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Behavioral Intervention

Mobile Therapy for Stimulant Use Disorder in HIV (COSTA Trial)

N/A
Waitlist Available
Led By Jose Szapocznik, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 9 and 15 months.
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a mobile therapy can help treat stimulant use disorder and keep HIV viral loads suppressed in gay men with HIV.

Who is the study for?
This trial is for men living with HIV who use stimulants and aren't currently in drug treatment. They must be over 18, patients at certain clinics in Atlanta, Dallas/Fort Worth, Fort Lauderdale, or Los Angeles, not have severe psychiatric symptoms or cognitive impairment, and be less than 90% adherent to their HIV treatment.
What is being tested?
The study tests if reSET—a mobile app approved by the FDA—helps men who have sex with men manage stimulant use disorder while maintaining stable HIV viral load suppression. Participants will either receive standard care or use the reSET app alongside their usual treatment.
What are the potential side effects?
Since reSET is a digital therapeutic application designed to support substance abuse treatment without using medication, it does not have traditional side effects like drugs do. However, users may experience stress or frustration if they find the technology challenging.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 9 and 15 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 9 and 15 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in days of stimulant use as measured by Timeline FollowBack
Secondary study objectives
Proportion of subjects with viral suppression

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: reSET GroupExperimental Treatment1 Intervention
Participants in this group will use the reSET mobile app for 12 weeks.
Group II: Standard of Care GroupExperimental Treatment1 Intervention
Participants in this group will receive standard of care treatment for 12 weeks.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,586 Previous Clinical Trials
3,328,030 Total Patients Enrolled
University of MiamiLead Sponsor
949 Previous Clinical Trials
427,964 Total Patients Enrolled
Jose Szapocznik, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
330 Total Patients Enrolled

Media Library

reSET (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05958017 — N/A
HIV Suppression Research Study Groups: Standard of Care Group, reSET Group
HIV Suppression Clinical Trial 2023: reSET Highlights & Side Effects. Trial Name: NCT05958017 — N/A
reSET (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05958017 — N/A
~333 spots leftby Nov 2028
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