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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA055532 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Maryland | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
| Johns Hopkins University | OTHER |
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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 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.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally Enhanced TAU | No Intervention | 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. | |
| IRIS | Experimental | Using the materials developed during study phase one, five approximately 60-90 minute sessions will be carried out with the 35 participants randomized to receive IRIS. Each by session will be administered by a trained interventionist and will be carried out over a virtual platform (e.g., Zoom, Teams). The sessions are based on cognitive behavioral therapy and social cognitive theory, and are intended to reduce negative thoughts about the self and improve self-efficacy to engage with HIV and substance use treatment. Any session hand-outs will be mailed and/or emailed to participants prior to each session and shared onscreen. Participants in the IRIS condition may also receive study-provided journals to supplement their IRIS experience. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ending Self Stigma for Persons living with HIV and Use Substances | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-Related Internalized Stigma | Change in Berger HIV Stigma scale scores (1 to 4, with higher scores meaning more internalized stigma) | 30 Days |
| Substance Use-Related Internalized Stigma | Changes in Substance Use Stigma Mechanism scores (1 to 5, with higher scores meaning more internalized stigma) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ART Adherence | Change in self-reported ART adherence (5-point scale, with larger numbers meaning better ART adherence) | 30 days |
| Mental Health Symptoms | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse B Fletcher, Ph.D. | Friends Research Institute, Inc. | Principal Investigator |
| Alicia Lucksted, Ph.D. | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Research Institute, Inc. Satellite Office | Newhall | California | 91321 | United States | ||
| University of Maryland School of Medicine |
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Two group randomized (1:1) design contrasting minimally enhanced treatment-as-usual (ME-TAU) with the IRIS intervention.
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| 7 days |
| Intervention Satisfaction | Participant intervention satisfaction scores (1 to 5, with larger numbers meaning greater intervention satisfaction) | 30 days |
| Substance Use | Self-reported days of substance use | 30 days |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| ID | Term |
|---|---|
| D057545 | Social Stigma |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069078 | Seroconversion |
| ID | Term |
|---|---|
| D055633 | Immune System Phenomena |
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