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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

25

Phase

  • 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

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
Intervention / Treatment
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

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

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)

December 10, 2020

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Pregnancy

Clinical Trials on SexHealth II

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe