CHOICE-AYA Counseling for Contraceptive Behavior

(CHOICE-AYA Trial)

Overseen By Ileana Cepeda, MPH

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Pregnancy, Severe cognitive delay

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young people experiencing homelessness access and use contraception more effectively. It focuses on adapting the CHOICE-AYA counseling program to meet the unique needs of this group and then tests its effectiveness. The trial is suitable for English-speaking individuals aged 14-21 with female reproductive organs who have experienced or anticipate sexual activity and are not currently using or wish to change their contraception method.

As an unphased trial, it allows participants to contribute to important research that could improve contraception access for vulnerable youth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should either not be on hormonal contraception or be interested in switching methods.

What prior data suggests that this counseling intervention is safe for adolescents experiencing homelessness?

Research has shown that the CHOICE-AYA counseling program is based on a proven contraceptive counseling method called CHOICE. This method was adjusted with input from young people who are homeless to better meet their needs. While specific data on the safety of CHOICE-AYA is not yet available, the original CHOICE method is well-respected.

The program involves discussing contraceptive options, without any medical procedures or medications. Therefore, it avoids physical safety concerns associated with drug treatments. The program focuses on improving access to contraception and ensuring young people feel informed and satisfied with their choices. This emphasis on support and information makes the program safe and generally well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHOICE-AYA counseling approach because it aims to enhance contraceptive use, satisfaction, and continuation among adolescents and young adults. Unlike standard contraceptive methods that primarily focus on the physical aspects of preventing pregnancy, CHOICE-AYA emphasizes personalized counseling to empower individuals with knowledge and confidence in their contraceptive choices. This method is unique in its proactive engagement with users, potentially leading to better adherence and more informed decision-making regarding birth control options.

What evidence suggests that the CHOICE-AYA counseling intervention is effective for improving contraceptive behavior in adolescents experiencing homelessness?

Research has shown that personalized contraceptive counseling greatly benefits young adults. Studies indicate that focusing on individual needs during counseling improves understanding, confidence, and satisfaction with contraceptive choices. For adolescents and young adults, researchers have identified different decision-making processes, allowing for customized counseling. Insights from Kenyan adolescents highlighted key factors, such as method effectiveness and side effects, which influence contraceptive decisions. This trial will assess the impact of the CHOICE-AYA program, which showed promise in improving contraceptive use and satisfaction, suggesting effectiveness for adolescents who are homeless. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young people aged 14-21 who are experiencing homelessness and have female reproductive organs. They should be interested in contraception, not currently pregnant or planning to become so within three months, and able to consent to sex. Participants must speak English and either be sexually active or anticipate sexual activity that could lead to pregnancy.

Inclusion Criteria

English speaking

I am 14-21, without a stable home, and have female reproductive organs.

I am not using hormonal birth control or am willing to change it.

Exclusion Criteria

I have a severe developmental or cognitive delay that affects my ability to consent to sexual activity.

I plan to become pregnant in the next 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation

Adaptation of the CHOICE counselling intervention using input from formative groups of AYA experiencing homelessness

Not specified

Intervention

Participants receive the CHOICE-AYA counseling intervention and provision of contraception based on participant choice

1 day

Follow-up

Participants are monitored for contraceptive use, continuation, and satisfaction at 1, 3, 6, and 12 months post intervention

12 months

Surveys at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• CHOICE-AYA

Trial Overview The study is testing CHOICE-AYA, a counseling intervention aimed at improving access to contraception among homeless adolescents and young adults (AYA). The trial has two phases: adapting the intervention with AYA input, then evaluating its effectiveness and feasibility.

How Is the Trial Designed?

Group I: Intervention (CHOICE-AYA) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39002697/

An Exploration of Contraceptive Choice Pathways in ... We identified distinct contraceptive decision-making pathways among AYA which could inform the framework for a more tailored counseling approach.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1083318824002419

An Exploration of Contraceptive Choice Pathways in ... The objective of this descriptive study was to visualize contraceptive choice pathways among AYA designated female at birth (DFAB) as a means of exploring the ...

3. contraceptionjournal.org contraceptionjournal.org/article/S0010-7824(23)00325-6/pdf

ASSESSING QUALITY OF CONTRACEPTIVE ... We identified salient attributes, such as bleeding pattern and effectiveness, driving contraceptive choice and tradeoffs among Kenyan AYA. These in- sights ...

4. jpagonline.org jpagonline.org/article/S1083-3188(24)00241-9/abstract

An Exploration of Contraceptive Choice Pathways in ... Outcomes of interest were current contraceptive method, desired contraceptive prior to contraceptive counseling, and then chosen contraception.

5. ajog.org ajog.org/article/S0002-9378(25)00162-0/fulltext

Effectiveness of interventions to support person-centered ... The 12 studies showed improvements in patient outcomes (ie, knowledge, self-efficacy, perceived benefits, quality of care, contraceptive choice, and ...

6. clinicaltrial.be clinicaltrial.be/en/details/176273?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Evaluating the Impact of CHOICE-AYA on Contraceptive ... This study will adapt an evidence-based contraceptive counseling intervention (CHOICE) using input from the formative groups of AYA ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1083318820304046

Contraceptive Counseling and Support for Adolescents ... This article summarizes the evidence supporting contraceptive counseling strategies linked with contraceptive initiation among young women.

8. jahonline.org jahonline.org/article/S1054-139X(25)00251-4/fulltext

Emergency Contraception Update for Adolescents and ... This group (AYA) are at considerable risk for unintended pregnancy and have many barriers to contraception and timely receipt of EC due to age, dependence on ...