Supporting Treatment Adherence for Resilience and Thriving (START)

Not Applicable

Active, not recruiting

• Conditions: Stimulant Use; HIV-1-infection; Adherence, Medication
• Interventions: Behavioral: START mHealth Intervention

• Registration Number: NCT05140876
• Lead Sponsor: Florida International University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-12-02
• Study Start: 2022-06-15
• Primary Completion: 2025-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 286

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Unsuppressed HIV Viral Load	6 Months	Proportion of participants with a viral load \> 300 copies/mL from dried blood spot samples

Secondary Outcome Measures

Name	Time	Method
Unsuppressed Viral Load	12 Months	Proportion of participants with a viral load \> 300 copies/mL from dried blood spot samples
Self-Reported Stimulant Use Severity	12 Months	The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) provides validated composite scores indexing the severity of cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).
Self-Reported Anti-Retroviral Therapy (ART) Adherence	12 Months	Participants will rate on a visual analogue scale the percentage (0% meaning no adherence to 100% meaning complete adherence) of ART medications that they took in the past 30 days
Positive Affect	12 Months	Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect.

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States