Harm Reduction in HIV Primary Care for PLWH Who Use Drugs
NCT ID: NCT05404750
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
768 participants
OBSERVATIONAL
2022-04-20
2026-06-30
Brief Summary
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Detailed Description
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Aim 1. Explore the relationship between healthcare providers' stigmatizing attitudes towards working with PLWH who use drugs and providers' acceptance and practice of structural and relational HR to elucidate the context for intervention development. Providers (n=125) working HIV clinics in Birmingham, AL and Pittsburgh, PA will be surveyed to understand subjective responses around preparedness for and delivery of HR care to PLWH who use drugs. A sequential explanatory mixed-methods approach will be utilized; surveys will be followed by semi-structured interviews (n=40) with multiple provider types in both regions to further explore HR perspectives and inform intervention development. It is hypothesized that providers with less stigmatizing attitudes toward serving people who use drugs are more likely to be accepting of relational and structural HR practices.
Aim 2. Explore the interplay between patient-perceived HR and stigma and clinical outcomes; specifically, the degree to which (a) relational HR moderates the effect of intersectional stigma experienced in healthcare settings (HIV- and substance use-related stigma and racial discrimination) on patients' perceptions of their relationship with providers, (b) structural HR moderates the relationship between the patient-provider relationship and clinical outcomes (ART adherence, retention in care, HIV and HCV viral suppression), and (c) patient-perceived HR care is directly associated with HIV clinical outcomes (see Figure 1). After qualitatively evaluating PAPHRS with HIV clinical and HR providers (n=20) and PLWH who use drugs (n=36), PLWH who use drugs (n=500) who receive care in the study sites will be surveyed to assess their perceptions of providers' relational HR care; experiences of intersectional stigma; and perceived quality of relationships with their providers. Other potential stigmatized identities (e.g., HCV) will be explored via patient focus groups (n=36). It is hypothesized that the effect of intersectional stigma on the patient-provider relationship is attenuated in higher degrees of relational HR care; structural HR attenuates the effect of poor patient-provider relationships on clinical outcomes; and higher degrees of HR care are associated with better clinical outcomes.
Aim 3. Using human-centered design approaches, develop and pre-test an intervention to operationalize HR care for PLWH who use drugs in HIV clinical settings. Results from Aims 1 and 2 will be shared with with stakeholders (n=20, PLWH who use drugs, clinical and HR providers) to develop an intervention. Acceptability and feasibility of the intervention design will be assessed with providers (n=12) in both regions.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
Patients
PWLH with current or lifetime substance use who receive care at one of our study sites.
Harm Reduction
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.
Interventions
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Harm Reduction
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.
Eligibility Criteria
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Inclusion Criteria
* Providing service or care to PLWH or people who use drugs at high risk for HIV acquisition
* Working in one of the following positions: front desk/patient engagement, social worker, nurse, medical assistant, advanced practice provider, or physician
* Able to verbally consent, read, and speak English
* Living with HIV
* Age 18 or older
* Able to verbally consent, read, and speak English
* Receiving HIV medical care from one of the study sites for at least one year
* Lifetime or recent use (past 3 months) of illicit substances (excluding marijuana) or prescription drugs for non-medical reasons in accordance with the NIDA-Modified ASSIST 2.0.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Allegheny Health Network
OTHER
University of Alabama at Birmingham
OTHER
National Institute on Drug Abuse (NIDA)
NIH
National Institutes of Health (NIH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Mary Hawk
Professor
Principal Investigators
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Mary Hawk, DrPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Emma Kay, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Creasy SL, Egan JE, Krier S, Townsend J, Ward J, Hawk M, Kay ES. "Let me hear what you're needing": exploring how HIV providers conceptualize patient-provider interactions with people with HIV who use drugs using a harm reduction framework. Ther Adv Infect Dis. 2025 Feb 27;12:20499361251323721. doi: 10.1177/20499361251323721. eCollection 2025 Jan-Dec.
Kay ES, Creasy S, Batey DS, Coulter R, Egan JE, Fisk S, Friedman MR, Kinsky S, Krier S, Noble V, Turan B, Turan JM, Yu L, Hawk M. Impact of harm reduction care in HIV clinical settings on stigma and health outcomes for people with HIV who use drugs: study protocol for a mixed-methods, multisite, observational study. BMJ Open. 2022 Sep 16;12(9):e067219. doi: 10.1136/bmjopen-2022-067219.
Other Identifiers
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STUDY21090002
Identifier Type: -
Identifier Source: org_study_id
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