Clinical trial NCT01434238: Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
Official title: Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of; Care, Infant (Child), Malnutrition
Keywords: infant feeding
HIV
growth
anemia
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
name: Weill Medical College of Cornell University
name: University of Virginia
First posted: 2011-09-14
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in prevalence of growth faltering during the intervention
timeFrame: end of intervention (approximately 12 months of age)
measure: Change in prevalence of growth faltering post-intervention
timeFrame: Six-months post-intervention (approximately 18 months of age)
Secondary outcomes:
measure: Change in prevalence of anemia during intervention
timeFrame: end of intervention (approximately 12 months of age)
measure: Dietary intake
timeFrame: end of intervention (approximately 12 months of age)
Other outcomes:
Locations:
city: Port-au-Prince
country: Haiti
facility: GHESKIO Centres
state: Quest
Study officials:
affiliation: Cornell University
name: Rebecca Heidkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.