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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Methamphetamine Abuse; Hiv; Social Stigma	Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• 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
• 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
• Estimated Study Start Date: June 1, 2024
• Estimated Primary Completion Date: May 1, 2026
• Estimated Study Completion Date: August 31, 2027

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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

Secondary Outcome Measures :

1. 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
2. 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. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cisgender men
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Arizona State University

More Information

• Responsible Party: Arizona State University
• ClinicalTrials.gov Identifier: NCT05784467
• Other Study ID Numbers: 1K01DA055521 ( U.S. NIH Grant/Contract )
• First Posted: March 27, 2023
• Last Update Posted: March 27, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Arizona State University:

Methamphetamine; Preexposure prophylaxis; Intersectional Stigma

Additional relevant MeSH terms:

Methamphetamine; Central Nervous System Stimulants; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors