Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
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|ClinicalTrials.gov Identifier: NCT01434238|
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Lack of; Care, Infant (Child), Malnutrition||Other: Counseling and nutrition supplement||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||May 2010|
|Experimental: Intervention participant||
Other: Counseling 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.
- Change in prevalence of growth faltering during the intervention [ Time Frame: 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 [ Time Frame: 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
- Change in prevalence of anemia during intervention [ Time Frame: end of intervention (approximately 12 months of age) ]Prevalence of anemia (Hb < 10.5 g/dl)
- Dietary intake [ Time Frame: end of intervention (approximately 12 months of age) ]dietary nutrient intakes assessed through 24-hour dietary recall
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434238
|Port-au-Prince, Quest, Haiti|
|Principal Investigator:||Rebecca Heidkamp, PhD||Cornell University|