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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+