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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05958017




Registration number
NCT05958017
Ethics application status
Date submitted
14/07/2023
Date registered
24/07/2023

Titles & IDs
Public title
ReSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Scientific title
ReSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Secondary ID [1] 0 0
R01DA055563
Secondary ID [2] 0 0
20221237
Universal Trial Number (UTN)
Trial acronym
COSTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - reSET
Other interventions - Standard of care

Experimental: reSET Group - Participants in this group will use the reSET mobile app for 12 weeks.

Other: Standard of Care Group - Participants in this group will receive standard of care treatment for 12 weeks.


BEHAVIORAL: reSET
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.

Other interventions: Standard of care
Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in days of stimulant use as measured by Timeline FollowBack
Timepoint [1] 0 0
3, 9 and 15 months.
Secondary outcome [1] 0 0
Proportion of subjects with viral suppression
Timepoint [1] 0 0
3, 9 and 15 months.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
University of Miami
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Drug Abuse (NIDA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jose Szapocznik, PhD
Address 0 0
University of Miami
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jose Szapocznik, PhD
Address 0 0
Country 0 0
Phone 0 0
(305) 6105723
Fax 0 0
Email 0 0
jszapocz@miami.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05958017