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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
COSTA Trial 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.Check my eligibility
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.See study design
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.
COSTA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 9 and 15 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 9 and 15 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in days of stimulant use as measured by Timeline FollowBack
Secondary outcome measures
Proportion of subjects with viral suppression
COSTA 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
2,467 Previous Clinical Trials
2,618,623 Total Patients Enrolled
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,182 Total Patients Enrolled
Jose Szapocznik, PhDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a male or a transgender female without hormonal treatment.I am mentally capable of understanding and consenting to participate.I am a man who has had sex with men in the past year.I am 18 years old or older.I am on HIV medication but haven't taken it as prescribed in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Group
- Group 2: reSET Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research study ongoing at present?
"As per information available on clinicaltrials.gov, this trial is no longer recruiting participants - the initial posting was made on September 1st 2023 and the last update occurred on July 14th 2023. Although it is not presently looking for volunteers, there are 467 other trials actively seeking patients at present."
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