Inpatient Adolescent Contraception

NCT04423068 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00001115
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Pregnancy Related; Contraception; Contraceptive Usage; Contraception Behavior; Pregnancy

Keywords

LARC; Long acting reversible contraception

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Overall Study

EXPERIMENTAL

Behavioral: SexHealth II; Drug: Contraceptive

Interventions

SexHealth II BEHAVIORAL

SexHealth II is an intervention that will focus exclusively on provision of hormonal contraception counseling and provision for hospitalized female adolescents

Overall Study

Contraceptive DRUG

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

Overall Study

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Related 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.

  PMID: 36897226 RESULT

MeSH Terms

Conditions

Contraception Behavior

Interventions

Contraceptive Agents

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Hospital Medicine

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: December 10, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 4, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)