Rigorous Evaluation of Yes and Know, a Fully Virtual Intervention Integrating Group-based Education With Digital Tools to Improve Youth Sexual Health and Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 449
- 试验地点
- 1
- 主要终点
- Rates of unprotected vaginal or anal sex
研究概览
简要总结
This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.
详细描述
For the Yes and Know study, cohorts of 5-25 participants will be recruited and randomized into one of the two study conditions: Yes and Know: Life Skills intervention (intervention condition) or Yes and Know: Nutrition Skills intervention (comparison condition). The programs will be delivered by trained health educators through synchronous virtual sessions. Participants can access the supplemental resources and activities for their respective programs on the program's website. Participants will be recruited by local community partners (with a focus on rural communities in the South and Southeast regions of the United States) as well as paid advertising on social media platforms. Young people must have consent and provide their assent to be part of the study. Yes and Know: Sexual Health and Life Skills covers sexual and reproductive health, healthy relationships, life skills, and educational and career success. Yes and Know: Nutrition Skills covers learning to make healthy decisions about food, weight and disordered eating, and creating nourishing meals. Both programs consist of nine 60-minute synchronous group sessions, totaling nine hours, to be taught at least once a week (or more frequently depending on cohort scheduling).
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 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 14-19; and
- •English speaking.
排除标准
- •- Anyone not meeting inclusion criteria.
研究组 & 干预措施
Nutrition Education for Adolescents
Youth will receive education about adolescent nutrition.
干预措施: Nutrition Education for Adolescents (Behavioral)
Yes and Know curriculum
Youth will receive the Yes and Know curriculum.
干预措施: Yes and Know curriculum (Behavioral)
结局指标
主要结局
Rates of unprotected vaginal or anal sex
时间窗: 12 months post-intervention
Single measure constructed from the number of times had vaginal sex without a contraceptive method in the past 3 months; number of times had anal sex without a condom in the past 3 months.
次要结局
- Use of sexual and reproductive health services in the past 3 months(12 months post intervention)
- Sexual and reproductive health knowledge(3 months post intervention)
- Positive attitudes towards sexual consent(3 months post intervention)
- Self-efficacy in relationship communication(3 months post intervention)
- Self-efficacy in using condoms correctly(3 months post intervention)