Enhanced Viral Load Counseling and Standardized Peer Mother Support Study (ENHANCED-SPS)
试验速览
- 阶段
- 不适用
- 入组人数
- 980
- 试验地点
- 1
- 主要终点
- Viral suppression
研究概览
简要总结
The ENHANCED -SPS study is a before and after cluster randomized trial that will be conducted in 14 public health facilities providing HIV care in Southwestern Uganda. The study will evaluate the effectiveness of a multi-component intervention package that targets barriers to achieving optimal viral suppression among pregnant and postpartum women infected with HIV. This will be in two phases; In Phase 1 ("Before"), all 14 clinics will have a baseline assessment of standard of care VL procedures and assess the barriers and facilitators to viral suppression for a period of 3 months. In Phase 2 ("After"), 7 clinics randomized to control arm will continue to experience standard of care counseling procedures, and 7 clinics randomized to intervention will initiate the ENHANCE-PS intervention. The Phase 2 ("After") phase I will last at least 12 months.
详细描述
The Investigators will test the hypothesis that the Enhanced viral load (VL) counseling and standardized peer mother support (ENHANCED-SPS) intervention will increase viral load suppression among HIV-infected pregnant and post-partum women and increase retention of mothers in care hence resulting in reduced risk of vertical transmission in south western Uganda.
Specific objectives are as follows:
1) To evaluate the effectiveness of an enhanced VL counseling and standardized peer mother support intervention on viral suppression among HIV infected pregnant women at 12 months of follow up; 2) To evaluate the effect of the enhanced counseling and peer support intervention on retention in care at 18 months postpartum follow up; The investigators will randomize 14 HIV clinics to the ENHANCED-SPS multi-component intervention vs. standard of care procedures (intervention=7 clinics and control=7 clinics,n=70 mothers/health facility) ;3) To assess the facilitators and barriers of VL and enhanced VL counseling and peer mother support intervention at 9 & 18 months of follow up.This will consider both patient and providers perspectives of the intervention implementation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All Pregnant women and breastfeeding mothers enrolled in the mother baby care points/HIV clinics with documented HIV infection
- •. HIV infected Pregnant women reporting for their first ANC within the study clinics or newly identified HIV positive mothers from the ANC clinics/breastfeeding
排除标准
- •. All women who will be critically ill and unable to communicate
- •. Those not willing to consent to participate in the study
- •. Women who will not be able to understand all information concerning the study
研究组 & 干预措施
Intervention
ENHANCED-SPS intervention implemented
干预措施: ENHANCED -SPS intervention (Behavioral)
Control
Standard of care maintained. These are procedures conducted during the routine HIV care visits at the health facilities include ART card documentation as required, general/routine counseling, and adherence counseling to the non suppressors, ART drug supply based on the clinicians prescription and laboratory monitoring.
结局指标
主要结局
Viral suppression
时间窗: 1 year
The proportion of women with HIV-1 RNA suppression at 12 months of follow up to assess the effect of the intervention
Retention in care
时间窗: 18 months
The proportion of women still in care at at 12 and 18 months postpartum
次要结局
- Mother to child transmission rate(18 months)