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

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: Sexual Behavior; Contraception Behavior; Reproductive Behavior
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Rates of reliable contraceptive use	Study Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraceptive satisfaction	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	brief survey	1, 3, 6, and 12 months post intervention
Feasibility of intervention (perceived by clinic staff and participants)	Brief survey based on Bowen's constructs of feasibility	Post-visit

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

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 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adolescent; Contraception
• 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