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

January 20, 2017 updated by: Taraneh Shafii, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

272

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during last 2 months (asked at 3 month follow-up visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during last 2 months (asked at the 3-month follow-up visit)
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
during last 2 months (asked at the 3-month follow-up visit)
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
over last 3 months (asked at the 3-month follow-up visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

June 30, 2013

Study Completion (Actual)

June 30, 2013

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32030-B
  • 5K23HD052621 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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