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

Study Overview
=================
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.

Conditions
-----------------
Alcohol Use, Marijuana Use, Sexual Behavior

Intervention / Treatment
-----------------
* Behavioral: OnTrack
* Behavioral: Treatment as Usual
* Behavioral: Brief Motivational Interviewing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OnTrack + BMI<br>Brief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors. | Behavioral: OnTrack<br> <br> Behavioral: Brief Motivational Interviewing<br> <br> |
| Active Comparator: Treatment as Usual<br>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<br> <br> |

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 | 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 |