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Enrolling by Invitation

NCT Number: NCT05022134

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

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).

Enrolling by Invitation

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Key information

Age range

14 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Research Institute

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CHOICE-AYA

Behavioral

Adapted contraceptive counseling specific to AYA experiencing homelessness

Primary outcomes

  1. Contraceptive uptake

    Time frame: Study Day 1

    Rates of reliable contraceptive use

Secondary outcomes

  1. 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

  2. Contraceptive continuation

    Time frame: 1, 3, 6, and 12 months post intervention

    brief survey

  3. Feasibility of intervention (perceived by clinic staff and participants)

    Time frame: Post-visit

    Brief survey based on Bowen's constructs of feasibility

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

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

Acronym: CHOICE-AYA

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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