RECRUITING

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

Conditions

HIV Infections Substance use Adherence to Anti-Retroviral Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-21

Study Completion:2029-01-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05958017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Jose Szapocznik, PhD

CONTACT

(305) 6105723

jszapocz@miami.edu

Principal Investigator

Jose Szapocznik, PhD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Jose Szapocznik, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-21

Study Completion Date2029-01-21

Study Record Updates

Study Start Date2025-01-21

Study Completion Date2029-01-21

Terms related to this study

Keywords Provided by Researchers

Substance use
Adherence to Anti-Retroviral Therapy

Additional Relevant MeSH Terms

HIV Infections