Inpatient Adolescent Contraception

Children's Mercy Hospital Kansas City logo

Children's Mercy Hospital Kansas City

Status and phase

Completed
Early Phase 1

Conditions

Contraception
Contraception Behavior
Contraceptive Usage
Pregnancy Related
Pregnancy

Treatments

Behavioral: SexHealth II
Drug: Contraceptive

Study type

Interventional

Funder types

Other

Identifiers

NCT04423068
STUDY00001115

Details and patient eligibility

About

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).

Full 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.)

Enrollment

25 patients

Sex

Female

Ages

14 to 21 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Overall Study
Experimental group
Treatment:
Drug: Contraceptive
Behavioral: SexHealth II

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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