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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: reSET
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reSET Group<br>Participants in this group will use the reSET mobile app for 12 weeks. | Behavioral: reSET<br>* 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.<br>|
| Other: Standard of Care Group<br>Participants in this group will receive standard of care treatment for 12 weeks. | Other: Standard of care<br>* Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3, 9 and 15 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with viral suppression | Changes in RNA viral load. Viral suppression (cv<200copies/ml) | 3, 9 and 15 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance use, Adherence to Anti-Retroviral Therapy