Inpatient Adolescent Contraception

April 3, 2023 updated by: Abbey Masonbrink, Children's Mercy Hospital Kansas City

Intervention to Facilitate Contraception Provision by Pediatric Hospitalists: A Feasibility Study

The overall goal of this study is to refine and pilot test the investigators novel intervention to offer contraception counseling and initiation for hospitalized female adolescents, focusing on long acting reversible contraception (LARC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are two primary objectives in this study. The first objective is to refine the investigators previously developed general sexual risk reduction intervention (SexHealth II) to focus on patient-centered contraception counseling and initiation for hospitalized female adolescents. The second objective is to conduct an open trial to assess feasibility of the investigators SexHealth II intervention among hospitalized females aged 14-21 years (N=75). Among key stakeholders (i.e., adolescent participants, parents/guardians, hospitalists and nurses), the investigators will assess Bowen's feasibility constructs: acceptability, demand, implementation, practicality, integration, and limited-efficacy testing. The investigators hypothesize that the SexHealth II intervention will be deemed feasible by female adolescent participants (i.e., the median score across all feasibility items will be > 2.5.)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adolescents who are biologically female and have reproductive potential (14-21 years old) admitted to the general pediatric hospitalist service will be eligible.
  • A convenience sample of parents/guardians of enrolled participants who are English speaking will be eligible for post-intervention feasibility survey. Parent consent or enrollment in the study is not required for female adolescent enrollment.
  • A convenience sample of hospitalists and nurses caring for enrolled participants and the health educator will be eligible for the post-intervention feasibility study.

Exclusion Criteria:

  • Subjects who are determined to be too ill, have severe psychiatric illness or cognitive impairment (based on hospitalist assessment), are seeking care related to sexual assault, or are not able to speak English fluently will not be eligible.

  • Parents/guardians, hospitalists, health educator and nurses who are not able to speak English fluently will not be eligible for post-intervention feasibility survey.

    • Adults unable to consent - Exclude
    • Individuals who are not yet adults (infants, children, teenagers) - Include
    • Pregnant women - Exclude
    • Prisoners - Exclude
    • Wards of the state - Include

Withdraw Criteria:

- Subjects who are screened and report no sexual activity (past or anticipated "unlikely"/"very likely" within few weeks to months) will be withdrawn from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Overall Study
Behavioral: SexHealth II
SexHealth II is an intervention that will focus exclusively on provision of hormonal contraception counseling and provision for hospitalized female adolescents
Drug: Contraceptive

The investigators will offer initiation of the following contraceptives:

Ethinyl Estradiol and Etonogestrel 0.015mg-0.12mg vaginal ring (Nuva Ring) Etonogestrel 68mg subcutaneous implant (Nexplanon) Medroxyprogesterone 150mg/ml 150 mg IM injection Ethinyl Estradiol and Norgestimate (Sprintec) 35mcg-0.25mg tablet Norelgestromin/Ethinyl estradiol transdermal patch (Ortho Evra) Norethindrone 0.35mg tablet

Emergency Contraception:

Ulipristal 30 mg tablet Levonorgestrel 1.5mg tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of SexHealth II, an intervention to provide contraception counseling and initiation among hospitalized female adolescents
Time Frame: 3 months

The investigators primary outcome is feasibility of the intervention among female adolescent participants, which the investigators will assess by administering a survey with 12 Likert-type items with responses ranging from 0 (strongly disagree) to 4 (strongly agree). The midpoint (neutral) point on the 0-4 scale is 2, and the investigators define "acceptable level of feasibility" as the median feasibility rating in the population exceeding 2.5, meaning at least half the ratings are positive. Thus, the investigators will test the hypothesis that the true median feasibility rating in the population of adolescents from which the sample is drawn is greater than 2.5.

The investigators expect the true median is above 2.5. Assuming its value is conservatively 2.75, a sample size of 75 provides 90% power to reject H0 using a two-sided sign test for the population median.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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