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Impacts of Specialized Food Products on HIV-infected Adults

and Malnourished Children: Emerging Evidence from

Randomized Trials

Tony CastlemanInternational Food Aid Conference

April 15, 2008

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Outline

1. Background

2. CSB vs. RUFS for Adult ART Clients in Malawi

3. FBF vs. No Food for HIV+ Adults in Kenya

4. CSB vs. milk-peanut RUTF vs. soy-peanut RUTF for children with moderate acute malnutrition in Malawi

5. Conclusions and Future Directions

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Background: Food and HIV

• Strong evidence on association between PLHIV nutritional status and mortality.

• Much less evidence on impacts of nutrition interventions for PLHIV.

• ART itself improves nutritional status but can also create additional nutrition issues.

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Background: Specialized Food Products

• Fortified blended foods (FBF)– CSB has a long history of use in a range of

programs with various objectives

– In many settings it is a more nutritious form of commonly used staple foods

– Questions have been raised about its effectiveness in addressing malnutrition

– Efforts to improve CSB have begun

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Background: Specialized Food Products

• Ready-to-use foods– Ready-to-use therapeutic food (RUTF) was

developed – and is very effective – for children with severe acute malnutrition

– Recent expansion to other populations: HIV+ adults, moderately malnourished children

– May not be optimal food for all groups; adaptations and alternative formulations are underway

– RUFs are relatively expensive, and cost-effectiveness is a consideration

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CSB vs. RUFS for Adult ART Clients: Research Question

For malnourished adults starting ART, does food supplementation with ready-to-use fortified spread (RUFS) improve nutritional and clinical status more than food supplementation with CSB does?

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CSB vs. RUFS for Adult ART Clients:Design

• Randomized, investigator-blinded effectiveness trial.

• Implemented at Queen Elizabeth Hospital, Malawi by Washington Univ. at St. Louis (Mark Manary, PI).

• Non-pregnant adults starting ART with BMI < 18.5 kg/m2 (average 16.5 kg/m2).

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374 g./day CSB (1,360 kcal/day) for 3.5 months

n=246

Enrollment

n=491

Randomization

CSB vs. RUFS for Adult ART Clients:Design

260 g./day RUFS (1,360 kcal/day) for 3.5 months

n=245

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CSB vs. RUFS for Adult ART Clients: Results

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CSB vs. RUFS for Adult ART Clients: Results

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CSB vs. RUFS: Results

After 3.5 months of supplementation

- Above differences were statistically significant.- Differences in CD4, survival, QOL, adherence were not significant.- At 3, 6, 9 months after food ended, there were no significant differences in any outcomes.- RUFS is approx. 3X the cost of CSB.

  Weight Gain Fat-Free Mass Gain

CSB 4.3 kg 2.2 kg

RUFS 5.6 kg 2.9 kg

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CSB vs. RUFS for Adult ART Clients: Results

• Subjects included mild, moderate, and severely malnourished. Difference between RUFS and CSB may be greater among severely malnourished.

• High case fatality rate– 27% after 3.5 months of food– 43% after 12.5 months (3.5 food + 9 follow-up)

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FBF vs. No Food for HIV+ Adults: Research Question

Does food supplementation of malnourished HIV-infected adult ART and pre-ART clients improve nutritional status, clinical outcomes, and drug adherence?

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FBF vs. No Food for HIV+ Adults: Design

• Randomized effectiveness trial.

• Implemented at 6 HIV treatment sites in Kenya by Kenya Medical Research Institute (KEMRI) .

• Non-pregnant ART adult clients with BMI < 18.5 kg/m2.

• Pre-ART adults clients taking cotrimoxazole with BMI < 18.5, or 18.5-20 with weight loss.

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FBF vs. No Food for HIV+ Adults: Design

6 months of 1,320 kcal/day fortified blended food (corn, soy, oil sugar, whey concentrate, MN) + nutrition counseling

OR nutrition

counseling alone

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Nutrition counseling

n=~315

ART Enrollment

n=~630

Randomization

FBF vs. No Food for HIV+ Adults: Design

300 g./day FBF +

counseling

n=~315

Nutrition counseling

n=~210

pre-ART Enrollment

n=~420

Randomization

300 g./day FBF +

counseling

n=~210

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CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children:

Research Question

How do CSB, milk-peanut RUTF, and soy-peanut RUTF compare in helping children recover from moderate acute malnutrition?

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CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children:

Design

• Randomized effectiveness trial.

• Children aged 12-59 months with -3 < WHZ < -2.

• 8 weeks of CSB or peanut-milk RUTF or soy-peanut RUTF.

• Implemented at 7 supplementary feeding sites in Malawi by Washington Univ. at St. Louis (Mark Manary, PI).

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75 kcal/kg/day CSB

n=~450

Enrollment

n=~1,350

Randomization

CSB vs. milk-RUTF vs. soy-RUTF: Design

75 kcal/kg/day soy-peanut

RUTF

n=~450

75 kcal/kg/day milk-peanut

RUTF

n=~450

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CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children:

Preliminary Results

• All groups had good recovery rates, with RUTF groups somewhat better

• Milk-peanut RUTF is 4X the cost of CSB and soy-peanut RUTF is 2X the cost of CSB

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Conclusions & Future Directions

• Need to balance effectiveness and cost-effectiveness.

• Program settings may matter in identifying most effective (and cost-effective) food products for a given target population, e.g. clinical vs. community setting.

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Conclusions & Future Directions

• Reports of CSB’s demise may be exaggerated: FBF products can help achieve nutrition objectives for some target groups.

• Need to adapt and enhance formulations of both types of products for specific target groups and objectives.

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(RUSF; RUFS; use soy instead of milk)

Conclusions & Future Directions

(enhanced FBFs)