Does Provision of Point of Care CD4 Technology and Early Knowledge of CD4 Levels Affect Early Initiation and Retention on Anti-retroviral Treatment (ART) in HIV Positive Pregnant Women in the Context of Option B+ for PMTCT?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 704
- 试验地点
- 32
- 主要终点
- Retention
研究概览
简要总结
The study will be conducted at 32 health care facilities in three provinces in Zimbabwe and will compare the impact of the provision Point of Care CD4 technology and early knowledge of CD4 levels on retention at 12 months, with or without POC CD4 and a programmatic mentoring package. Option B+ will be implemented at all sites and 16 intervention sites will receive POC CD4 machines and visits from a team of clinical mentors.
The study also aims to assess rates of ART initiation and time to ART initiation of HIV positive pregnant women in settings implementing option B+ with or without POC CD4 and related counselling/support; rates of retention in care of HIV positive mothers at 6 months post ART initiation in settings implementing option B+ with or without POC CD4 and related counselling/support; rates of ART initiation and retention at 6 and 12 months post ART initiation according to different levels of CD4 count; cost of retaining HIV positive pregnant women until 6 and 12 months; acceptability and feasibility of POC CD4 as an adjunct to good clinical care of HIV positive pregnant women.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant at the time of booking
- •HIV positive diagnosis
- •Not on ART at the time of booking
- •Present up to 38 weeks into gestation
- •Presents more than 48 hours prior to delivery
排除标准
- •Already on ART at booking
- •Presents more than 38 weeks into gestation or less than 48 hours prior to delivery
研究组 & 干预措施
Standard of Care
Sites implementing Option B+ for pregnant and lactating women according to the standard of care prescribed by the Ministry of health and Child Care national guidelines
POC Plus
Sites implementing Option B+ according to the standard of care prescribed by the Ministry of Health and Child Care, as well as programmatic mentoring and POC CD4 machines
干预措施: POC CD4 (Device)
POC Plus
Sites implementing Option B+ according to the standard of care prescribed by the Ministry of Health and Child Care, as well as programmatic mentoring and POC CD4 machines
干预措施: Programmatic Mentoring (Other)
结局指标
主要结局
Retention
时间窗: 12 months
Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation
次要结局
- Retention by CD4 count(6 months , 12 months)
- Time-to-initiation(12 months)
- Retention at 6 months(6 months)
- Cost per pregnant woman retained on ART(6 months , 12 months)
- Initiation within 1 month(1 month)