NOTRE: optimizing long-acting pre-exposure prophylaxis and medications for opioid use disorder interventions in carceral settings
Project Number1R61DA060583-01
Contact PI/Project LeaderBRINKLEY-RUBINSTEIN, LAUREN Other PIs
Awardee OrganizationDUKE UNIVERSITY
Description
Abstract Text
ABSTRACT
Co-occurring substance use and HIV risk among people in carceral settings is a syndemic. Approximately 17%
of all incarcerated people have an opioid use disorder (OUD), and the prevalence of HIV is 3-5 times that of the
general population. Gold standard interventions exist to stem adverse OUD outcomes and prevent HIV infection:
pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD, e.g., buprenorphine).
However, implementation of these efficacious interventions is underemployed in carceral settings and during
community re-entry, and even when they are put into practice, barriers to optimal uptake, adherence, and
continuation often occur. However, long-acting injectable (LAI) formulations of both PrEP and buprenorphine
have recently been approved by the FDA, providing opportunities to innovate on how these medications are
deployed. In addition, evidence in the community proves that MOUD + HIV efforts, when delivered in tandem,
improve outcomes for those with OUD, and that retention in MOUD predicts positive HIV prevention outcomes.
Therefore, we propose conducting a hybrid implementation-effectiveness type 2 study to optimize and test the
efficacy of a LAI PrEP + buprenorphine (XR-B) co-packaged intervention among people in carceral and
community re-entry settings in Ending the Epidemic Sites in Maryland and Washington, DC. Our specific aims
are: Aim 1 (R61): Develop the intervention protocol for delivery of LAI PrEP + XR-B; Aim 2 (R33): Evaluate
implementation facilitation as a strategy to support co-located LAI PrEP + XR-B in carceral and re-entry settings;
and Aim 3 (R33): Compare the effectiveness of LAI PrEP + XR-B to oral PrEP +SL-B. Our long-term goal is to
1) provide guidance on how to implement LAI interventions in these settings, 2) generate evidence relevant to
the efficacy of co-packaging LAI PrEP + XR-B to improve adherence and continuation of PrEP and
buprenorphine.
Public Health Relevance Statement
NARRATIVE
Co-occurring substance use and HIV risk among people in carceral settings is a syndemic. Yet, gold standard
interventions to stem adverse OUD outcomes and prevent HIV infection (e.g., pre-exposure prophylaxis, PrEP;
and medications for opioid use disorder, MOUD, e.g., buprenorphine) have been underemployed in carceral and
community re-entry settings. Therefore, we propose conducting a hybrid implementation-effectiveness type 2
study to optimize and test the efficacy of a long-acting injectable PrEP + buprenorphine (XR-B) co-located
intervention in jail and prison settings located in Ending the Epidemic Sites in Maryland and Washington, DC.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AIDS preventionAdherenceAdultBuprenorphineClinicalCollaborationsCommon Data ElementCommunitiesComplexConsolidated Framework for Implementation ResearchCountyDataDropoutEducationEligibility DeterminationEpidemicFDA approvedFormulationGeneral PopulationGoalsHIVHIV InfectionsHIV SeropositivityHIV riskHybridsImprisonmentInjectableInstitutional Review BoardsInterventionInterviewJailMaintenanceMarylandOralOutcomeParticipantPersonsPharmaceutical PreparationsPhasePopulationPrevalencePrisonsProceduresProtocols documentationQualitative ResearchRandomizedResearchResearch PersonnelRisk BehaviorsSafetyScreening procedureServicesSiteSurveysTimeUnderemploymentVisitWashingtonWorkadherence ratebuprenorphine treatmentcommunity partnerscommunity reentrycompare effectivenesseffectiveness/implementation hybrideffectiveness/implementation trialefficacious interventionefficacy testingexperiencefollow-uphealth care settingshigh risk populationhousing instabilityimplementation barriersimplementation evaluationimplementation facilitationimplementation outcomesimprovedimproved outcomeinnovationmedication for opioid use disorderopioid use disorderpre-exposure prophylaxispreventprimary outcomeprospectiverecruitsocialstemsubstance usesyndemictrial enrollmentuptake
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