Reproductive BehavioreKISSNCT03027531
eKISS: Electronic KIOSK Intervention for Safer-Sex
A study testing eKISS: electronic KIOSK for Safer-Sex in people with Reproductive Behavior and Contraception, run by University of Washington.
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. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Reproductive Behavior, Contraception, Sexually Transmitted Diseases
- What is being tested?
- eKISS: electronic KIOSK for Safer-Sex
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 30 Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Currently pregnant or actively seeking pregnancy in self or partner
About this study
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
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.
Read the 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.
- Being tested
- eKISS: electronic KIOSK for Safer-Sex
- Keywords
- reproductive health, condoms, sexually transmitted diseases, contraception
- Medical subject headings
- Reproductive Behavior, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eKISS: electronic KIOSK for Safer-SexBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: eKISS: electronic KIOSK for Safer-Sex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected sex (no condoms) from self-report via computerized survey
number of unprotected sex events when participant did not use condom during sex
Measured: 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
number of unprotected sex events when participant did not use birth control during sex
Measured: 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
Measured: 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
Measured: over last 3 months (asked at the 3-month follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Feb 2012
- Primary completion30 Jun 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive BehaviorStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Taraneh Shafii, University of Washington
- Investigators
- Taraneh Shafii, MD, MPH, Principal investigator, University of WashingtonKing K Holmes, MD, PhD, Principal investigator, University of Washington; Center for AIDS and STD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027531
- Sponsor's protocol ID
- 32030-B
- Other IDs
- 5K23HD052621
- Acronym
- eKISS
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03027531
- Acronym / sponsor ID
- eKISS / 32030-B
- Keywords
- reproductive health, condoms, sexually transmitted diseases, contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: eKISS: electronic KIOSK for Safer-SexControl 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 |
| Intervention | Experimental | Behavioral: eKISS: electronic KIOSK for Safer-SexIntervention 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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Currently pregnant or actively seeking pregnancy in self or partner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eKISS: electronic KIOSK for Safer-SexAn 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. | Behavioural | Control, Intervention |
Primary outcome
Unprotected sex (no condoms) from self-report via computerized survey
Time frame: during last 2 months (asked at 3 month follow-up visit)
number of unprotected sex events when participant did not use condom during sex
3 secondary outcomes
Unprotected sex (no birth control) from self-report via computerized survey
Time frame: during last 2 months (asked at the 3-month follow-up visit)
Number of sex partners from self-report via computerized survey
Time frame: 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
Time frame: over last 3 months (asked at the 3-month follow-up visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taraneh Shafii, MD, MPH principal investigator
University of Washington
King K Holmes, MD, PhD principal investigator
University of Washington; Center for AIDS and STD
Questions about this trial
What is this clinical trial studying?
A study testing eKISS: electronic KIOSK for Safer-Sex in people with Reproductive Behavior and Contraception, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unprotected sex (no condoms) from self-report via computerized survey (time frame: during last 2 months (asked at 3 month follow-up visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.