Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti
研究概览
详细说明
The need for better nutrition during infancy to improve growth and child survival outcomes is well recognized and is especially acute in the context of maternal human immunodeficiency virus (HIV) infection. WHO Guidelines on Infant Feeding and HIV call for support of HIV-infected caregivers during infant feeding transitions across the first year of life. However, there are few published examples of programmatic approaches that effectively integrate PMTCT and infant feeding support at the service delivery level.
The objectives of this study are to develop and test an infant feeding support intervention among non-breastfed HIV-exposed infants age 6-12 months enrolled in the Prevention of Mother-to-Child Transmission of HIV program at the GHESKIO centres, an HIV and TB treatment clinic in urban Port-au-Prince, Haiti. The investigators hypothesize that growth and anemia outcomes will be better in the intervention cohort compared to historical controls. The investigators also hypothesize that the infant feeding support intervention will be feasible and acceptable to mothers and clinical staff.
To accomplish these objectives, the investigators will enroll 82 HIV-exposed infants age 5.5-6.5 months recruited from the GHESKIO pediatric clinic in a 24-week intervention that includes a) a daily ration of fortified lipid-based nutrient supplement and b) nutrition counseling delivered through biweekly group and individualized sessions. Data on growth, supplement use, infant feeding knowledge and practices will be collected every 4 weeks during the intervention period. Hemoglobin and dietary intake will be assessed at baseline, mid-point and end of intervention. Intervention children will be seen 6-months post intervention to assess growth and anemia outcomes. Growth and anemia outcomes in the intervention group will be compared to medical record data from same-age HIV-exposed children seen at GHESKIO in the previous year.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Quest
-
Port-au-Prince、Quest、海地
- GHESKIO Centres
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Confirmed maternal HIV-infection
- Age 5.5-6.5 months at intervention start
- Weight-for-length z-score > -3 SD (WHO 2006 reference)
Exclusion Criteria:
- Confirmed or suspected allergy to peanuts
- Participation in a concurrent clinical trial at GHESKIO
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Intervention participant
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24-week intervention that includes a) a daily ration of fortified lipid-based nutrient supplement and b) nutrition counseling delivered through biweekly group and individualized sessions.
Dietary supplement is a locally- produced lipid-based nutrient spread (Meds and Foods for Kid, Cap Haitian, Haiti) that in a 65g daily ration provides 345 kcal energy and single allowance of key micronutrients for the 6-12 month age group.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in prevalence of growth faltering during the intervention
大体时间:end of intervention (approximately 12 months of age)
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Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
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end of intervention (approximately 12 months of age)
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Change in prevalence of growth faltering post-intervention
大体时间:Six-months post-intervention (approximately 18 months of age)
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Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
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Six-months post-intervention (approximately 18 months of age)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in prevalence of anemia during intervention
大体时间:end of intervention (approximately 12 months of age)
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Prevalence of anemia (Hb < 10.5 g/dl)
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end of intervention (approximately 12 months of age)
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Dietary intake
大体时间:end of intervention (approximately 12 months of age)
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dietary nutrient intakes assessed through 24-hour dietary recall
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end of intervention (approximately 12 months of age)
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合作者和调查者
合作者
调查人员
- 首席研究员:Rebecca Heidkamp, PhD、Cornell University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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