Efficacy Trial of a Brief Health Enhancement Intervention for Newly Diagnosed Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 5
- 主要终点
- Viral load
研究概览
简要总结
The study involves delivering one of two interventions - either Promoting Action Towards Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men (MSM) who have recently been diagnosed with HIV and assessing whether participants who received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of care and adherence to treatment, and engage in less sexual HIV transmission risk behavior than participants who received PCC.
- PATH consists of two preliminary sessions plus "booster" sessions after 1, 3, and 6 months.
- Personalized Cognitive Counseling consists of one session.
Participants will complete assessments before participating in their intervention (i.e., at "baseline") and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be measured at approximately 6 and 12 months following baseline.
详细描述
Objectives:
The investigators will conduct a randomized controlled trial to test the efficacy of Promoting Action Towards Health (PATH), a brief health-enhancement and risk reduction intervention targeting newly HIV diagnosed men who have sex with men (MSM).
Specific Aims:
The investigators will establish the efficacy of PATH. The following hypotheses will be tested: Participants in the experimental condition will (1) achieve significantly greater suppression of HIV viral load; (2) demonstrate greater uptake of care and adherence to treatment; and (3) engage in less sexual HIV transmission risk behavior across the study duration than participants in the comparison condition.
Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •receiving an HIV diagnosis within the previous 12 months
- •entry into HIV primary care
- •residence in the greater New York metropolitan area
- •aged 18 or older
- •provision of written informed consent
排除标准
- •demonstrating cognitive impairment, acute psychosis, or suicidal intent or plans
结局指标
主要结局
Viral load
时间窗: 12 months
次要结局
- Viral load(6 months)
- Care and treatment uptake/adherence(Baseline, post (3 months), 6, 9, and 12 months)
- Sexual HIV transmission risk behavior(Baseline, post (3 months), 6, 9, and 12 months)