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

NCT05022134 | Enrolling By Invitation

• 1 other identifier: STUDY00001846
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Sexual Behavior; Reproductive Behavior; Contraception Behavior

Keywords

Adolescent; Contraception

Outcome Measures

Primary Outcomes (1)

• Contraceptive uptake

  Rates of reliable contraceptive use

  Study Day 1

Secondary Outcomes (3)

• Contraceptive satisfaction

  1, 3, 6, and 12 months post intervention

• Contraceptive continuation

  1, 3, 6, and 12 months post intervention

• Feasibility of intervention (perceived by clinic staff and participants)

  Post-visit

Study Arms (1)

Intervention (CHOICE-AYA)

EXPERIMENTAL

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

Behavioral: CHOICE-AYA

Interventions

CHOICE-AYA BEHAVIORAL

Adapted contraceptive counseling specific to AYA experiencing homelessness

Intervention (CHOICE-AYA)

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Research Institute

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Contraception Behavior; Sexual Behavior; Reproductive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 26, 2021
• Study Start: March 29, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)