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临床试验/NCT04494477
NCT04494477已完成不适用

The Evaluation of IN•Clued - Inclusive Health Care: Youth & Providers Empowered

Philliber Research & Evaluation2 个研究点 分布在 1 个国家目标入组 1,401 人开始时间: 2017年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,401
试验地点
2
主要终点
Nine months after the end of the program are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?

研究概览

简要总结

The INclued program was implemented in 16 states across the US. The purpose of this study is to measure: Nine months after the end of the program and one year after the workshop, are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?

详细描述

The IN•clued program for youth consists of a three-hour in-person workshop for youth which includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style booklet, that they may take home. They also receive a list of local healthcare providers that highlights those that have participated in the IN•clued healthcare provider workshop or have had training on working with the LGBTQ population. Program youth can also receive text messages with health tips and reminders to visit a healthcare center.

Workshops take place with LGBTQ youth groups through schools, community-based organizations, or conferences. Each segment is led by adult facilitators or trained peer educators with adult facilitator support. These peer educators are from the Planned Parenthood Teen Council peer education program. Teen Council is a unique peer education program created in 1989 by PPGNHI. It is a strong and successful peer education program that trains high school youth to become experts in delivering inclusive, comprehensive sexual health education to their peers via group and community presentations. If trained peer educators are used, they implement the intervention with the guidance and oversight of an adult facilitator.

Participants in the control condition receive a benign intervention, which like IN•clued, meets in a group setting.

Once a site or group is defined, facilitators send implementation forms to Philliber. The evaluation team reviews the information and asks any needed questions which vary by group or site. The two groups cannot differ in any significant way (e.g., gender, SES, ethnicity, or special characteristic such as pregnant and parenting participants). All decisions about final eligibility are made by the research team. If two groups or sites are similar, they are approved. If they differ in a significant way, they are not eligible for the study.

Random assignment of the groups does not technically occur until the baseline administration of the survey is completed as participants can be both added and subtracted from the group list until the time of survey administration. One facilitator at each location is informed of the outcome of random assignment before or during the administration of the baseline survey. This is done so random assignment can occur immediately after surveys are conducted as this is a one-time workshop and participants do not give assent to participate until this time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Youth participants are already in LGBTQ groups, such as gay-straight alliances in schools or local community groups or those who are recruited to attend a special event at a community-based organization or conference. Participants must be at least 14 and preferably younger than
  • Ideally, they are part of the LGBTQ community, although this is not required.

排除标准

  • Cannot require ESL support.

结局指标

主要结局

Nine months after the end of the program are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?

时间窗: One year after baseline

If participants had recent (in the past three months) vaginal sex without a condom or birth control, recent oral sex without protection, or recent anal sex without a condom, they were coded as having engaged in recent unprotected or risky sexual behavior.

次要结局

未报告次要终点

研究者

发起方
Philliber Research & Evaluation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley Philliber

Principal Investigator

Philliber Research & Evaluation

研究点 (2)

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