NCT04423068

Inpatient Adolescent Contraception

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: Female
• Age: 14 Years – 21 Years
• Healthy volunteers: Not accepted

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).

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.)

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-10
• Primary completion: 2022-04-01
• Completion: 2023-04-04
• First posted: 2020-06-09
• Last updated: 2023-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study