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, Dale A Barnhart, Monica Gandhi, David Sando, Guy Harling, Till Bärnighausen, Donna Spiegelman, Winfrida Onesmo Akyoo, Hannah Goymann, Idda H Mosha, Doreen Donald Kamori, Theodora Mbunda, Judith Kipeleka, Rose Mpembeni

Journal: PloS one 2024;19(6):e0304077

PMID: 38935796

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Abstract

BACKGROUND

Pre-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.

METHODS

In 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 REGISTRATION

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

Copyright: © 2024 Chebet et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Address: Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, The University of Arizona, Tucson, Arizona, United States of America.; Department of Behavioural Sciences, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania.; Heidelberg Institute of Global Health, Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.; Institute for Global Health, University College London, London, United Kingdom.; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.; Africa Health Research Institute, KwaZulu-Natal, South Africa.; Harvard Center for Population and Development Studies, Harvard T. H. Chan School of Public Health, Cambridge, Massachusetts, United States of America.; MRC/Wits Rural Public Health & Health Transitions Research Unit (Agincourt), University of the Witwatersrand, Johannesburg, Gauteng, South Africa.; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania.; Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco (UCSF), San Francisco, California, United States of America.; Management and Development for Health, Dar es Salaam, Tanzania.; Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.; Department of Biostatistics and Center for Methods in Implementation and Prevention Science, Yale School of Public Health, New Haven, Connecticut, United States of America.; Department of Epidemiology and Biostatistics, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania.; Heidelberg Institute of Global Health, Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.; Africa Health Research Institute, KwaZulu-Natal, South Africa.; Management and Development for Health, Dar es Salaam, Tanzania.

DOI: 10.1371/journal.pone.0304077

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Full Text Sources:

Medical:

https://medlineplus.gov/hivinwomen.html

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https://assays.cancer.gov/non-CPTAC-3867

MeSH Terms: Humans, Female, Pre-Exposure Prophylaxis, HIV Infections, Tanzania, Anti-HIV Agents, Sex Workers, Adult, Medication Adherence, Adolescent, Young Adult, Tenofovir, Randomized Controlled Trials as Topic