Advanced HIV Re-engagement in Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 724
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Adults who are hospitalized in Lusaka, Zambia, and found to have advanced HIV disease will be enrolled and randomly assigned to receive the ARC intervention or standard of care. All participants will then be followed through the end of the hospitalization and for up to 1 year after discharge from hospital.
详细描述
The ARC intervention includes support from a community health worker that begins during admission and continues after discharge to address gaps in the care cascade for HIV and serious coinfections and comorbidities. ARC components were previously developed and pilot tested at hospitals in Zambia.
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
- 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
- •Living with HIV
- •Advanced HIV defined as CD4 <350 cells/mm3 or WHO stage 3 or 4 event
- •Currently admitted to study hospital's internal medicine department
排除标准
- •Planning to reside outside Lusaka after discharge
- •Too sick to provide informed consent
- •Known to have advanced cancer (defined as requiring chemo/radiation therapy or referred to hospice) other than Kaposi Sarcoma
- •Known to have end stage kidney disease
- •Known to have end stage liver disease
- •No access to a telephone
- •Currently incarcerated
研究组 & 干预措施
Standard of Care (SOC)
In this arm, participants will be managed according to the standard of care.
Advanced HIV Re-engagement in Care (ARC)
In this trial arm, participants will be provided with the ARC intervention package.
干预措施: ARC (Behavioral)
结局指标
主要结局
All-cause mortality
时间窗: Enrollment to up to 1 year
Mortality will be ascertained as follows. All participants will receive monthly phone check-ins and if they don't respond a study staff member will trace their whereabouts in the community. This process will lead investigators to find out about deaths. In addition, investigators may be informed by a hospital staff member where a participant was admitted and died.
次要结局
- HIV viral suppression(Enrollment, 3 months and 1 year)
- Retention in HIV care(At 3 months and 1 year)
- Medication possession ratio(At 3 months and 12 months)
研究者
Michael Vinikoor
Professor of Medicine
University of Alabama at Birmingham