preventing mtct in africa: using new paradigms - a dr besser presentation

Mitchell J. Besser, MDFounder and Medical Director

mothers2mothers

14 December 2010

mothers2mothers: Preventing Mother-to-Child HIV

Transmission in Africa Using New Paradigms in Health Care

Delivery

Population HIV Prevalence

0

10

20

30

Bo

tsw

an

a

Le

so

tho

So

uth

Afric

a

Za

mb

ia

Ma

law

i

Ke

ny

a

Ta

nza

nia

Ug

an

da

Rw

an

da

Eth

iop

ia

Co

te D

'Ivo

ire

Bu

rkin

a

Sie

rra L

eo

ne

Ca

me

roo

n

Gu

ine

a

Gh

an

a

Se

ne

ga

l

Ma

li

Ca

mb

od

ia

Ha

iti

DR

Pe

ru% Population

Zim

bab

we

So

uth

A

frica

Bo

tswan

a

Sen

egal M

ali

with high HIV prevalence:

ZimbabweSouth AfricaBotswana

with low HIV prevalence:MadagascarSenegalMali

Source: UN Department of Economic and Social Affairs (2001) World Population Prospects, the 2000 Revision.

30

35

40

45

50

55

60

65

Lif

e e

xp

ecta

ncy

(y

ears

)

1950– 1955

1955- 1960

1960-1965

1965-1970

1970-1975

1975-1980

1980-1985

1985-1990

1990-1995

1995-2000

2000-2005

Life Expectancy: 1950-2005

Grim RealityU

NA

IDS

: 20

10

FACTS:

• 2.6 million new HIV infections (2010)

• 1.8 million adults and children died of HIV/AIDS (2010)

• 1.2 million people started on treatment in 2010

Each year:►Twice as many people become infected with HIV as start on treatment;►Twice as many people die of AIDS as start on treatment.

Global HIV Prevalence

33.3 million living with HIV in 2010

Sub-Saharan Africa

22.4 million

90% of HIV-positive pregnant women are in Sub-Saharan Africa

1.4 million pregnant women in low- and middle-income countries are infected with HIV

Towards Universal Access, WHO, 2009

Grim Inequities

Prevalence in Pregnancy

Nigeria 2.4 - 4%

South Africa 29%

US and UK 0.6%

Adult Prevalence

Nigeria 3%

South Africa 18%

US and UK 0.3 - 0.6%

PMTCT Coverage

Nigeria 10%

South Africa 73%

US and UK > 95%

ARV Coverage (children)

Nigeria 12%

South Africa 61%

US and UK > 95%

Pediatric HIV infections in U.S.

80% decline

CDC

PACTG 076 – AZT treatment starts

Siripon Kanshana, 2007

Pediatric HIV infections in Thailand

80% decline

HIV testing PMTCT ARVs

National PMTCT program

UNAIDS estimates 2008

Pediatric HIV infections in World

1100 children infected per day in 2008

≈1000 in Africa

<1 in the US1 in Europe

100 in Asia & the Pacific

Annual pregnancies in HIV-positive women

United States (7000)

Rwanda (8000)

South Africa (300,000)

Baragwanath Hospital (8000)

(Soweto)

0

10

20

30

40

50

60

70

80

90

100

ANC clinic visits Accepting VCT Receive results HIV-positive NVP Mom NVP baby

PMTCT CascadePMTCT Cascade

Gap = Missed Opportunities

Reducing the Risk: Treatment

PMTCT TreatmentTransmission

Rate at 6 Weeks

No Treatment 25%

Single-dose Nevirapine (sdNVP) 12%

AZT (28 weeks) + sdNVP 3%

HAART 1%

Myth of the 80s

640

512

Enter into program

800

488 No Rx (25% MTCT):

122 infected

200

160

128

Missed - no PMTCT

Transmission rates:• NVP (12% MTCT): 61

infected• AZT+NVP (3% MTCT): 15 infected• HAART (1% MTCT): 5

infectedAdapted from P. Barker, IHI, WHO PMTCT Mtg Nov 2008, L Mofenson, 2009

Number of HIV+ babies:• NVP: 183• AZT+NVP: 137• HAART: 127

Attend ANC: 80%

Counseled and tested for HIV: 80%

Get ARVs: 80%

1000 positive mothers

Reality of the 80s

865

804

Enter into program

930

196 No Rx (25% MTCT):

49 infected

70

65

61

Missed - no PMTCT

Transmission rates:• NVP (12% MTCT): 96

infected• AZT+NVP (3% MTCT): 24 infected• HAART (1% MTCT): 8

infectedAdapted from P. Barker, IHI, WHO PMTCT Mtg Nov 2008, L Mofenson, 2009

Number of HIV+ babies:• NVP: 145• AZT+NVP: 73• HAART: 57

Attend ANC: 93%

Counseled and tested for HIV: 93%

Get ARVs: 93%

1000 positive mothers

HIV Infected Babies

Myth of the 80s

Reality of the 80s

NVP:

