Network-Wide Assessment of Current Health Status and Behavioral Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,712
- 试验地点
- 15
- 主要终点
- Rates of adherence to medical regimens, sexual risk behavior, substance use and mental health concerns; basic demographic and biomedical data for adolescents and young adults with HIV infection engaged in care at the AMTUs.
研究概览
简要总结
This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at the ATN sites.
详细描述
The proposed study is a cross sectional study intended to be conducted at each of the 15 Adolescent Medicine Trials Units (AMTUs) participating in the ATN and to enroll all participating patients followed at each site. This approach will allow for the examination of the broad spectrum of youth participating in the ATN, including those newly entered into care.
Psychosocial and risk-taking behavioral data will be collected using Audio Compute-Assisted Self-Interview (ACASI); biomedical information will be collected through medical chart abstraction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laboratory evidence of HIV-1 infection documented by a positive result on any of the following licensed tests at any time: Any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR > 1,000 copies/ml;
- •Knowledge of HIV positive diagnoses;
- •Age 12 years through 24 years, inclusive;
- •Engaged in care at the AMTU or its affiliate and/or partnering clinic. Individuals will be considered to be engaged in care if:
- •Diagnosed less than or equal to 12 months prior to the date of approval to generate the master list and has attended a minimum of one visit since diagnosis for the management of HIV disease or its sequelae; or
- •Diagnosed more than 12 months prior to the date of approval to generate the master list and has had a minimum of one visit, as described above, within the past 12 months.
- •Ability to understand written and/or verbal English
- •Ability and willingness to provide signed consent/assent;
- •Parental/legal guardian permission (if applicable)
排除标准
- •Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individuals' ability to complete the study measures;
- •Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or
- •Intoxicated or under the influence of alcohol or other substances at the time of consent/assent.
结局指标
主要结局
Rates of adherence to medical regimens, sexual risk behavior, substance use and mental health concerns; basic demographic and biomedical data for adolescents and young adults with HIV infection engaged in care at the AMTUs.
时间窗: within 2 weeks of enrollment
次要结局
- To better understand the complex relationships between adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, and basic demographic and biomedical data in adolescents and young adults with HIV infection.(1.3 years)