Protocol for a cluster randomized controlled trial of Using PrEP, Doing it for Ourselves [UPDOs] Protective Styles: a salon-based intervention to improve PrEP uptake among Black cis-gender women

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Black cis-gender women in the USA, particularly in the Southeastern region, experience disproportionately high rates of new HIV diagnoses despite the effectiveness of pre-exposure prophylaxis (PrEP). PrEP awareness, access, and uptake remain low among this population due to structural barriers, stigma, limited culturally relevant messaging, and medical mistrust. Beauty salons are trusted community spaces that offer a promising venue for delivering sexual health information and linking women to PrEP services. Using PrEP, Doing it for Ourselves (UPDOs) Protective Styles is a multilevel, culturally tailored intervention designed with and for Black women to improve PrEP decision-making and uptake. This trial is a cluster-randomized, parallel-group, superiority trial using an effectiveness–implementation Hybrid Type I design. Thirty-two beauty salons across six North Carolina counties will be randomized 1:1 to UPDOs Protective Styles or a control condition. Black women salon customers ( N = 1000) will be enrolled on a rolling basis and followed for 52 weeks. The UPDOs intervention includes (1) stylist opinion leader training, (2) a six-episode edutainment video series with structured debrief vlogs, and (3) facilitated access to PrEP via the Q Care Plus telehealth platform. Control participants will receive weekly CDC PrEP educational materials for 6 weeks. The primary outcome is progression along the Motivational PrEP Cascade, assessed using the 1-item PrEP Contemplation Ladder at baseline and 6, 12, 24, 32, and 52 weeks, with electronic health record confirmation when available. Secondary outcomes include PrEP knowledge/awareness, stigma, trust, decisional balance, and eHealth usability. A mixed-methods implementation evaluation guided by CFIR will assess acceptability, appropriateness, fidelity, adaptations, and contextual determinants to inform scalability. This trial will provide rigorous evidence on the effectiveness and implementation potential of a culturally grounded, salon-based PrEP intervention for Black women. Findings will inform scalable strategies to reduce HIV inequities, accelerate PrEP uptake, and strengthen community-engaged prevention models across the US South. ClinicalTrials.gov NCT06638892. Registered on 9 October 2024 (URL: https://clinicaltrials.gov/study/NCT06638892?cond=UPDOs&rank=1 ).

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