Washington D.C., USA, 22-27 July 2012www.aids2012.org

Field experiences in scaling-up promotion of exclusive breastfeeding in the context of HIV

Prof. Thorkild TylleskärCentre for International Health,

University of Bergen

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Why is breast milk infective?

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Danger

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

BurkinaFaso

Zambia

Uganda

South Africa

West Africa

East

Afri

caCentralAfrica

SouthernAfrica

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Burkina Faso Uganda

S. Africa ZambiaNov 2007 – Feb 2008

Washington D.C., USA, 22-27 July 2012www.aids2012.org

InterventionPeer-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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Intervention and data collection visits

Birth 2w 4w 6w 8w 10 12 14 16 18 20 22 24

Recruitment Intervention5 visits

Data collection 3, 6, 12, 24 wks

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Inclusion criteria

Mother:• Intending to

BF• No intention to

move in the follow-up period

• Consenting

Infant:• Singleton• Above 2 kg• No malformation

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Electronic data collection used in Uganda, Zambia, Burkina Faso

www.openxdata.org

Washington D.C., USA, 22-27 July 2012www.aids2012.orgopenXdata.org

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Analysis

• Country-specific outcomes

• Adjustment for cluster effect

• Intention-to-treat analysis (ITT)

• Outcome based on – 24-h recall and – 7-day recall

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Burkina Faso

24 clusters

894 women

Uganda

24 clusters

863 women

South Africa

34 clusters

1148 women

I

453

I

359

Randomised

3 mo follow-up

C

441

C

368

I

442

I

370

C

421

C

322

I

598

I

447

C

550

C

399

Participants

Washington D.C., USA, 22-27 July 2012www.aids2012.org

I C I C I C

Maternal age Median (± IQR) 25 (10) 25 (10) 25 (9) 24 (10) 23 (9) 23 (9)

Education years (± IQR) 0 (0) 0 (0) 6 (4) 6 (4) 10 (3) 10 (3)

Monthly income Euros (± IQR) 3 (6) 3 (5) 14 (22) 12 (19) 97 (93) 101 (94)

% % % % % %

Married 86 88 61 63 26 26

First child 18 16 22 24 48 51

ANC Attendance 71 71 71 76 99 98

Birth outside facility 62 65 55 42 6 8

Electricity 4 1 15 18 74 91

Thatched roof 58 52 12 13 15 12

No toilet or open toilet 98 98 25 18 31 16

Surface water as only water source 28 38 30 23 25 23

Wood only as cooking fuel 99 99 51 48 22 14

Burkina Faso Uganda South Africa

Baseline characteristics

Washington D.C., USA, 22-27 July 2012www.aids2012.org

EBF at 12 weeksby 24 hours recall

0

10

20

30

40

50

60

70

80

90

100

Burkina Faso Uganda South Africa

I C I CI C

(%)

2.1** 1.9** 1.8**

Burkina Faso Uganda South Africa

** p<0.01

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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)

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Washington D.C., USA, 22-27 July 2012www.aids2012.org

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

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

Washington D.C., USA, 22-27 July 2012www.aids2012.org

PROMISE EBF• 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, Jeremi Rouamba, 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, Chafye Siuluta, Seter Siziya

• South Africa: Debra Jackson, Mickey Chopra, Mark Colvin, Tanya Doherty, Ameena E Googa, Lyness Matizirofa, Lungiswa Nkonki, David Sanders, Wanga Zembe

• European Union 6th Framework Programme • Research Council of Norway• Sida/Sarec, Sweden• Medical Research Council, South Africa

Funding:

Washington D.C., USA, 22-27 July 2012www.aids2012.org