independently individually randomized to either receive or not receive an omni-channel PrEP champion intervention (support from an experienced PrEP user) to improve PrEP adherence. We expect to screen 1,205 FBWs to enroll at least 160 HIV negative women in the study. Follow-up visits will be scheduled monthly. HIV testing will be performed at baseline, month 1, 4 and 6; and TDF testing at months 2 and 6. Primary outcomes for this trial are: (1) initiation on PrEP (proportion of those offered PrEP directly observed to initiate PrEP); and (2) adherence to PrEP (detectable urine TDF drug level at 6-months post-enrollment). The primary outcomes will be analyzed using Intention-to-Treat (ITT) analyses. DISCUSSION: Using a randomized trial design, we will evaluate two interventions aiming to reduce barriers to uptake and retention on PrEP among FBWs, a vulnerable population at risk of HIV acquisition and onward transmission. If these interventions prove effective in promoting PrEP among FBWs, they could assist in abating the HIV epidemic in Africa.

trial registrationRegistered with German Clinical Trials Register (www.drks.de) on 29 April 2020; Registration number DRKS00018101.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisSex WorkersAdolescentAdultFemaleHumansMedication AdherenceRandomized Controlled Trials as TopicTanzaniaTenofovirYoung AdultAnti-HIV AgentsTenofovir

Identifiers

PMID38935796
PMCPMC11210872

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.