NCT05404750 Harm Reduction in HIV Primary Care for PLWH Who Use Drugs
| NCT ID | NCT05404750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Human Immunodeficiency Virus |
| Study Type | OBSERVATIONAL |
| Enrollment | 768 participants |
| Start Date | 2022-04-20 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 768 participants in total. It began in 2022-04-20 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Providers' Inclusion Criteria * Working at one of our 3 study sites (UPMC HIV/AIDS Program, Positive Health Clinic, or 1917 Clinic) or one of their partner sites offering substance use treatment (Internal Medicine Recovery Engagement Program, Center for Inclusion Health, or UAB's Outpatient-Based Opioid Treatment Clinic) for at least one year * 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 2. Patient Inclusion Criteria * 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: \-
Contact & Investigator
Mary Hawk, DrPH
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05404750 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05404750 currently recruiting?
Yes, NCT05404750 is actively recruiting participants. Contact the research team at meh96@pitt.edu for enrollment information.
Where is the NCT05404750 trial being conducted?
This trial is being conducted at Birmingham, United States, Pittsburgh, United States, Pittsburgh, United States.
Who is sponsoring the NCT05404750 clinical trial?
NCT05404750 is sponsored by University of Pittsburgh. The principal investigator is Mary Hawk, DrPH at University of Pittsburgh. The trial plans to enroll 768 participants.