Stimulant Use DisorderCOSTANCT05958017
reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
A study testing reSET in people with Stimulant Use Disorder and People Living With HIV, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Stimulant Use Disorder, People Living With HIV
- What is being tested?
- reSET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI
- Reports that he is not currently in drug treatment
Show all 14Show fewer
- Is living with HIV
- Reports having an active antiretroviral prescription
- Have access to a smartphone or tablet with stable internet at least twice a week and can download applications to the smartphone or tablet
- Able to understand English
- Consents to participation in the study
- Provides sufficient locator information
- Identifies as non-Hispanic White, non-Hispanic Black/African American or Latinx/Hispanic
- Has been in stable housing for the past 3 months and intends to remain housed for the next 15 months
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Mariya Petrova, Ph.D., 786-338-6432, mpp72@miami.edu
Jose Szapocznik, PhD
About this study
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.
- Conditions
- Stimulant Use Disorder, People Living With HIV
- Being tested
- reSET, Standard of care
- Keywords
- Substance use, Adherence to Anti-Retroviral Therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reSETBehavioural
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.
Standard of careOther
Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.
| Study group | Role | What they receive |
|---|---|---|
| reSET Group | Experimental | Participants in this group will use the reSET mobile app for 12 weeks. Receives: Behavioral: reSET |
| Standard of Care Group | Other | Participants in this group will receive standard of care treatment for 12 weeks. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3, 9 and 15 months.
Secondary outcomes (1)
Proportion of subjects with viral suppression
Changes in RNA viral load. Viral suppression (cv<200copies/ml)
Measured: 3, 9 and 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start4 Mar 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jose Szapocznik, University of Miami
- Investigators
- Jose Szapocznik, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958017
- Sponsor's protocol ID
- 20221237
- Other IDs
- R01DA055563
- Acronym
- COSTA
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
- ClinicalTrials.gov ID
- NCT05958017
- Acronym / sponsor ID
- COSTA / 20221237
- Conditions
- Stimulant Use Disorder, People Living With HIV
- Keywords
- Substance use, Adherence to Anti-Retroviral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reSET Group | Experimental | Behavioral: reSETParticipants in this group will use the reSET mobile app for 12 weeks. |
| Standard of Care Group | Other | Other: Standard of careParticipants in this group will receive standard of care treatment for 12 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reSETParticipants 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. | Behavioural | reSET Group |
| Standard of careParticipants in this group will receive assistance connecting to an in person community-based outpatient treatment program. | Other | Standard of Care Group |
Primary outcome
Change in days of stimulant use as measured by Timeline FollowBack
Time frame: 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
1 secondary outcome
Proportion of subjects with viral suppression
Time frame: 3, 9 and 15 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Szapocznik, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reSET in people with Stimulant Use Disorder and People Living With HIV, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariya Petrova, PhD (7863386432, mpp72@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in days of stimulant use as measured by Timeline FollowBack (time frame: 3, 9 and 15 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.