12%183 146

AZT+NVP:

3%137 73

HAART:

1%127 57

HIV Infected Babies

Myth of the 80s

Reality of the 80s

NVP:

12%183 146

AZT+NVP:

3%137 73

HAART:

1%127 57

Four Prongs of PMTCT

Prevention of unintended pregnancies among

HIV infected women

Preventing mother to child

transmission of HIV

Primary prevention of HIV infection in women

Provision of care and support for HIV

infected mothers, their infants, partners and families

Incident HIVIncident HIV

Challenges and Responses

Country Ratio Data Source

Ethiopia 6:1 DHS-05

Tanzania 3:1 AIS 03/04

Kenya 2:1 DHS-03

Uganda 2:1 AIS-04/5

Discordant/concordant

Couple Status – Discordance Predominates

Country …% Woman HIV + Data Source

Ethiopia 27% DHS-05

Tanzania 37% AIS 03/04

Uganda 55% AIS-04/5

Kenya 57% DHS-03

If man is HIV+ and in a couple…

Couple Status – Discordance Predominates

Incident HIV in pregnancy = new infections in women with a documented negative test in that pregnancy

Where effective interventions have reduced transmission in women identified as HIV-positive, new infections during pregnancy may be a major

source of MTCT.

MTCT rates associated with new infection to mother:• 70% during pregnancy and childbirth• 36% during breastfeeding

HIV Incidence in Pregnancy

T Creek, personal communication 2008

Impact of Incident HIV Infection in Pregnancy

A study in Botswana showed:

Among women testing negative in early pregnancy:

Botswana National PMTCT program transmission data show:

Extrapolating incident HIV to the national Botswana figures :

Incident HIV is thus estimated to account for 470/1090 (43%) of all infant infections in 2007

1.3% were infected in 17 weeks before

delivery

1.8% were infected in the first year after

delivery

13,900 HIV+ women infected estimated 620 infants (4.7%)

Estimate 950 women acquired HIV during pregnancy or first postpartum year, and infected 470 infants

Feeding the BabyFeeding the Baby

• Infant feeding is one of the most difficult and most emotive issues in HIV management in low-resource settings

• An estimated 300,000 children acquire infection through breast feeding each year

• HIV transmission in early childhood remains a challenge in places where infant formula cannot be safely provided

Infant feeding and HIV

Am J Epidem 1995

Timing of HIV Transmission (non Breastfeeding cohort)

Months

0

5

10

15

20

25

30

35

1 12 18

% H

IV

infe

cte

d

Transmission

Cumulative

4%4% Transmission of HIV for every Transmission of HIV for every 66 months of breast-feeding months of breast-feeding

6-3

Deli

very

Timing of HIV Transmission

Delivery

Infant Feeding and HIV Transmission

Infant Age

Coutsoudis,13th AIDS Conf, 2000

8% 7% 7%

19% 19%

26%

0

10

20

30

% T

ran

smis

sio

n

1 Day 6 Mos

Never Breastfed (N=157)Exclusive Breastfed (N=118)Mixed Feeding (N=276)

35.1% 35.1% 29.9%

18.0%

35.2%

11.9%

0%

20%

40%

60%

80%

100%

% E

xclu

sive

BF

Uganda (J Trop Ped

2004)

Kenya (JAIDS2004)

S Africa (AIDS 2001)

Botswana (CROI 2005)

Ivory Coast (AIDS Conf

2004)

Zimbabwe(AIDS Conf

2004)

Exclusive Breastfeeding in HIV+ Women in Clinical Trials in Resource-Poor Countries

Requirements for safe replacement feeding

Assessment should also include:

• Health service accessibility• Counselling and support

available

Is replacement feeding…

…for the mother and baby

Henderson, WHO, 2006

A cceptableF easibleA ffordableS ustainable S afe

Feeding Method - Issues

• Clean water – “tap”

• Clean bottles – “flame” or “electric”

• Source of formula– Free– Accessible

• Disclosure

HIV Infection through Age 7 Months is Higher in Breast Fed than Formula Fed Infants

