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 |
| 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 |