Supporting Treatment Adherence for Resilience and Thriving (START)

NCT ID: NCT05140876

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adherence, Medication HIV-1-infection Stimulant Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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START mHealth Intervention

Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization.

Group Type EXPERIMENTAL

START mHealth Intervention

Intervention Type BEHAVIORAL

The START mHealth intervention is a mobile application that will be downloaded by participants through their mobile phones. The application targets information, motivation, and behavioral skills relevant to ART adherence. Participants will have access to this application for 6 months.

Website referrals

Participants in this condition will receive no intervention and will have access to a website with resources related to substance use disorder treatment and HIV treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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START mHealth Intervention

The START mHealth intervention is a mobile application that will be downloaded by participants through their mobile phones. The application targets information, motivation, and behavioral skills relevant to ART adherence. Participants will have access to this application for 6 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Florida International University

OTHER

Sponsor Role lead

Responsible Party

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Adam Carrico, PhD

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam W Carrico, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

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Florida International University

Miami, Florida, United States

Site Status

Countries

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United States

References

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Davis-Ewart L, Atkins L, Ghanooni D, Diaz JE, Chuku CC, Balise R, DeVries BA, Miller-Perusse M, Ackley Iii D, Moskowitz JT, McCollister K, Fardone E, Hirshfield S, Horvath KJ, Carrico AW. Supporting treatment adherence for resilience and thriving (START): protocol for a mHealth randomized controlled trial. BMC Public Health. 2024 Aug 29;24(1):2350. doi: 10.1186/s12889-024-19745-7.

Reference Type DERIVED
PMID: 39210314 (View on PubMed)

Other Identifiers

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R01DA049843

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20190578

Identifier Type: -

Identifier Source: org_study_id

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