5.0% 4.6% 5.6%

9.1%

0%

10%

20%

% H

IV

Tra

ns

mis

sio

n

1 Month 7 Months

Infant age

Formula Breast

p=0.04

Thior I et al. JAMA 2006;296:794-805

7 Months

Mortality through Age 7 Months is Higher in Formula Fed than Breast Fed Infants

4.3%1.5%

9.3%

4.9%

0%

10%

20%

% M

ort

ali

ty

1 Month 7 MonthsInfant age

Formula Breast

p=0.004

Predominant causes infant death:Diarrheal disease and pneumonia

7 Months

No Difference in 18-Month HIV-Free Survival

Between Formula Fed and Breast Fed Infants

8.9%6.1%

12.6% 12.9% 14.2%15.6%

0%

10%

20%

30%

% H

IV-F

ree

Su

rviv

al

1 Month 7 Months 18 Months

Infant age

Formula Breast

p=0.41

Thior I et al. JAMA 2006;296:794-805

18 Months

No Difference in 18-Month HIV-Free Survival

Between Formula Fed and Breast Fed Infants

8.9%6.1%

12.6% 12.9% 14.2%15.6%

0%

10%

20%

30%

% H

IV-F

ree

Su

rviv

al

1 Month 7 Months 18 Months

Infant age

Formula Breast

p=0.41

Thior I et al. JAMA 2006;296:794-805

18 Months

FF: 33 infected, 46 deathsBF: 54 infected, 34 deaths

BAN: Probability HIV positive or death by week 28 visit in infants uninfected at birth

Age (weeks)

Pro

babi

lity

HIV

pos

itive

or

deat

h

1 4 8 12 16 20 24 28

0.00

0.02

0.04

0.06

0.08 Control vs Maternal HAART: p= 0.03

7.6%

4.7%

2.9%

Control – No ARVs

Maternal HAART

Infant NVP

BAN Study: Probability of HIV+ or Death by 28 week visit in infants uninfected at birth

BAN: Probability HIV positive or death by week 28 visit in infants uninfected at birth

Age (weeks)

Pro

babi

lity

HIV

pos

itive

or

deat

h

1 4 8 12 16 20 24 28

0.00

0.02

0.04

0.06

0.08 Control vs Maternal HAART: p= 0.03

7.6%

4.7%

2.9%

Control – No ARVs

Maternal HAART

Infant NVP

BAN Study: Probability of HIV+ or Death by 28 week visit in infants uninfected at birth

7.6%

4.7%

BAN: Probability HIV positive or death by week 28 visit in infants uninfected at birth

Age (weeks)

Pro

babi

lity

HIV

pos

itive

or

deat

h

1 4 8 12 16 20 24 28

0.00

0.02

0.04

0.06

0.08 Control vs Infant NVP: p <0.0001

7.6%

4.7%

2.9%

Control – No ARVs

Maternal HAART

Infant NVP

BAN Study: Probability of HIV+ or Death by 28 week visit in infants uninfected at birth

7.6%

2.9%

BAN: Probability HIV positive or death by week 28 visit in infants uninfected at birth

Age (weeks)

Pro

babi

lity

HIV

pos

itive

or

deat

h

1 4 8 12 16 20 24 28

0.00

0.02

0.04

0.06

0.08 Maternal HAART vs Infant NVP: p= 0.07

7.6%

4.7%

2.9%

Control – No ARVs

Maternal HAART

Infant NVP

BAN Study: Probability of HIV+ or Death by 28 week visit in infants uninfected at birth

4.7%

2.9%

Integrating HIV into the push for MDGs 4 & 5

GOAL 4: REDUCE CHILD MORTALITY

GOAL 5: IMPROVE MATERNAL HEALTH

GOAL 6: COMBAT HIV/AIDS, MALARIA & OTHER DISEASES Target 1: Have halted by 2015 and begun to reverse the spread of HIV/AIDS

Target 2:Achieve, by 2010, universal access to treatment for HIV/AIDS for all those who need it

Target 1: Reduce by two thirds, between 1990 and 2015, the under-five mortality rate

Target 1: Reduce by three quarters the maternal mortality ratio

Target 2:Achieve universal access to reproductive health

H

IV /

AID

S

Magical Magical ThinkingThinking

Health Systems

Global HIV Prevalence

Doctors Working in the World

Sub-Saharan Africa:

25% of global disease burden

3% of world’s health workers

Health care workers per 100,000 population (2007)

