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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV, Opioid Use, Cocaine Use, Stigma, Social

Intervention / Treatment
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* Behavioral: Ending Self Stigma for Persons living with HIV and Use Substances


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group randomized design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Minimally Enhanced TAU<br>Participants assigned to the minimally enhanced treatment-as-usual condition will receive an educational pamphlet about internalized stigma to read at their leisure and will be encouraged to continue in all their customary HIV- and substance use-related services. | |
| Experimental: ESS-HSU<br>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). | Behavioral: Ending Self Stigma for Persons living with HIV and Use Substances<br>* Group-based intervention based on principles of cognitive behavioral therapy and social cognitive theory designed to reduce internalized stigma related to HIV and/or drug use.<br>* Other names: ESS-HSU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | Achievement of Undetectable Viral Load (<50 copies/mL) | 6 months | 
| ART Adherence | Self-report adherence to antiretroviral therapy (pill count last seven days) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Use | 10-panel Dipcard Urine Toxicology Screen | 6 months | 
| Substance Use | Timeline Followback Assessment for drugs and alcohol use | 6 months |