eKISS: Electronic KIOSK Intervention for Safer-Sex

NCT03027531 | Completed

• 2 other identifiers: 32030-B5K23HD052621
• Study Type: interventional
• Target: 272
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reproductive Behavior; Contraception; Sexually Transmitted Diseases

Keywords

reproductive health, condoms, sexually transmitted diseases, contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 sex partners from self-report via computerized survey

  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

  over last 3 months (asked at the 3-month follow-up visit)

Study Arms (2)

Control

EXPERIMENTAL

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

Intervention

EXPERIMENTAL

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

Interventions

eKISS: electronic KIOSK for Safer-Sex BEHAVIORAL

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.

Control; Intervention

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Currently pregnant or actively seeking pregnancy in self or partner

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Reproductive Behavior; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Taraneh Shafii, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• King K Holmes, MD, PhD

  University of Washington; Center for AIDS and STD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics, Division of Adolescent Medicine

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: February 1, 2012
• Primary Completion: June 30, 2013
• Study Completion: June 30, 2013
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share