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eKISS: Electronic KIOSK Intervention for Safer-Sex (eKISS)

Primary Purpose

Reproductive Behavior, Contraception, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eKISS: electronic KIOSK for Safer-Sex
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reproductive Behavior focused on measuring reproductive health, condoms, sexually transmitted diseases, contraception

Eligibility Criteria

14 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Unprotected sex (no condoms) from self-report via computerized survey
    number of unprotected sex events when participant did not use condom during sex

    Secondary Outcome Measures

    Unprotected sex (no birth control) from self-report via computerized survey
    number of unprotected sex events when participant did not use birth control during sex
    Number of sex partners from self-report via computerized survey
    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
    Incident chlamydia, gonorrhea, and pregnancy since baseline visit

    Full Information

    First Posted
    January 19, 2017
    Last Updated
    January 20, 2017
    Sponsor
    University of Washington
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03027531
    Brief Title
    eKISS: Electronic KIOSK Intervention for Safer-Sex
    Acronym
    eKISS
    Official Title
    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
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2012 (Actual)
    Primary Completion Date
    June 30, 2013 (Actual)
    Study Completion Date
    June 30, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reproductive Behavior, Contraception, Sexually Transmitted Diseases
    Keywords
    reproductive health, condoms, sexually transmitted diseases, contraception

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    272 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    eKISS: electronic KIOSK for Safer-Sex
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Unprotected sex (no condoms) from self-report via computerized survey
    Description
    number of unprotected sex events when participant did not use condom during sex
    Time Frame
    during last 2 months (asked at 3 month follow-up visit)
    Secondary Outcome Measure Information:
    Title
    Unprotected sex (no birth control) from self-report via computerized survey
    Description
    number of unprotected sex events when participant did not use birth control during sex
    Time Frame
    during last 2 months (asked at the 3-month follow-up visit)
    Title
    Number of sex partners from self-report via computerized survey
    Description
    number of partners with which the participant had sex
    Time Frame
    during last 2 months (asked at the 3-month follow-up visit)
    Title
    Biomarkers: urine sample tested with nucleic acid amplification test for STDs and urine sample pregnancy test
    Description
    Incident chlamydia, gonorrhea, and pregnancy since baseline visit
    Time Frame
    over last 3 months (asked at the 3-month follow-up visit)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Taraneh Shafii, MD, MPH
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    King K Holmes, MD, PhD
    Organizational Affiliation
    University of Washington; Center for AIDS and STD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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