Project HEART- Overview

Stephen LEE. MDElizabeth Glaser Pediatric AIDS Foundation

presenting for the Project HEART Team

The Elizabeth Glaser Pediatric AIDS Foundation

Our Mission

The Elizabeth Glaser Pediatric AIDS Foundation seeks to prevent pediatric HIV infection and to eradicate pediatric AIDS through research, advocacy, and prevention and treatment programs

Program Overview

• USAID funded PMTCT CTA program initiated in 2002

• CDC funded Project HEART care and treatment initiated in 2004

• Five countries, low-to-middle income, Sub-Saharan Africa- Côte d’Ivoire, South Africa, Zambia, Tanzania

- Mozambique added in Year Three

• Goal for PY4: 166, 220 patients on ART by Feb 23, 2008• 85% of the target has been reached

• Total number ever enrolled into care as of June 30, 2007 246,558 adults, 23,091 children

• Total number ever enrolled into ART program as of June 30, 2007 142,249 adults, 11,525 children

Project HEART supports activities in five countries

Côte d’Ivoire

Mozambique

South Africa

Tanzania

Zambia

Côte d’Ivoire

Zambia

Tanzania

South Africa

Mozambique

Countries Involved in Project HEART

Project HEART Framework

• Comprehensive approach:– Local Leadership– Standard Operating Procedures– Human Resources– Physical Infrastructure– Training– Drug and Health Commodities Management– Laboratory Services– Monitoring and Evaluation– Community Services– Linkages of HIV Programs– Integration in PHC system– HIV Prevention

Côte d’Ivoire EGPAF-Supported Sites

Number of active ART sites in June 2007 = 77

Zambia EGPAF-Supported Sites

Number of active ART sites in June 2007 = 40

Tanzania EGPAF-Supported Sites

Number of active ART sites in June 2007 =38

South Africa EGPAF-Supported Sites

Number of active ART sites in June 2007 = 11

Mozambique EGPAF-Supported Sites

Number of active ART sites in June 2007 = 17

Project HEART: Patient Enrollment1

269,649

226,227

189,820

167,401

134,426117,996

96,37079,706

41,88531,337

15,039

142,249

20,84936,712

45,56157,882 68,536

86,69697,870

117,203

0

50,000

100,000

150,000

200,000

250,000

300,000

Q1-05 Q2-05 Q3-05 Q4-05 Q1-06 Q2-06 Q3-06 Q4-06 Q1-07 Q2-07

Cumulative Number on HIV Care

Cumulative Number on ART

30

36

56

73

92

94

119

144

163

183

1. CUMULATIVE data by June 30, 2007

2. Boxed numbers indicate the number of active sites each quarter

1. Number of patients living with HIV, ever enrolled in long-term clinical care and support programs.2. Of those enrolled, number of patients started on ARV therapy.

CUMULATIVE data from March 1, 2004 through June 30, 2007

Project HEARTCumulative Patient Enrollment

Country

HIV Palliative Care1 Antiretroviral Treatment2

Children Adults Total Children Adults Total

Zambia 7,453 (7%) 98,749 106,202 4,570 (7%) 61,532 66,102

Cote d'Ivoire 7,537 (9%) 81,437 88,974 2,322 (6%) 38,225 40,547

South Africa 3,978 (12%) 28,621 32,599 2,978 (17%) 14,320 17,298

Tanzania 3,463 (12%) 26,751 30,214 1,477 (10%) 13,016 14,493

Mozambique 660 (6%) 11,000 11,660 178 (5%) 3,631 3,809

Total 23,091 (9%) 246,558 269,649 11,525 (8%) 130,724 142,249

Project HEART Current Patient Enrollment

All patients CURRENTLY on care and treatment on June 30, 2007

Country

HIV Palliative Care1 Antiretroviral Therapy2

Children Adults Total Children Adults Total

Zambia 5,814 ( 7%) 77,602 83,416 3,885 (7%) 50,070 53,955

Cote d'Ivoire 1,972 ( 6%) 29,832 31,804 1,554 (6%) 25,324 26,878

South Africa 3,015 ( 18%) 13,893 16,908 2,628 (20%) 10,778 13,406

Tanzania 2,584 (11% ) 20,142 22,726 1,184 (10%) 10,484 11,668

Mozambique 599 ( 6%) 9,629 10,228 155 (5%) 3,165 3,320

Total 13,984 (9% ) 151,098 165,082 9,406 (9%) 99,821 109,227

1. Number of HIV-positive patients who received care anytime during April 1st-June 30th 2007.

2. Number of patients on Treatment on June 30th 2007.

One-Year Patients Retention on ART 07/01/06 – 06/30/07

CountryPts on ART as of 7-01-06

Pts Enrolled on ART, 7-01-06 to 6-30-07

Pts No Longer on ART 7-01-06 to 6-30-07

Pts on ART as of 6-30-07

ART Retention

Rate 7-01-06 to 6-30-07

Number of sites 7-01-06

Number of sites 6-30-07

  (1) (2) (3) (4) (5) (6) (7)

