NCT05140876

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

November 15, 2021

Last Update Submit

February 14, 2026

Conditions

Stimulant UseAdherence, MedicationHIV-1-infection

Outcome Measures

Primary Outcomes (1)

  • Unsuppressed HIV Viral Load

    Proportion of participants with a viral load \> 300 copies/mL from dried blood spot samples

    6 Months

Secondary Outcomes (4)

  • Unsuppressed Viral Load

    12 Months

  • Self-Reported Stimulant Use Severity

    12 Months

  • Self-Reported Anti-Retroviral Therapy (ART) Adherence

    12 Months

  • Positive Affect

    12 Months

Study Arms (2)

START mHealth Intervention

EXPERIMENTAL

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

Behavioral: START mHealth Intervention

Website referrals

NO INTERVENTION

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.

Interventions

START mHealth InterventionBEHAVIORAL

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.

START mHealth Intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIdentifies as male
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (1)

  • 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.

    PMID: 39210314DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Adam W Carrico, PhD

    Florida International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 2, 2021

Study Start

June 15, 2022

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)