Dr. John Nkengasong

MILLER: This is Dr. Bess Miller, and I'm here with Dr. John Nkengasong. Today's date is October 30, 2017, and we are in Atlanta, Georgia, at the Centers for Disease Control and Prevention [CDC]. I am interviewing Dr. Nkengasong as part of the Oral History Project: The Early Years of AIDS, CDC's Response to a Historic Epidemic. We are here to discuss your experience during the early years of CDCs work on AIDS, the acquired immunodeficiency syndrome. Dr. Nkengasong, do I have your permission to interview you and to record this interview?

NKENGASONG: Yes.

MILLER: John, you have been a visionary with respect to laboratory research and capacity building for work on AIDS and the AIDS virus in the United States and especially in Africa. In 1996, you were asked to create a retrovirus laboratory in the CDC HIV/AIDS field station in Abidjan, Côte d'Ivoire, so-called Projet RETRO-CI. This would be the first of its kind in Africa. Then in 2005, you came 00:01:00to CDC headquarters to head up the newly formed international laboratory branch of the Global AIDS Program, the CDC implementing arm of PEPFAR, the President's Emergency Plan for AIDS Relief. This involved providing leadership and oversite for all lab activities in all Forty-one PEPFAR countries, which were primarily in Africa as well as Asia. During this period, you had a lead role in forming the African Society for Laboratory Medicine and served as the first chair of its board of directors. You have been a prolific researcher with over 200 peer-reviewed publications and have been Editor-in-Chief of the African Journal for Laboratory Medicine and a board member of many journals, including Expert 00:02:00Review of Clinical Immunology. Most recently, you've been chosen to serve as director of the newly created Africa Centers for Disease Control and Prevention in conjunction with the African Union in Addis Ababa, Ethiopia. We have a lot to talk about.

NKENGASONG: Indeed.

MILLER: Let's begin with your background. Would you tell me about where you grew up and your early family life and then where you went to college?

NKENGASONG: Thank you, Bess, and pleased to be part of this oral history of the HIV/AIDS epidemic. I was born in Cameroon. I attended my undergraduate school at the University of Yaoundé Cameroon. In 1988, I actually had the privilege to meet, when I was doing my internship at the medical school, with [Dr.] Peter 00:03:00Piot. And I went over to Antwerp [Belgium] to study virology at the Institute of Tropical Medicine and subsequently stayed there for a Ph.D. at the school of medicine at the University of Brussels. So, I spent quite a good number of my formative years at the Institute of Tropical Medicine in Antwerp, Belgium.

MILLER: Tell us a little bit more about your childhood. What was your family like, and how did you know that you might be interested in science?

NKENGASONG: That's a very interesting question. I have a very interesting childhood story. It's unique in the context of Africa, where the tendency was for so many families to have many children. So, I was the lone child of my parents. I was actually born when my mother was about 53. So, I was the only 00:04:00child she had, and it became a partnership with her, and it lasted until she died at 103, just four years ago.

MILLER: That is unusual. Were you a good student? Were you from a wealthy family that could afford to send you to school? Was it unique to be going to school?

NKENGASONG: Absolutely. I'm forever thankful to the government of Cameroon for providing free education. Right up to university, it was a really free education. All you needed to do was to go to school and pay for what they call primary education. What here would be the equivalent of elementary school and up to middle school and university. To the extent that in high school and university, if you passed your exams, you were actually given a stipend. I mean, 00:05:00a monthly stipend, in addition to housing in a hostel. So, the system was designed to encourage education, and those students that were guided and had a family setup that could encourage them to go to school actually went to school and subsequently to college literally free of charge.

MILLER: So, were there uncles and aunts or cousins that you knew that were intellectually directed? Were there doctors in the family?

NKENGASONG: No, that is very interesting. I count myself fortunate in many ways. That I didn't grow up having uncles and brothers or siblings that had gone to school, sadly. So, because I was the only child from my mother, she decided to 00:06:00take me amongst her sister's children. Her sister had six children, so that I should have that environment of growing up with other siblings. So that's how I at least got siblings, and I was not stigmatized like not having siblings. Then you literally just follow the flow, you went to school, you competed with others, and you wanted to get a score in mathematics, physics, or whatever and subsequently, you just move with the flow. I don't think there was any inspiration to become a scientist. You just went to school, and you did the minimum or maximum to get grades.

MILLER: That's fascinating. And your cousins, did they go off to college?

NKENGASONG: Yes. Some of them went off to college, but not all. Just because, I had this drive for, maybe it was my unique situation, which I was always aware of. I was always aware that even though I was growing up with my cousins, I 00:07:00didn't really belong there biologically. So, it gave me the extra sense of working hard and always trying to be the best and to prove myself, always. So that really helped me a lot because of my six cousins that I had. Just one of them went to a university, the rest of them, even though they had more privileges in terms of economic possibilities to go to school, they didn't take that advantage to achieve higher education.

MILLER: So interesting. When did you get interested in the sciences? Was that in college or before college?

NKENGASONG: It was actually in what you call the elementary school. In Cameroon at that time, they referred to it as a secondary school. The education system was designed that you spend seven years in primary education, then five years in secondary school, and then two years of high school, then university. So that 00:08:00was the design. Now, when I go to the secondary school, I developed a lot of interest in biology, physics, chemistry, mathematics, and that's where my scientific interest developed, and the teachers were very encouraging. Then we grew a positive competition amongst a group of kids that were inclined Nkengasong describes his graduate program in Antwerp, Belgium as well as his PhD virology work on characterizing strains of HIV in Africa to do the sciences, and we were almost competing amongst ourselves. I believe that is what I carried through to high school and to university.

MILLER: Now, you met Peter Piot when you were in secondary school?

NKENGASONG: No, I met Peter Piot when I had graduated with a bachelor's degree in science, and I was doing an internship at a medical school in Yaoundé, and he came in 1987 or so for an STD [sexually transmitted disease] conference. And 00:09:00before that they were attending a conference in Stockholm [Sweden] on HIV [human immunodeficiency virus], where a strain of HIV was reported from a Cameroonian and this virus was called HIV Group O. At that time, they used to name it ANT70 because it was isolated in Antwerp and it was isolate number 70. So, his purpose in coming to Cameroon was to expand that collaboration to explore the prevalence of this strange virus in Cameroon. So, when he came, he met me in the laboratory, and I was working for Peter [M.] Ndumbe and developed an interest. He said this young man seems to be very engaged, you could come over to Antwerp and get a Master's degree in Virology, and that will help strengthen the collaboration. And that's why I left a year later to go to the Institute of Tropical Medicine [Antwerp].

MILLER: How fortuitous. So, you went to medical school in Cameroon.

NKENGASONG: I went to the Faculty of Science in Cameroon.

MILLER: And did you know you were interested in laboratory medicine at that time? How did you move from the human to the laboratory direction?