Region/Country Physicians Nurses

United States 256 937

South Africa 77 408

Botswana 40 265

Zambia 12 174

Zimbabwe 16 72

Lesotho 5 62

Mozambique 3 21http://www.hst.org.za/uploads/files/cahp9_07.pdf

Staffing Ratios

Health care workers per 100,000 population (2007)

Region/Country Physicians Nurses

United States 256 937

South Africa 77 408

Botswana 40 265

Zambia 12 174

Zimbabwe 16 72

Lesotho 5 62

Mozambique 3 21http://www.hst.org.za/uploads/files/cahp9_07.pdf

Staffing Ratios

SA Population (2009): 49 million

population dependent on public health sector

health professionals in public sector

85% 44%

10%

vacant posts in public

health sector

Doctors

Nurses36%

34%30%

Has only minutes per

patient

1) Counsel for HIV test 2) Perform HIV test, explain results3) Dispense single dose nevirapine,4) Explain how to take5) Discuss infant feeding options6) Reinforce exclusive infant feeding7) Perform infant HIV test at 12-months, 8) Explain results

PMTCT Program Interventions:

In 2001…

Transmission Rates: 14-16%

Nurse:

Still has only minutes per

patient

1) Counsel for HIV test 2) Perform HIV test, explain results3) Perform CD4 test, get and explain results. Refer for HAART if CD4<3504) Dispense cotrimoxazole5) Discuss infant feeding options6) Dispense AZT (from 14 weeks), explain how to take7) Dispense HAART (if eligible), explain how to take8) Counsel on adherence to HAART

9) Screen for HAART related toxicity 10) Reinforce exclusive infant feeding 11) Where ARVS for breast feeding are

available, explain how to use 12) Perform infant HIV test at 6

weeks, 13) Explain results 14) Refer mother to follow-up care,

15) Encourage her to attend 16) RH/FP

PMTCT Program Interventions:

In 2010…

Transmission Rates: 2-5%

Nurse:

...

mothers2mothers

• Individual and group meetings

• Daily presence for education and support

• Mentor Mothers: professional members of health care team - paid for service

Mothers are a community’s single greatest resource

Mothers living with HIV (Mentor Mothers) educate and support HIV-positive pregnant women and new mothers in health facilities

Simple, scale-able model of careSimple, scale-able model of care

Goal 3. Empowerment

Goal 2. Healthy mothers

and infants

Threem2m goals:

Goal 1. PMTCT

Site Coordinators and Mentor Mothers

• Recruited locally

• Selection Criteria: Mothers HIV-positive Attended PMTCT Disclosed

• Basic numeracy and literacy skills

• Site Coordinators manage services

• Mentor Mothers engaged for up to two years

• Curriculum based education• 2 weeks - Mentor Mothers • 3 weeks - Site Coordinators• Periodic top-up training

Training

Training Cascade:National Trainer Site Coordinator / Mentor Mother Patients

Points of ServicePoints of Service

• Prenatal clinics• Labor and delivery• Postnatal programs• Targeted community outreach

m2m services

task-shifting

m2m Services

• Counsel for, or perform HIV testing• Provide medication• Distribute formula

• Support medical services that do

m2m Does:

m2m Does Not:

Site Management Plan

MM MM

MM

MM

SC

MM

SC

Tertiary Care

Hospital

Primary Health Center

Site Systems

Regional or District Program Manager

SC = Site CoordinatorMM = Mentor Mother

Community Outreach

Community Outreach Community Outreach

Satellite Health Centres

Hospital or Major HC

Site System

Research Questions

Does mothers2mothers:

• Increase HIV-positive women’s utilization of PMTCT services?

• Improve PMTCT outcomes and psychosocial well-being?

Population Council: Horizons Study (2007)

• PMTCT– 95% of mothers received nevirapine– 88% of babies received nevirapine

• Care– 79% had CD4 counts– 88% knew CD4 count results

• Infant Feeding– 89% chose exclusive infant feeding method

• Family Planning– 70% using contraception

• Disclosure – 97% disclosed (4.4x non-participants)

Population Council: Horizons Study (2007)

• Pregnant women felt they could:– Do things to help themselves – Cope with taking care of baby– Live positively

• Postpartum women felt less:– Alone in the world– Overwhelmed by problems– Hopeless about future

Program Participants Report Better Psychosocial Well-Being

Population Council: Horizons Study (2007)

m2m Outcomes – Lesotho (2010)

