ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,004
- 试验地点
- 10
- 主要终点
- Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing.
研究概览
简要总结
Purpose: To compare the effectiveness of a combination intervention strategy (CIS), consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and accelerated ART initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on linkage to and retention in HIV care at 12 months among adults testing positive for HIV in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+ non-cash financial incentives (FI) compared to CIS without FI on study outcomes.
详细描述
Design: Two-arm cluster site-randomized trial with a pre-post intervention two-sample design nested in the intervention arm.
Study Population: The study population is any adult who tests HIV positive at the HIV counseling and testing points participating in this study. The study unit (SU), the level of randomization for the study, includes specific HIV counseling and testing points at primary health care clinics and the HIV care and treatment services located in the same health facility. A total of 10 SU will be included.
Sample Size: A total of 2,250 adults from the 10 study units will be included in the study, 750 in the SOC arm, 750 receiving CIS without FI and 750 receiving CIS+FI.
Participants will be enrolled and followed for 12 months after enrollment.
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
- •18 years of age or older
- •Testing HIV positive at the largest-volume HIV point of testing (other than prevention of mother-to-child transmission or tuberculosis) at SU with written proof of test result
- •Agreeing to be referred to the HIV care services associated with the SU
- •Agreeing to provide locator information
- •Agreeing to adhere to study procedures, including a baseline interview, interviews 1 and 12 months after study enrollment, and extraction of data from the HIV care and treatment electronic database
- •Able to provide informed consent
排除标准
- •Being pregnant at study enrollment
- •Planning on leaving the community where they currently reside in the next 12 months
- •Enrolled in HIV care in the past 6 months at any clinic
- •Initiated ART (for any duration) in the past 6 months at any clinic
- •Currently on ART
- •Does not speak or understand Portuguese or Xitswa/Matswa
结局指标
主要结局
Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing.
时间窗: 1 month and 12 months after testing
An increase in linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. Participants are considered to achieve this outcome if they successfully link to the SU HIV care services within 1 month of testing HIV positive as measured from the electronic patient-level database used at the HIV care clinic (EPTS).
次要结局
- Time to linkage to care(12 months)
研究者
Batya Elul
Assistant Professor of Epidemiology
Columbia University