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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03027531
Other study ID # 32030-B
Secondary ID 5K23HD052621
Status Completed
Phase N/A
First received January 19, 2017
Last updated January 20, 2017
Start date February 1, 2012
Est. completion date June 30, 2013

Study information

Verified date January 2017
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date June 30, 2013
Est. primary completion date June 30, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 24 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Outcome

Type Measure Description Time frame Safety issue
Primary Unprotected sex (no condoms) from self-report via computerized survey 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 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 during last 2 months (asked at the 3-month follow-up visit)
Secondary Number of sex partners from self-report via computerized survey number of partners with which the participant had sex during last 2 months (asked at the 3-month follow-up visit)
Secondary Biomarkers: urine sample tested with nucleic acid amplification test for STDs and urine sample pregnancy test Incident chlamydia, gonorrhea, and pregnancy since baseline visit over last 3 months (asked at the 3-month follow-up visit)
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