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

NCT ID: NCT05022134

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-29
• Study Completion Date: 2027-08-30

Brief 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).

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.

Conditions

Contraception Behavior; Sexual Behavior; Reproductive Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention (CHOICE-AYA)

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

Group Type: EXPERIMENTAL

CHOICE-AYA

Intervention Type: BEHAVIORAL

Adapted contraceptive counseling specific to AYA experiencing homelessness

Interventions

CHOICE-AYA

Adapted contraceptive counseling specific to AYA experiencing homelessness

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Stephani Stancil

Assistant Professor, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Mercy Research Institute

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

STUDY00001846

Identifier Type: -

Identifier Source: org_study_id