NCT05404750

Harm Reduction in HIV Primary Care for PLWH Who Use Drugs

Recruiting now Last updated 17 April 2025

What this trial tests

trial testing Harm Reduction in Human Immunodeficiency Virus in 768 participants. Currently enrolling.

Timeline

20 April 2022

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	University of Pittsburgh
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	768
Start date	20 April 2022
Primary completion	30 June 2026
Estimated completion	30 June 2026
Sites	3 locations across United States

Drugs / interventions tested

• Harm Reduction

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
• Substance Use — all drugs for Substance Use →
• Stigma, Social — all drugs for Stigma, Social →

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with Human Immunodeficiency Virus or Substance Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Kay ES, Creasy S, Batey DS, Coulter R, et al · · 2022 · cited 6× · PMID 36113946 · DOI 10.1136/bmjopen-2022-067219
2. "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.
   Creasy SL, Egan JE, Krier S, Townsend J, et al · · 2025 · PMID 40017794 · DOI 10.1177/20499361251323721