NCT Number: NCT05704764
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Friends Research Institute, Inc. Satellite Office, Newhall, California, United States
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.).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One-on-one intervention based on principles of cognitive behavioral therapy and social cognitive theory designed to reduce internalized stigma related to HIV and/or drug use.
Other names: IRIS
Time frame: 30 Days
Change in Berger HIV Stigma scale scores (1 to 4, with higher scores meaning more internalized stigma)
Time frame: 30 days
Changes in Substance Use Stigma Mechanism scores (1 to 5, with higher scores meaning more internalized stigma)
Time frame: 30 days
Change in self-reported ART adherence (5-point scale, with larger numbers meaning better ART adherence)
Time frame: 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.
Time frame: 30 days
Participant intervention satisfaction scores (1 to 5, with larger numbers meaning greater intervention satisfaction)
Time frame: 30 days
Self-reported days of substance use
Friends Research Institute, Inc.
Other
IRIS: Intervention to Reduce Internalized Stigma (IRIS) Among People Living With HIV Who Use Substances
Acronym: IRIS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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