500 Participants Needed

Mobile Therapy for Stimulant Use Disorder in HIV

(COSTA Trial)

JS
Overseen ByJose Szapocznik, PhD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Miami
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to have an active Antiretroviral Therapy prescription, so you should continue taking your HIV medication.

Is the mobile therapy for stimulant use disorder in HIV safe for humans?

The research on the combined contingency management and behavioral activation intervention for stimulant use disorder in HIV-positive individuals suggests it was well-received and acceptable, with participants attending all sessions and rating it positively. This indicates that the intervention was generally safe for the participants involved in the study.12345

How is the treatment reSET unique for stimulant use disorder in HIV?

The treatment reSET is unique because it combines mobile therapy with contingency management (reward-based incentives) and behavioral activation (engaging in positive activities) to help reduce stimulant use in individuals with HIV, offering a novel approach compared to traditional methods that may not sustain long-term effects.13678

What data supports the effectiveness of the treatment reSET for stimulant use disorder in HIV?

The research suggests that combining contingency management (reward-based therapy) with behavioral activation (engaging in positive activities) can help reduce stimulant use in people with HIV. This approach was well-received and showed a reduction in stimulant use over six months, indicating it might enhance the effectiveness of treatments like reSET.12379

Who Is on the Research Team?

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Jose Szapocznik, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Reports that he is not currently in drug treatment
I am a male or a transgender female without hormonal treatment.
I am a man who has had sex with men in the past year.
See 7 more

Exclusion Criteria

Persons residing in criminal justice facilities will be excluded because they will not have access to a mobile device as required by reSET
Patients who can benefit from another type of treatment because of severity of stimulant use disorder or opiate use disorder will be referred appropriately
I am mentally capable of understanding and consenting to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care treatment or use the reSET mobile app for 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in RNA viral load and days of stimulant use

15 months

What Are the Treatments Tested in This Trial?

Interventions

  • reSET
Trial Overview 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.
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

A pilot trial combining contingency management (CM) and behavioral activation (BA) for HIV-infected individuals with stimulant use disorder showed promising results, with participants reporting a significant reduction in self-reported stimulant use by an average of 4.14 days at 3 months and 5.0 days at 6 months.
The intervention was well-received, with 100% retention and attendance, suggesting that this combined approach may enhance the effectiveness and sustainability of treatment for stimulant use in this population.
Applying behavioral activation to sustain and enhance the effects of contingency management for reducing stimulant use among individuals with HIV infection.Mimiaga, MJ., Closson, EF., Pantalone, DW., et al.[2020]
A study involving focus groups of stimulant-using HIV-positive men revealed that app features such as user control, perceived usefulness, and security significantly influence their decision to download and continue using mobile health apps.
Participants suggested that effective ART adherence apps should include social networking features, local resource connections, and engaging feedback mechanisms, highlighting the importance of tailoring app design to meet the specific needs of this high-risk group.
Creating Effective Mobile Phone Apps to Optimize Antiretroviral Therapy Adherence: Perspectives From Stimulant-Using HIV-Positive Men Who Have Sex With Men.Horvath, KJ., Alemu, D., Danh, T., et al.[2023]
People living with HIV (PLWH) are at a higher risk for substance use disorders (SUDs), particularly with drugs like cocaine and methamphetamine, which can worsen their neurocognitive health and overall well-being.
Chronic use of psychostimulants disrupts brain function and cognition in PLWH, leading to poorer health outcomes, highlighting the need for targeted interventions that address both HIV and substance use issues.
Neurological, Behavioral, and Pathophysiological Characterization of the Co-Occurrence of Substance Use and HIV: A Narrative Review.Vines, L., Sotelo, D., Giddens, N., et al.[2023]

Citations

Applying behavioral activation to sustain and enhance the effects of contingency management for reducing stimulant use among individuals with HIV infection. [2020]
Creating Effective Mobile Phone Apps to Optimize Antiretroviral Therapy Adherence: Perspectives From Stimulant-Using HIV-Positive Men Who Have Sex With Men. [2023]
Neurological, Behavioral, and Pathophysiological Characterization of the Co-Occurrence of Substance Use and HIV: A Narrative Review. [2023]
Provigil (modafinil) plus cognitive behavioral therapy for methamphetamine use in HIV+ gay men: a pilot study. [2021]
Substance use, Unlike Dolutegravir, is Associated with Mood Symptoms in People Living with HIV. [2022]
Lifetime Methamphetamine Use Disorder and Reported Sleep Quality in Adults Living with HIV. [2021]
Stimulant Use and Study Protocol Completion: Assessing the Ability of Men Who Have Sex with Men to Collect Dried Blood Spots for Laboratory Measurement of HIV Viral Load. [2021]
Efficacy of central nervous system stimulant treatment for cocaine dependence: a systematic review and meta-analysis of randomized controlled clinical trials. [2018]
Human immunodeficiency virus-associated neurocognitive disorder: pathophysiology in relation to drug addiction. [2019]
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