Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants

Study Overview
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Brief Summary
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The purpose of this quasi-experimental study is to evaluate the effectiveness of an infant feeding intervention in improving growth and anemia outcomes among HIV-exposed infants 6-12 months of age.

Detailed Description
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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.

Official Title
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Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti

Conditions
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Lack of; Care, Infant (Child), Malnutrition

Intervention / Treatment
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* Other: Counseling and nutrition supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention participant<br> | Other: Counseling and nutrition supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in prevalence of growth faltering during the intervention | Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard | end of intervention (approximately 12 months of age) | 
| Change in prevalence of growth faltering post-intervention | Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard | Six-months post-intervention (approximately 18 months of age) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in prevalence of anemia during intervention | Prevalence of anemia (Hb < 10.5 g/dl) | end of intervention (approximately 12 months of age) | 
| Dietary intake | dietary nutrient intakes assessed through 24-hour dietary recall | end of intervention (approximately 12 months of age) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant feeding, HIV, growth, anemia