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."
Project Number1R01NR021692-01A1
Former Number1R01MH135749-01A1
Contact PI/Project LeaderRANDOLPH, SCHENITA D.
Awardee OrganizationDUKE UNIVERSITY
Description
Abstract Text
HIV disproportionately affects Black cisgender women living in the United States south threatening progress
toward the Ending the HIV Endemic initiative's 2030 goals. Although Pre-exposure Prophylaxis (PrEP), an oral
or injectable medication that if taken is highly effective in preventing HIV, Black cisgender women have not
equitably benefited from its use due to multiple complex factors. For example, lack of awareness and
knowledge to PrEP, not trusting PrEP, PrEP stigma, providers not knowing about or offering PrEP,
accessibility, and cost. These factors all contribute to only 2% of eligible women taking PrEP. Thus,
interventions that take into consideration the lived experiences and broad culture for Black cisgender women
are urgently needed to take a woman from medication precontemplation to uptake to maintenance. In
partnership with Black cisgender women, an established community advisory council (CAC), an online
telehealth platform (Q Care Plus), and beauty salon stylists, the research team co-developed Using PrEP,
Doing it for Ourselves (UPDOs) Protective Styles, an e-Health intervention that strongly considers the unique
needs of Black cisgender women, consisting of a training for stylists to become opinion leaders (trusted
gatekeepers who share health information in the community) in HIV prevention (i.e., PrEP) and a 6-week web-
based, edutainment video series (i.e., six 20-minute episodes), structured debrief blogs, and telehealth service
access. The CAC was invaluable in this development process having collaborated with the research team
across sexual health-based projects that informed and contributed to UPDOs preliminary research. UPDOs
web content share core concepts by telling the stories of women from various backgrounds and role-plays a
woman's decision-making process to use PrEP. Pilot research found UPDOs acceptable, improved PrEP trust,
increased knowledge – for both PrEP aware and unaware participants, and decreased perceptions of PrEP
stigma within personal relationships. This proposed effectiveness-implementation type I hybrid study will test
UPDOs effectiveness in a larger, more geographically diverse sample using a cluster-randomized control trial
and examine implementation determinants of UPDOs. In collaboration with Q Care Plus, a secure online
platform to access telehealth services for home delivered HIV testing and PrEP prescriptions, we will track how
many women reach out to a provider, get HIV testing, start PrEP, and maintain PrEP as prescribed. A cohort of
32 beauty salons will be randomized to either an intervention group (n=16) or control group (n=16). Salons (1
salon = 1 cluster) will be randomized to UPDOs (Edutainment videos + blogs + Q Care Plus) or usual care
(CDC videos + website) conditions. Once salons are randomized, the recruitment and enrollment period of
female customers will occur over 24-months. Study participation will include data collection at baseline with
follow-up measures at 1, 12, 24, 32, and 52 weeks. To assess implementation outcomes and context, we will
use a mixed methods approach guided by the Consolidated Framework for Implementation Research (CFIR).
Public Health Relevance Statement
We propose an effectiveness-implementation type I hybrid study to test an intervention, Using PrEP, Doing it
for Ourselves (UPDOs) Protective Styles, and its effectiveness to improve PrEP uptake among Black
cisgender women using a cluster-randomized control trial and examining implementation determinants of
UPDOs as a real-world intervention that can be scaled across the Southern US. Project activities will be
delivered by an interdisciplinary team – advised by an external advisory panel and established community
advisory council, and implemented across six counties in North Carolina, a southern region where HIV
incidence is high— Cumberland, Durham, Forsyth, Guilford, Mecklenburg, and Wake counties. At the
conclusion of the funded project, we will have rigorously evaluated the intervention ready for scale-up across
the US south that has potential to significantly advance EHE goals, specifically for Black cisgender women, an
invisible population in HIV prevention.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AIDS preventionAddressAffectAwarenessBeautyBlack raceCaringCluster randomized trialCodeCollaborationsCommunitiesComplexConsolidated Framework for Implementation ResearchContinuing EducationControl GroupsCountyData CollectionDecision MakingDevelopmentDramaEffectivenessEligibility DeterminationEnrollmentFemaleFoundationsFundingFutureGatekeepingGenderGeographyGoalsHIVHIV disparitiesHealthHealth ServicesHealth Services AccessibilityHomeHourHuman immunodeficiency virus testHumorHybridsIncidenceIndividualInequalityInjectableInternetInterventionIntervention TrialInterviewKnowledgeLived experienceMaintenanceMeasuresMethodsMotivationNewly DiagnosedNorth CarolinaOnline SystemsOralParticipantPerceptionPharmaceutical PreparationsPlayPopulationPrivacyProcessProviderRandomizedRandomized, Controlled TrialsReportingResearchRoleSamplingSecureSeriesSexual HealthSpeedStructureSurveysTestingTrainingTrustUnited StatesUse EffectivenessWomanWomen's HealthWorkacceptability and feasibilityblack womencis-femalecohortcommunity engagementcomparison controlcostcost effective interventiondesigndistrusteHealtheffectiveness testingeffectiveness/implementation designfollow-upgroup interventionhybrid type 1 studyimplementation contextimplementation determinantsimplementation evaluationimplementation frameworkimplementation outcomesimplementation strategyimplementation/effectivenessimprovedinterestmen who have sex with menpre-exposure prophylaxispreventrecruitscale upsocial stigmatelehealththeoriestreatment as usualuptakevirtualweb site
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