NKENGASONG: That's a very good question. The truth is that I didn't know. And then when I graduated at the age of 21 or 22, the world was still very open for me to explore, and the reason I went to the medical school to do internship was that there was an opportunity to work on a Hepatitis B project, to look at the prevalence of Hepatitis B in pregnant women in Cameroon. So, I offered myself as an unpaid internist to work on that project. So, I developed an interest in immunology to understand what I was doing with doing basic ELISA's 00:11:00[enzyme-linked immunosorbent assay], but I had a strong interest to read immunology of what that meant and the antigen-antibody relationship, and that's how I started shifting from basic sciences to virology and immunology.

MILLER: That is amazing. So, the opportunities in Cameroon sound like they were pretty good then for a school in Africa. Would you say that in terms of laboratory training?

NKENGASONG: Yeah. The school system at that time, I believe I would characterize it as pretty good because, in high school, my teachers were all Peace Corps. I had four Peace Corps teachers in mathematics, physics, biology, and chemistry. So, I owe a lot to my science being due to the Peace Corps that taught me in 00:12:00high school and actually ingrained me to develop an interest in the university. So, at that time, I would say the school system was fairly solid. In Cameroon, as a young country, was still relying on a lot of expatriates from France and from other European countries to lecture us at the university because they had not trained enough people to take on senior leadership at the university. So, even at university, a lot of the professors we had were from France, in particular, and of course, some young Cameroonians that were coming up after finishing their studies in Europe. So, it was a very strong educational system that we had, a unique university that we had at that time.

MILLER: So then when you got to Antwerp and the Tropical Institute, was that a 00:13:00big jolt for you? Was that amazing getting to Europe and getting a very different environment scientifically? What was that like?

NKENGASONG: It was amazing and a life-changing experience in many respects. One, the size of the class was extremely small, only about 20 in our graduate program. So, you could literally sit around the table and interact with the lecturer or the teacher, which was not the case in my undergraduate where the teacher was very distant, and you found it difficult. There was this barrier between you and the professor because of the size of the class-- we had about 500 to 600 in the class. And then suddenly you're in a classroom with about 20 people, so that's one. Second, the facilities to enabling environment to study. The library was open most of the time, including weekends. You had top journals that were published each week, and they were stored in a small room for people 00:14:00to go visit before they put them on the shelf. The librarians were very cooperative. They wanted to give you anything that you wanted, any paper that you requested within days, they would give you that. So, it was just unbelievable the change in the facilities and exposure that we had. Then the most striking thing was the ability to enable you or force you to think yourself. Not direct you, not being directed. Like in Cameroon, you asked the teacher to say, well, you have to do these things. When I go Antwerp, I remember my first meeting with Peter Piot, his first question was, what are your interests? What do you want to do in the lab? And I was like, what? You tell me what I want to do-- I'm here to learn. And it took a while for me to learn that I could develop my own ideas, my own hypothesis. That was the beginning of developing my scientific skills.

MILLER: So, you ended up getting a doctorate in--was it in retrovirology or-

NKENGASONG: In virology.

MILLER: -virology in general?

NKENGASONG: Yes. It was interesting when I initially went to Belgium through the Belgium Cooperation Scholarship, so after one year, I did very well. And Peter Piot came to the lab, and I remember him walking to the lab and said, John, you've done extremely well here. We think there's an opportunity from the Belgium Cooperation to give you a scholarship for another four years to do a Ph.D. I was totally surprised because I had planned to go back to Cameroon, and that was never part of my arrangement. And I was missing my mother. I wanted to go back and meet her. And I said, for how long would this program be? He said, for four years. Come on-- I was like no this is too long. Would I be able to go 00:16:00back in between? And he said, yes, we could design some projects that you could go back to Cameroon. So that's how I ended up doing a Ph.D. in virology.

MILLER: And what was your emphasis for your Ph.D. in virology?

NKENGASONG: My emphasis was on characterizing strains of HIV in Africa, about the biologic, antigenic, and virologic characterization of HIV strains. We look at the HIV strains at that time, which was very fascinating. At that time, remember we're into the 1989 timeframe, and HIV was broadly known to be HIV-1 or 2, and we did HIV -1. There were two types, and they would call them not American and United States strains and then the African strains. That's all that was. But we knew there was something different. Remember, I said earlier that 00:17:00there was a strange aberrant virus that was isolated in Antwerp called ANT70 and ended up being classified as Group O, so we knew that even the diversity that HIV could not just be simply divided. So my Ph.D. thesis was first of all to characterize the different genetics subtypes of HIV that existed in Africa and then look for the biological differences and ask the question if there were some biological differences that existed between the strains, and then ask the question if there were some neutralizing properties between one type of virus and another type of virus, so that was my entire spectrum of it, Ph.D. in four years.

MILLER: Well, you did some things between these, but in 1996, you were asked to create and direct a laboratory in Projet RETRO-CI, which had been established 00:18:00earlier in 1988. And that was a large field station sponsored by CDC, sort of initially to look a little bit more into HIV-2, but then, of course, went on to look at many, many aspects of the epidemic. Can you tell us a little bit about what you were thinking when you took this position and what were the circumstances on the ground when you got there?

NKENGASONG: Yeah, interesting. As I said earlier, when I went to Antwerp, I used to go to the library every Monday to look at new journals, new publications because I was on top of everything and I mean everything that was published in Africa be it in epidemiology or lab, it wasn't just in laboratory but nearly 00:19:00everything. And there were certain researchers that I was tracking in Africa on what their work was and especially in Kenya, in Côte d'Ivoire, and of course in the [Democratic Republic of the Congo] Congo, at that time called Zaire. In one of my Monday visits to the library, I took the Lancet, and I saw that there was a position advertised there for, they are looking for a virologist to run the virology lab in Abidjan [Côte d'Ivoire] for CDC. And at that time, I was already the chief of the virology lab at the Institute of Tropical Medicine. I had done my Ph.D. there, and Peter Piot named me the head of the virology lab there. But I was eager to go back to Africa. I'd already spent about close to eight years in Europe-- I thought it was about time to go back to Africa, and I was very, very interested in the work CDC was doing because we used to be almost like competitors. We knew that [Dr.] Marcia [L.] Kalish and others and [Dr. Gerald] Gerry Schochetman was doing work on subtyping, and we were also doing 00:20:00work on subtyping in Antwerp. So, we would track their work very closely to understand what they were doing. So, I developed an interest in CDC's work. So, when I saw the opportunity in Abidjan, I immediately applied by fax. I remember going back to the lab, and I wrote an application and just went to the fax machine and faxed it to Côte d'Ivoire. That's how it all started. And then weeks passed, I didn't get any reply and then one day the secretary called and said that there was a call for me from Abidjan. And I took the call and on the other side of the phone was [Dr.] Alan [E.] Greenberg. Alan Greenberg was the director of RETRO-CI [Retrovirus Côte d'Ivoire] at that time and requested to talk to me, and he started off by saying they've seen my application and my CV, they are interested in talking to me. So then arranged for an interview at an airport in Brussels between me and Dr. Mark Rayfield.

