ClinicalTrials.gg
Enrolling by invitationNCT05022134CHOICE-AYAUpdated Feb 17, 2026

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

An interventional study of CHOICE-AYA in Contraception Behavior, Sexual Behavior and Reproductive Behavior, sponsored by Children's Mercy Hospital Kansas City. Enrolling by invitation at 1 site in United States. Open to female participants aged 14 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
14 Years to 21 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Contraception Behavior
  • Sexual Behavior
  • Reproductive Behavior

Keywords

  • Adolescent
  • Contraception
03

In context

Contraception Behavior

132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.

This study's planned enrollment of 200 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 21 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 OR interested in switching methods

Exclusion criteria

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Intervention (CHOICE-AYA)

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

    Behavioral: CHOICE-AYA

Interventions

  • BehavioralCHOICE-AYA

    Adapted contraceptive counseling specific to AYA experiencing homelessness

06

What researchers measure

Primary outcomes

  1. Contraceptive uptake

    Rates of reliable contraceptive use

    Time frame: Study Day 1

Secondary outcomes

  1. Contraceptive satisfaction

    brief likert-style survey assessing whether they are still on the method, how satisfied they are with this method

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

  2. Contraceptive continuation

    brief survey

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

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

    Brief survey based on Bowen's constructs of feasibility

    Time frame: Post-visit

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05022134
Responsible party
Stephani Stancil (Assistant Professor, Department of Pediatrics, Children's Mercy Hospital Kansas City) — Principal investigator
First posted
Aug 26, 2021
Start date
Mar 29, 2022
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Feb 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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