Methamphetamine, PrEP, and Intersectional Stigma Study (eMPrISe)

• ClinicalTrials.gov Identifier: NCT05784467
• Recruitment Status: Not yet recruiting
• First Posted: March 27, 2023
• Last Update Posted: March 27, 2023
• Sponsor: Arizona State University
• Information provided by (Responsible Party): Arizona State University

Tracking Information

• First Submitted Date: March 13, 2023
• First Posted Date: March 27, 2023
• Last Update Posted Date: March 27, 2023
• Estimated Study Start Date: June 1, 2024
• Estimated Primary Completion Date: May 1, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2023)

• 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.
• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 24, 2023)

• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Methamphetamine, PrEP, and Intersectional Stigma Study
• Official Title: 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

Brief Summary

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.

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
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Each group will receive the same intervention components, but one group will be facilitated in English and the other, Spanish.

Masking: None (Open Label)
Primary Purpose: Prevention

Condition

• Methamphetamine Abuse
• Hiv
• Social Stigma

Intervention

Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study

Group behavioral intervention with 12 weekly sessions lasting 2 hours focusing on coping, resistance, and resilience.

Study Arms

• English
  Participants in the English arm will receive the eMPrISe intervention materials in English.
  Intervention: Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study
• Spanish
  Participants in the English arm will receive the eMPrISe intervention materials in Spanish.
  Intervention: Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 24, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2027
• Estimated Primary Completion Date: May 1, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cisgender men

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Angel B Algarin, PhD, MPH; (602) 496-0845; angel.algarin@asu.edu

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05784467
• Other Study ID Numbers: 1K01DA055521( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Arizona State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Arizona State University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Arizona State University
• Verification Date: March 2023