Prof. Thorkild Tylleskär Centre for International Health, University of Bergen

1. Field experiences in scaling-up promotion of exclusive breastfeeding in the context of HIV Prof. Thorkild Tylleskär Centre for International Health, University of Bergen

2. Exclusive breastfeeding (EBF) • Advised up to 6 months of age • Beneficial for all children (exposed and unexposed) • Cuts mother-to-child transmission to half • Promotion must be carried out in the general population • would fail if only promoted among HIV+ women

3. Why is breast milk infective?

4. Danger

5. Tylleskar et al. Lancet 2011;378:420-27 + webappendix

6. PROMISE EBF • Promoting infant health and nutrition in Sub-Saharan Africa: Safety and efficacy of exclusive breastfeeding promotion in the era of HIV • Clinicaltrials.gov: NCT00397150 Objective: To assess in a cluster-randomised trial: • the impact of peer-counselling on exclusive breastfeeding rates at 3 months of age • Data collection 2006-2008

7. Burkina Faso Uganda Zambia South Africa West Africa Central Africa East Africa Southern Africa

8. Burkina Faso Uganda Nov 2007 – Feb 2008 S. Africa Zambia

9. Peer-counsellors were: Women recruited from the clusters Trained as peer-counsellors for 1-week according to WHO IYCF course 2005 Unaware of the woman’s HIV status Regularly supervised by skilled staff Paid 10% of a teacher’s salary Task: Breastfeeding support to pregnant and lactating mothers in her own cluster Intervention

10. Intervention and data collection visits Recruitment Intervention 5 visits Data collection 3, 6, 12, 24 wks Birth 2w 4w 6w 8w 10 12 14 16 18 20 22 24

11. Mother: Intending to BF No intention to move in the follow-up period Consenting Infant: Singleton Above 2 kg No malformation Inclusion criteria

12. Electronic data collection used in Uganda, Zambia, Burkina Faso www.openxdata.org

13. openXdata.org

14. Analysis • Country-specificoutcomes • Adjustment for clustereffect • Intention-to-treatanalysis (ITT) • Outcomebasedon • 24-h recall and • 7-day recall

15. Participants Burkina Faso 24 clusters 894 women Uganda 24 clusters 863 women South Africa 34 clusters 1148 women I 453 C 441 I 442 C 421 I 598 C 550 Randomised I 359 C 368 I 370 C 322 I 447 C 399 3 mo follow-up

16. Baseline characteristics Burkina Faso Uganda South Africa

17. 2.1** 1.9** 1.8** EBF at 12 weeksby 24 hours recall (%) Burkina Faso Uganda South Africa I C I C I C ** p<0.01

18. Conclusions • Peer-counselling for EBF increases EBF rates at 3 months 2-fold depending on the local context • Large country differences in • Baseline characteristics • Baseline EBF rates • South Africa is a case of its own (Nor B, et al. J Hum Lact 2009)

19. Post-hoc reflections • Complementary feeding needs to be included • Individual or group counselling? Home-based or facility-based? • BF alone or combined with other interventions? • Focus on early BF and initiation • Most important to be exclusive in the beginning • Golden opportunity for closer integration between HIV-care and maternal, newborn and child care

20. Victora et al. Lancet 2008; 371: 340–57webappendix

21. Post-hoc reflections • Complementary feeding needs to be included • Individual or group counselling? Home-based or facility-based? • BF alone or combined with other interventions? • Focus on early BF and initiation • Most important to be exclusive in the beginning • Golden opportunity for closer integration between HIV-care and maternal, newborn and child care

24. Post-hoc reflections • Complementary feeding needs to be included • Individual or group counselling? Home-based or facility-based? • BF alone or combined with other interventions? • Focus on early BF and initiation • Most important to be exclusive in the beginning • Golden opportunity for closer integration between HIV-care and maternal, newborn and child care

25. PROMISE PEP (ANRS 12174) • BF advice is not enough to protect the child • A randomised controlled trial comparing the efficacy of infant peri-exposure prophylaxis with lopinavir/ritonavir (LPV/r) versus lamivudine to prevent HIV-1 transmission by breastfeeding • Clinicaltrials.gov registration # NCT00640263

26. Steering Committee: Thorkild Tylleskär, Philippe Van de Perre, Eva-Charlotte Ekström, Nicolas Meda, James K. Tumwine, Chipepo Kankasa, Debra Jackson Norway: Thorkild Tylleskär, Ingunn MS Engebretsen, Lars Thore Fadnes, Eli Fjeld, Knut Fylkesnes, Jørn Klungsøyr, Anne Nordrehaug-Åstrøm, Øystein Evjen Olsen, Bjarne Robberstad, Halvor Sommerfelt France: Philippe Van de Perre Sweden: Eva-Charlotte Ekström, Barni Nor Burkina Faso: Nicolas Meda, Hama Diallo, Thomas Ouedrago, JeremiRouamba, Bernadette Traoré Germain Traoré, Emmanuel Zabsonré Uganda: James K. Tumwine, Caleb Bwengye, Charles Karamagi, Victoria Nankabirwa, Jolly Nankunda, Grace Ndeezi, Margaret Wandera Zambia: Chipepo Kankasa, Mary Katepa-Bwalya, ChafyeSiuluta, SeterSiziya South Africa: Debra Jackson, Mickey Chopra, Mark Colvin, Tanya Doherty, Ameena E Googa, LynessMatizirofa, Lungiswa Nkonki, David Sanders, WangaZembe PROMISE EBF Funding: • European Union 6th Framework Programme • Research Council of Norway • Sida/Sarec, Sweden • Medical Research Council, South Africa