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Recruiting

NCT Number: NCT05958017

reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)

The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Jose Szapocznik, PhD

PRINCIPAL_INVESTIGATOR

Paco Castellon, MPH, MBA

CONTACT

[email protected]

305-205-0072

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Assigned male sex at birth and has not undergone any transgender hormonal treatment
  • Reports having had sex with a male in the past 12 months
  • Age 18 or older
  • Is affiliated with a study referral source (e.g., AHF clinic, registry, other healthcare program or clinic) or resides in a city or county where a participating healthcare center or health program is located
  • Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI
  • Reports that he is not currently in drug treatment
  • Is living with HIV
  • Reports having an active antiretroviral prescription
  • Have access to a smartphone or tablet with stable internet at least twice a week and can download applications to the smartphone or tablet
  • Able to understand English
  • Consents to participation in the study
  • Provides sufficient locator information
  • Identifies as non-Hispanic White, non-Hispanic Black/African American or Latinx/Hispanic
  • Has been in stable housing for the past 3 months and intends to remain housed for the next 15 months

Exclusion criteria

  • Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
  • Persons that meet criteria for prisoner status will be excluded at baseline.
  • Patients who screen positive for moderate to severe opioid use disorder will be excluded from the study because effective pharmacological agents exist for the treatment of this disorder. These patients will be referred to community-based programs that provide specialized treatment for this disorder.
  • Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.

Treatment and study plan

RESET

Behavioral

Participants in this group will use a mobile application that delivers treatment for substance use disorder. 31 required and 30 optional modules. Among many topics covered in the modules, some are substance use management, communication, emotion management, relationship skills, HIV/Sexually Transmitted Infections and triggers for risky sex. In the reSET app you will get the chance to earn rewards for two activities: (1) completing a module and (2) providing a negative urine drug screen in exchange for a motivational or monetary prize. You will have 12 weeks to complete as many modules as you like, about 4 modules per week. Each module takes approximately 10-15 min. Every 3-4 days you will meet with the same study team member to provide a urine drug screen from a place comfortable for you (e.g. home) which will be observed and read via Zoom.

Standard of care

Other

Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.

Primary outcomes

  1. Change in days of stimulant use as measured by Timeline FollowBack

    Time frame: 3, 9 and 15 months.

    Number of days of stimulant use as measured by the Timeline FollowBack using the formula: Daily opioid use- the proportion of days of use

Secondary outcomes

  1. Proportion of subjects with viral suppression

    Time frame: 3, 9 and 15 months.

    Changes in RNA viral load. Viral suppression (cv<200copies/ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Szapocznik, PhD

CONTACT

[email protected]

(305) 6105723

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: COSTA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2023
Registry last updated
Jun 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.

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