eKISS: Electronic KIOSK Intervention for Safer-Sex

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT03027531
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 272
• Arms: 2
• Actual Duration (Months): 16.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Reproductive Behavior; Contraception; Sexually Transmitted Diseases	Behavioral: eKISS: electronic KIOSK for Safer-Sex	N/A

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 Design

• Study Type: Interventional
• 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: Feb 1, 2012
• Actual Primary Completion Date: Jun 30, 2013
• Actual Study Completion Date: Jun 30, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Unprotected sex (no condoms) from self-report via computerized survey [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 [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 [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 [over last 3 months (asked at the 3-month follow-up visit)]

   Incident chlamydia, gonorrhea, and pregnancy since baseline visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taraneh Shafii, Associate Professor, Department of Pediatrics, Division of Adolescent Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT03027531
• Other Study ID Numbers: 32030-B; 5K23HD052621
• First Posted: Jan 23, 2017
• Last Update Posted: Jan 24, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Associate Professor, Department of Pediatrics, Division of Adolescent Medicine, University of Washington: reproductive health, condoms, sexually transmitted diseases, contraception
• Additional relevant MeSH terms: Sexually Transmitted Diseases

Study Results

No Results Posted as of Jan 24, 2017