Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02530645
Other study ID # #7018
Secondary ID
Status Completed
Phase N/A
First received August 19, 2015
Last updated October 11, 2016
Start date November 2015
Est. completion date August 2016

Study information

Verified date October 2016
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 21 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
OnTrack

Treatment as Usual

Brief Motivational Interviewing


Locations

Country Name City State
United States Covenant House New York New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
See also
  Status Clinical Trial Phase
Completed NCT02493647 - Love, Sex & Choices: A Web Series on Mobile Devices to Reduce Black Women's HIV Risk N/A
Completed NCT03533192 - Replication of Evidence-based Programs N/A
Completed NCT02548871 - Evaluation of the Teen Outreach Program in Chicago Public Schools N/A
Completed NCT00220597 - Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood Sexual Abuse N/A
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Completed NCT04035694 - Evaluation Study of the Online High School Media Aware Program N/A
Completed NCT04070950 - Sexuality of Women With Pelvic Cancer
Completed NCT04079608 - Rigorous Evaluation of High School FLASH N/A
Completed NCT03366636 - Project Legacy Impact Evaluation Study N/A
Completed NCT02613039 - Oral Contraceptive Therapy and Sexuality Phase 4
Completed NCT02736214 - Reproductive Life Plan-based Counseling With Men N/A
Withdrawn NCT01169922 - HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response N/A
Completed NCT00249496 - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1 N/A
Completed NCT02993185 - Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention N/A
Active, not recruiting NCT01088542 - The Community Youth Development Study: A Test of Communities That Care N/A
Completed NCT03330522 - Reducing HIV Risk in Urban Women: Soap Opera Videos on Video-Capable Cell Phones N/A
Completed NCT02866292 - The Pelvic Floor Muscles Strength and Sexual Function in Primigravid and Non-pregnant Nulliparous N/A
Completed NCT00109421 - Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females N/A
Recruiting NCT05140980 - Sexuality Education: Knowledge of Women Aged 18 to 25
Completed NCT04962802 - Evaluation of Manhood 2.0: A Community-Based Teen Pregnancy Prevention Program for Young Men N/A