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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Lack of; Care, Infant (Child), Malnutrition	Other: Counseling and nutrition supplement	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	82 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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

Arms and Interventions

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Arm

Intervention/treatment

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.

Outcome Measures

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Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. 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)
2. Dietary intake [ Time Frame: end of intervention (approximately 12 months of age) ]
   dietary nutrient intakes assessed through 24-hour dietary recall

Eligibility Criteria

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Ages Eligible for Study:	6 Months to 18 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Locations

Haiti
GHESKIO Centres
Port-au-Prince, Quest, Haiti

Sponsors and Collaborators

Cornell University

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

Weill Medical College of Cornell University

University of Virginia

Investigators

Principal Investigator:	Rebecca Heidkamp, PhD	Cornell University

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heidkamp RA, Stoltzfus RJ, Fitzgerald DW, Pape JW. Growth in late infancy among HIV-exposed children in urban Haiti is associated with participation in a clinic-based infant feeding support intervention. J Nutr. 2012 Apr;142(4):774-80. doi: 10.3945/jn.111.155275. Epub 2012 Feb 29.

Responsible Party:	Cornell University
ClinicalTrials.gov Identifier:	NCT01434238 History of Changes
Other Study ID Numbers:	IRB 0907000316
First Posted:	September 14, 2011
Last Update Posted:	September 15, 2011
Last Verified:	September 2011

Keywords provided by Cornell University:

infant feeding; HIV; growth; anemia

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders