Sexual Behavior Clinical Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Covenant House New York | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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