Methamphetamine AbuseeMPrISeNCT05784467
Methamphetamine, PrEP, and Intersectional Stigma Study
A study testing Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study in people with Methamphetamine Abuse and Hiv, run by Arizona State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Methamphetamine Abuse, Hiv, Social Stigma
- What is being tested?
- Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- N/A
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Methamphetamine Abuse, Hiv, Social Stigma
- Being tested
- Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study
- Keywords
- Methamphetamine, Preexposure prophylaxis, Intersectional Stigma
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) studyBehavioural
Group behavioral intervention with 12 weekly sessions lasting 2 hours focusing on coping, resistance, and resilience.
| Study group | Role | What they receive |
|---|---|---|
| English | Other | Participants in the English arm will receive the eMPrISe intervention materials in English. Receives: Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study |
| Spanish | Other | Participants in the English arm will receive the eMPrISe intervention materials in Spanish. Receives: Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 Months
Secondary outcomes (3)
Resistance
Assessed using items adapted from the Stigma Resistance Scale Scores range from 0 - 76, where higher scores indicate higher levels of resistance
Measured: 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
Measured: 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
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start15 Apr 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784467
- Sponsor's protocol ID
- 1K01DA055521
- Acronym
- eMPrISe
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05784467
- Acronym / sponsor ID
- eMPrISe / 1K01DA055521
- Conditions
- Methamphetamine Abuse, Hiv, Social Stigma
- Keywords
- Methamphetamine, Preexposure prophylaxis, Intersectional Stigma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each group will receive the same intervention components, but one group will be facilitated in English and the other, Spanish.
| Arm | Type | Receives |
|---|---|---|
| English | Other | Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) studyParticipants in the English arm will receive the eMPrISe intervention materials in English. |
| Spanish | Other | Behavioral: Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) studyParticipants in the English arm will receive the eMPrISe intervention materials in Spanish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) studyGroup behavioral intervention with 12 weekly sessions lasting 2 hours focusing on coping, resistance, and resilience. | Behavioural | English, Spanish |
Primary outcome
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.
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
3 secondary outcomes
Resistance
Time frame: 3 Month
Resilience
Time frame: 3 Month
Coping
Time frame: 3 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Methamphetamine, PrEP, and Intersectional Stigma (eMPrISe) study in people with Methamphetamine Abuse and Hiv, run by Arizona State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angel B Algarin, PhD, MPH ((602) 496-0845, angel.algarin@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methamphetamine use risk (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.