People Living With HIV, Stimulant Use Disorder
Conditions
Keywords
Substance use, Adherence to Anti-Retroviral Therapy
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.
Interventions
BEHAVIORALreSET
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.
OTHERStandard of care
Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.
Sponsors
University of Miami
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Assigned male sex at birth and has not undergone any transgender hormonal treatment 2. Reports having had sex with a male in the past 12 months 3. Age 18 or older 4. 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 5. Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI 6. Reports that he is not currently in drug treatment 7. Is living with HIV 8. Reports having an active antiretroviral prescription 9. Have access to a smartphone or tablet with stable internet at least twice a week and can download applications to the smartphone or tablet 10. Able to understand English 11. Consents to participation in the study 12. Provides sufficient locator information 13. Identifies as non-Hispanic White, non-Hispanic Black/African American or Latinx/Hispanic 14. Has been in stable housing for the past 3 months and intends to remain housed for the next 15 months
Exclusion criteria
1. Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis). 2. Persons that meet criteria for prisoner status will be excluded at baseline. 3. 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. 4. Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with viral suppression | 3, 9 and 15 months. | Changes in RNA viral load. Viral suppression (cv\<200copies/ml) |
Countries
United States
Contacts
CONTACTMariya Petrova, PhD
CONTACTAllison Krause
PRINCIPAL_INVESTIGATORJose Szapocznik, PhD
University of Miami
Outcome results
None listed