Using the Ending Self-Stigma Intervention to Reduce Internalized Stigma Among People Living with HIV Who Use Substances
- Conditions
- Opioid UseCocaine UseStigma, SocialHIV
- Interventions
- Behavioral: Ending Self Stigma for Persons living with HIV and Use Substances
- 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- Does not meet all inclusion criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESS-HSU Ending Self Stigma for Persons living with HIV and Use Substances Using the materials developed during study year one, up to nine approximately 60-90 minute sessions will be carried out with groups of 8-10 participants at a time randomized to receive ESS-HSU. Each by session will be administered by two facilitators and will be carried out over a virtual platform (e.g., Zoom, Teams). Any session hand-outs will be mailed and/or emailed to participants prior to each session and shared onscreen. Participants in the ESS-HSU condition may also receive study-provided tablet computers with data plans to facilitate their engagement in the intervention (as needed).
- Primary Outcome Measures
Name Time Method Viral Suppression 6 months Achievement of Undetectable Viral Load (\<50 copies/mL)
ART Adherence 6 months Self-report adherence to antiretroviral therapy (pill count last seven days)
- Secondary Outcome Measures
Name Time Method Drug Use 6 months 10-panel Dipcard Urine Toxicology Screen
Substance Use 6 months Timeline Followback Assessment for drugs and alcohol use
Trial Locations
- Locations (2)
Friends Research Institute, Inc. Office Building
🇺🇸Cerritos, California, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States