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Supporting Treatment Adherence for Resilience and Thriving (START) | Clinical Trials | Clareo Health

COMPLETEDNA

Supporting Treatment Adherence for Resilience and Thriving (START)

Supporting Treatment Adherence for Resilience and Thriving

NCT05140876•Florida International University

Summary

This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Assigned male at birth;
•2. Identifies as male;
•3. Age 18 or older;
•4. Reads and speaks English;
•5. Continental US residency;
•6. Reports ever having had anal sex with a man;
•7. Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)
•8. Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports \< 90% adherence to ART;
•9. Screens positive for a moderate or severe stimulant use disorder in the past 3 months with an abbreviated version of the National Institute on Drug Abuse (NIDA)-modified Alcohol, Smoking and Substance. Involvement Screening Test (ASSIST);
•10. Has an iPhone or Android smartphone;
+1 more criteria

Exclusion Criteria

•1. HIV-negative or never tested for HIV;
•2. HIV-positive men without a current ART prescription;
•3. Does not return a viable DBS specimen at baseline for viral load testing
•4. Not a sexual minority man

Locations (1)

Florida International University

Miami, Florida, United States

Key Dates

Start Date

June 15, 2022

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2025

Last Updated

February 17, 2026

Enrollment

286

ACTUAL participants

Conditions

Adherence, MedicationHIV-1-infectionStimulant Use

Interventions

START mHealth Intervention

BEHAVIORAL

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

NCT07055451

HIV-1-infection

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RECRUITINGPHASE1

Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

NCT06790576

Stimulant Use Disorder

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RECRUITINGNA

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

NCT05136703

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Supporting Treatment Adherence for Resilience and Thriving (START)

Inclusion Criteria

Exclusion Criteria

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Enhancing Prospective Thinking in Early Recovery

Project neuroARTEMIS

A Clinical Trial to Evaluate the Safety and Efficacy of Neuromodulation Using 'ExAblate 4000 Type 2.1' in Patients With Psychostimulant Use Disorder(PUD)