eKISS: Electronic KIOSK Intervention for Safer-Sex

Contraception Clinical Trial

— 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

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
• 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

Related Conditions & MeSH terms

• Contraception
• Reproductive Behavior
• Sexually Transmitted Diseases

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)