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Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults

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ClinicalTrials.gov Identifier: NCT02530645
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Marijuana Use Sexual Behavior Behavioral: OnTrack Behavioral: Treatment as Usual Behavioral: Brief Motivational Interviewing Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

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.
Behavioral: OnTrack Behavioral: Brief Motivational Interviewing
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.
Behavioral: Treatment as Usual



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530645


Locations
United States, New York
Covenant House New York
New York, New York, United States
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Ronald G Thompson, Ph.D. Columbia University

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02530645     History of Changes
Other Study ID Numbers: #7018
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016