Harm Reduction in HIV Primary Care for PLWH Who Use Drugs

NCT05404750 | Recruiting

• 2 other identifiers: STUDY21090002R01DA054832
• Study Type: observational
• Target: 768
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Substance Use; Stigma, Social; Human Immunodeficiency Virus

Keywords

Harm Reduction; Patient-Provider Relationship

Outcome Measures

Primary Outcomes (1)

• HIV Viral Load

  Viral load will be assessed as a continuous and dichotomous variable (virally suppressed \<200 copies/ml)

  Retrospective, past 5 years

Secondary Outcomes (5)

• Retention in care - Missed Visits

  Retrospective, past 5 years

• Retention in care - Kept visits

  Retrospective, past 5 years

• Hepatitis C Viral Load

  Retrospective, past 5 years

• HIV Adherence

  Retrospective, past 5 years

• Retention in Substance use treatment

  Retrospective, past 5 years

Study Arms (2)

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.

Patients

PWLH with current or lifetime substance use who receive care at one of our study sites.

Behavioral: Harm Reduction

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Providers of services to people living with or at high risk for HIV. Providers include all members of the healthcare team; i.e., reception, nurses, clinical providers, social workers, and pharmacists. Providers must have worked in one of our study settings for at lease one year. 2. Patients living with HIV who have receive care at one of our study sites with lifetime or current use of illicit drugs (excluding marijuana), or of prescription drugs for non-medical reasons.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Allegheny Health Network: collaborator
• University of Alabama at Birmingham: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35222, United States

RECRUITING

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 40017794 DERIVED

• 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.

  PMID: 36113946 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders; Social Stigma; Harm Reduction

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Mary Hawk, DrPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Emma Kay, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Hawk, DrPH

CONTACT

412-648-2342; meh96@pitt.edu

Stephanie Creasy, MPH

CONTACT

412-624-7000; stc69@pitt.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 3, 2022
• Study Start: April 20, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)