Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults
Primary Purpose
Alcohol Use, Marijuana Use, Sexual Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OnTrack
Treatment as Usual
Brief Motivational Interviewing
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use
Eligibility Criteria
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
Sites / Locations
- Covenant House New York
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OnTrack + BMI
Treatment as Usual
Arm Description
Brief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors.
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.
Outcomes
Primary Outcome Measures
Alcohol use in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
As measured by number of drinks per drinking day and percentage of days abstinent.
Marijuana use in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
As measured by times used marijuana per day.
HIV sexual risk behavior in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
As measured by the number of days the respondent engaged in unprotected sex.
Secondary Outcome Measures
Full Information
NCT ID
NCT02530645
First Posted
August 19, 2015
Last Updated
October 11, 2016
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT02530645
Brief Title
Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness of OnTrack (a smartphone application to self-monitor substance use and sexual behaviors among homeless young adults) plus a brief motivational intervention (BMI), in comparison to treatment as usual (TAU) at Covenant House New York (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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Marijuana Use, Sexual Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OnTrack + BMI
Arm Type
Experimental
Arm Description
Brief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
OnTrack
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Interviewing
Primary Outcome Measure Information:
Title
Alcohol use in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
Description
As measured by number of drinks per drinking day and percentage of days abstinent.
Time Frame
Baseline, 2, 4 (end of treatment), 6 weeks
Title
Marijuana use in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
Description
As measured by times used marijuana per day.
Time Frame
Baseline, 2, 4 (end of treatment), 6 weeks
Title
HIV sexual risk behavior in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
Description
As measured by the number of days the respondent engaged in unprotected sex.
Time Frame
Baseline, 2, 4 (end of treatment), 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald G Thompson, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covenant House New York
City
New York
State/Province
New York
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults
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