Intervention Development for Newly Diagnosed Youth With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- The appropriateness of specific instruments proposed.
研究概览
简要总结
This study will pilot test an HIV intervention for newly diagnosed youth (diagnosed for less than 15 months) to assess its acceptability and feasibility preliminary to and leading up to a full-scale, randomized trial. The general focus of the intervention is to aid in the psychosocial adjustment of adolescents who have recently been diagnosed with HIV.
详细描述
The intervention will consist of a combination of individual and group-based sessions in which the youth will participate. This combination allows for more intensive individualized attention as well as supportive group sessions. Youth will first participate in two individual sessions, followed by nine group sessions, and end with one additional individual session.
Individual Session I: Orientation I
Part A - meet with interventionist for ecological assessment, rapport building, and preparation for meeting with medical provider Part B - meet with medical provider to answer HIV specific medical questions (i.e., transmission information, viral load/t-cells, opportunistic infections,etc.). The interventionist will be present in Part B as well.
Individual Session II: Orientation II
Part A - meet with interventionist for continued debriefing, question/answer, preparation for group participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •To be considered eligible for enrollment in ATN 068, a participant must meet the criteria listed below:
- •Receive services at one of the 4 selected ATN sites or their community partners;
- •HIV-infected as documented by medical record review or verbal verification with referring professional;
- •Received HIV diagnosis less than 15 months ago as documented by medical record review or verbal verification with referring professional;
- •Fall between the ages of 16-24 (inclusive) at the time of informed consent/assent;
- •Must be willing to participate in the both the individual and group sessions;
- •Give informed consent/assent for study participation.
排除标准
- •Participants who meet any of the exclusion criteria listed below are considered ineligible:
- •Acquired HIV through perinatal infection;
- •Presence of serious psychiatric symptoms (active hallucinations, thought disorder);
- •Visibly distraught (suicidal, homicidal, exhibiting violent behavior);
- •Intoxicated or under the influence of alcohol or other substances at the time of study enrollment.
结局指标
主要结局
The appropriateness of specific instruments proposed.
时间窗: 7 months
The perceived sensitivity of measures to change over time.
时间窗: 7 months
The best procedures for a larger trial (e.g. timing, content etc. of ACASI administration)
时间窗: 7 months
次要结局
未报告次要终点