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

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05958017
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
500
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: reSET
  • Other: Standard of care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2028
Anticipated Study Completion Date :
Sep 1, 2028

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Proportion of subjects with viral suppression [3, 9 and 15 months.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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 Tx;

  • 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 LWH who is an 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 ASSIST17;

  • Reports that he is not currently in drug Tx;

  • Currently has an active ART 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 Tx because of severity of SUD 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

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Jose Szapocznik, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jose Szapocznik, Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT05958017
Other Study ID Numbers:
  • 20221237
  • R01DA055563
First Posted:
Jul 24, 2023
Last Update Posted:
Jul 24, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jose Szapocznik, Professor, University of Miami
Substance use
Adherence to Anti-Retroviral Therapy
Additional relevant MeSH terms:
HIV Infections

Study Results

No Results Posted as of Jul 24, 2023