Clinical trial NCT04423068: Inpatient Adolescent Contraception
Official title: Intervention to Facilitate Contraception Provision by Pediatric Hospitalists: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pregnancy Related
Contraception
Contraceptive Usage
Contraception Behavior
Pregnancy
Keywords: LARC
Long acting reversible contraception
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 25
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.)

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of SexHealth II, an intervention to provide contraception counseling and initiation among hospitalized female adolescents
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
References:
citation: 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.