HIVIRISNCT05704764
Using the Ending Self-Stigma Intervention to Reduce Internalized Stigma Among People Living With HIV Who Use Substances
A study testing Ending Self Stigma for Persons living with HIV and Use Substances in people with HIV and Stigma, Social, run by Friends Research Institute, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Stigma, Social, Substance Use
- What is being tested?
- Ending Self Stigma for Persons living with HIV and Use Substances
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ 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.
Who cannot join
- Does not meet all inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Friends Research Institute, Inc. Satellite Office
Newhall, California, 91321
About this study
Official title: IRIS: Intervention to Reduce Internalized Stigma (IRIS) Among People Living With HIV Who Use Substances
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.
Read the detailed description
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.).
- Conditions
- HIV, Stigma, Social, Substance Use
- Being tested
- Ending Self Stigma for Persons living with HIV and Use Substances
- Keywords
- cognitive behavioral therapy, social cognitive theory, stigma
- Medical subject headings
- Social Stigma, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ending Self Stigma for Persons living with HIV and Use SubstancesBehavioural
Also called IRIS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Ending Self Stigma for Persons living with HIV and Use Substances |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-Related Internalized Stigma
Change in Berger HIV Stigma scale scores (1 to 4, with higher scores meaning more internalized stigma)
Measured: 30 Days
Substance Use-Related Internalized Stigma
Changes in Substance Use Stigma Mechanism scores (1 to 5, with higher scores meaning more internalized stigma)
Measured: 30 days
Secondary outcomes (4)
ART Adherence
Change in self-reported ART adherence (5-point scale, with larger numbers meaning better ART adherence)
Measured: 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.
Measured: 7 days
Intervention Satisfaction
Participant intervention satisfaction scores (1 to 5, with larger numbers meaning greater intervention satisfaction)
Measured: 30 days
Substance Use
Self-reported days of substance use
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start17 Feb 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomized (1:1) design contrasting minimally enhanced treatment-as-usual (ME-TAU) with the IRIS intervention.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, National Institute on Drug Abuse (NIDA), Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Jesse B Fletcher, Ph.D., Principal investigator, Friends Research Institute, Inc.Alicia Lucksted, Ph.D., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704764
- Sponsor's protocol ID
- IRIS-ESS-HSU
- Other IDs
- R34DA055532
- Acronym
- IRIS
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRIS: Intervention to Reduce Internalized Stigma (IRIS) Among People Living With HIV Who Use Substances
- ClinicalTrials.gov ID
- NCT05704764
- Acronym / sponsor ID
- IRIS / IRIS-ESS-HSU
- Conditions
- HIV, Stigma, Social, Substance Use
- Keywords
- cognitive behavioral therapy, social cognitive theory, stigma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- University of Maryland, National Institute on Drug Abuse (NIDA), Johns Hopkins University
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group randomized (1:1) design contrasting minimally enhanced treatment-as-usual (ME-TAU) with the IRIS intervention.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Ending Self Stigma for Persons living with HIV and Use SubstancesUsing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18+ 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
Key exclusion criteria (1 listed)
- Does not meet all inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ending Self Stigma for Persons living with HIV and Use SubstancesAlso: IRISOne-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. | Behavioural | IRIS |
Primary outcome
HIV-Related Internalized Stigma
Time frame: 30 Days
Change in Berger HIV Stigma scale scores (1 to 4, with higher scores meaning more internalized stigma)
Substance Use-Related Internalized Stigma
Time frame: 30 days
Changes in Substance Use Stigma Mechanism scores (1 to 5, with higher scores meaning more internalized stigma)
4 secondary outcomes
ART Adherence
Time frame: 30 days
Mental Health Symptoms
Time frame: 7 days
Intervention Satisfaction
Time frame: 30 days
Substance Use
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for HIV
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse B Fletcher, Ph.D. principal investigator
Friends Research Institute, Inc.
Alicia Lucksted, Ph.D. principal investigator
University of Maryland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ending Self Stigma for Persons living with HIV and Use Substances in people with HIV and Stigma, Social, run by Friends Research Institute, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-Related Internalized Stigma (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.