Methamphetamine, PrEP, and Intersectional Stigma Study (eMPrISe)

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: Hiv; Social Stigma; Methamphetamine Abuse
• Intervention / Treatment: Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study

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 (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angel B Algarin, PhD, MPH; Phone Number: (602) 496-0845; Email: angel.algarin@asu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2024
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): 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): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Methamphetamine; Preexposure prophylaxis; Intersectional Stigma
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• 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