Supporting Treatment Adherence for Resilience and Thriving (START) (START)

Supporting Treatment Adherence for Resilience and Thriving

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.

Study Overview

• Status: Completed
• Conditions: Adherence, Medication; HIV-1-infection; Stimulant Use
• Intervention / Treatment: Behavioral: START mHealth Intervention

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • Florida International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;
11. Is willing to participate in an mHealth intervention

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: START mHealth Intervention; Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unsuppressed HIV Viral Load	Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Stimulant Use Severity	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).	12 Months
Self-Reported Anti-Retroviral Therapy (ART) Adherence	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	12 Months
Positive Affect	Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect.	12 Months
Unsuppressed Viral Load	Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples	12 Months

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Adam W Carrico, PhD, Florida International University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Medication Adherence
• Other Study ID Numbers: 20190578; R01DA049843 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No