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NCT05140876 | Recruiting | Adherence, Medication


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

Florida International University

Information provided by (Responsible Party):

Adam Carrico, PhD

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.

Condition or disease

Adherence, Medication

HIV-1-infection

Stimulant Use

Intervention/treatment

START mHealth Intervention

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 350 participants
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Supporting Treatment Adherence for Resilience and Thriving
Actual Study Start Date : June 15, 2022
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : April 30, 2025
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.

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.

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Criteria
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

    Supporting Treatment Adherence for Resilience and Thriving (START)

    Location Details


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    Supporting Treatment Adherence for Resilience and Thriving (START)

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations


    Recruiting

    United States, Florida

    University of MIami Miller School of Medicine

    Miami, Florida, United States, 33136

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