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临床试验/NCT05022134
NCT05022134Enrolling By Invitation不适用

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

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
1
主要终点
Contraceptive uptake

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
14 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Intervention (CHOICE-AYA)

Experimental

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

干预措施: CHOICE-AYA (Behavioral)

结局指标

主要结局

Contraceptive uptake

时间窗: Study Day 1

Rates of reliable contraceptive use

次要结局

  • Contraceptive satisfaction(1, 3, 6, and 12 months post intervention)
  • Contraceptive continuation(1, 3, 6, and 12 months post intervention)
  • Feasibility of intervention (perceived by clinic staff and participants)(Post-visit)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephani Stancil

Assistant Professor, Department of Pediatrics

Children's Mercy Hospital Kansas City

研究点 (1)

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