A Couples-based Approach to Improving Engagement in HIV Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Change from Baseline HIV viral load at 3, 6 and 9 months
研究概览
简要总结
This is a randomized controlled trial of a new behavioral intervention designed to improve engagement in HIV care for couples. Investigators will compare the HIV viral load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to an individual adherence intervention (LifeSteps).
详细描述
The investigators will test the intervention to improve HIV care engagement by enrolling 150 sexual or gender minority couples and randomizing 75 couples each to one of two conditions: 1) DuoPACT, a newly-developed couples intervention; or 2) LifeSteps, a standardized antiretroviral adherence intervention for HIV+ individuals. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention effects via behavioral indicators of engagement in HIV care, the couple's relationship dynamics, and the primary outcome of HIV viral load.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years old;
- •Identifies as a sexual or gender minority;
- •In a primary romantic relationship for at least 3 months;
- •At least one partner is HIV+;
- •English-speaking;
- •Able to provide informed consent; and
- •For HIV+ participants: Evidence of suboptimal engagement in HIV care.
排除标准
- •Must be able to consent to and follow study protocol;
- •Evidence of severe cognitive impairment or active psychosis;
- •Lives outside California or plans to relocate from the state of California in the next 6 months; or
- •Participation in the DuoPACT pilot.
结局指标
主要结局
Change from Baseline HIV viral load at 3, 6 and 9 months
时间窗: 3, 6 and 9 months
Follow-up blood draws will be performed on all HIV+ partners at 3, 6, and 9 months post randomization. HIV-1 viral load levels will be measured by the COBAS® AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.), which has a threshold for undetectability = \< 20 copies/mL.
次要结局
- Change from Baseline behavioral indicators of engagement in HIV care at 3, 6 and 9 months(3, 6 and 9 months)