- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02530645
Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Homeless young adults have high rates of substance abuse and HIV infection and, therefore, developing effective, acceptable, and sustainable interventions to reduce their substance abuse and sexual risk behaviors is of high public health significance.
HealthCall for Smartphone (HealthCall-S) is a smartphone application originally designed for self-monitoring of alcohol use and other HIV-related health behaviors, and receiving personalized feedback on these behaviors among urban substance-abusing HIV primary care patients. Building upon prior HealthCall-S studies, individual qualitative interviews were conducted with 10 homeless young adults (age 18-21 years) at Covenant House New York (CHNY), the largest provider of crisis shelter and services for homeless young adults (age 18-21 years) in NYC. The purpose of the individual interviews was to obtain reactions to various aspects of HealthCall-S and determine how it could be adapted to better suit the needs and interests of homeless young adults. HealthCall-S has since been adapted to target alcohol use, marijuana use, and sexual risk behaviors among homeless young adults and renamed 'OnTrack.' A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness of OnTrack plus a brief motivational intervention (BMI), in comparison to treatment as usual (TAU) at CHNY for those with substance abuse problems and who engage in risky sex. Following referral, screening, and eligibility determination, 60 participants will complete informed consent and be randomly assigned to one of two conditions: 1) TAU or 2) OnTrack + BMI. All participants will be assessed at baseline, 2 weeks, 4 weeks, and 6 weeks after baseline to evaluate alcohol consumption, marijuana use, HIV sexual risk behaviors, and other relevant variables.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States
- Covenant House New York
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-21 years of age
- Engaged in unprotected vaginal, anal, or oral sex in the past year
- Drank alcohol in the past year
- Used marijuana on 4 or more days in past month
Exclusion Criteria:
- Actively psychotic, suicidal, or homicidal
- Does not speak English
- Has a vision/hearing impairment that would preclude participation
- Has definite plans to leave the greater New York metropolitan area within the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OnTrack + BMI
Brief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors.
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Active Comparator: Treatment as Usual
Treatment as usual involves substance use/HIV referral and treatment as regularly offered to all participants who report substance use and sexual risk behaviors at Covenant House New York.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol use in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
Time Frame: Baseline, 2, 4 (end of treatment), 6 weeks
|
As measured by number of drinks per drinking day and percentage of days abstinent.
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Baseline, 2, 4 (end of treatment), 6 weeks
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Marijuana use in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
Time Frame: Baseline, 2, 4 (end of treatment), 6 weeks
|
As measured by times used marijuana per day.
|
Baseline, 2, 4 (end of treatment), 6 weeks
|
HIV sexual risk behavior in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
Time Frame: Baseline, 2, 4 (end of treatment), 6 weeks
|
As measured by the number of days the respondent engaged in unprotected sex.
|
Baseline, 2, 4 (end of treatment), 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ronald G Thompson, Ph.D., Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #7018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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