MILLER: Mark Rayfield and [Dr.] Dale [J.] Hu

NKENGASONG Dale Hu they were in Abidjan providing technical support to the field site, and on their way back to the United States, they stopped in Brussels, and I came in, and we sat at the airport and had coffee, and they did an interview if I had an interest or the qualifications. And it was a very detailed technical interview. Like how many PCRs [Polymerase chain reaction] have you done? How would you set up a culture laboratory? And those were things I was doing in Antwerp. Weeks later, I received an offer that I should come to Côte d'Ivoire to see the position, and if I like, they would be happy to offer the position to me. I went to Côte d'Ivoire, and Alan Greenberg took me around the building. In this building, Projet RETRO-CI was within the infectious disease clinic at the university teaching hospital in Treichville and showed me an abandoned building. 00:22:00That building had been abandoned for years-- it used to be a place that they quarantined patients were there. And the government of Côte d'Ivoire had offered that to Projet RETRO-CI to renovate for a virology lab. So, it was really a contrast between what I've read in the Lancet about starting a virology lab and then a virology lab itself. He pointed to the building and said, John, I see a dilapidated building, but I see a virology lab there. They look at me and say, what do you see here? And I said, yes, I see a virology lab. But to be honest, I was completely discouraged. This was not a lab. I was working in a lab, publishing in the Journal of Infectious Diseases, Journal of Virology, and I'm looking at this like how am I going to start doing this here. But I saw in him, the seriousness and the commitment that he was ready to support me to get the lab started. So, I went back to Belgium, convinced my wife and I took a 00:23:00one-year contract.

MILLER: Oh, you had a wife at that time?

NKENGASONG: Yes, I had a wife at that time, and son, three years old. We took a one-year contract to come to Côte d'Ivoire. My wife was devastated. She said you must be stupid, you're leaving a job, a full-time job in Antwerp, you are chief of the lab, you have twenty-something people working for you, and you're going to Côte d'Ivoire with a one-year contract. And I said, look dear if we go there and we do this well, there is no reason why after one year, if we do the job well, it won't continue to do this job, and they'll extend this contract. So that's how it happened.

MILLER: So, why a virology lab in Abidjan, Côte d'Ivoire? What was their thinking, and what was your thinking about that? Was that something that was needed for Africa? Was that something to prove that you could do it in Africa? 00:24:00We'll talk later about the general, but maybe even now, you can tell us a little bit about the status of laboratory medicine in Africa at that time.

NKENGASONG: I think it is fair to say that at that time there were so many things that CDC was doing in Côte d'Ivoire at that time and remember Projet SIDA had just collapsed shortly after, and they were looking for a state of the art facility to do many things there including understanding the differences between HIV-1 and 2, understanding the dual infection HIV-1 and 2 dual infections, understanding mother to child transmission. So, they were actually shipping specimens to Antwerp to the lab that I was working previously for virus isolation. Remember, there was no PCR at that time actually for specific form for HIV, so culture was like, you have to culture the virus which means you 00:25:00isolate the cells, present them in liquid nitrogen, ship them to Antwerp or to Atlanta, and then hope that this whole process goes somewhere so that the cells are still viable for you to isolate the virus. Most of the time, when the cells got to Antwerp, they were dead. They were dead cells, so it was a wasted effort. I think the idea was to have instead of the laboratory in place where you could do all of those tests and analysis locally in Côte d'Ivoire and avoid shipping specimens. And the second concept or idea was to be duel capacity. If you have a state of art lab, you could actually build local capacity, support the studies that were quicker for interactions between the epidemiologist and the lab to interact and shipping specimens to Atlanta or Antwerp for testing. I think that was the rationale at that time. And now certain tests, Sub-Saharan Africa, there 00:26:00was no lab that was doing that kind of work.

MILLER: So, nothing in South Africa--

NKENGASONG: In Sub-Saharan Africa. South Africa, the National Institute of Virology at that time, now it's called The National Institute of Communicable Diseases, what was called the National Institute of Virology had the ability to do that, but in Sub-Saharan Africa, you had nobody who was doing that kind of work. The Abidjan lab became the state-of-the-art lab across the board.

MILLER: So, a challenge.

NKENGASONG: Yeah, a big challenge. Later on, we can talk about how it started supporting all our initiatives in Africa and Nigeria, and Senegal and Togo.

MILLER: So, you get to Abidjan, now obviously the French was another advantage. You speak fluent French-- you grew up speaking French. How did you begin? How do 00:27:00you even begin something like that?

NKENGASONG: It was challenging. That's a very good question. Before I came, I arrived in Côte d'Ivoire-- they had a serology lab. A lab that mainly did two things-- they did CD4 [cluster of differentiation 4 lymphocyte] count analysis, and then they did HIV serology.

MILLER: Again, it's 1996-- there's no treatment for AIDS in Africa. There's the presence of antibody testing, so are people beginning to get tested in Abidjan at that time?

NKENGASONG: Yes.

MILLER: So that's where you're entering and trying to set your priorities.

NKENGASONG: Exactly. So, it was 1996, early days. HIV treatment had just been 00:28:00made available in the West. Very costly, but it was available in Africa. Everything that we did at that time in Côte d'Ivoire were studies. We were studying multiple populations, i.e., STD clinics, tuberculosis patients, doing trials from mother to child transmission. I needed the testing, so the backbone of all the studies was a reliable HIV test. The assays were there, but of course ELISA, the enzyme link immunosorbent assays and western blot. You think it was easy to be done-- it wasn't because interpreting the western blot profile was challenging. So, it took a lot of time, and there was a lot of cross-reactivity between, antibody cross re-activities between HIV-1 and HIV-2, western blot. So, we ended up in a consensus that people just didn't know the true prevalence of HIV-2 and dual infections. So that was one of the main things I studied. So, I 00:29:00arrive in Côte d'Ivoire, Abidjan, and I'm embedded first of all in the serology lab that was already in place while waiting to build my virology lab. I took on that, my first assignment was, and I remember vividly that there was a site visit with [Dr.] Helene Gayle, [Dr] Kevin De Cock, [Dr. Kenneth G.] Ken Castro, Tom Forks, Gerry Schochetman. So, they all came to Abidjan to do a site review, and each department presented their priorities, and I presented my priorities for the virology lab. Remember, I was coming from a university setting, not a public health setting, so my project setup presented was more on pathogenesis. I wanted to look at the pathogenesis of HIV-1 and 2, compare the two, look at how 00:30:00immunologic activation in Africa could contribute to disease progression, and all the things like that. At the end of the one-week retreat, they pulled me aside, and they said, John, you are a very bright young man. I was like 34 at that time. They said we think you should focus and try to help this serology lab to identify a good testing algorithm for the lab because we are struggling to do proper diagnostics with quality assurance. So, my reaction was, what? I came from Antwerp to be doing basic serology. You want to ruin my career. I mean my natural reaction was like, these guys must not be--but anyway, fast forward, I took it seriously. We started analyzing different assays that we could use to eliminate western blot from the test combinations. My first evaluation was based 00:31:00on about 9,000 specimens. It came out one of those with striking results that we submitted a paper to AIDS, we never heard from them and realized months after--remember the old days, you used to make hard copies, and you wait for months. And then months later we found out that it is published without comments and there was an editorial written on it. I mean, this was fantastic work done on serology, and that's the only paper I've published with no comments on the reviewer. And that was based on serology. So that became the standard that we gradually took off western blot and started using a combination of ELISA.

