Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2015
CompletedFirst Posted
Study publicly available on registry
August 21, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 12, 2016
October 1, 2016
9 months
August 19, 2015
October 11, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Baseline, 2, 4 (end of treatment), 6 weeks
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.
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
As measured by the number of days the respondent engaged in unprotected sex.
Baseline, 2, 4 (end of treatment), 6 weeks
Study Arms (2)
OnTrack + BMI
EXPERIMENTALBrief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors.
Treatment as Usual
ACTIVE COMPARATORTreatment 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covenant House New York
New York, New York, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald G Thompson, Ph.D.
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2015
First Posted
August 21, 2015
Study Start
November 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 12, 2016
Record last verified: 2016-10