Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Quest
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Port-au-Prince、Quest、ハイチ
- GHESKIO Centres
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Intervention participant
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in prevalence of growth faltering during the intervention
時間枠:end of intervention (approximately 12 months of age)
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Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
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end of intervention (approximately 12 months of age)
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Change in prevalence of growth faltering post-intervention
時間枠:Six-months post-intervention (approximately 18 months of age)
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Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
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Six-months post-intervention (approximately 18 months of age)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in prevalence of anemia during intervention
時間枠:end of intervention (approximately 12 months of age)
|
Prevalence of anemia (Hb < 10.5 g/dl)
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end of intervention (approximately 12 months of age)
|
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Dietary intake
時間枠:end of intervention (approximately 12 months of age)
|
dietary nutrient intakes assessed through 24-hour dietary recall
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end of intervention (approximately 12 months of age)
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Rebecca Heidkamp, PhD、Cornell University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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