MILLER: And, by the way, 9,000 specimens, so there's a real machine going on out of Projet RETRO-CI that's acquiring specimens. It's a big operation that you've entered.

NKENGASONG: Yes. It was a big operation. When I came to join RETRO-CI, they were 00:32:00testing about 35 to 40 thousand samples a year from different populations because it was mainly surveys and epidemiologic studies from all kinds of populations, the sick patients, the children's population. So, a lot going on there, so we had designed the study in two ways. One was a cross-sectional study where I just took about 1,500 specimens and checked five assays and see which ones were performing better. Then I took out three of them and let them run for one year. So, within a year, we could analyze our 9,000 samples and then use that to tease out which assays were performing better. But it became the standard. That's how we knocked off western blot from our testing algorithm. That led to a lot of cost savings and simplified the testing process in Côte d'Ivoire. That was the first thing that I did on serology.

MILLER: And who was working for you? Were the laboratory personnel that were managing these studies Ivoirians? Were they from CDC Atlanta? Who were these folks?

NKENGASONG: All of them were Ivoirians. My colleague, who was running the serology lab was Chantal Maurice, also Ivoirian, and had been trained a lot in France, exceptionally well trained, a senior professional. Underneath her, there were about 25 technicians -- all of them Ivoirians. None of them had any exposure to working in the virology lab. So, I literally had to start from zero recruiting people that could work in a virology lab, do virus isolation, also introduce them to polymerase chain reaction, PCR testing, because none of that was going on in Côte d'Ivoire at that time. Gradually, I set up the PCR testing 00:34:00in the lab, and when we did our first PCR results, and it was positive, I remember Alan Greenberg-- somehow, he knew that I was experimenting that setup and someone had told him. He bought a bottle of champagne, came to the lab, and we popped that in the lab because that was the first time PCR was done in Projet RETRO-CI. That was the beginning of that thing. Gradually, the virology lab was built, and then we transferred the technology into the lab, and under me I had five technicians to work for me, and we moved over to the virology lab.

MILLER: So, did that take years?

NKENGASONG: It took about two years to get from the time we built a lab to the time it actually went operational, slowly. Then I went to France and Belgium and started looking for Ivoirians that were out there with a Ph.D. or post docs to bring them back to Côte d'Ivoire. Like Christiane Adje-Toure was just about to 00:35:00finish her Ph.D. at the Catholic University of Leuven in Belgium. So, I went there and to kind of scout, do kind of intelligence around her, and then finally brought her to Côte d'Ivoire Stephania Koblavi at the Institute Pasteur in Paris. We also brought her back to--so that's how we started building a team of at least mid-level Ivoirians who were scientists that could support me in that initiative.

MILLER: You didn't leave after a year, and you told your wife you might leave after a year, but then you got into it. So, for someone who was a deep-thinking scientist, were you moving into more of a sense of mentoring and creating something in Africa? What were you thinking about as you were getting excited about the work in Abidjan?

NKENGASONG: I think there were two things that as we settled into my first year of the contract. It occurred to me the opportunities that existed there to do good science. I was beginning to learn public health and what it was because I had no clue of what it was. I was a basic scientist out of the Institute of Tropical Medicine. I was looking at epitopes --genetic subtypes and not relating it to the patient at all. I would go to the lab and see a virus that had switched from a non-syncytia to syncytia inducing virus, and I was excited - That virus change. So, in Côte d'Ivoire, when I joined CDC, it was more about a test for a patient, and what does that mean, and how do you do quality work to advance at that. So, I saw that opportunity to grow in public health. The second thing that was uniquely lacking was the rigor, the professional rigor of the 00:37:00staff that was there to really understand what it meant to exercise quality around the test. They did their work, but it wasn't where it had to be. I saw also an opportunity where they were open to learning, and they needed that mentorship to bring them to a level that I expected. Especially, the standards that I was used to working in Belgium. So that's why I told John "you can succeed in this endeavor if you grow a team around people that you can mentor and bring their standards to where it has to be." MILLER: Who is mentoring you during that time period? Who did you look to for guidance? There were so many decisions you had to make in terms of how to prioritize and how to mentor. Do you remember some people that you looked to at the time?

NKENGASONG: Yes. There were two people that were instrumental in that. Not truly 00:38:00as lab mentor because there was no lab--I was a senior lab person at that time, maybe 34 years I was. But the team was pretty young. I mean, Alan Greenberg was probably a little bit older than me. [Dr.] Stefan Wiktor as well --So Alan Greenberg and Stefan Wiktor were the people that I would bounce ideas with, and they would reign me into how to align my write-up's to make it look public health. Like I would start describing my specimens, I didn't bother where they came from, I didn't bother with the years they were collected. For me, as a virologist, that did not matter. I was just interested in the virus. And they would say, John, this abstract is good, but you have to say that between April 2000 and April you collected these specimens and it was systematic. So, I said, gosh, how is this important? I just like to work on the virus, not on this. But this way, the people that really mentored me and guided my first steps into 00:39:00public health virology as I would say.

MILLER: So, it's 1996 up to 2000, which I think was a watershed year in terms of thinking about getting ART into Africa. It's a mess-- it's a nightmare, it's a terrible epidemic, there's people dying, funerals every weekend. How did that affect you? Were you kind of cloistered in your lab away from the disease and death in the city, or was that everywhere?

NKENGASONG: It was a life-changing experience. When they finally constructed my virology building, my office was overseeing the infectious disease clinic of the 00:40:00hospital, the main hospital. And literally, I could open the window and see people come with a taxi, pull out their loved ones and dump them there, and people are dying and shouting and crying. And they were all HIV patients. So, some days, I would just shut off the curtain and just not see that. It was very stressful to see that it was real. I mean, it was not in a specimen. I saw specimens but not on AIDS patients, but now you saw them live in front of you in very miserable conditions there. They would come in very skinny and almost in a coma because people delayed bringing them to the hospital. Of course, there was no treatment at that time. It was a very traumatizing experience daily to be seeing that on a daily basis in Côte d'Ivoire.

MILLER: Those were some tough days. Once you got the lab up and running, and 00:41:00actually there were some early ART [Antiretroviral therapy] programs in Africa including and specifically in Côte d'Ivoire, the UN [United Nations] AIDS Drug Access Initiative, there was a lot of, thousands of viral load requesting viral load testing CD-4 counts and so on. Can you tell us a little bit about that? Once it started really scaling up and you had a huge burden of programmatic responsibilities, how did you manage that? How big did your staff get? And did you have to say no to some aspects?

