eKISS: Electronic KIOSK Intervention for Safer-Sex

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Reproductive Behavior, Contraception, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: eKISS: electronic KIOSK for Safer-Sex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>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<br>* 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.<br>|
| Experimental: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reproductive health, condoms, sexually transmitted diseases, contraception