Lack of; Care, Infant (Child), Malnutrition Clinical Trial
Official title:
Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention