Clinical trial NCT05404750: Harm Reduction in HIV Primary Care for PLWH Who Use Drugs
Official title: Impact of Harm Reduction Care in HIV Clinical Settings on Stigma and Health Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Immunodeficiency Virus
Substance Use
Stigma, Social
Keywords: Harm Reduction
Patient-Provider Relationship
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Allegheny Health Network
name: University of Alabama at Birmingham
name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2022-06-03
Enrollment: 768
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: 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.

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:

-

Primary outcomes:
measure: HIV Viral Load
timeFrame: Retrospective, past 5 years
Secondary outcomes:
measure: Retention in care - Missed Visits
timeFrame: Retrospective, past 5 years
measure: Retention in care - Kept visits
timeFrame: Retrospective, past 5 years
measure: Hepatitis C Viral Load
timeFrame: Retrospective, past 5 years
measure: HIV Adherence
timeFrame: Retrospective, past 5 years
measure: Retention in Substance use treatment
timeFrame: Retrospective, past 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Pittsburgh
country: United States
facility: Allegheny Health Network Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mary Hawk, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Emma Kay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.