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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Quasi-experimental Study to Evaluate the Feasibility of CHOICE-AYA for Unintended Pregnancy Prevention in Adolescents and Young Adults (AYA) Experiencing Homelessness.

Conditions
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Contraception Behavior, Sexual Behavior, Reproductive Behavior

Intervention / Treatment
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* Behavioral: CHOICE-AYA


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (CHOICE-AYA)<br>The impact of CHOICE-AYA contraceptive counseling on contraceptive use, satisfaction, and continuation will be assessed. | Behavioral: CHOICE-AYA<br>* Adapted contraceptive counseling specific to AYA experiencing homelessness<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Contraception