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Behavioral Intervention

Ending Self-Stigma Program for HIV/AIDS with Substance Use (IRIS Trial)

N/A
Waitlist Available
Led By Jesse B Fletcher, Ph.D.
Research Sponsored by Friends Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

IRIS Trial Summary

This trial will test an intervention to reduce stigma among people living with HIV & using opioids/cocaine, with the aim of improving HIV care outcomes. 70 participants will receive treatment &/or up to 10 group-based meetings to discuss common stigmas.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is a psychosocial intervention involving group discussions rather than medication, traditional physical side effects are not expected. Emotional discomfort may arise from discussing personal experiences of stigma.

IRIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ART Adherence
Viral Suppression
Secondary outcome measures
Drug Use
Substance Use
Other outcome measures
Internalized Stigma

IRIS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ESS-HSUExperimental Treatment1 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 TAUActive Control1 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.

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,481,062 Total Patients Enrolled
Friends Research Institute, Inc.Lead Sponsor
52 Previous Clinical Trials
20,538 Total Patients Enrolled
University of MarylandOTHER
160 Previous Clinical Trials
302,213 Total Patients Enrolled

Media Library

Ending Self Stigma for Persons living with HIV and Use Substances (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05704764 — N/A
HIV/AIDS Research Study Groups: Minimally Enhanced TAU, ESS-HSU
HIV/AIDS Clinical Trial 2023: Ending Self Stigma for Persons living with HIV and Use Substances Highlights & Side Effects. Trial Name: NCT05704764 — N/A
Ending Self Stigma for Persons living with HIV and Use Substances (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05704764 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still the capacity to include new participants in this experiment?

"Clinicaltrials.gov confirms that this research project is not currently looking for volunteers, having last been updated on January 20th of the current year. However, there are an abundance of alternative clinical trials actively searching for new participants at this time - 380 in total."

Answered by AI
~38 spots leftby Sep 2025