Clinical trial NCT03027531: eKISS: Electronic KIOSK Intervention for Safer-Sex
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Behavior
Contraception
Sexually Transmitted Diseases
Keywords: reproductive health, condoms, sexually transmitted diseases, contraception
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-01-23
Enrollment: 272
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unprotected sex (no condoms) from self-report via computerized survey
timeFrame: during last 2 months (asked at 3 month follow-up visit)
Secondary outcomes:
measure: Unprotected sex (no birth control) from self-report via computerized survey
timeFrame: during last 2 months (asked at the 3-month follow-up visit)
measure: Number of sex partners from self-report via computerized survey
timeFrame: during last 2 months (asked at the 3-month follow-up visit)
measure: Biomarkers: urine sample tested with nucleic acid amplification test for STDs and urine sample pregnancy test
timeFrame: over last 3 months (asked at the 3-month follow-up visit)
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Taraneh Shafii, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington; Center for AIDS and STD
name: King K Holmes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: