October 7, 2019 On October 7, 2019, the Harvard Global Health Institute will host a one-day symposium to explore what enabled this visionary program, and to showcase how it has transformed not just the worldwide HIV/AIDS response but global health delivery more broadly. There are many lessons learned in PEPFAR’s story - from what it took to build a supply chain where there was none, to establishing the use of generic antiretroviral therapies (ARTs) and leveraging human capacity. This event convened the early architects of PEPFAR as well as experts and implementers currently leading the charge. We took a historically informed look at what it will take to stop global transmission, and shared tools useful for others hoping to move the needle on vexing problems in global health. For more information, visit our website at https://petrieflom.law.harvard.edu/events/details/15-years-of-pepfar

1. 15+ Years of PEPFAR: Getting to Zero
Phyllis J Kanki
Harvard T.H. Chan School of Public Health
October 7, 2019

2. The Track 1.0 program request for funding was released in late
2003.
Required experience in care of HIV-infected individuals in > 3 of
the target countries: Botswana, Cote d’Ivoire, Ethiopia, Guyana,
Haiti, Kenya, Mozambique, Nigeria, Rwanda, South Africa,
Tanzania, Uganda, and Zambia.
President’s Emergency Plan For AIDS Relief
Four grants were awarded, 2004-2012.
Goals: Treatment to > 2 million people
Care to >10 million people
Prevention of Mother-to-Child Treatment ~ 16 million.

3. The Track 1.0 program provided ART to 1.3 million patients
at 1,300 health facilities across 13 countries.
(2004-2012)

4. Provided ART to
79,584 AIDS
patients
Provided HIV care to 95,389
and ART to 61,891
Master Trainer Corps:
Trainers treated 13,578 AIDS patients

5. 90-90-90
An ambitious treatment target
to help end the AIDS epidemic
through global solidarity, evidence-based action
and multisectoral partnerships.
Although many strategies will be needed to close
the book on the AIDS epidemic, one thing is
certain. It will be impossible to end the epidemic
without bringing HIV treatment to all who need it.
As the world contemplates the way forward
following the 2015 deadline for the targets and
commitments in the 2011 Political Declaration on
HIV and AIDS, a final target is needed to drive
progress towards the concluding chapter of the
AIDS epidemic, promote accountability and unite
diverse stakeholders in a common effort. Whereas
previous AIDS targets sought to achieve
incremental progress in the response, the aim in
the post-2015 era is nothing less than the end of
the AIDS epidemic by 2030.
consultations focused on civil society, laboratory
medicine, paediatric HIV treatment, adolescents
and other key issues.
Powerful momentum is now building towards a
new narrative on HIV treatment and a new, final,
ambitious, but achievable target:
By 2020, 90% of all people living with HIV
will know their HIV status.
By 2020, 90% of all people with diagnosed
HIV infection will receive sustained
antiretroviral therapy.
By 2020, 90% of all people receiving
antiretroviral therapy will have viral
suppression.
THE TREATMENT TARGET
virally suppresseddiagnosed on treatment
90% 90% 90%

6. I. Data Systems
Paper
Records
Daily, on-
site data
entry
Regular
transfer to
data
managers
Physician views
patient data in
clinic
APIN
Harvard
provides TA to
APIN SI team
Feedback
to sites

7. I. High quality data systems enabled
robust outcome analyses
RESEARCH ARTICLE
Long-Term Outcomes on Antiretroviral
Therapy in a Large Scale-Up Program in
Nigeria
Seema T. Meloni1
, Charlotte A. Chang1
, Geoffrey Eisen2
, Toyin Jolayemi3
,
Bolanle Banigbe3
, Prosper I. Okonkwo3
, Phyllis J. Kanki1
*
1 Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston,
Massachusetts, United States of America, 2 Center for Global Health, Northwestern University Feinberg
School of Medicine, Chicago, Illinois, United States of America, 3 AIDS Prevention Initiative in Nigeria,
Limited by Guarantee, Abuja, Federal Capital Territory, Nigeria
* pkanki@hsph.harvard.edu
Abstract
Background
While there has been a rapid global scale-up of antiretroviral therapy programs over the
past decade, there are limited data on long-term outcomes from large cohorts in resource-
constrained settings. Our objective in this evaluation was to measure multiple outcomes
during first-line antiretroviral therapy in a large treatment program in Nigeria.
Methods
We conducted a retrospective multi-site program evaluation of adult patients (age 15
years) initiating antiretroviral therapy between June 2004 and February 2012 in Nigeria.
The baseline characteristics of patients were described and longitudinal analyses using pri-
mary endpoints of immunologic recovery, virologic rebound, treatment failure and long-
term adherence patterns were conducted.
Results
Of 70,002 patients, 65.2% were female and median age was 35 (IQR: 29–41) years; 54.7%
were started on a zidovudine-containing and 40% on a tenofovir-containing first-line regi-
men. Median CD4+ cell counts for the cohort started at 149 cells/mm3
(IQR: 78–220) and
, Jolayemi
Long-Term
a Large
E 11(10):
164030
an open
ms of the
which
nd
the original
hese data
dical
cy would be
M A J O R A R T I C L E
Tuberculosis Incidence and Risk Factors Among
Human Immunodeficiency Virus (HIV)-Infected
Adults Receiving Antiretroviral Therapy in a
Large HIV Program in Nigeria
Charlotte A. Chang,1
Seema Thakore Meloni,1
Geoffrey Eisen,3
Beth Chaplin,1
Patrick Akande,4
Prosper Okonkwo,4
Holly E. Rawizza,1,5
Eric Tchetgen Tchetgen,2
and Phyllis J. Kanki1
Departments of 1
Immunology and Infectious Diseases and 2
Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; 3
Center for
Global Health, Northwestern University Feinberg School of Medicine, Chicago, Illinois; 4
AIDS Prevention Initiative Nigeria, Ltd./Gte., Abuja; and 5
Brigham
and Women’s Hospital, Boston, Massachusetts
Background. Despite the benefits of antiretroviral therapy (ART), tuberculosis (TB) is the leading cause of
mortality among human immunodeficiency virus (HIV)-infected persons in Africa. Nigeria bears the highest TB
burden in Africa and second highest HIV burden globally. This long-term multicenter study aimed to determine
the incidence rate and predictors of TB in adults in the Harvard/AIDS Prevention Initiative in Nigeria (APIN)
and President’s Emergency Plan for AIDS Relief (PEPFAR) Nigeria ART program.
Methods. This retrospective evaluation used data collected from 2004 to 2012 through the Harvard/APIN PEP-
FAR program. Risk factors for incident TB were determined using multivariate Cox proportional hazards regression
with time-dependent covariates.
Results. Of 50 320 adults enrolled from 2005 to 2010, 11 092 (22%) had laboratory-confirmed active TB disease
at ART initiation, and 2021 (4%) developed active TB after commencing ART. During 78 228 total person-years (PY)
of follow-up, the TB incidence rate was 25.8 cases per 1000 PY (95% confidence interval [CI], 24.7–27.0) overall, and
it decreased significantly both with duration on ART and calendar year. Risk factors at ART initiation for incident TB
included the following: earlier ART enrollment year, tenofovir-containing initial ART regimen, and World Health
Organization clinical stage above 1. Time-updated risk factors included the following: low body mass index, low
Tuberculosis incidence rate and risk factors
among HIV-infected adults with access to
antiretroviral therapy
Enju Liua
, Abel Makubie
, Paul Drainf
, Donna Spiegelmana,b,c,d
,
David Sandog
, Nan Lia
, Guerino Chalamillag
, Christopher R. Sudfelda
,
Ellen Hertzmarkb
and Wafaie W. Fawzia,b,d
Objective: The objective of this study is to determine the incidence rate and risk factors
of tuberculosis (TB) among HIV-infected adults accessing antiretroviral therapy (ART) in
Tanzania.
n=70,002 patients
person-years= 136,852
n=50,320 patients
person years= 78,228
n=67,686 patients
Open Forum Infectious Diseases, 2015
Plos One, 2016
AIDS, 2015

8. II. Laboratory Infrastructure
Laser-based CD4+ cell counts
24 laboratories
Automated Hematology
Chemistries for toxicity
24 laboratories
HIV serologic diagnosis
64 laboratories
Sequencing
Drug resistance mutations
3 laboratories
PCR-based viral load monitoring
PCR-based early infant diagnosis
10 laboratories

9. 48% (205/430)
HIV drug
resistance
muta;ons,
primarily to
NNRTIs
HIV prevalence
CRF02_AG
G.WA-I
G.WA-II
G.CA
A
CRF06
Rec/Other
CRF02_A
G
G.WA-I
G.WA-II
G.CA
A
CRF06
Rec/Othe
r
CRF02_AG
G.WA-I
A-II
G.CA
A
CRF06
Rec/Other
NORTH
SOUTH
NORTH-
CENTRAL

10. III. The importance of training
Botswana’s Clinical Master Trainer program
Mother Sites
Middlepit
Bokspit
Goodhope
Palapye
Masunga
Werda
Kalkfontein
Newxade
Clinics supported by Mother site

