Clinical trial NCT05704764: Using the Ending Self-Stigma Intervention to Reduce Internalized Stigma Among People Living With HIV Who Use Substances
Official title: IRIS: Intervention to Reduce Internalized Stigma (IRIS) Among People Living With HIV Who Use Substances
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Opioid Use
Cocaine Use
Stigma, Social
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: National Institute on Drug Abuse (NIDA)
name: Johns Hopkins University
First posted: 2023-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized design.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test an intervention to reduce stigma among people living with HIV who use opioids and cocaine. The main question it aims to answer is:

- Does reducing internalized stigma about HIV and/or drug use lead to improved HIV care outcomes?

After a year spent adapting an existing intervention to be applied specifically among people living with HIV who use substances, 70 participants will be randomized to receive either treatment-as-usual or the newly adapted intervention. The intervention itself will consist of less than ten group-based meetings to discuss and work through the stigmas people commonly associate with HIV and/or drug use.

Detailed description: Different types of stigma (e.g., anticipated, enacted, internalized) associated with illicit substance use (SU) and HIV positive status impede HIV treatment outcomes (incl. HIV healthcare retention, antiretroviral therapy \[ART\] adherence and viral load suppression). The premise of this study is that individuals can learn to diminish the personal effects of public stigma, thereby reducing internalized stigma and improving expected health outcomes.

To this end, this study will adapt an existing evidence-based stigma reduction intervention, Ending Self-Stigma (ESS), which has shown efficacy in reducing internalized and anticipated stigma in populations experiencing mental health challenges, to be applied specifically among people living with HIV and using opioids and cocaine. The new group-based intervention will be called ESS-HSU, and will use cognitive behavioral therapy strategies and social cognitive theory constructs to facilitate reductions in internalized stigma.

In the first year, an iterative process beginning with formative interviews with service delivery key informants and people living with HIV/AIDS (PLWH) who use illicit opioids and/or cocaine, and ending with two rounds of pilot studies with the PLWH and SU, will generate an initial version of ESS-HSU. Intervention content will be adapted based on participant feedback and intervention delivery will be adapted for a virtual format. Year one will end with two small pilot trials (n = 8 per trial) to elicit participant feedback and further refine the adapted intervention.

In years 2-3, a clinical trial testing the newly adapted ESS-HSU intervention will be carried out with 70 participants (Group 1: Minimally Enhanced Treatment-as-Usual; Group 2: ESS-HSU; 1:1 randomization) to determine feasibility and acceptability of the intervention in addition to collecting data on intervening variables (incl. internalized and anticipated stigma, depressive symptoms, anxiety, and social support). Primary HIV-related outcomes will include ART adherence, suppressed viral load, and retention in HIV healthcare at 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* English speaking
* Living with HIV
* Screen positive for opioid use disorder and/or cocaine use disorder on the Composite International Diagnostic Interview
* Willing and able to provide full informed consent
* Responds affirmatively to having ever experienced one or more of the following types of stigma related to HIV status or SU: (1) enacted, (2) anticipated, and/or internalized.

Exclusion Criteria:

* Does not meet all inclusion criteria.

Primary outcomes:
measure: Viral Suppression
timeFrame: 6 months
measure: ART Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Drug Use
timeFrame: 6 months
measure: Substance Use
timeFrame: 6 months
Other outcomes:
measure: Internalized Stigma
timeFrame: 6 months
Locations:
city: Cerritos
country: United States
facility: Friends Research Institute, Inc. Office Building
state: California
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Jesse B Fletcher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Alicia Lucksted, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: