Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 8
- 主要终点
- Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention
研究概览
简要总结
The proposed study is a two-group randomized repeated measures design that will examine the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU sites across the United States. Youth will be randomized into one of two study arms; Project ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison condition. Both arms consist of two individual sessions followed by six group sessions and a final individual session which is expected to take approximately nine weeks after which youth will have four follow-up visits at the following time points:
- post intervention (immediately after the last session);
- 3 months post the last session;
- 6 months post the last session; and
- 12 months post the last session. The trial will be repeated in up to three waves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected and aware of his/her status as documented by medical record review or verbal verification by provider (i.e., medical or mental health care provider, case manager, social worker, etc.);
- •Received HIV diagnosis within the past 12 months (+ 3 months) at the time of consent/assent as documented by medical record review or verbal verification with referring professional (i.e., medical or mental health care provider, case manager, social worker, etc.);
- •Between the ages of 16-24 (inclusive) at the time of informed consent/assent;
- •Receives services at one of the selected AMTUs or one of their community partners;
- •Willing to participate in both the individual and group sessions;
- •Ability to speak and understand spoken English;
- •Able to understand and willing to provide signed informed consent/assent in English or Spanish; and
- •Willingness to provide signed informed consent or assent with parental/legal guardian permission as applicable.
排除标准
- •Participated in a previous wave, if enrolling into Wave 2 or 3;
- •Intoxicated or under the influence of alcohol or other substances at the time of consent/assent;
- •Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) in the opinion of the site personnel would interfere with the ability to give true informed consent; and
- •Any concurrent participation in other behavioral studies. Permission from the protocol team may be provided for uncertain cases.
结局指标
主要结局
Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention
时间窗: 3 years
Conduct a randomized controlled trial to examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention (HEALTH). The goals of the intervention are to improve engagement in care, decrease psychosocial barriers to care, and decrease sexual risk for youth newly diagnosed with HIV.
次要结局
- Explore the relationship between HIV biomarkers and participant's level of engagement in care(3 years)