Trials Today

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

Purpose

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.

Condition

HIV Infections

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: Male
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental reSET Group	Participants in this group will use the reSET mobile app for 12 weeks.	Behavioral: reSET 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.
Other Standard of Care Group	Participants in this group will receive standard of care treatment for 12 weeks.	Other: Standard of care Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.

Recruiting Locations

University of Miami
Miami, Florida 33136

Contact:
Paco Castellon, MPH, MBA
305-205-0072
pcastellon@med.miami.edu

More Details

NCT ID: NCT05958017
Status: Recruiting
Sponsor: University of Miami

Study Contact

Jose Szapocznik, PhD
(305) 6105723
jszapocz@miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.