11. University of Ibadan – D. Olaleye, I. Adewole
Ahmadu Bello University – H. Muktar
University of Jos – O.Agbaji, S. Sagay
University of Lagos – S. Ogunsola, S. Akanmu
University of Maiduguri – W. Gashau
University of Nigeria – C. Chukwuka, E. Nwobi
AIDS Prevention Initiative in Nigeria – P. Okonkwo
Harvard T H Chan School of Public Health – P. Kanki
Northwestern University – R. Murphy
Medical Education Partnership In Nigeria
(2010-2015)

12. Minister of Health Isaac Adewole launches
Turning the Tide: AIDS in Nigeria
Abuja
April 11, 2019

13. Kanki Lab
Charlotte Chang
Beth Chaplin
A.Dieng Sarr
Lana Dinic
G. Eisen
Steve Fake
Rocio Garza
Morgaine Gilchrist-
Scott
Don Hamel
Jalal Hosseini
Lydia Lo
M-F Mclane
Seema Meloni
Chris Mullins
Nsovu Nulenga
Harry Reyes
Matt O Rourke
Tara Rao
Holly Rawizza
J-L Sankalé
Connie Smith
Craig Wen

14. Our partners in Botswana, Tanzania and Nigeria

15. Acknowledgements
This work was funded, in part, by the U.S. Department of Health and
Human Services, Health Resources and Services Administration.
P. Kanki (PI)
S. Meloni
B. Chaplin
C. Chang
H. Rawizza
J-L. Sankalé
G. Eisen
D. Hamel
N. Ulenga
L. Dinic
J. Hosseini
C. Smith
R. Murphy
K. Scarsi
K. Hurt
B. Taiwo
C.Achenbach
P. Okonkwo
T. Jolayemi
J. Samuels
B. Banigbe
R. Olaitan
P. Akande
B. Akinyemi
O. Eberendu
I. Adewole
D. Olaleye
J. Idoko
S. Sagay
O. Agbaji
O. Idigbe
D. Onwujekwe
C. Okany
R. Nkado
W. Gashau
H. Muktar
J. Abah
C. Chukwuka
S. Akanmu
F. Ogunsola
All our colleagues at the APIN PEPFAR sites in Nigeria
Most of all, our patients

16. PMTCTCounseling & Testing
ART treatment
Adults & Pediatric
100,000 patients
1,000,000
HIV/TB
HIV Adults Care
Pediatric Care
Orphans
150,000
Lab Infrastructure
Monitoring & Evaluation

17. Microbial Sequencing Workshop
December 6-12, 2016, Boston, MA
NIH/Fogarty Medical Education Partnership Initiative
Universities of Ibadan, Jos and Lagos

18. Harvard School of Public Health
PEPFAR
Nigeria
2000
Tanzania
1992
Botswana
1995

19. Harvard PEPFAR Nigeria
•Through Bill & Melinda Gates funding, Harvard has
been working with multiple hospitals and prevention
programs in Nigeria since 2000
•Started PEPFAR ART activities at 6 tertiary hospitals in
2004 and expanded to a total of 26 ART sites and 64
PMTCT sites.

20. Implementation Research
• Diagnostics for the Real World: Evaluation of point of
care SAMBA HIV Q and SQ nucleic acid (Harvard,
JUTH, NIMR)
• CDC-U01-GH000770: HIV Drug Resistance:
Implications for optimizing antiretroviral therapy
(NIMR, JUTH, UCH, Harvard)
• CDC-U01-GH002109: Reaching 90% target of HIV
viral suppression: The role of point of care VL
monitoring in resource constrained settings
(JUTH, Harvard, DRW)

21. University of Ibadan MEPI
Junior Faculty Research Training Program
(UI-MEPI-J)
STAMINA
Support for Training and Mentoring in Nigeria for Academics
UNIVERSITY OF JOS & AHMADU BELLO UNIVERSITY
Medical Education Partnership Initiative
Research Capacity Building Junior Faculty
(2015-2020)
University of Lagos

22. CD4
Each green triangle indicates one
pickup of antiretroviral medications.
Orange triangles indicate a change
in regimen.
Log of Viral Load
Laboratory Values
Pharmacy Pickups

23. Honourable Minister of Health Professor Lambo
launches the AIDS in Nigeria book for APIN
Abuja
April 12, 2006
Book Launch and Reception:
AIDS in Nigeria:AIDS in Nigeria:
a Nation on thea Nation on the
ThresholdThreshold
April 12,
2006, 4PM
Ladi Kwali Hall
Sheraton Abuja
Funded by
The Bill and Melinda Gates Foundation