Inpatient Adolescent Contraception

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423068
• Other study ID #: STUDY00001115
• Status: Completed
• Phase: Early Phase 1
• Start date: December 10, 2020
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 4, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception
• Contraception Behavior
• Contraceptive Usage
• Pregnancy
• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (1)

Masonbrink AR, Noel-MacDonnell J, Staggs VS, Stancil S, Goggin K, Miller MK. Feasibility of a Contraception Intervention for Hospitalized Adolescents and Young Adults. Hosp Pediatr. 2023 Apr 1;13(4):337-344. doi: 10.1542/hpeds.2022-006996. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of SexHealth II, an intervention to provide contraception counseling and initiation among hospitalized female adolescents	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