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

University of Miami

Status: Enrolling

Conditions: Stimulant Use Disorder; reSET; People Living With HIV

Treatments: Other: Standard of care; Behavioral: reSET

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05958017

20221237

R01DA055563 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Identifies as male
2. Reports past year anal intercourse with a male
3. Age 18 or older (reSET is only approved for use with adults)
4. Person living with HIV who is an AIDS Healthcare Foundation (AHF) patient at one of the four metro areas: Atlanta, Dallas/Fort Worth, Fort Lauderdale, Los Angeles
5. Screens positive for a moderate or severe stimulant use disorder in the last 3-months using the MINI
6. Reports that he is not currently in drug treatment
7. Currently has an active antiretroviral therapy prescription and reports < 90% HIV Tx adherence on the 3-item Wilson measure in the past 30 days
8. Can obtain access to stable internet with privacy acceptable to the participant at least twice a week
9. Indicates being able to understand English (reSET is only available in English; can be read or heard)
10. Consents to participation in the study
11. Provides sufficient locator information

Exclusion criteria

1. Otherwise eligible participants will be excluded if they appear to display diminished capacity to consent either because of: (a) an apparent inability to provide consent (e.g., cognitive impairment) or (b) apparent severe psychiatric symptoms (e.g., mania, psychosis) that may impair capacity to consent.
2. Persons that meet criteria for prisoner status will be excluded at baseline.
3. 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.
4. Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

reSET Group

Experimental group

Description:

Participants in this group will use the reSET mobile app for 12 weeks.

Treatment:

Behavioral: reSET

Standard of Care Group

Other group

Description:

Participants in this group will receive standard of care treatment for 12 weeks.

Treatment:

Other: Standard of care