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

Not Applicable

Active, not recruiting

• Conditions: HIV; Stigma, Social; Substance Use

• Registration Number: NCT05704764
• Lead Sponsor: Friends Research Institute, Inc.

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 five one-on-one sessions with a trained interventionist to discuss and work through the stigmas people commonly associate with HIV and/or substance 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 adapted 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 drugs and/or alcohol (or are currently in treatment for substance use). The new one-on-one intervention is IRIS, and it uses cognitive behavioral therapy strategies and social cognitive theory constructs to facilitate reductions in internalized stigma.

In the first phase, an iterative process beginning with formative interviews with service delivery key informants and people living with HIV/AIDS (PLWH) who use substances generated an initial version of IRIS. Intervention content was adapted based on participant feedback and intervention delivery was adapted for a virtual format.

In the second phase, a small pilot of the newly created IRIS intervention was carried out with persons living with HIV and using substances. Feedback from participants and intervention staff were used to refine the IRIS intervention.

In the third phase, a clinical trial testing the newly adapted IRIS intervention will be carried out with 70 participants (Group 1: Minimally Enhanced Treatment-as-Usual; Group 2: IRIS; 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, etc.).

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-30
• Study Start: 2023-02-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 18+ years of age
• English speaking
• Living with HIV
• Self-report recent drug and/or alcohol use OR currently enrolled in substance use treatment
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIV-Related Internalized Stigma	30 Days	Change in Berger HIV Stigma scale scores (1 to 4, with higher scores meaning more internalized stigma)
Substance Use-Related Internalized Stigma	30 days	Changes in Substance Use Stigma Mechanism scores (1 to 5, with higher scores meaning more internalized stigma)

Secondary Outcome Measures

Name	Time	Method
ART Adherence	30 days	Change in self-reported ART adherence (5-point scale, with larger numbers meaning better ART adherence)
Intervention Satisfaction	30 days	Participant intervention satisfaction scores (1 to 5, with larger numbers meaning greater intervention satisfaction)
Substance Use	30 days	Self-reported days of substance use
Mental Health Symptoms	7 days	Changes in CES-D (1 to 4, with larger numbers meaning more depression symptoms) and Spielberger Anxiety (1 to 4, with larger numbers meaning more anxiety) scale scores.

Trial Locations

Locations (2)

Friends Research Institute, Inc. Satellite Office; 🇺🇸 Newhall, California, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States