Study of Impacts of Food Supplementation on Malnourished HIV-Infected Adults in Kenya

Study Overview
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Brief Summary
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The purpose of the study is to test whether food supplementation of malnourished HIV-infected adults (both pre-ART and ART) in resource constrained settings improves their nutritional status, clinical status, effectiveness of treatment, quality of life, functioning, and survival.

Detailed Description
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Malnutrition remains a significant problem among HIV-infected populations, even among those with access to ART. In patients with HIV infection, poor nutritional status is associated with significant reduction in survival rates, accelerated disease progression, diminished response to therapies including ART, increased susceptibility to opportunistic infections, and reduced work capacity and quality of life. However, there is not evidence whether delay or reversal of weight loss improves life expectancy, nor is there evidence about the specific benefits food supplementation has on people with HIV infection. As antiretroviral therapy (ART) services continue to scale up in sub-Saharan Africa, there is a critical need for information about the impacts of appropriate food supplementation on the effectiveness of ART, on the health status of clients, and on the progression of the disease. Malnourished adult ART and pre-ART clients at six clinical sites in Kenya are randomly allocated either to a group that receives nutrition counseling only or a group that receives nutrition counseling and supplementary feeding for six months. All patients continue to receive medical treatment (ART and other medicine) according to their condition. Baseline measures of socioeconomic and demographic status are collected. Measures of both nutritional and non-nutritional clinical outcomes are collected at baseline, 3, 6, 9, and 12 months. Clients beginning ART are treated as one arm and randomized between food and non-food, and clients not yet eligible for ART (pre-ART) are treated as a second arm and randomized between food and non-food. Within each arm, outcomes of subjects receiving supplemental food will be compared with outcomes of those who are not.

Official Title
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Randomized Controlled Evaluation of the Impact of Food Supplements on Malnourished HIV-Infected Adult ART Clients and Malnourished, HIV-Infected Pre-ART Adults in Kenya

Conditions
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HIV, Malnutrition, HIV Infections

Intervention / Treatment
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* Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
* Other: nutrition counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected BMI < 18.5 Resident of area for past 6 months Exclusion Criteria: Pregnant or lactating (child < 6 months) BMI > 18.5, BMI < 14 Already receiving other food supplements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ART: food<br>ART + food supplementation + nutrition counseling | Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)<br>* 300 grams/day for 6 months<br>* Other names: Insta Products Ltd. Foundation Plus product with whey protein concentrate.;Other: nutrition counseling<br> <br> |
| Active Comparator: ART: no food<br>ART + nutrition counseling | Other: nutrition counseling<br> <br> |
| Active Comparator: pre-ART: food<br>no ART (cotrimoxazole provided) + food supplementation + nutrition counseling | Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)<br>* 300 grams/day for 6 months<br>* Other names: Insta Products Ltd. Foundation Plus product with whey protein concentrate.;Other: nutrition counseling<br> <br> |
| Active Comparator: pre-ART: no food<br>no ART (cotrimoxazole provided) + nutrition counseling | Other: nutrition counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 counts |  | every three months (quarterly) | 
| Quality of Life |  | monthly | 
| drug adherence |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food supplementation, HIV, malnutrition