Methamphetamine, PrEP, and Intersectional Stigma Study (eMPrISe)

February 17, 2026 updated by: Arizona State University

Addressing Intersectional Stigma Through Coping, Resistance, and Resilience to Improve Methamphetamine Use and Factors Influencing PrEP Uptake Among Latino MSM: a Step Towards Ending HIV by 2030

The goal of this clinical trail is to test the developed eMPrISe study in HIV-negative, adult, Latino men who have sex with men (MSM) who use non-injection substances. The main questions it aims to answer are:

  • Can participation in the developed eMPrISe study reduce methamphetamine ('meth') use risk?
  • Can participation in the developed eMPrISe study improve preexposure prophylaxis (PrEP) cascade progression? Participants will participate in 12 weekly modules that: (1) build critical thinking skills, (2) identify and discuss the link between oppression and harmful behaviors, (3) take action, (4) voice and validate feelings and experiences, and (5) share knowledge and resources.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a clinical trial research experience to support Dr. Angel B Algarin's training. Findings from secondary analyses from AIMs 1 & 2 will guide the selection and adaptation of evidence-based, multi-level coping resistance and resilience intervention strategies to reduce the harmful effects of intersectional stigma on meth use and PrEP cascade progression.

Resistance: I plan to adapt Community Wise which is a 12-week multi-level, group intervention that moves participants from a cycle of oppression, feelings of powerlessness, and health risk behaviors to a cycle of empowerment, self-efficacy, and health promoting behaviors. The intervention was found to be effective in reducing recent substance use.

Coping: I plan to integrate effective components of the Effective Skills to Empower Effective Men (ESTEEM) study which utilizes a cognitive based therapy (CBT) approach to enhance stigma coping among MSM and has been found effective in reducing drug use and sexual risk behaviors.

Resilience: I plan to integrate resilience intervention strategies from the HealthMpowerment study which is grounded in the Institute of Medicine's Integrated Model of Behavior Theory and has been shown to reduce sexual risk behaviors and stigma among MSM.

The eMPrISe study will be developed using the ADAPT-ITT (Assessment, Decision, Adaptation, Production, Topical experts, Integration, Training, Testing) model and will be formatively evaluated among n=20 Latino MSM (10 English speaking & 10 Spanish speaking) with moderate meth use risk scores determined by Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Quantitative data will be collected via Qualtrics and Network Canvas for a 60-minute interviewer driven survey pre- and post-evaluation of adapted intervention, and for 10-minute self-administered questionnaires following each of the 12 modules. Qualitative data will be collected via audio recordings of participants' real time responses as they progress through the intervention to assess feasibility of the 12 weekly modules. Quantitative results will also inform semi-structured focus groups (1 English, 1 Spanish) to contextualize the acceptability of each of the 12 intervention modules and the intervention as a whole. While the formative evaluation will assess trends, it is not powered to detect pre-post changes in these measures.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18+ years of age
  • cisgender male
  • self-identify as Latino or Hispanic
  • fluent in English or Spanish
  • any sexual activity with men in the past 12 months
  • HIV-negative
  • moderate methamphetamine use risk (as determined by the the ASSIST assessment)
  • experience of intersectional stigma within their social network in the past 12 months
  • willing to provide written informed consent

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: English
Participants in the English arm will receive the eMPrISe intervention materials in English.
Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study
Group behavioral intervention with 12 weekly sessions lasting 2 hours focusing on coping, resistance, and resilience.
Other: Spanish
Participants in the English arm will receive the eMPrISe intervention materials in Spanish.
Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study
Group behavioral intervention with 12 weekly sessions lasting 2 hours focusing on coping, resistance, and resilience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methamphetamine use risk
Time Frame: 3 Months
Assessed using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Scores range from 0 - 39, where higher scores indicate higher risk.
3 Months
PrEP cascade progression
Time Frame: 3 Months
Assessed using the Motivational PrEP Cascade Ordinal outcome including: 1= PrEP pre-contemplation, 2= PrEP contemplation, 3=PrEParation, 4=PrEP Action & Initiation, 5=PrEP Maintenance
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistance
Time Frame: 3 Month
Assessed using items adapted from the Stigma Resistance Scale Scores range from 0 - 76, where higher scores indicate higher levels of resistance
3 Month
Resilience
Time Frame: 3 Month
Assessed using items from the Connor-Davidson Resilience Scale (CD-RISC) Scores range from 0-40, where higher scores indicate higher levels of resilience
3 Month
Coping
Time Frame: 3 Month
Assessed using the Coping Inventory for Stressful Situations (CISS) Scores range from 0-84, where higher scores indicate higher levels of coping
3 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K01DA055521 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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