NCT03502226

Brief Summary

This is an exploratory pilot study to evaluate the feasibility and potential effects of an innovative, individualized electronic inpatient sexual health intervention (iRAP) for adolescent females. The central hypothesis is that the electronic intervention, a sexual health questionnaire with tailored feedback based on the Trans Theoretical Model (TTM) of behavior change, will significantly increase adolescent females' requests for sexually transmitted infection (STI) screening and sexual health management during their hospital admission.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

April 4, 2018

Last Update Submit

April 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with requests for sexual health services, as assessed by sexual health options questionnaire

    All participants were able to request sexual health services while admitted to the hospital (options included: STI testing, speak with their MD, or watching contraception video). The services were offered using an electronic REDCap questionnaire, with prompt of "Would you like to request X during your hospital stay?" and response options of yes/no. The outcome will be assessed for each sexual health option (number of participants requesting STI testing, discussion with MD, or contraception video viewing) individually, as well as a variable created to show "any uptake" ie. request made for any one or more services.

    Immediate

Study Arms (2)

Intervention group

EXPERIMENTAL

Received tailored feedback regarding sexual health risks

Behavioral: Tailored feedback

Control group

NO INTERVENTION

Did not receive tailored feedback.

Interventions

Electronic feedback based on participants "stage of change" which provided risk reduction behavior regarding their sexual health including use of condoms, contraceptions, and STI testing.

Intervention group

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Admitted to the Hospitalist service, English speaking, parent available for consent, medically/psychologically stable.

You may not qualify if:

  • Wards of the state, no parent/guardian for consent, non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adolescent BehaviorSexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 18, 2018

Study Start

January 4, 2017

Primary Completion

October 29, 2017

Study Completion

October 29, 2017

Last Updated

April 18, 2018

Record last verified: 2018-03