Cote d'Ivoire

18,234 16,750 8,106 26,878 77% 28 77

South Africa

3,921 12,059 2,574 13,406 84% 10 11

Tanzania 3,720 9,633 1,685 11,668 87% 18 38

Zambia 30,619 34,165 10,829 53,955 83% 28 40

Total 56,494 72,607 23,194 105,907 82.% 84 166

Total Attrition

25.3%

19.7%

9.1%

26.1%

33.1%

18.0%14.6% 14.5%

25.7%

33.8%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

Zambia South Africa Mozambique

Children (0-14 years) Adults (15 years or more)

% of patients who ever started ART at a facility who were not on ART at the end of June 2007

Reasons for Attrition

Country Stopped Transferred out

Died Lost to FU Unknown

Zambia 4% 36% 28% 16% 16%

Côte d’Ivoire 2% 8% 17% 52% 21%

South Africa 7% 55% 21% 9% 8%

Tanzania 3% 30% 37% 29% 2%

Mozambique 7% 13% 21% 30% 29%

Total 4% 18% 14% 9% 9%

Change in Median CD4 Count 6-Month Cohort

12795

149129

271

141

261285

0

50

100

150

200

250

300

350

Cote d'Ivoire South Africa Tanzania Zambia

CD

4 co

un

t ce

ll/m

m3

CD4 at baseline CD4 at 6 months

Change in Median CD4 Count 12-Month Cohort

107 94 98120

300

238

148

319

0

50

100

150

200

250

300

350

400

Cote d'Ivoire South Africa Tanzania Zambia

CD

4 co

un

t ce

ll/m

m3

CD4 at baseline CD4 count at 12 months

Outcomes after 1 year of ART:Côte d’Ivoire

• Retrospective cohort of 10,211 patients on ART at 19 sites in Côte d’Ivoire (2004-2007)

• First line ARV– ZDV/3TC/EFV (20%)

– d4T/3TC/ EFV (22%) – d4T/3TC/NVP (53%)

• Median baseline CD4: 123/mm3

• Outcome at 12 months – Loss to follow up: 10% – Death rate: 13%– Median time to death: 1.9 month– Survival rate: 77%- 94%

ACONDA/ISPED

Pediatric Outcomes after 1 year of ART: South Africa

• Retrospective Cohort of 151 children on ART in McCord Hospital, South Africa (2003-2005)

• Median age: 6 years (Range: 0.3-15)• Median follow-up time: 8 months (3.5-13.5)• Treatment: ARV/CTX• Outcome at 12 month

– Median gain in CD4%: 16% (IQR 9.6-20.3)– 12 month survival: 91% (IQR 84.8-94.6)

MCCord Hospital: BMC Pediatrics 2007, 7:13

Number of EGPAF PMTCT sites,Project HEART countries (2004-2007)

0

50

100

150

200

250

300

350

400

450

Ju

n-0

4

Au

g-0

4

Oct-

04

Dec-0

4

Feb

-05

Ap

r-05

Ju

n-0

5

Au

g-0

5

Oct-

05

Dec-0

5

Feb

-06

Ap

r-06

Ju

n-0

6

Au

g-0

6

Oct-

06

Dec-0

6

Feb

-07

Ap

r-07

Ju

n-0

7

Cote d'Ivoire

Mozambique

South Africa

Tanzania

Zambia

EGPAF PMTCT sites: Project HEART countries(Uptake %, counseling, testing, results; HIV+ among tested)

0

200000

400000

600000

800000

1000000

1200000

Eligiblewomen

Counseled Tested Results HIV+

Cumulative July 05 - June 06 July 06 - June 07

105%

101%

108%

81%

77%

84%

97%

98%

98%

16%

12%12%

EGPAF PMTCT sites: Project HEART countries(HIV+, uptake %, Women and Infant ARV)

0

20000

40000

60000

80000

100000

120000

140000

160000

HIV+ Women ARV Infant ARV

Cumulative July 05 - June 06 July 06 - June 07

Integration of HIV/TB

• Training of facility health care providers • HIV testing for patients with TB: Côte d’Ivoire

41%; South Africa: 80% • TB screening for HIV-infected patients on

ART: South Africa: 80%• ART to HIV-infected patients with TB• Effective integration remains a challenge due

to increased work load and limited TB lab capacity

Infrastructure, Systems Support Technical Assistance

• Infrastructure– Renovation of health facilities– Upgrade of laboratories, pharmacies

