Using the Ending Self-Stigma Intervention to Reduce Internalized Stigma Among People Living With HIV Who Use Substances — IRIS  

HIV Clinical Trial

Official title: IRIS: Intervention to Reduce Internalized Stigma (IRIS) Among People Living With HIV Who Use Substances

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cocaine Use
• HIV
• Opioid Use
• Stigma, Social

• NCT number: NCT05704764
• Study type: Interventional
• Source: Friends Research Institute, Inc.
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 17, 2023
• Completion date: December 31, 2025