NDLI: Study protocol of a randomized controlled trial to assess the efficacy of the “PrEPare for Work” intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S.

Content Provider	Springer Nature : BioMed Central
Author	Biello, Katie B. Chan, Philip A. Ndoye, Colleen D. Nelson, Lance Nelson, Elizabeth Silva, Vanessa Kwak, Eun Napoleon, Siena Cormack Orellana, Carolina Richards, Olly G. Davis, Evan Mimiaga, Matthew J.
Abstract	Background Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as “sex workers.” This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs’ unique life circumstances and provide support in exploring their sexual health options are needed. Methods In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of “PrEPare for Work,”— a theory-based, manualized PrEP uptake and adherence intervention for MSW — using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the “PrEPare for Work Stage 1 intervention” (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the “PrEPare for Work Stage 2 intervention” (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. Discussion Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs’ unique life circumstances are urgently needed. In this study, we are evaluating whether “PrEPare for Work” can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. Trial registration ClinicalTrials.gov number NCT05736614, registered February 8, 2023.
Related Links	https://bmcpublichealth.biomedcentral.com/counter/pdf/10.1186/s12889-024-17710-y.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	14712458
DOI	10.1186/s12889-024-17710-y
Journal	BMC Public Health
Issue Number	1
Volume Number	24
Language	English
Publisher	BioMed Central
Publisher Date	2024-02-09
Access Restriction	Open
Subject Keyword	Public Health Medicine Epidemiology Biostatistics Vaccine Environmental Health HIV infections Male sex work Pre-exposure prophylaxis Efficacy trial Motivational interviewing Social cognitive theory Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Public Health, Environmental and Occupational Health
Journal Impact Factor	3.5/2023
5-Year Journal Impact Factor	3.9/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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