Alcohol UseNCT02530645
Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults
A study testing OnTrack, Treatment as Usual and Brief Motivational Interviewing in people with Alcohol Use and Marijuana Use, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 21 years
- Conditions the study is for
- Alcohol Use, Marijuana Use, Sexual Behavior
- What is being tested?
- OnTrack, Treatment as Usual and Brief Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- OnTrack, Treatment as Usual, Brief Motivational Interviewing
- Medical subject headings
- Alcohol Drinking, Marijuana Use, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnTrackBehavioural
Treatment as UsualBehavioural
Brief Motivational InterviewingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| OnTrack + BMI | Experimental | Brief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors. Receives: Behavioral: OnTrack; Behavioral: 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. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2, 4 (end of treatment), 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald G Thompson, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530645
- Sponsor's protocol ID
- #7018
- Status last verified
- Oct 2016
- First submitted
- 19 Aug 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults
- ClinicalTrials.gov ID
- NCT02530645
- Acronym / sponsor ID
- #7018
- Conditions
- Alcohol Use, Marijuana Use, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OnTrack + BMI | Experimental | Behavioral: OnTrack, Behavioral: Brief Motivational InterviewingBrief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment 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. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnTrack | Behavioural | OnTrack + BMI |
| Treatment as Usual | Behavioural | Treatment as Usual |
| Brief Motivational Interviewing | Behavioural | OnTrack + BMI |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G Thompson, Ph.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OnTrack, Treatment as Usual and Brief Motivational Interviewing in people with Alcohol Use and Marijuana Use, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.