eKISS: Electronic KIOSK Intervention for Safer-Sex

Overview

This study is a randomized controlled trial to test acceptability, feasibility and preliminary efficacy of an interactive computer-based intervention with individualized feedback to promote sexual health in adolescents and young adults with assessment of behavioral and biomarker outcomes.

Full Title of Study: “eKISS Electronic KIOSK Intervention for Safer-Sex: A Pilot Randomized Controlled Trial of an Interactive Computer-based Intervention for Sexual Health in Adolescents and Young Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2013

Detailed Description

This study is a randomized controlled trial to test acceptability, feasibility and preliminary efficacy of an interactive computer-based intervention (ICBI) with individualized feedback to promote sexual health in adolescents and young adults. The intervention uses physician avatars and uses elements of motivational interviewing to elicit sexual risk behaviors and motivation to change risky behavior. Feedback includes instructive video modules. Participants were asked to identify one behavior to change and were reassessed at 3-month follow-up for interim sexual behavior including condom and birth control use. Participants were tested for chlamydia, gonorrhea, and pregnancy(females) at baseline and 3-month follow-up.

Interventions

  • Behavioral: eKISS: electronic KIOSK for Safer-Sex
    • An interactive computer-based intervention for safer-sex which provides individualized feedback about protective and risky sexual behaviors; offers instructive video modules for safe-sex; elicits change behavior and identification of behavior change goal using elements of motivational interviewing.

Arms, Groups and Cohorts

  • Experimental: Control
    • Control group entered sexual history via computer assisted self-interview and provided specimens for chlamydia, gonorrhea and pregnancy(females) testing. The do not receive the feedback intervention of eKISS: electronic KIOSK for safer-sex
  • Experimental: Intervention
    • Intervention group entered sexual history via computer assisted self-interview and received the interactive computer-based intervention with individualized feedback eKISS: electronic KIOSK for safer-sex. They provided specimens for chlamydia, gonorrhea and pregnancy(females) testing.

Clinical Trial Outcome Measures

Primary Measures

  • Unprotected sex (no condoms) from self-report via computerized survey
    • Time Frame: during last 2 months (asked at 3 month follow-up visit)
    • number of unprotected sex events when participant did not use condom during sex

Secondary Measures

  • Unprotected sex (no birth control) from self-report via computerized survey
    • Time Frame: during last 2 months (asked at the 3-month follow-up visit)
    • number of unprotected sex events when participant did not use birth control during sex
  • Number of sex partners from self-report via computerized survey
    • Time Frame: during last 2 months (asked at the 3-month follow-up visit)
    • number of partners with which the participant had sex
  • Biomarkers: urine sample tested with nucleic acid amplification test for STDs and urine sample pregnancy test
    • Time Frame: over last 3 months (asked at the 3-month follow-up visit)
    • Incident chlamydia, gonorrhea, and pregnancy since baseline visit

Participating in This Clinical Trial

Inclusion Criteria

  • English speaking and reading – Report at least one episode of unprotected vaginal sex (no condom OR no birth control) in the last 2 months – Not currently pregnant or actively seeking pregnancy in self or partner Exclusion Criteria:

  • Currently pregnant or actively seeking pregnancy in self or partner

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Taraneh Shafii, Associate Professor, Department of Pediatrics, Division of Adolescent Medicine – University of Washington
  • Overall Official(s)
    • Taraneh Shafii, MD, MPH, Principal Investigator, University of Washington
    • King K Holmes, MD, PhD, Principal Investigator, University of Washington; Center for AIDS and STD

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