Harm Reduction in HIV Primary Care for PLWH Who Use Drugs

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Pittsburgh
Study ID
NCT05404750
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Harm Reduction — BEHAVIORAL
    Harm reduction aims to reduce negative effects of risky health behaviors without necessarily terminating the behaviors completely.Though often thought of as structural approaches (e.g., policy or syringe services), Harm reduction is also a relational approach to care focusing on non-punitive patient-provider interactions to promote autonomy. The degree to which harm reduction care is offered in study settings and is associated with clinical outcomes is the focus of this study.

Study Details

People living with HIV (PLWH) who use drugs experience significant health disparities including lower rates of retention in HIV care and higher rates of unsuppressed viral load, resulting in secondary infections and increased mortality. The proposed study will used mixed methods to explore (a) the relationship between healthcare providers' attitudes towards working with PLWH who use drugs and providers' acceptance and practice of structural and relational harm reduction; (b) the degree to which relational harm reduction moderates the effect of intersectional stigma experienced in healthcare settings on patients' perceptions of their relationship with providers; (c) the degree to which structural HR moderates the relationship between the patient-provider relationship and clinical outcomes, and (d) whether patient-perceived HR approaches to care are directly associated with HIV clinical outcomes. The study will also use these findings to inform the development and pre-testing of an intervention to operationalize harm reduction in HIV clinical settings, using stakeholder-engaged and human-centered design approaches, presenting a novel path to reducing HIV health inequities for PLWH who use drugs.

Key Dates

Start date
Apr 20, 2022
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
768 participants (estimated)

Arms

  • Arm: Providers
    Individuals providing service or care to PLWH or people who use drugs at high risk for HIV acquisition working at our study sites in one of the following positions: front desk/patient engagement, social worker, nurse, medical assistant, advanced practice provider, or physician.
  • Arm: Patients
    PWLH with current or lifetime substance use who receive care at one of our study sites.

Primary Outcome Measure

HIV Viral Load [ Time Frame: Retrospective, past 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35222
Emma Kay, PhD
205-934-5428
Emma Kay, PhD (PRINCIPAL_INVESTIGATOR)
Allegheny Health Network Research InstitutePittsburghPennsylvania15212
412-337-6370
Kristi Seemiller, MA (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Deborah McMahon, MD
412-647-0996
Sherri Karas, MEd
412-383-1313

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