reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-90
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Assigned male sex at birth and has not undergone any transgender hormonal treatment
Reports having had sex with a male in the past 12 months
Age 18 or older
Is affiliated with a study referral source (e.g., AHF clinic, registry, other healthcare program or clinic) or resides in a city or county where a participating healthcare center or health program is located
Disqualifiers
Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
Persons that meet criteria for prisoner status will be excluded at baseline.
Patients who screen positive for moderate to severe opioid use disorder will be excluded from the study because effective pharmacological agents exist for the treatment of this disorder. These patients will be referred to community-based programs that provide specialized treatment for this disorder.
Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.
Trial design
Design model
Parallel
Treatments tested in this trial
reSET
BehavioralParticipants 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.
Standard of care
Other interventionParticipants in this group will receive assistance connecting to an in person community-based outpatient treatment program.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: reSET GroupExperimental treatment 1 intervention
Group B: Standard of Care GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
3, 9 and 15 months.Secondary outcomes
1
Proportion of subjects with viral suppression
Changes in RNA viral load. Viral suppression (cv\<200copies/ml)
Time frame
3, 9 and 15 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov