Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05784467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-27
First Post:
2023-03-13
Brief Title:
Methamphetamine PrEP and Intersectional Stigma Study
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eMPrISe
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
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 Algarins 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 Medicines 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 n20 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
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 Medicines 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 n20 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None