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Trial record 21 of 175 for:    chlamydia infection | "Sexually Transmitted Diseases"

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

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ClinicalTrials.gov Identifier: NCT03027531
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Taraneh Shafii, University of Washington

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.

Condition or disease Intervention/treatment Phase
Reproductive Behavior Contraception Sexually Transmitted Diseases Behavioral: eKISS: electronic KIOSK for Safer-Sex Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : February 1, 2012
Actual Primary Completion Date : June 30, 2013
Actual Study Completion Date : June 30, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027531


Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Taraneh Shafii, MD, MPH University of Washington
Principal Investigator: King K Holmes, MD, PhD University of Washington; Center for AIDS and STD

Responsible Party: Taraneh Shafii, Associate Professor, Department of Pediatrics, Division of Adolescent Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03027531     History of Changes
Other Study ID Numbers: 32030-B
5K23HD052621 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taraneh Shafii, University of Washington:
reproductive health, condoms, sexually transmitted diseases, contraception

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female