Ending Self-Stigma Program for HIV/AIDS with Substance Use

(IRIS Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Friends Research Institute, Inc.

Disqualifiers: Under 18, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing stigma among people with HIV who use opioids and cocaine.

How does the Ending Self-Stigma treatment for HIV/AIDS with substance use differ from other treatments?

The Ending Self-Stigma treatment is unique because it specifically targets the internalized stigma (negative self-judgments) experienced by people living with HIV who also use substances, which can hinder their access to healthcare and overall well-being. Unlike traditional medical treatments, this program focuses on reducing self-stigma to improve mental health and social interactions, thereby enhancing the quality of life and engagement in HIV care. ^{1 2 3 4 5}

What data supports the effectiveness of the Ending Self Stigma treatment for people living with HIV and using substances?

Research shows that reducing self-stigma can improve mental health and engagement in HIV care. A community-based program in Zimbabwe improved self-worth and wellbeing among young people with HIV, suggesting that similar approaches could help those with substance use issues. ^{3 4 6 7 8}

Who Is on the Research Team?

Jesse B Fletcher, Ph.D.

Principal Investigator

Friends Research Institute, Inc.

Alicia Lucksted, Ph.D.

Principal Investigator

University of Maryland

Are You a Good Fit for This Trial?

This trial is for adults over 18 living with HIV who also use opioids or cocaine. Participants must have experienced stigma related to their HIV status or substance use, be able to give informed consent, and speak English.

Inclusion Criteria

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

Living with HIV

Exclusion Criteria

Does not meet all inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Adaptation of the existing intervention to be applied specifically among people living with HIV who use substances, including formative interviews and pilot studies.

1 year

Treatment

Participants receive either the newly adapted ESS-HSU intervention or minimally enhanced treatment-as-usual. The ESS-HSU intervention consists of up to nine group-based virtual sessions.

6 months

Up to 9 virtual sessions

Follow-up

Participants are monitored for primary HIV-related outcomes including ART adherence, viral suppression, and retention in HIV healthcare.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ending Self Stigma for Persons living with HIV and Use Substances

Trial Overview The study tests an intervention designed to reduce internalized stigma in people with HIV who use substances. It involves less than ten group meetings where participants discuss and address the stigmas associated with HIV/drug use.

How Is the Trial Designed?

Group I: ESS-HSU Experimental Treatment 1 Intervention

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).

Group II: Minimally Enhanced TAU Active Control 1 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.

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

University of Maryland

Collaborator

Trials

171

Recruited

325,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A survey of 286 HIV care sites in 45 countries showed that from 2014-2015 to 2017, there was a notable increase in the provision of substance use education (up 9%), screening (up 16%), and referrals (up 8%) for patients, indicating a positive trend in integrating substance use services into HIV care.

Despite these improvements, significant gaps remain, especially in screening and referral services for children and adolescents, and in lower-income countries, highlighting the need for continued efforts to enhance these services in resource-constrained settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017. Parcesepe, AM., Lancaster, K., Edelman, EJ., et al.[2023]

A systematic review of 20 studies involving 9536 participants across various low- and middle-income countries found that structural interventions, such as improving access to antiretroviral treatment and social empowerment, significantly reduced self-stigma among people living with HIV.

In contrast, studies that did not address structural risks showed mixed results, highlighting the importance of comprehensive approaches that include both individual and structural components to effectively combat self-stigma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Management of a spoiled identity': systematic review of interventions to address self-stigma among people living with and affected by HIV. Pantelic, M., Steinert, JI., Park, J., et al.[2022]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Wakakosha "You are Worth it": reported impact of a community-based, peer-led HIV self-stigma intervention to improve self-worth and wellbeing among young people living with HIV in Zimbabwe. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Substance Use Stigma and Antiretroviral Therapy Adherence Among a Drug-Using Population Living with HIV. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Predictors of substance use frequency and reductions in seriousness of use among persons living with HIV. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

HIV stigma among substance abusing people living with HIV/AIDS: implications for HIV treatment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017. [2023]

6. England pubmed.ncbi.nlm.nih.gov

'Management of a spoiled identity': systematic review of interventions to address self-stigma among people living with and affected by HIV. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

HIV-Related Self-Stigma and Health-Related Quality of Life of People Living With HIV in Finland. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

HIV Stigma, Depressive Symptoms, and Substance Use. [2021]