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Clinical Trials/NCT03855410
NCT03855410
Completed
Not Applicable

Preventing Substance Use and HIV/STI Among Urban Youth Via an M-Health Primary Care Preventive Intervention

University of Michigan2 sites in 1 country50 target enrollmentOctober 27, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Use
Sponsor
University of Michigan
Enrollment
50
Locations
2
Primary Endpoint
Change in Tobacco Use from baseline to 30 days
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The study aims to develop tobacco modules to be included in an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) and to determine the feasibility and preliminary efficacy of the updated version of S4E in an urban youth-centered community health clinic in Southeast Michigan.

Detailed Description

Tobacco use remains a significant public health concern in the US, and youth are disproportionately affected. Among high school youth , 38% report lifetime cigarette use, and 9.3% report having smoked a whole cigarette before the age of 13. In Southeast Michigan, African-American youth are at disproportionate risk of engaging in tobacco use and co-occuring substance use and other risk behaviors. To address these significant public health concerns, we developed Storytelling 4 Empowerment (S4E), a targeted and tailored mobile-health (mHealth) application (app) intervention to be delivered in health clinic settings. The proposed research aims to develop culturally congruent and developmentally appropriate modules focused on tobacco use prevention and risk reduction to be included as part of the S4E mHealth app. The proposed research will also determine the preliminary efficacy of S4E in reducing tobacco use, alcohol and other drug use, sexual risk behaviors, and improving HIV/STI testing in a sample (n=50) of youth ages 13-21 living in Southeast Michigan.

Registry
clinicaltrials.gov
Start Date
October 27, 2016
End Date
August 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Cordova

Associate Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Female, Male, and Transgender adolescents
  • Adolescents 13-21 years of age
  • Adolescents must live in Southeast Michigan
  • Adolescents must provide assent and consent

Exclusion Criteria

  • Report of a prior psychiatric hospitalization by adolescent or caregiver
  • Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study.

Outcomes

Primary Outcomes

Change in Tobacco Use from baseline to 30 days

Time Frame: baseline and 30 days post-baseline

Tobacco use will be measured at baseline and 30-days post intervention, to assess change in usage.

Secondary Outcomes

  • Change in contraception (non-condom) use from baseline to 30 days(baseline and 30 days post-baseline)
  • Change in Number of sexual partners from baseline to 30 days(baseline and 30 days post-baseline)
  • Change in Alcohol Use from baseline to 30 days(baseline and 30 days post-baseline)
  • Change in Drug Use from baseline to 30 days(baseline and 30 days post-baseline)
  • Change in alcohol or drug use before sex from baseline to 30 days(baseline and 30 days post-baseline)
  • Change in Unprotected sex from baseline to 30 days(baseline and 30 days post-baseline)
  • Change in Binge Drinking from baseline to 30 days(baseline and 30 days post-baseline)
  • Change in HIV/STI testing from baseline to immediately post-intervention and 30 day post-intervention(baseline, immediately post-intervention, and 30 days post-intervention)

Study Sites (2)

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