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

Primary Purpose

HIV Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
reSET
Standard of care
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Substance use, Adherence to Anti-Retroviral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

reSET Group

Standard of Care Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in days of stimulant use as measured by Timeline FollowBack
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

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

Full Information

First Posted
July 14, 2023
Last Updated
August 16, 2023
Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05958017
Brief Title
reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Acronym
COSTA
Official Title
reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2028 (Anticipated)
Study Completion Date
November 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Substance use, Adherence to Anti-Retroviral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
reSET Group
Arm Type
Experimental
Arm Description
Participants in this group will use the reSET mobile app for 12 weeks.
Arm Title
Standard of Care Group
Arm Type
Other
Arm Description
Participants in this group will receive standard of care treatment for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
reSET
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.
Primary Outcome Measure Information:
Title
Change in days of stimulant use as measured by Timeline FollowBack
Description
Number of days of stimulant use as measured by the Timeline FollowBack using the formula: Daily opioid use- the proportion of days of use
Time Frame
3, 9 and 15 months.
Secondary Outcome Measure Information:
Title
Proportion of subjects with viral suppression
Description
Changes in RNA viral load. Viral suppression (cv<200copies/ml)
Time Frame
3, 9 and 15 months.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Szapocznik, PhD
Phone
(305) 6105723
Email
jszapocz@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Szapocznik, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jude Fleurimont
Phone
305-243-2000
Email
j.fleurimont@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Jose Szapocznik, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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