Achieving HIV Viral Suppression in Refugee Settlements in Uganda With Head StART: A Cluster Randomized Trial Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,720
- 试验地点
- 1
- 主要终点
- HIV viral suppression at 12 months
研究概览
简要总结
This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression.
详细描述
Community antiretroviral therapy (ART) delivery is a differentiated care model that fosters social support and reduces time and transportation barriers yielding improved engagement in HIV care. In Uganda, to participate in community ART delivery, clients must be "stable" in care (> 1 year on ART and viral load < 1,000 copies/mL). Therefore, persons newly diagnosed with HIV are not eligible for community ART delivery. Community ART delivery may benefit persons newly diagnosed with HIV in refugee settlements by bolstering social support and by bringing ART closer to individuals living in these expansive rural settlements. The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Adult ≥18 years of age or mature minors or emancipated minor. Mature minors are defined as individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient.
- •Tested HIV positive in the past 6 months and not already known to be HIV positive.
- •Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English.
- •Inclusion criteria for data abstraction only:
- •Adult ≥18 years of age or mature minors or emancipated minor.
- •Tested HIV positive in the past 6 months and not already known to be HIV positive.
排除标准
- •Pregnant and breastfeeding women.
- •Clients deemed by the clinician(s) unfit for community-based care secondary to medical need.
- •Concurrently enrolled in another biomedical clinical trial.
结局指标
主要结局
HIV viral suppression at 12 months
时间窗: 12 months (+/- 2 months)
HIV viral suppression is defined as \<1,000 copies/mL
次要结局
- HIV viral suppression at 6 months(6 months (+/- 2 months))
- Antiretroviral therapy adherence among those virally unsuppressed at 12 months(12 months (+/- 2 months))
研究者
Kelli O'Laughlin
Associate Professor, Departments of Emergency Medicine and Global Health
University of Washington