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

(IRIS Trial)

Not currently recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Ending Self-Stigma Program for Persons Living with HIV and Substance Use can reduce stigma among individuals with HIV who also use opioids or cocaine. Researchers seek to understand whether improved self-perception enhances HIV care and treatment outcomes. Participants will either continue their usual care or participate in five online sessions with a trained counselor to address negative self-thoughts and boost confidence in managing HIV and substance use. This trial suits English-speaking individuals living with HIV who have used drugs or are in substance use treatment and have experienced stigma related to their HIV status or substance use. As an unphased trial, it offers a unique opportunity to contribute to understanding and improving self-stigma interventions for those living with HIV and substance 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.

What prior data suggests that this intervention is safe for people living with HIV who use substances?

Research shows that programs designed to reduce self-stigma are generally safe for people. These programs can help individuals with mental health issues combat negative self-perceptions. The program in this trial builds on this concept and uses cognitive behavioral therapy, a type of talk therapy that helps people change negative thinking patterns.

A review of similar programs found that participants generally handle them well, with no major reports of harm or negative effects. This suggests that the treatment is safe for people in the trial. Although the program is newly adapted for individuals with HIV and substance use issues, it is based on proven methods. This background provides some confidence in its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ending Self-Stigma Program for HIV/AIDS with Substance Use because it targets internalized stigma, a factor often overlooked in traditional treatments. Unlike standard care options, which primarily focus on medical management and counseling, this program uses cognitive behavioral therapy and social cognitive theory to tackle negative self-perceptions. The treatment is delivered through virtual sessions, making it accessible and convenient for participants who may face barriers to in-person therapy. By improving self-efficacy and reducing self-stigma, this program has the potential to enhance engagement with existing HIV and substance use treatments, offering a holistic approach to care.

What evidence suggests that the Ending Self-Stigma Program is effective for reducing stigma in people living with HIV who use substances?

Research shows that programs aimed at reducing self-stigma can improve mental health and care engagement for people living with HIV who also use substances. In this trial, participants may receive the Ending Self-Stigma Program, which uses methods like cognitive behavioral therapy to change negative self-views and boost confidence effectively. Evidence suggests that addressing stigma can lead to better health by helping people adhere to their treatment plans. Early results from similar programs demonstrated positive effects in reducing shame and improving overall well-being. These findings suggest that the Ending Self-Stigma Program may enhance HIV care by addressing internalized stigma. ^{3 6 7 8 9}

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: IRIS Experimental Treatment 1 Intervention

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.

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 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]

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]

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