Evaluation of Unstained
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Receipt of sexually transmitted infection (STI) testing in the past four months
研究概览
简要总结
The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 22 years old who are at risk for or involved in the legal system. The primary research questions it aims to answer are:
- Three months after being offered the intervention, does Unstained impact youth's receipt of sexually transmitted infection testing in the past four months?
- Nine months after being offered the intervention, does Unstained impact youth's frequency of having vaginal and anal sex without condoms in the past four months?
Researchers will compare participants randomized to receive Unstained (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 Unstained as a virtual, individual-based intervention delivered during three ~60 minute sessions over a 3-6 week period. 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 Unstained 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 (five months after baseline); and nine months post-intervention (eleven 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
- •United States resident
- •Owns or has regular access to a personal device with internet access
- •Comfortable reading, speaking, and writing in English
- •Has had vaginal or anal sex in the past 3 months
- •At risk for or involved in the legal system
排除标准
- •Currently trying to start a pregnancy
- •Currently in jail or being detained in a facility
- •Enrolled in an ongoing PRG-run TPP study
- •Identified as fraudulent
- •Participating in another known OPA-funded research study
研究组 & 干预措施
Unstained
干预措施: Unstained (Behavioral)
Like
干预措施: Like (Behavioral)
结局指标
主要结局
Receipt of sexually transmitted infection (STI) testing in the past four months
时间窗: Assessed three months after the intervention period has ended (five months post-baseline)
Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 4 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 four months and 1 indicates a person who has received STI testing in the past four months.
Times having vaginal and anal sex without condoms in the past four months
时间窗: Assessed nine months after the intervention period has ended (11 months post-baseline)
Participants are asked the following two items: 1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 4 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 four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months.
Receipt of sexually transmitted infection (STI) testing in the past four months
时间窗: Assessed three months after the intervention period has ended (five months post-baseline)
Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 4 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 four months and 1 indicates a person who has received STI testing in the past four months.
Times having vaginal and anal sex without condoms in the past four months
时间窗: Assessed nine months after the intervention period has ended (11 months post-baseline)
Participants are asked the following two items: 1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 4 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 four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months.
次要结局
未报告次要终点