Inpatient Adolescent Contraception

Early Phase 1

Completed

• Conditions: Contraception; Contraceptive Usage; Pregnancy; Pregnancy Related; Contraception Behavior
• Interventions: Behavioral: SexHealth II; Drug: Contraceptive

• Registration Number: NCT04423068
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.)

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Study Start: 2020-12-10
• Primary Completion: 2022-04-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Study Completion: 2023-04-04
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overall Study	SexHealth II	-
Overall Study	Contraceptive	-

Primary Outcome Measures

Name	Time	Method
Feasibility of SexHealth II, an intervention to provide contraception counseling and initiation among hospitalized female adolescents	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.

Trial Locations

Locations (1)

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States