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

Sexual Behavior Clinical Trial

— CHOICE-AYA  

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05022134
• Other study ID #: STUDY00001846
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: August 30, 2027

Study information

• Verified date: February 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 30, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Contraception Behavior
• Reproductive Behavior
• Sexual Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Children's Mercy Research Institute	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive uptake	Rates of reliable contraceptive use	Study Day 1
Secondary	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
Secondary	Contraceptive continuation	brief survey	1, 3, 6, and 12 months post intervention
Secondary	Feasibility of intervention (perceived by clinic staff and participants)	Brief survey based on Bowen's constructs of feasibility	Post-visit