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Clinical Trials/NCT05022134
NCT05022134
Enrolling By Invitation
Not Applicable

A Prospective, Quasi-experimental Study to Evaluate the Feasibility of CHOICE-AYA for Unintended Pregnancy Prevention in Adolescents and Young Adults (AYA) Experiencing Homelessness.

Children's Mercy Hospital Kansas City1 site in 1 country200 target enrollmentMarch 29, 2022

Overview

Phase
Not Applicable
Intervention
CHOICE-AYA
Conditions
Contraception Behavior
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
200
Locations
1
Primary Endpoint
Contraceptive uptake
Status
Enrolling By Invitation
Last Updated
2 months ago

Overview

Brief Summary

This is a prospective study involving two phases: 1) adaptation and 2) intervention, in adolescents aged 14-21 experiencing homelessness. The overarching goal is to develop and evaluate the effectiveness and feasibility of a counselling intervention to improve access to contraception among AYA experiencing homelessness. During the first phase, referred to as the adaption phase, we will rely on collective input from formative groups of AYA experiencing homelessness to adapt the CHOICE counselling intervention for this underserved and under-resourced population. In the second phase, referred to as the intervention phase, we will evaluate the effectiveness and feasibility of the adapted intervention (CHOICE-AYA).

Detailed Description

This study will adapt an evidence-based contraceptive counseling intervention (CHOICE) using input from the formative groups of AYA experiencing homelessness and study the impact of the adapted counseling (CHOICE-AYA) on contraceptive use, continuation, and satisfaction in a specialized community care setting. After informed consent is obtained, participants will receive the CHOICE-AYA counseling intervention by trained clinic staff. Provision of contraception based on participant choice will occur through the clinic provider same day. Participants will be sent links to complete the follow-up surveys at 1, 3, 6, and 12 months. In addition, Clinic staff (e.g., prescribers and nurses) will be sent electronic surveys following randomly selected study visits. Findings will inform best practices for this vulnerable population and provide foundational evidence for future studies focused on expanding care to other sites that serve this group.

Registry
clinicaltrials.gov
Start Date
March 29, 2022
End Date
August 30, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Responsible Party
Principal Investigator
Principal Investigator

Stephani Stancil

Assistant Professor, Department of Pediatrics

Children's Mercy Hospital Kansas City

Eligibility Criteria

Inclusion Criteria

  • Adolescents and young adults experiencing homelessness and housing instability (defined as those seeking care at our community-based clinic on the campus of a youth shelter) aged 14-21 who have female reproductive organs (In Missouri, youth aged ≤13 are not legally able to consent to sex)
  • English speaking
  • Prior sexual activity or anticipated future sexual activity that creates the risk of pregnancy
  • Either not currently on hormonal contraception OR interested in switching methods

Exclusion Criteria

  • AYA currently seeking pregnancy in the next 3 months
  • AYA with a severe developmental or cognitive delay that interferes with the ability to engage in consensual reproductive sex (determined by the investigator)

Arms & Interventions

Intervention (CHOICE-AYA)

The impact of CHOICE-AYA contraceptive counseling on contraceptive use, satisfaction, and continuation will be assessed.

Intervention: CHOICE-AYA

Outcomes

Primary Outcomes

Contraceptive uptake

Time Frame: Study Day 1

Rates of reliable contraceptive use

Secondary Outcomes

  • Contraceptive satisfaction(1, 3, 6, and 12 months post intervention)
  • Contraceptive continuation(1, 3, 6, and 12 months post intervention)
  • Feasibility of intervention (perceived by clinic staff and participants)(Post-visit)

Study Sites (1)

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