NKENGASONG: In 1998, I remember I was in Cameroon, December 1998, I was in 00:42:00Cameroon for my end of year at Holy Days, and I heard that the minister of health of Côte d'Ivoire, a professor, had announced on television that CDC Projet RETRO-CI was going to provide viral load testing to the program, to the UNAIDS Drug Access Initiative. And the cost of viral load was- several things that concerned me at that time from Cameroon because I was barely called to say that, John, this is what's going on and you should be ready too. The cost of viral load was at that time more than, close to about $200 a test. Secondly, there was no viral load test that was suitable for use in Africa at that time.

MILLER: Why is that?

NKENGASONG: Because of the genetic subtypes. The viruses that we use to produce a viral load test were based on what we call subtype B at that time and not the strains of HIV that were there. So, those two parameters were--and the know-how 00:43:00of even if we had the test, where are we going to do it? Who is going to do it? It wasn't there. But there was a big initiative then. So, I came back, and the first thing I did was to go to Roche in New Jersey to understand the test that they had. I got trained on that test. It was called the Roche AmpliPrep test. Came back to Côte d'Ivoire and did the usual things that you and I would do. You evaluate it on your own prepared, stored panels, serum, or plasma. And guess what? The sensitivity of the Roche test at that time was 60 percent. So here, we are supposed to scale viral load? So, we ended up working with Roche and CDC here in Atlanta to design a hybrid where the standard test that we produced, 00:44:00we'll add in some new primers. The primers that will correspond to the virus strains in Côte d'Ivoire and that brought the sensitivity up to about 96 percent, and that's how we started doing viral load testing in Côte d'Ivoire. I would publish all of those things in the Journal of Clinical Microbiology-- it's really fascinating to show how, see how the things that we did. I tried two different assays, NUCLISENS and the Roche Assay, and they fell flat on the sensitivity side. So that was one challenge. The second challenge was as specimens were coming in, we're doing the testing. It became clear to me that the clinicians were not using the tests because they didn't know what viral load was, about how do you interpret viral load. I would spend hours and hours every day going across to the infectious disease clinic to provide seminars and do one-on-ones with the clinicians, and they would look at the results like, okay 00:45:00this patient has 500,000 copies per ml or log10 copies and then they started treatment one month ago, and they fall into 200,000 or what does that really mean. So, I explained to them what is the difference between the absolute numbers, and the log10 copies. It took a lot of interaction, a lot of seminars to teach the clinicians what it was we were trying to do and how they could use that result to appropriately manage a patient. The bulk of the results that were done initially were not to be used for any effective patient management.

MILLER: And what was your thinking about that at the time? I recall that as slowly as ART's brought into Africa and more after, I think 2000, this was an early intervention. There was a lot of discussions and there were papers and 00:46:00protocols comparing CD-4, viral load, no laboratory, because it's not practical for Africa. What was your thinking about that? Were you wanting to prove that it could be done in Africa? What was your underlying thoughts on doing this very complicated test?

NKENGASONG: The very first reflection was to do it the way it was done in the West--the US guidelines or International guidelines for treating HIV/AIDS as published in the JAMA [The Journal of the American Medical Association] at that time? This stipulated that you do your first baseline viral load, and then after one month of treatment, you do another viral load and then every after three months. So, then we progressively started saying, well, if you really have to 00:47:00scale up ART treatment and you do it the way it's done in the West, you would never be able to succeed because without that support from RETRO-CI it would be impossible. And keep in mind, the RETRO-CI lab was the only lab in the entire Sub-Saharan Africa with a virology capabilities. So how would you scale that up? So many people could not even do it. So, we had regional meetings where we started at that time Michel Kazatchkine who later on became the Director of The Global Fund to Fight AIDS, Tuberculosis, and Malaria. He was a professor of infectious disease in France and had projects in Senegal. So, we would convene meetings in Senegal, Côte d'Ivoire, to discuss the original approach on how we do this with minimal viral load [testing] and just use CD-4 counts as a marker to see how this was done. So, in 1988, we had about 2,000 to 3,000 patients on 00:48:00treatment in Côte d'Ivoire. Senegal had about 100 patients. Everybody was learning. Okay, 100 patients on treatment and what was the viral load results in this patient. So, we'd meet, and Senegal would present the national ART program with 100 patients. Côte d'Ivoire would present the national ART program with about 3,000 patients. By the time I subsequently left Côte d'Ivoire in 2002, we had about 8,000 patients on treatment as part of the UN Drug Access Initiative. So, a lot was learned from that, and we did a supplement in the AIDS journal where we explained our experience, and I think it was really helpful in informing the way forward with how you could expand ART treatment without all the complexities of the viral load testing.

MILLER: There were a number of aspects that you were able to look at. Genetic 00:49:00diversity, you mentioned cell-mediated immune response, a variety of serologic assays. Were you able to get some of your research interest done in the midst of all the programmatic demands?

NKENGASONG: A lot. I think that was the great fortune of being in Projet RETRO-CI. I recognized early on that I needed to build a strong partnership with the clinicians and the epidemiologists and the lab, to the extent that when I supported what was required as an emergency or an immediate priority, then the specimens were available for me to use in addressing any other question that I needed to. But the priority was to make sure that you met their needs first. For 00:50:00example, when we did the short course trial to see how azidothymidine [AZT] administered at 36 weeks of pregnancy could reduce mother-to-child transmission, later on, the specimens were there, brought from the mothers and infants for me to explore and ask any virologic question then. When we did microbicide trials in female sex workers clinics in Côte d'Ivoire, afterwards, I used the left-over specimens to look at all kind of cell-mediated immunity. We addressed the question of why some women were exposed but not infected. And we published a lot of that in the Journal of Immunology and others, but the first priority was to make sure they got their lab test, that way they stayed away from--they leave you alone to go do whatever you wanted to do. So, I think it was extremely--we also looked at the interaction between HIV-1 and 2. And the hypothesis there that--at that time the Harvard Group had published a paper that said that HIV-2 00:51:00protected against HIV-1 -- published in Science. And we said, if this is true, then for individuals who are co-infected with HIV-1 and 2, the HIV-2 can downgrade HIV-1, so that you have lower viral loads. And the way to measure that would be that you expect to see lower viral loads in people that are dually infected because the HIV-2 is in their playing some-

MILLER: And did you?

NKENGASONG: Yeah, we did all of this, but we didn't confirm at all. So, we look at dual infection, what HIV-1 did to HIV-2, what HIV-2 did to HIV-1, and published all of this. That was really like the science, I mean it was more pathogenesis that we did but at a sideline of supporting the clinical trials or interventions that was going on.

MILLER: You ended up working quite a bit with the WHO [World Health Organization] in Geneva and AFRO [WHO Regional office for Africa] at that time. 00:52:00Can you talk a little bit about that whether it had to do with lab aspects of implementing ART in other countries, setting up drug resistance networks, phenotyping, and neutralization assays? How did you and how did CDC relate to WHO at that time?

NKENGASONG: I think that as our work grew in Côte d'Ivoire in the virology lab, it was clear that we became, I'll say, continental recognized player. So, the WHO and we would work together on quality assurance programs for diagnostics. We began to scale up HIV testing. I think it's fair to say that outside of South Africa, no testing sites, and I repeat no testing site, was enrolled in a proficiency testing program, no quality assurance. You did your test, and that 00:53:00was it. So, the whole concept of quality management systems--So our first meeting in 1999 in Harare, Zimbabwe was to bring countries together and begin to talk about quality assurance for HIV. Colleagues from CDC who attended the meeting included Drs. Thomas Hearn, John, John Ridderhof, and Robert Martin. These were people that were driving it from the US side and were in the fields. So, we had a very good meeting on how to together rollout the concept of quality assurance for HIV testing in Africa. So that was just one thing. Then we moved into drug resistance. The very first network, the so-called HIVResNet, which is the WHO drug-resistant network, I was an integral part of that when it was set up, and I would go to Geneva, was part of the steering committee designing how do we work together as a network to do sequencing of viruses and dictate 00:54:00antimicrobial resistance as we're beginning to scale up antiretroviral therapy. So, we published a series of papers from the Drug Access Initiative on HIV-2 drug resistance, on HIV-1 drug resistance, and even drug resistance in the short course in azidothymidine trial. So that really rapidly positioned us as a very good place very early on to be leaders in the areas of antimicrobial resistant testing in Africa.

MILLER: You mentioned that no one was doing quality assurance and proficiency testing in HIV work. What about other work? Was there much in the way of general laboratory quality assurance in Africa?

NKENGASONG: Very, very little. What we saw in the HIV mirrored what was going on in the general laboratory settings. Just to put it in the appropriate context, 00:55:00when we started work, and I'm leapfrogging to the PEPFAR years, no lab in Sub-Saharan Africa, government lab, no Ministry of Health labs had any accreditation by International standards besides South Africa. South Africa is always an exception because they have some of these concepts going on forever. But if you look at the Sub-Saharan Africa government labs, none of them had it. The only labs that were meeting international standards were research labs and partner labs in the US CDC labs that were doing research or the US military labs in Kenya that were doing the research, and they would bring it to international standards. So that was striking, but today the whole field has changed in a dramatic way.

MILLER: Before we move onto another phase, it sounds like part of your work, and then part of your maybe your own personal feelings were that training and capacity building in Africa at some point started to be a very big part of what you were doing. And maybe what you wanted to do. Can you talk a little bit about that? Were there colleagues that you were discussing laboratory training with? It seems like it could've been so overwhelming. I'm wondering how you were thinking of that?

NKENGASONG: After many years of doing the work in Côte d'Ivoire and doing presentations across the continent, it came to me that we needed two things to 00:57:00help them there. One, to invest in the human capacity, the virologists, and the immunologists in Africa and to create that network as much as possible so that people in East Africa, Central, and West Africa are connected. So that was one. The second thing that drove me a lot was the lack of institutions, laboratory institutions in Africa. There was no associations of anything. Like if you came to the US, you would see the American Society for Microbiology, the American Society for Clinical Pathology, the Association of Public Health Laboratory. None of that existed in Africa. And I knew that the only way to sustain our efforts was to make people begin to talk and share experiences across Africa. I think investing in people that would share that vision was critical. So, we started sending people from Projet RETRO-CI to be trained in Antwerp and at 00:58:00Berkeley [University of California-Berkeley]. People like Mireille Kalou, who used to work for me was sent to Berkeley to do a master's degree, and part of them came back, continued to work there, and others went out for short term training. So, we started building, and each time you did this, it was a lengthy process because they went away for a year or two, but when they came back, their quality of work increased. You were on the same page. You have basic things like how to do a presentation became much better, and that lessened the burden on you. I mean, we had to do basic things like reviewing slides, make sure what you say when you put it on the slide there, and you read the title, the axis, and then the main message. Basic things like that had to be done. I think that was very, very important because when we left Côte d'Ivoire, I would say that we trained about 15 senior people who are all over the continent today running 00:59:00programs from Botswana to Namibia, to Côte d'Ivoire. People like Stephania Koblavi, who used to work for me, there is the director of ICAP [International Center for AIDS Care and Treatment Program], running the program in Côte d'Ivoire. Mireille Kalou is a unit lead here at the US CDC running the whole quality assurance program in Africa for HIV. So that was a very good investment. Christiane Adje is the branch chief in Côte d'Ivoire running the lab there. And then, my interest shifted to institutions. The only way that would make me stop was to build institutions for them. So, I started thinking about how do we create a sustained society for lab medicine that can truly be that umbrella that brings people together to think about laboratory medicine very broadly and create consistency for the continent that will drive the agenda for laboratory testing. So that's how we ended up creating the African Society for Lab Medicine.

MILLER: You came back to US CDC Headquarters in 2002 and served as chief of the HIV International Vaccine and Support Laboratory. But then in 2005, as the PEPFAR program was scaling up, you were selected to serve as chief of the International Lab Branch of the Global AIDS Program and as co-chair of the Office of Global AIDS Coordinator of the Washington arm of PEPFAR. You were asked to serve as co-chair of this laboratory technical working group, which had a very large mandate of looking at leadership of this entire PEPFAR program, which was a five billion dollar a year effort and looks at all the lab activities in these forty-one PEPFAR countries. So, it was a lot of resources, 01:01:00probably more than you had dealt with in the past, but a lot of responsibility. Can you describe why you took this assignment, and what was your initial thinking about the challenges?

NKENGASONG: First of all, when I left Côte d'Ivoire in 2002 and came to Atlanta, I was working in the Division of HIV/AIDS Prevention, DHAP, but assigned to, work in [Dr. Steven] Steve McDougal's lab. And my essential role there was to support the vaccine trials that the DHAP epidemiology branch under Alan Greenberg was doing overseas. Of course, Côte d'Ivoire was shaky because of the instability there-- Kenya, Thailand, and I think we were looking at Uganda as well. So, I started looking at that--and Botswana, we were doing 01:02:00another trial in Botswana to look at PrEP [Pre-exposure prophylaxis]. So, my goal there was to support all of this. But as we did all of this, I realized, and PEPFAR was ramping up and becoming exciting. I said if I have to sit somewhere and not do science but do support work internationally, the best place to do this was not in DHAP, but it was in PEPFAR. So, I shifted, and I remember when I took the job in 2005, people were very surprised. They said, you are a very good researcher, you've done all of this nice work, what are you going to be doing in PEPFAR? You're going to be doing logistic support work. Someone characterized it as, John, why would you step into cow dung? And I said I want I think I could do--but it was very challenging because, at that time, they were not even up to forty-one countries, there were 15 focused countries. And just to 01:03:00make sure you put in basic serology in a way that you had accountability and quality control of the testing in the fifteen countries was a big, big challenge. The very first thing we did, of course, in partnership with Bob Martin, John Ridderhof, and Tom Hearn, was to develop a package on guidance on how to do appropriate rapid tests. Here we are in 2002/3, and HIV serology has been going on forever. But the challenge that we had here was not just doing the test-- it was to scale up the test, which was significantly different from what we were doing before PEPFAR, which was limited to hundreds of thousands. Like I said, in Côte d'Ivoire, thirty thousand to forty thousand, now you had to go up to a hundred thousand of tests and using rapid tests. So rapid tests, even 01:04:00though a few years before there were only about five to six HIV rapid tests, because of PEPFAR, many companies started producing rapid tests, and it was our responsibility to ensure the quality of that, to put multiple layers of quality there. And CDC had no process in place to ensure the quality of rapid testing up front. When I joined PEPFAR, and the questioned arose in the country, if we knew what the performance was, we call a few directors like [Dr.] Robert Downing and say, Robert, have you used this test? And you say, yes, it seems to be working well in the hands, and I would recommend that. So, when Ambassador [Deborah L.] Birx, came, at that time Dr. Birx, the first thing that we did with her was to agree that we put in a panel, an internationally collected panel, characterize it and use that systematically to evaluate or test from headquarters, then 01:05:00advise PEPFAR on which test kits to purchase for the partner countries.

MILLER: So, the panel is people, or the panel is a panel of specimens?

NKENGASONG: Of specimens. Plasma or serum that we collected from multiple countries. From Kenya, Uganda, Cameroon, Côte d'Ivoire, China, Thailand, and we all-- large volumes, blood units because we wanted to make sure we had enough volumes that could be used for a long period of time. So that was the first analysis. That almost looked like a laboratory process where a rapid test would come in, and we'd evaluate it, and it was based on about 1,500 units of blood that we collected and sequenced the virus. So, we actually knew the subtype of virus that was there, we knew the plasma and used that. And I think some of that is still being used today in evaluating the test which we set up thirteen years ago.

MILLER: Where was that done primarily? In Atlanta?

NKENGASONG: It was done primarily, yeah. We collected blood units, HIV infected, and negative units across multiple countries and shipped them here, characterized it, and stored it in deep freezers in smaller amounts in order to take out and test it.

MILLER: So how many lab people did you have working for you at that time?

NKENGASONG: At that time, when I just started the lab program in PEPFAR, there were just over ten people that we had in the lab. Fast forward, when I left last year, we had around the program up to seventy-six people in the lab. So, it was a very steep curve going up very quickly to about seventy something. Very importantly, in the field, I believe there were only about two lab people in the field. It was Robert Downing in Uganda, and I think Jane Mwangi in Kenya. But as 01:07:00I left, nearly all our programs had a lab advisor in the field-- there were 40 something lab advisors in the field. So, if you combine the colleagues in the field and headquarters, we were running a tight operation of close to one hundred and something people.

MILLER: So, for PEPFAR, initially, you needed to standardize the rapid testing approach. What were some other priorities as you moved along, and since there was a dramatic scale-up of treatment of HIV in Africa during those years and continuing?

NKENGASONG: There were two tests that took a lot of our time. One was, I said, rapid testing because, without rapid testing, we would never have made any breakthroughs in scaling up ARTs. The second test was a CD-4 count. Even though 01:08:00viral load was around, WHO guidelines had suggested or recommended that we use CD-4 count as a marker to monitor treatment. So, scaling of viral load, CD-4 was also a big challenge.

MILLER: What's challenging about that? What do you have to do to implement? I know there was the FACS [fluorescence-activated cell sorting] counter, other equipment. What did that involve?

NKENGASONG: It was the technology and the human resource to do that. One, a serologist said the FACSCount was there, and not everybody had the ability to, afford a big FACSCount machine, and then even if you had it, gauging the amount of platelets was not easy. You needed qualified people to do that. So as the market grew, the companies also got savvy, and then they developed the 01:09:00FACSCount, which was still using the same technology, but it required less manipulation. Then as the field for that evolved, it went down to a very simple process where you just stick in a tube of blood, and then it gave you, what we call, point of care CD-4 count machines. But the early days was really mainly FACSCount machine and BD FACSCalibur. from Becton Dickinson. So that was also a challenge. Now, we also had to extend our drive for quality assurance from the HIV rapid testing to CD-4 because you had to have panels from that you challenge the labs all the time to do the quality assurance for the CD-4.

MILLER: Can you talk a little bit about, you mentioned you finally got to the point of care, and that theme carries out in many lab interventions in Africa. 01:10:00So initially, for example, with the FACS counter, would it be put in a central location, at a district location? What were some of the challenges in thinking about how to operationalize this new level of sophistication, really?

NKENGASONG: When we set up with the FACSCount machines, it was highly centralized. That required that you get blood from the district or the distant sites to the laboratory and tested them, and it came with all the challenges. The transportation process was difficult, and when they came in there, some of the blood had been hemolyzed, and it wasn't in any good condition. So, I don't you had the expected results there. So that was the first challenge, maintenance of equipment. Even if you had the equipment placed around say Kenya, multiple sites there, you still needed to have Becton Dickinson, the company that 01:11:00produced them, to be able to send the service providers to go around there because this was very specialized missions that you didn't allow for local technicians to go in and do any manipulations. So, was the company able to support all of this? At times it did. At times admission will break down or not breakdown, but it wasn't serviced for months, so that became a problem.

MILLER: Maybe looking back now, what were some of the decisions made? How was some of that fixed?

NKENGASONG: Some of that was fixed very rapidly. It was two ways. Multiple companies started getting involved in the CD-4 business like the Becton, and others started getting involved and producing different simple to use CD-4 machines. Becton Dickinson moved quickly to developing a smaller point of care 01:12:00test. So, it became easier for people to use in the clinic facility without a lot of training because all it required was to stick in a tube, and you wait for 10 minutes, and the results will show up and print itself out. Those changes change a lot, and they reduce the time from when you did testing and enrollment of patients into ART treatment compared to what it used to be previously.

MILLER: What about the cost? How was that dealt with?

NKENGASONG: The cost was still problematic. I would say because of the cost of reagents, the cost of the service contracts were always very high. How do you maintain a service contract for these machines? Now, the point of care machine 01:13:00didn't require a lot of service contracts, but the unit cost was higher than what you had for a FACSCount just because they had to compensate for the technology.

MILLER: And where did the money come from for that?

NKENGASONG: The money essentially was donor money from PEPFAR or the Global Fund. That was essentially just that we're driving those, not necessarily the countries. It might be shifting to there, but I think it was mainly donor funding.

MILLER: So, a good investment in terms of laboratory development.

NKENGASONG: A good investment in terms of expanding the technology into remote areas and using them for programmatic engagement and outputs and impact. But unfortunately, the conversation got a little bit confusing because people 01:14:00thought the availability of point of care tests meant that you could ignore your laboratory networks in the countries, which is not true. And there was tension for a while until people realized that if you don't have a good laboratory network in the country, you can't properly introduce a point of care testing. For example, who's going to evaluate your old validated point of care test at the national level. So, if you brought in a point of care machine for CD-4 or viral load, who is going to validate it? Who is going to provide quality assurance? Who is going to ensure that the test is being done appropriately in the field? So, you needed a lab network in the country to work well before you actually introduce appropriately a point of care testing.

