NCT02530645

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

August 19, 2015

Last Update Submit

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

EXPERIMENTAL

Brief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors.

Behavioral: OnTrackBehavioral: Brief Motivational Interviewing

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

OnTrackBEHAVIORAL
OnTrack + BMI
Treatment as Usual
OnTrack + BMI

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Alcohol DrinkingMarijuana UseSexual Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSubstance-Related DisordersMental Disorders

Study Officials

  • Ronald G Thompson, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

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

Locations