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Supporting Treatment Adherence for Resilience and Thriving (START)

Florida International University (FIU) logo

Florida International University (FIU)

Status

Active, not recruiting

Conditions

HIV-1-infection
Adherence, Medication
Stimulant Use

Treatments

Behavioral: START mHealth Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05140876
20190578
R01DA049843 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

286 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

286 participants in 2 patient groups

START mHealth Intervention
Experimental group
Description:
Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization.
Treatment:
Behavioral: START mHealth Intervention
Website referrals
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Adam W Carrico, PhD

Data sourced from clinicaltrials.gov

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