An observational study in Human Immunodeficiency Virus, Substance Use and Stigma, Social, sponsored by University of Pittsburgh. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University of Pittsburgh · Observational
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.
This observational study takes place across three study sites and will explore the extent to which harm reduction care mitigates stigma experienced in healthcare settings and contributes to improved clinical outcomes. This will be explored via the following aims.
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 641 is above the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Providers' Inclusion Criteria
Patient Inclusion Criteria
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
PWLH with current or lifetime substance use who receive care at one of our study sites.
Behavioral: 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.
HIV Viral Load
Viral load will be assessed as a continuous and dichotomous variable (virally suppressed \<200 copies/ml)
Time frame: Retrospective, past 5 years
Retention in care - Missed Visits
Proportion of missed versus kept HIV primary care visits
Time frame: Retrospective, past 5 years
Retention in care - Kept visits
At least 2 kept HIV primary care visits separated ≥90 days during a 12-month period
Time frame: Retrospective, past 5 years
Hepatitis C Viral Load
HCV Viral suppression
Time frame: Retrospective, past 5 years
HIV Adherence
Self-report of ART adherence - CASE Index
Time frame: Retrospective, past 5 years
Retention in Substance use treatment
Retention in MOUD or behavioral health treatment for diagnosis of substance use disorder. We will calculate the proportion of kept to scheduled visits.
Time frame: Retrospective, past 5 years
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →