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Methamphetamine, PrEP, and Intersectional Stigma Study

Studies

Study First Submitted Date 2023-03-13
Study First Posted Date 2023-03-27
Last Update Posted Date 2023-03-27
Start Month Year June 1, 2024
Primary Completion Month Year May 1, 2026
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-27

Detailed Descriptions

Sequence: 20620515
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.

Browse Interventions

Sequence: 95548393 Sequence: 95548399 Sequence: 95548390 Sequence: 95548391 Sequence: 95548392 Sequence: 95548394 Sequence: 95548395 Sequence: 95548396 Sequence: 95548397 Sequence: 95548398 Sequence: 95548400 Sequence: 95548401 Sequence: 95548402 Sequence: 95548403
Mesh Term Sympathomimetics Mesh Term Adrenergic Agents Mesh Term Methamphetamine Mesh Term Central Nervous System Stimulants Mesh Term Physiological Effects of Drugs Mesh Term Autonomic Agents Mesh Term Peripheral Nervous System Agents Mesh Term Dopamine Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Adrenergic Uptake Inhibitors Mesh Term Neurotransmitter Uptake Inhibitors Mesh Term Membrane Transport Modulators Mesh Term Dopamine Uptake Inhibitors
Downcase Mesh Term sympathomimetics Downcase Mesh Term adrenergic agents Downcase Mesh Term methamphetamine Downcase Mesh Term central nervous system stimulants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term autonomic agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term dopamine agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term adrenergic uptake inhibitors Downcase Mesh Term neurotransmitter uptake inhibitors Downcase Mesh Term membrane transport modulators Downcase Mesh Term dopamine uptake inhibitors
Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51912600 Sequence: 51912601 Sequence: 51912602
Name Methamphetamine Abuse Name Hiv Name Social Stigma
Downcase Name methamphetamine abuse Downcase Name hiv Downcase Name social stigma

Id Information

Sequence: 39955911
Id Source org_study_id
Id Value 1K01DA055521
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/1K01DA055521

Design Groups

Sequence: 55319797 Sequence: 55319798
Group Type Other Group Type Other
Title English Title Spanish
Description Participants in the English arm will receive the eMPrISe intervention materials in English. Description Participants in the English arm will receive the eMPrISe intervention materials in Spanish.

Interventions

Sequence: 52227044
Intervention Type Behavioral
Name Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study
Description Group behavioral intervention with 12 weekly sessions lasting 2 hours focusing on coping, resistance, and resilience.

Keywords

Sequence: 79457844 Sequence: 79457845 Sequence: 79457846
Name Methamphetamine Name Preexposure prophylaxis Name Intersectional Stigma
Downcase Name methamphetamine Downcase Name preexposure prophylaxis Downcase Name intersectional stigma

Design Outcomes

Sequence: 176489819 Sequence: 176489820 Sequence: 176489821 Sequence: 176489822 Sequence: 176489823
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Methamphetamine use risk Measure PrEP cascade progression Measure Resistance Measure Resilience Measure Coping
Time Frame 3 Months Time Frame 3 Months Time Frame 3 Month Time Frame 3 Month Time Frame 3 Month
Description Assessed using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Scores range from 0 – 39, where higher scores indicate higher risk. Description 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 Description Assessed using items adapted from the Stigma Resistance Scale Scores range from 0 – 76, where higher scores indicate higher levels of resistance Description Assessed using items from the Connor-Davidson Resilience Scale (CD-RISC) Scores range from 0-40, where higher scores indicate higher levels of resilience Description Assessed using the Coping Inventory for Stressful Situations (CISS) Scores range from 0-84, where higher scores indicate higher levels of coping

Sponsors

Sequence: 48075676
Agency Class OTHER
Lead Or Collaborator lead
Name Arizona State University

Central Contacts

Sequence: 11952401
Contact Type primary
Name Angel B Algarin, PhD, MPH
Phone (602) 496-0845
Email angel.algarin@asu.edu
Role Contact

Design Group Interventions

Sequence: 67818704 Sequence: 67818705
Design Group Id 55319797 Design Group Id 55319798
Intervention Id 52227044 Intervention Id 52227044

Eligibilities

Sequence: 30611728
Gender Male
Minimum Age 18 Years
Maximum Age N/A
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
Gender Description Cisgender men
Gender Based True
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253924085
Registered In Calendar Year 2023
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30358961
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking None (Open Label)
Intervention Model Description Each group will receive the same intervention components, but one group will be facilitated in English and the other, Spanish.

Responsible Parties

Sequence: 28730592
Responsible Party Type Sponsor