Lack of; Care, Infant (Child), Malnutrition
Conditions
Keywords
infant feeding, HIV, growth, anemia
Brief summary
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
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.
Interventions
OTHERCounseling and nutrition supplement
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.
Sponsors
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Weill Medical College of Cornell University
University of Virginia
Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in prevalence of growth faltering during the intervention | end of intervention (approximately 12 months of age) | Change in weight-for-age, length-for-age and weight-for-length \<-2 SD based on WHO 2006 Growth Standard |
| Change in prevalence of growth faltering post-intervention | Six-months post-intervention (approximately 18 months of age) | Change in weight-for-age, length-for-age and weight-for-length \<-2 SD based on WHO 2006 Growth Standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in prevalence of anemia during intervention | end of intervention (approximately 12 months of age) | Prevalence of anemia (Hb \< 10.5 g/dl) |
| Dietary intake | end of intervention (approximately 12 months of age) | dietary nutrient intakes assessed through 24-hour dietary recall |
Countries
Haiti
Outcome results
None listed