Evaluation of Are You Ready?
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 1,850
- 试验地点
- 1
- 主要终点
- Receipt of sexually transmitted infection (STI) testing in the past three months
研究概览
简要总结
The goal of this randomized trial is to learn if the Are You Ready? (AYR) intervention has a positive impact on the sexual and mental health behaviors of sexually active youth between the ages of 14 and 22 years old who are at risk for or involved in the juvenile justice and/or child welfare systems. The primary research questions it aims to answer are:
- Three months after being offered the intervention, does AYR impact youth's receipt of sexually transmitted infection testing in the past three months?
- Three months after being offered the intervention, does AYR impact youth's use of coping skills?
- Nine months after being offered the intervention, does AYR impact youth's frequency of having vaginal and anal sex without condoms in the past three months?
Researchers will compare participants randomized to receive AYR (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).
Participants randomized to the treatment group will be offered AYR as a virtual or in-person, 2.5 hour group session. Participants randomized to the control group will be offered a virtually delivered control condition.
详细描述
This is an individual-level, randomized control trial to rigorously evaluate the impact of the Are You Ready? (AYR) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (four months after baseline); and nine months post-intervention (ten months after baseline).
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 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At risk for or involved in the juvenile justice and/or child welfare systems
- •Has had vaginal or anal sex in the last 6 months or has ever had vaginal or anal sex and self-report likelihood of having sex in the next 6 months
- •Comfortable reading, speaking, and writing in English
- •United States resident
排除标准
- •Has received other known sexual and reproductive health evidence-based interventions implemented in their local area.
- •Enrolled in an ongoing PRG-run TPP study
- •Identified as fraudulent
研究组 & 干预措施
Are You Ready?
干预措施: Are You Ready? (AYR) (Behavioral)
Social Media Awareness Shorts
干预措施: Social Media Awareness Shorts (SMAS) (Behavioral)
结局指标
主要结局
Receipt of sexually transmitted infection (STI) testing in the past three months
时间窗: Assessed three months after the intervention period has ended (four months post-baseline)
Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 3 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past three months and 1 indicates a person who has received STI testing in the past three months.
Use of coping skills
时间窗: Assessed three months after the intervention period has ended (four months post-baseline)
Participants are asked on a 4-point scale ranging from "I did not use" (1) to "I used almost all the time" (4) how often they used the following strategies: 1. I talked to someone to find out more about the situation. 2. I let people know what I needed. 3. I talked to someone who could act in some way to change the situation. 4. I asked for ideas from a friend who I could trust. 5. I made a great effort to make things work. 6. I spent time with someone I wanted to be with. 7. I tried to look after my health by eating food that was good for me. 8. I tried to eat regularly. 9. I made a plan of action and followed it through. 10. I tried to release my anger by exercising. 11. I tried to look after myself by getting plenty of sleep. 12. I tried to be physically fit. The measure is calculated as the average response to all 12 items in the scale.
Times having vaginal and anal sex without condoms in the past three months
时间窗: Assessed nine months after the intervention period has ended (ten months post-baseline)
Participants are asked the following two items: 1. In the past 3 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 3 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past three months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past three months.
Receipt of sexually transmitted infection (STI) testing in the past three months
时间窗: Assessed three months after the intervention period has ended (four months post-baseline)
Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 3 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past three months and 1 indicates a person who has received STI testing in the past three months.
Use of coping skills
时间窗: Assessed three months after the intervention period has ended (four months post-baseline)
Participants are asked on a 4-point scale ranging from "I did not use" (1) to "I used almost all the time" (4) how often they used the following strategies: 1. I talked to someone to find out more about the situation. 2. I let people know what I needed. 3. I talked to someone who could act in some way to change the situation. 4. I asked for ideas from a friend who I could trust. 5. I made a great effort to make things work. 6. I spent time with someone I wanted to be with. 7. I tried to look after my health by eating food that was good for me. 8. I tried to eat regularly. 9. I made a plan of action and followed it through. 10. I tried to release my anger by exercising. 11. I tried to look after myself by getting plenty of sleep. 12. I tried to be physically fit. The measure is calculated as the average response to all 12 items in the scale.
Times having vaginal and anal sex without condoms in the past three months
时间窗: Assessed nine months after the intervention period has ended (ten months post-baseline)
Participants are asked the following two items: 1. In the past 3 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 3 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past three months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past three months.
次要结局
未报告次要终点