NCT05704764

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
2mo left

Started Feb 2023

Typical duration for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Feb 2023Jun 2026

First Submitted

Initial submission to the registry

January 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

July 20, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

January 20, 2023

Last Update Submit

July 16, 2025

Conditions

HIVStigma, SocialSubstance Use

Keywords

cognitive behavioral therapysocial cognitive theorystigma

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • ART Adherence

    30 days

  • Mental Health Symptoms

    7 days

  • Intervention Satisfaction

    30 days

  • Substance Use

    30 days

Study Arms (2)

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.

Behavioral: Ending Self Stigma for Persons living with HIV and Use Substances

Interventions

Ending Self Stigma for Persons living with HIV and Use SubstancesBEHAVIORAL

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.

Also known as: IRIS
IRIS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years of age
  • English speaking
  • Living with HIV
  • Self-report recent drug and/or alcohol use OR currently enrolled in substance use treatment
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Friends Research Institute, Inc. Satellite Office

Newhall, California, 91321, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Social StigmaSubstance-Related Disorders

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • Jesse B Fletcher, Ph.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

  • Alicia Lucksted, Ph.D.

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two group randomized (1:1) design contrasting minimally enhanced treatment-as-usual (ME-TAU) with the IRIS intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 30, 2023

Study Start

February 17, 2023

Primary Completion

March 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 20, 2025

Record last verified: 2025-03

Locations

US(2)