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

Not Applicable

Recruiting

• Conditions: HIV Infections
• Interventions: Behavioral: reSET; Other: Standard of care

• Registration Number: NCT05958017
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-24
• Status Verified: 2025-01
• Study Start: 2025-01-21
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-20
• Primary Completion: 2029-01-21
• Study Completion: 2029-01-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

• Identifies as male or as a female, who was assigned male sex at birth and who has not undergone any hormonal Treatment;
• Reports past year anal intercourse with a male, or identifies as a man who has sex with other men;
• Age 18 or older (reSET is only approved for use with adults);
• 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;
• Screens positive for a moderate or severe stimulant use disorder in the last 3-months using the Alcohol, Smoking and Substance Involvement Test (ASSIST);
• Reports that he is not currently in drug Treatment;
• Currently has an active Antiretroviral Therapy prescription and reports < 90% HIV Tx adherence on the 3-item Wilson measure in the past 30 days69;
• Has an iPhone, Android smartphone or a tablet computer;
• Can obtain access to stable internet with privacy acceptable to the participant at least twice a week*
• Indicates being able to understand English (reSET is only available in English; can be read or heard);
• Consents to participation in the study.

Exclusion Criteria

• Otherwise eligible participants will be excluded if they appear to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
• Patients who can benefit from another type of Treatment because of severity of Stimulant Use Disorder or opiate use disorder will be referred appropriately.
• We will exclude persons residing in criminal justice facilities because they will not have access to a mobile device as required by reSET.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
reSET Group	reSET	Participants in this group will use the reSET mobile app for 12 weeks.
Standard of Care Group	Standard of care	Participants in this group will receive standard of care treatment for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in days of stimulant use as measured by Timeline FollowBack	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 Outcome Measures

Name	Time	Method
Proportion of subjects with viral suppression	3, 9 and 15 months.	Changes in RNA viral load. Viral suppression (cv\<200copies/ml)

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States