Clinical trial NCT05022134: Evaluating the Impact of CHOICE-AYA on Contraceptive Use, Continuation and Satisfaction
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Contraception Behavior
Sexual Behavior
Reproductive Behavior
Keywords: Adolescent
Contraception
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Contraceptive uptake
timeFrame: Study Day 1
Secondary outcomes:
measure: Contraceptive satisfaction
timeFrame: 1, 3, 6, and 12 months post intervention
measure: Contraceptive continuation
timeFrame: 1, 3, 6, and 12 months post intervention
measure: Feasibility of intervention (perceived by clinic staff and participants)
timeFrame: Post-visit
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Research Institute
state: Missouri
Study officials:
References: