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Enrolling by invitation NCT05022134

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

No phase Interventional Contraception Behavior Sexual Behavior Reproductive Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHOICE-AYA.
Who it may be relevant to
Registry conditions: Contraception Behavior, Sexual Behavior, Reproductive Behavior. Basic parameters: 14 years — 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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.

Overview

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.

Interventions

  • Behavioral CHOICE-AYA
    Adapted contraceptive counseling specific to AYA experiencing homelessness

Primary outcome measures

  • Contraceptive uptake [Time frame: Study Day 1]
Secondary outcome measures (3)
  • Contraceptive satisfaction [Time frame: 1, 3, 6, and 12 months post intervention]
  • Contraceptive continuation [Time frame: 1, 3, 6, and 12 months post intervention]
  • Feasibility of intervention (perceived by clinic staff and participants) [Time frame: Post-visit]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Children's Mercy Research Institute — Kansas City

Identifiers

NCT: NCT05022134 · STUDY00001846

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