Tony Castleman International Food Aid Conference April 15, 2008

1. Impacts of Specialized Food Products on HIV-infected Adults and Malnourished Children: Emerging Evidence from Randomized Trials Tony Castleman International Food Aid Conference April 15, 2008

2. Outline • Background 2. CSB vs. RUFS for Adult ART Clients in Malawi 3. FBF vs. No Food for HIV+ Adults in Kenya • CSB vs. milk-peanut RUTF vs. soy-peanut RUTF for children with moderate acute malnutrition in Malawi 5. Conclusions and Future Directions

3. 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.

4. 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

5. 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

6. 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?

7. 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).

8. CSB vs. RUFS for Adult ART Clients:Design Enrollment n=491 Randomization 374 g./day CSB (1,360 kcal/day)for 3.5 months n=246 260 g./day RUFS (1,360 kcal/day) for 3.5 months n=245

9. CSB vs. RUFS for Adult ART Clients: Results

10. CSB vs. RUFS for Adult ART Clients: Results

11. 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.

12. 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)

13. 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?

14. 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.

15. 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

16. FBF vs. No Food for HIV+ Adults: Design ART Enrollment n=~630 pre-ART Enrollment n=~420 Randomization Randomization Nutrition counseling n=~315 300 g./day FBF + counseling n=~315 Nutrition counseling n=~210 300 g./day FBF + counseling n=~210

17. 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?

18. 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).

19. CSB vs. milk-RUTF vs. soy-RUTF: Design Enrollment n=~1,350 Randomization 75 kcal/kg/day milk-peanut RUTF n=~450 75 kcal/kg/day soy-peanut RUTF n=~450 75 kcal/kg/day CSB n=~450

20. 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

21. 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.

22. 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.

23. Conclusions & Future Directions (RUSF; RUFS; use soy instead of milk) (enhanced FBFs)