A randomized clinical trial of client-centered care coordination to improve pre-exposure prophylaxis use for Black men who have sex with men
Project Number5R01MH134721-02
Contact PI/Project LeaderWHITFIELD, DARREN LOVELL Other PIs
Awardee OrganizationUNIVERSITY OF MARYLAND BALTIMORE
Description
Abstract Text
Project Abstract
In view of the continued disproportionate rates of HIV infection among Black men who have sex with men
(MSM), there is an urgent public health need to identify scalable interventions to support Black MSM at risk of
HIV to decide to take pre-exposure prophylaxis (PrEP), help access PrEP, and adhere to PrEP. Currently,
Black MSM have the highest rates of HIV acquisition in the United States yet have the lowest rates of PrEP
utilization. Innovative methods to support use of this lifesaving medication are few and those that are available
are seldom rigorously tested. One intervention demonstrated in early studies to have potential for positive
impact a client-centered care coordination (C4) intervention model. C4 was piloted in the NIH-funded HIV
Prevention Trials Network (HPTN) 073 study and showed promise, yet more evaluation is required to assess
and leverage this intervention. The aims of this study are to further the work done in HPTN 073 with regard to
C4 in real-world clinical settings in Washington, DC and in New York City. Aim 1 will determine the efficacy of
C4 for increasing PrEP adherence among Black MSM, Aim 2 will identify the optimal dose of C4
implementation for maximizing its effect on PrEP adherence, and Aim 3 will d Describe the acceptability and
feasibility of C4 implementation in community settings. Findings from this study will contribute to the NIH
priorities to reduce HIV incidence as well as cross-cutting areas of using implementation science to contribute
to our understanding of structural and psychosocial barriers to care and reduction of healthcare disparities.
Public Health Relevance Statement
Project Narrative
HIV pre-exposure prophylaxis (PrEP) use and adherence among Black men who have sex with men (MSM) is
hampered by structural and psychosocial barriers, resulting in inadequate coverage to reduce HIV infections
among this population. We will conduct a randomized control trial (RCT) with a standard of care (SOC) waitlist
control to determine the efficacy of C4, an intervention based on self-determination theory, to increase PrEP
use and adherence among Black MSM. The findings of this trial will result in an intervention tailored for Black
MSM which can be implemented in community setting to increase PrEP use and adherence among Black
MSM.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AIDS preventionAddressAdherenceAreaBiological AssayBlack raceCase ManagementClientClinicClinicalCollaborationsCommunitiesDataData CollectionDistrict of ColumbiaDoseElementsEnrollmentEpidemicEvaluationExposure toFrequenciesFundingGaysGoalsHIVHIV InfectionsHIV prevention trials networkHealth InsuranceHealth PersonnelHealth care facilityHealthcareIncidenceIndividualInequityInstitutionalizationInterventionInterviewJob lossLaboratoriesLearningLengthLifeMethodologyMethodsModelingNew York CityParticipantPharmaceutical PreparationsPopulationProviderPsychosocial FactorPublic HealthRacial EquityRandomizedRandomized, Controlled TrialsRecommendationRegimenReportingResearchRiskRisk ReductionSamplingScienceSecureSelf DeterminationSerumService delivery modelServicesSpecific qualifier valueStatistical MethodsSupportive careSurveysTestingTimeTransportationUnited StatesUnited States National Institutes of HealthVisitWaiting ListsWashingtonWorkacceptability and feasibilityarmbarrier to careblack men who have sex with mencare coordinationcare systemsclinical research sitecommunity settingcostdosageefficacy evaluationefficacy trialexperiencefollow-uphealth care disparityhealth trainingimplementation scienceimprovedinnovationmen who have sex with menmulti-component interventionnovelpre-exposure prophylaxisprevention servicepsychosocialracial disparityracismrandomized, clinical trialsrecruitscale upservice providerssocial stigmastaff interventionstandard of caretheoriestrial design
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