Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 469
- 试验地点
- 3
- 主要终点
- Neurodevelopment at 18 months post enrollment
研究概览
简要总结
Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. Scaling up ECD is now a priority of Zambia's national strategy, but CHEUs are not currently targeted.
There is a need to better understand the scope and mechanism of CHEU-related neurodevelopmental differences and what interventions are most effective. This randomized clinical trial (RCT) is a true effectiveness trial as the intervention will deploy a home-based adaptation of the same curriculum that is currently used elsewhere in the country, named Scaling Up Early Childhood Development In Zambia (SUPERCDZ). The effectiveness of a scalable early childhood development (ECD) intervention for CHEUs will be evaluated using normalized Z-scores of neurodevelopmental testing at age 24 months.
In this RCT the investigators will test the following hypotheses:
Hypothesis 1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs.
Hypothesis 2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or antiretroviral (ARV) exposure.
This RCT will build on an existent, actively recruiting cohort of 1500 pregnant women-infant dyads in a peri-urban hospital in Zambia, the Zambian Infant Cohort Study (ZICS), by extending the follow-up of a subsample of infants from 6 months to 2 years amongst the last 525 children enrolled (ZICS-BOOST- Brains Optimized to Survive and Thrive). The study will have three arms: Arm 1) CHEU + ECD intervention (n=175); Arm 2) CHEU without ECD intervention (n=175); Arm 3) HUU without intervention (n=175).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Zambia Infant Cohort Study (ZICS) cohort participants who are >18 years old AND are still pregnant OR whose infants are less than 9 months of age by February
- •ZICS inclusion criteria were pregnant women (1:1, HIV+:HIV-) presenting for antenatal care at Chawama First Level Hospital and intending to deliver at Chawama First Level Hospital and less than 26 weeks gestation by ultrasound
排除标准
- •Mother-infant dyads not enrolled in ZICS
- •Mother-infant dyads where mother is <18 years of age
结局指标
主要结局
Neurodevelopment at 18 months post enrollment
时间窗: 18 months
The Malawi Developmental Assessment Tool (MDAT) will be used to assess neurodevelopment. MDAT provides an independent evaluation of development in the domains of gross motor, fine motor, language and social skills. The MDAT can be administered in any environment as it requires minimal equipment and is more culturally relevant to our context. The scores from the MDAT are relatable and comparable to those obtained from the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III). Primary outcomes will be z-scores from four neurodevelopmental domain measurements-gross motor, fine motor, language, and social.
次要结局
- Neurodevelopment at 6 months post enrollment(6 months)
- Language development at 6, 12, and 18 months post enrollment(6 months. 12 months, 18 months)
- Child's age-specific tasks at 6, 12, and 18 months post enrollment(6 months, 12 months, 18 months)
- Caregiver mental health and wellbeing at 6, 12 and 18months post enrollment(6 months, 12 months, 18 months)