Evaluating the Impact of CHOICE-AYA on Contraceptive Use, Continuation and Satisfaction (CHOICE-AYA)

February 13, 2026 updated by: Stephani Stancil, Children's Mercy Hospital Kansas City

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (CHOICE-AYA)
The impact of CHOICE-AYA contraceptive counseling on contraceptive use, satisfaction, and continuation will be assessed.
Behavioral: CHOICE-AYA
Adapted contraceptive counseling specific to AYA experiencing homelessness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contraceptive uptake
Time Frame: Study Day 1
Rates of reliable contraceptive use
Study Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contraceptive satisfaction
Time Frame: 1, 3, 6, and 12 months post intervention
brief likert-style survey assessing whether they are still on the method, how satisfied they are with this method
1, 3, 6, and 12 months post intervention
Contraceptive continuation
Time Frame: 1, 3, 6, and 12 months post intervention
brief survey
1, 3, 6, and 12 months post intervention
Feasibility of intervention (perceived by clinic staff and participants)
Time Frame: Post-visit
Brief survey based on Bowen's constructs of feasibility
Post-visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2022

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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