• Human resources– Training, mentoring, supportive supervision– FTE staff, Salary supplement

• Technical assistance– Program management– Review of national guidelines– M&E system development – Quality management– PHE/Operations research

Country

HCW Trained in ARTHCW Trained in

non-ART

Physicians Nurses Other Total Total

Zambia 331 3781 1839 5951 571

Côte d'Ivoire 334 19 83 436 179

South Africa 380 190 436 1006 859

Tanzania 293 280 89 662 21

Mozambique* NA NA 92 92 85

Total 1338 4270 2539 8147 1715

Trained Health Care Workers

Cumulative from October 1, 2005 - June 30, 2007

*Mozambique training data includes data from July 1, 2006-June 30, 2007

Major Achievements

• Strong commitment to working within national guidelines

• Comprehensive care and treatment in all countries

• In-country partnerships are contributing to national programs

• Targets met and exceeded

• Strong in-country teams

Major Challenges

• Inadequate public health infrastructure • Limited trained Human Resource• Vast territory e.g. Tanzania, Côte d’Ivoire, Mozambique• Difficult terrain with poor access• Potential for civil unrest• Occasional drug and laboratory supply stock-outs• Limited basic laboratory screening and follow-up of

patients; reagent supplies• Pediatric enrollment into care and treatment programs• Integration with PMTCT, TB, MCH programs

Sustainability Plan

• Leadership role in country• Close collaboration with host government• Progressive integration of program into

primary health care system• Staff training and mentoring• Development of sub-grantees capacity • Graduation of experienced sites

– Ex Côte d’Ivoire ACONDA

Future Goals

• Increase the number of children enrolled in care and treatment programs

• Improve laboratory system

• Improve quality of services

• Strengthen the Continuum of Care

• Public health evaluation/operations research

• Documentation of lessons learned

CÔTE D’IVOIRE• Xavier Anglaret• Francois Dabis• Joseph Essombo• Catherine Seyler • Anthony Tanoh• Siaka Toure

EGPAF• Georgette Adjorlolo-Johnson• Agbessi Amouzou• Nicole Buono• Charlotte Colvin• Elizabeth Flanagan• Christophe Grundmann• Smita Kumar• Richard Marlink• Rose McCullough• Lulu Oguda• Sara Paque-Margolis• Allison Spensley• Andrea Wahl• Cathy Wilfert• Lee Yerkes

SOUTH AFRICA• Janet Giddy• Helga Holst• Hitesh Hurkchand• Shanila Maharaj • Tshiwela Neluheni• Okey Nwanyanwu• Celicia Serenata

TANZANIA• Christy Gavitt• Anja Giphart• Werner Schimana• Mark Swai• Denis Tindyebwa• Stefan Wiktor

ZAMBIA• Carolyn Bolton• Marc Bulterys• Deborah Conner• Stewart Reid• Moses Sinkala• Elizabeth Stringer• Jefferey Stringer

PARTNERS

Baylor• Nancy Calles• Mark Kline

John Snow International

• Muka Chikuba• Mike Farabaugh• Andrew Fullum• Lisa Hirschhorn• Vince Masi

University of CA, San Francisco

• John Friend• Diane Havlir• Catherine Lyons

USG• Tedd Ellerbrock• Louise Perry• Vivian Walker• Bud Bowen• CDC Staff in Côte d’Ivoire Mozambique, South Africa Tanzania, Zambia

Acknowledgements

This presentation was made possible through support provided by the U.S. Centers for Disease Control and Prevention (CDC), through the President’s Emergency Plan for AIDS Relief (PEPFAR), as part of the Elizabeth Glaser Pediatric AIDS Foundation's International Family AIDS Initiatives (“Project HEART”/Cooperative Agreement No. U62/CCU123451). The opinions expressed herein are those of the authors and do not necessarily reflect the views of CDC.

Elizabeth Glaser Pediatric AIDS Foundation

NRTI-Induced Lactic AcidosisSouth Africa

• Cohort of 891 patients on ART at McCord Hospital, South Africa (2004-2005)

• Median baseline CD4 count: 132 cells/mm3 (43-173)• Follow up time: 18 months• Incidence of lactic acidosis: 14/891

– ART regimen: d4T+ 3TC EFV/NVP– All female– Median age 36 years (IQR 35-39)– Median weight: 81kg (IQR 69-97)– Median time: 7.5 months (IQR 7-12)– Median peak lactate level: 9.3 mmol/l– Fatal cases: 4 (29%)

McCord Hospital, South Africa 2006; S Afr Med; 96:722-724