MILLER: And then the suggestion of having a national lab strategic plan?

NKENGASONG: Yeah, and then we started up a movement around 2005, 2006. I 01:15:00remember the very first country that we went to, to have them develop the national strategic plan was Kenya. And at that time, Ethiopia had developed a national strategic plan for HIV labs. So, we were in dialogue with them to convert that into a more broad-based strategic plan for laboratories.

MILLER: Exciting.

NKENGASONG: Those two countries started up developing but fast forward as years would go on, we supported our thirty-seven countries in developing their national strategic laboratory plan that we integrated because we're pushing along the concept of integration. We cannot just have one HIV lab and then another TB [tuberculosis] lab. We wanted to use the big three-- malaria, tuberculosis, and HIV to actually develop an integrated lab strategic plan.

MILLER: When you look back at the PEPFAR days, what would you say you're most 01:16:00proud of? What were the top things accomplished? There were so many, of course.

NKENGASONG: Strictly from the laboratory standpoint, I would say the period between 2008 and other years that coincided with the reauthorization of PEPFAR was personally my most exciting years because we've learned the lessons from PEPFAR 1, which said that one of the lessons was that because of our efforts, we had created silos, a lot in countries because we're deeply focused on HIV. So, a hospital lab next door that didn't receive PEPFAR was almost in horrible conditions, and then the PEPFAR lab was--a lab supported by PEPFAR actually was doing better than that. In 2008 when Congress reauthorized PEPFAR, there was 01:17:00language there that said you should strengthen systems. We took that language, and we ran with it and develop what we call the strengthening of lab management towards accreditation. And then generated a movement in the continent that was really, really exciting. We said, look, instead of just looking at proficiency testing, we should look at it in a holistic way. So, we called a meeting in Kigali, Rwanda, in 2009 with WHO and others, and we agreed on what we call the step-wise laboratory improvement process towards accreditation. And today, about 100 labs, government labs in Africa are accredited, and many more as of last week, naturally they've gone through the process now and independently without PEPFAR support, they are getting to where they are supposed to be. That is really a remarkable achievement. A steep turning point. When we started that in 2009 in partnership with the Clinton Foundation, the American Society for 01:18:00Clinical Pathology, people said, John, you are dreaming that, there's no lab in Africa, a government lab, that will ever be accredited because their standards were so low. But the situation is very different today. That was a very proud moment for us. The second proud moment that I can think of is our ability to scale up the diagnostics for infants. When we started this process in 2003, only three countries had the ability, PEPFAR supported countries, had the ability to diagnose infants using PCR. Those were Rwanda, South Africa, and Botswana. Years later, after we get multiple countries and multiple labs even within the country being able to do PCR testing, which we couldn't ourselves believe that we would be able to scale up PCR testing that quickly in Africa where basic serology was still a challenge. Because of that, many more children were diagnosed and put on treatment.

MILLER: Are we talking about the use of dried blood spots? What were some of the key elements of that scale up to enable a child for diagnosis?

NKENGASONG: The game-changer there was the ability to adapt PCR testing to dried blood spot, which is what we did here extensively with [Dr.] Chin-Yih [Ou]. In 1988, Chin-Yih had published a paper in Science that showed that you could detect DNA [deoxyribonucleic acid] in the cells of infected patients using PCR testing. But that was using whole blood. Now, adapting it to a dried blood spot where you just prick a child's finger, and you take a blood spot, and then you transport it to a reference lab or a more centralized facility and do PCR on it 01:20:00was a game-changer.

MILLER: So, the blood, is it put on a little piece of card board, or how is it transported?

NKENGASONG: The blood is, first of all, a finger or a heel prick is done, and then about three drops of blood are collected and put on a piece of paper called the dried blood filter paper and transported. You just allow it to sit at room temperature for overnight, it's dried, and you package it well and then ship it to the reference lab. When they receive it, they just punch it, and you do PCR testing on the extract, of course, the DNA and do a PCR testing on it. You could transport many samples-- there was no risk of infection. That dramatically changed the way we approached diagnostics of infants, especially when we're trying to do testing as early as four to six weeks.

MILLER: Was that methodology used for widespread beyond children for peripheral sites where it's difficult to get the work done in the periphery? What was the rate-limiting aspect of using that technology?

NKENGASONG: The only challenge that you had, and a significant challenge, was returning the results in a timely fashion back to the clinics so they could be used in managing the patients. As we know, technology, as I've learned over the years, is that you're all excited to get new technology be it viral load or CD-4, but the other end is that the dialogue between the lab and clinicians doesn't really occur in real-time. The PCR results in infants were available, so the labs would test it and put it on a shelf, and it took way longer for the 01:22:00results to leave those shelves and go back to the clinic to be used for managing the patient. It's a process that, over time, it got improved, but often there was fifty percent of the results were either delayed or never went back to the laboratories. But the situation has actually improved a lot today.

MILLER: And the use of cell phones and message technology.

NKENGASONG: Exactly, use of cell phones, yes, texting.

MILLER: Well, as we're coming to the end, I guess in looking back, you've had an amazing career. Can you talk a little bit about how CDC contributed or not to this aspect, all of this development? What did we do terrifically, what could we have done better?

NKENGASONG: I think overall, my reflection is, instead, [one] of gratitude, my 01:23:00personal gratitude of ever being part of the CDC because they offered me personally the latitude to really transform myself from a basic scientist into a public health [leader]. I didn't go to a school of public health to learn that. I learned public health on the spot and by observing people like you and Kevin De Cock and others who actually did public health as such. So, CDC provided that enabling involvement. When I mentor people, I tell them that CDC is a great resource. But don't get carried away by the fact that it allows you to do what you want to do but stay focused and always ask yourself the question, what is my contribution in what I'm doing? Are you really contributing, or are you just being part of the show? I think that is a question I ask all the time when I'm part of anything. What is your own contribution? Because CDC has all these 01:24:00resources. The only limitation that you see at CDC is it's a very big enterprise, and you may not even know what is going on upstairs. One day if you finally cross--it may take you four years trying to do something that somebody has done already at CDC. So how do you really know about the partnerships, the prospects, that exist within CDC? But if you can reach out to people across CDC, it becomes a wealth of opportunities that exist. The only thing I can say for CDC is just to be part of the work that as an organization they did from basic science and HIV. When we started off, we were doing basic HIV work in Thailand and Côte d'Ivoire and then expanded to forty-one countries. Today PEPFAR is 01:25:00what it is. I would say that half of the success of PEPFAR could be attributed to CDC's engagement using the few experienced, a few offices, their commitment to public health. I truly think that it has done great. If I had to advise PEPFAR, I would say that they should also think of investing in training senior public health officers in the country the way we used to do prior to PEPFAR: to send some senior people to do public health training in some universities in the US or even in Africa., so that you build that level of capacity. We spend a lot of time expecting the countries to take leadership in managing their program, but without the people, the seniority, and know-how of the people, I think it will continue to be a challenge.

MILLER: Thank you very much.