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

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05022134
Collaborator
(none)
200
1
1
29.1
6.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CHOICE-AYA
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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.
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Contraceptive uptake [Study Day 1]

    Rates of reliable contraceptive use

Secondary Outcome Measures

  1. Contraceptive satisfaction [1, 3, 6, and 12 months post intervention]

    brief likert-style survey assessing whether they are still on the method, how satisfied they are with this method

  2. Contraceptive continuation [1, 3, 6, and 12 months post intervention]

    brief survey

  3. Feasibility of intervention (perceived by clinic staff and participants) [Post-visit]

    Brief survey based on Bowen's constructs of feasibility

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 21 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Mercy Research Institute Kansas City Missouri United States 64108

Sponsors and Collaborators

  • Children's Mercy Hospital Kansas City

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephani Stancil, Assistant Professor, Department of Pediatrics, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT05022134
Other Study ID Numbers:
  • STUDY00001846
First Posted:
Aug 26, 2021
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stephani Stancil, Assistant Professor, Department of Pediatrics, Children's Mercy Hospital Kansas City

Study Results

No Results Posted as of Jun 22, 2022