• Program started 2007– 58 program sites

• 64% m2m country coverage • 77% disclosure rates among clients attending

>3 times• 79% early infant diagnosis

CD4 and HAART uptake among m2m antenatal clients (N=1246)

Antenatal m2m clients

CD4 Tests

CD4 Results

CD4 <350

HAART

CD4 and HAART uptake among m2m antenatal clients by number of visits (N=1246)

“Standard” intervention

Clinic based care only

•Improved education on importance of early infant HIV testing•Use of m2m wheel to estimate date of return visit•Client information sheet – date and location of baby HIV test

“Enhanced” intervention

Clinic based care + active client follow-up

•8 week telephone call •10 week call + home visit if needed

Early Baby Testing Study

Baby HIV Testing Tool

Baby HIV Test Card

Resources Developed for StudyResources Developed for Study

“Standard” intervention

Clinic based care only

•Improved education on importance of early infant HIV testing•Use of m2m wheel to estimate date of return visit•Client information sheet – date and location of baby HIV test

“Enhanced” intervention

Clinic based care + active client follow-up

•8 week telephone call •10 week call + home visit if needed

Early Baby Testing Study

Cellphone Subscribers - 2009

North America: 276m

Africa: 358m

Non-ACFU Sitesn = 204

ACFU Sitesn=214

Eligible 8 week callYes =179 (84%), No =35 (16%)

Eligible 10 week call & home visit Yes =53 (32%), No =114 (68%)

* Of 167 consenting for home visit

10 week home visitReached =24 (45%)

Not Reached = 22 (42%)Excluded/too far = 7 (13%)

Early Infant Diagnosis StudyEarly Infant Diagnosis Study

Non-ACFU Sitesn = 204

ACFU Sitesn=214

Eligible 8 week callYes =179 (84%), No =35 (16%)

Eligible 10 week call & home visit Yes =53 (32%), No =114 (68%)

* Of 167 consenting for home visit

10 week home visitReached =24 (45%)

Not Reached = 22 (42%)Excluded/too far = 7 (13%)

Early Infant Diagnosis StudyEarly Infant Diagnosis Study

60% reached by phone (108)

Non-ACFU Sitesn = 204

ACFU Sitesn=214

Eligible 8 week callYes =179 (84%), No =35 (16%)

Eligible 10 week call & home visit Yes =53 (32%), No =114 (68%)

* Of 167 consenting for home visit

10 week home visitReached =24 (45%)

Not Reached = 22 (42%)Excluded/too far = 7 (13%)

Early Infant Diagnosis StudyEarly Infant Diagnosis Study

Non-ACFU Sitesn = 204

ACFU Sitesn=214

Eligible 8 week callYes =179 (84%), No =35 (16%)

Eligible 10 week call & home visit Yes =53 (32%), No =114 (68%)

* Of 167 consenting for home visit

10 week home visitReached =24 (45%)

Not Reached = 22 (42%)Excluded/too far = 7 (13%)

Early Infant Diagnosis StudyEarly Infant Diagnosis Study

Non-ACFU Sitesn = 204

ACFU Sitesn=214

Eligible 8 week callYes =179 (84%), No =35 (16%)

Eligible 10 week call & home visit Yes =53 (32%), No =114 (68%)

* Of 167 consenting for home visit

10 week home visitReached =24 (45%)

Not Reached = 22 (42%)Excluded/too far = 7 (13%)

Early Infant Diagnosis StudyEarly Infant Diagnosis Study

11% of total (214) reached by home visit

Early Infant Diagnosis StudyEarly Infant Diagnosis Study

(N = 55,13) (N = 115,167)

p < 0.01

Early Infant Diagnosis StudyEarly Infant Diagnosis Study

(N = 55,13) (N = 115,167)

p < 0.01

Early Infant Diagnosis StudyEarly Infant Diagnosis Study

(N = 55,13) (N = 115,167)

* Of those with known test results

mothers & babies

communities

healthcare systems

Demand and Supply Side:

South Africa

M2M2B - 2001M2M2B - 2001

South Africa

Malawi

Ethiopia

Kenya

Rwanda

Zambia

Swaziland

Lesotho

Botswana

Uganda

Mozambique ???

Tanzania

m2m 2010

84

mm22mm Today Today

Total HIV-positive pregnant women enrolled:

20% of the global disease burden

mm22mm Activities 2010 Activities 2010

Current Date Nov-10Sites 703Field Staff 1766Patient Encounters Per Month 267,103

New HIV-positive Women Per Month 22,111

Helping MothersSaving Babies