Skip to main content
OpenTrials
Completed

NCT Number: NCT05140876

Supporting Treatment Adherence for Resilience and Thriving (START)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adherence, Medication Behavior HIV-1-infection Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Stimulant Use Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University

Miami, Florida, 33199, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Assigned male at birth;
  • Identifies as male;
  • Age 18 or older;
  • Reads and speaks English;
  • Continental US residency;
  • Reports ever having had anal sex with a man;
  • Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)
  • Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports < 90% adherence to ART;
  • 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);
  • Has an iPhone or Android smartphone;
  • Is willing to participate in an mHealth intervention

Exclusion criteria

  • 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

Treatment and study plan

START mHealth Intervention

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.

Primary outcomes

  1. Unsuppressed HIV Viral Load

    Time frame: 6 Months

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

Secondary outcomes

  1. Unsuppressed Viral Load

    Time frame: 12 Months

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

  2. Self-Reported Stimulant Use Severity

    Time frame: 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).

  3. Self-Reported Anti-Retroviral Therapy (ART) Adherence

    Time frame: 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

  4. Positive Affect

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Supporting Treatment Adherence for Resilience and Thriving

Acronym: START

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.