Skip to main content
Clinical Trials/NCT03368456
NCT03368456
Completed
Not Applicable

Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention

University of Michigan1 site in 1 country100 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS and Infections
Sponsor
University of Michigan
Enrollment
100
Locations
1
Primary Endpoint
Change in Adolescent HIV Testing
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The study evaluates the preliminary efficacy of an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) to improve human immunodeficiency virus and sexually transmitted infection testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan. A Stage I randomized control trial will be conducted to examine the preliminary efficacy of S4E, relative to Usual Care (UC), over a period of six months.

Detailed Description

HIV/STI and drug abuse remain significant public health priorities in the US and youth are disproportionately affected. Youth between the ages of 15 - 24 constitute 25% of the sexually experienced population, yet account for 46% and 50% of HIV infections and new STIs, respectively. National surveillance data indicate that youth disproportionately engage in HIV/STI risk behaviors, including condomless sex and licit and illicit drug use, which increase their risk for HIV/STI infection. Despite the disproportionately high rates of HIV/STI infection and risk behaviors in youth, fewer than 14% report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. In Southeast Michigan, HIV/STI are disproportionately high. To address these significant public health concerns, a mobile-health (mHealth) intervention was developed for health clinic settings. The proposed research aims to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both IOS and Android operating systems, and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic. The proposed research will also evaluate the preliminary efficacy of S4E to improve HIV/STI testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan by conducting a Stage I RCT to examine the preliminary efficacy of S4E, relative to Usual Care, among a sample of 100 at-risk youth over six months.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
August 12, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Cordova

Assistant Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Female or male youth 14-21 years of age
  • Sexually active
  • Live in Southeast Michigan
  • Have access to a smartphone or tablet
  • Youth must see an enrolled clinician to participate in the study.

Exclusion Criteria

  • Report of prior psychiatric hospitalization by adolescent
  • Visible cognitive impairment due to drug use
  • Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study

Outcomes

Primary Outcomes

Change in Adolescent HIV Testing

Time Frame: baseline, 3 and 6 month post-baseline

Post-intervention, we will assess whether youths requested to receive HIV testing at the clinic, and at 3 and 6 months post-baseline (yes/no).

Secondary Outcomes

  • Change in drug use behaviors(baseline, 3 and 6 month post-baseline)
  • Change in condomless sex behaviors(3 and 6 month post-baseline)

Study Sites (1)

Loading locations...

Similar Trials