People of AMPATH: Professor Edwin Were

YOU HAVE BEEN INVOLVED WITH AMPATH SINCE THE BEGINNING. WHAT ROLES HAVE YOU SERVED IN?

Professor Edwin Were

I have been involved with AMPATH since its inception, as I contributed to the initial project write-up (for the HIV program) around 2000. The project document was essentially based on the background of the development of the inter-university collaborations with Indiana University. However, my contribution to the collaborative network that eventually developed AMPATH began in 1991 when I joined Moi University, Faculty of Medicine.

When AMPATH was conceived around 2000, I worked with AMPATH as part of the clinician and university lecturers involved in HIV management. When we received the initial AMPATH HIV grants I was in the Department of Reproductive Health, and my concerns then were how to manage HIV to reduce Mother-to-Child Transmission among women living with HIV. This is an aspect that I worked on for quite a while. Later, between 2012 and 2015, I worked with AMPATH as the Deputy Chief of Party (DCOP), leading the Prevention of Mother-to-Child Transmission (PMTCT). However, after 2015 I veered off the mainstream AMPATH, though I still work on aspects of the AMPATH program and research.

WHAT ARE SOME AMPATH PROJECTS YOU HAVE BEEN INVOLVED WITH THAT YOU THINK HAVE BEEN MOST IMPACTFUL DURING YOUR CAREER?

During my tenure as the DCOP leading PMTCT, the Ministry of Health (MOH) developed a policy to integrate PMTCT into normal Mother and Child Health (MCH). This was per the adoption of World Health Organization (WHO) policy recommendation called “Test and Treat” in management of HIV. The policy involved commencing full antiretroviral treatment for life as soon as HIV diagnosis was made. This policy simplified the management of HIV cases and made it possible for involvement of lower cadres (including MCH staff) to be enjoined in the management of ART. During this integration, I led the team in moving the PMTCT program from AMPATH to the MCH program.

In addition, there are two major clinical trials that I participated in through the AMPATH collaboration that impacted my career and were an outstanding contribution to policy development in HIV care. In 2004, I got involved in a large multicenter HIV prevention trial among discordant couples (one person is living with HIV and one is not) that tested the transmission of HIV in situations where the HIV partner in a discordant couple also had the herpes simplex virus. The hypothesis was that having both HIV and herpes made it easier to transmit the HIV to the HIV negative partner in the discordant couple during episodes where they did not adhere to condom use as recommended. The idea was then to suppress the herpetic eruptions in the genitalia using a (then easily available) antiviral drug against herpes called Acyclovir and that should reduce HIV transmission to the HIV negative partner. After about two years of follow-up on the study participants, the results were negative: Acyclovir did not significantly reduce HIV transmission in the HIV negative partner in a discordant couple. Still, there was evidence of the suppression of the herpes simplex virus, and there were lessons learned on how to do discordant couple testing and counselling leading to manuals on Discordant Couple Counselling and Testing. This was the first significant clinical trial I was involved in and I developed skills and expertise in clinical trials.

The second trial was called the Partners PrEP study which started in 2008. The multicenter trial in multiple sites around East Africa and Central Africa tested Pre-Exposure Prophylaxis (PrEP) in discordant couple partners. This study leveraged the experiences working with HIV discordant couples in the previous Acyclovir Study. The hypothesis was that if the HIV negative partner was on antiretroviral drugs for prevention, they would be significantly less likely to acquire the HIV infection from their HIV positive partner during episodes of unprotected sex if they were not fully adherent to condom use. The study lasted about five years and demonstrated a high level of protection for the negative partner using PrEp in discordant partner relationships. It was a landmark study for me as it gave me another excellent exposure to prevention clinical trial. This study is one of the primary studies that contributed to incorporating PrEP as part of the strategy of HIV prevention which has been adopted globally for specific key populations. I have also been involved in other HIV-related clinical trials and observational HIV studies.

WHAT IS THE ROLE OF THE MOI INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE (IREC) AND WHY IS IT IMPORTANT?

I was inducted to the MTRH-MU Research and Ethics Committee in the early 90s and served as secretary for more than 15 years. I served as the Chairman of the committee from 2015 to date. During this time, IREC has grown from a committee working ad hoc without guidelines to one with formal structures and Standard Operation Procedures (SOPs). IREC's first SOPs were developed in 2000, guided by WHO recommendations and adapting many structures from Indiana University.

Regarding AMPATH research, one of the most significant achievements that IREC had is its accreditation to the Office of Human Research Protections in the U.S and being assigned a Federal Wide Assurance number. This critical milestone in 2003 meant that institutions forming the AMPATH partnership could access research and care funding from the US federal funding pool. Without the accreditation and a functioning Institutional Review Board (IRB) supported by IREC, the grants from the US that to date are cumulatively over 27 billion Kenyan shillings would not have been accessed. IREC also helps the research enterprise in Moi Teaching and Referral Hospital and Moi University to develop scientifically sound and ethical research and provides peer review and mentorship for the researchers.

WHAT IS THE ROLE OF THE MOI UNIVERSITY RESEARCH INTEGRITY OFFICE? HOW IS THIS DIFFERENT FROM THE ROLE THAT THE IREC PLAYS?

The Moi University Research Integrity Office (MURIO) was launched in April 2022.

IREC's accreditations by the Office of Human Research Protections in the US came with conditionalities. One of them was the requirement to have the committee generate annual reports of incidents of research misconduct encountered. For many years, IREC struggled with the structures to identify and deal with research misconduct. The perfect opportunity to establish systems to address this was the Research Integrity Oversight project (RIO) capacity building grant application that was awarded in 2017.

This grant from the Fogarty International Center at the National Institutes of Health (NIH) enabled us to document the existence and occurrence of research misconduct. The information was used to convene a national workshop that developed a consensus framework that institutions in Kenya could use to develop their own structures and guidelines for managing research misconduct. The framework accepted that institutions must develop a procedure embedded in the existing institutional structures to oversee the transgressions.

The Moi University Research Integrity Office (MURIO) was then developed to pilot the structures for managing alleged cases of research misconduct in Moi University. Funds from the RIO project helped procure the equipment for the MURIO office. We then embedded research misconduct in the Moi University Research Policy and developed standard operating procedures to operationalize the office. After the senate's approval, MURIO was officially launched by the office of the Vice Chancellor on 25th April 2022. The MURIO is being run by a small secretariat, currently under the Directorate of Research of Moi University led by Ms. Bridgit Kosgei, who was seconded by the research director.

The difference between IREC and MURIO is this: While IREC is meant to help people develop ethical and scientific research through peer review, MURIO is mainly mandated to manage misconduct. When IREC finds a case of research misconduct, their job is to whistle blow to MURIO, which will then make the decision on investigation and determination of the allegation. The process at MURIO is quasi-legal and very adversarial, with punishment at the end of it. MURIO, however, is also expected to focus on preventing misconduct by organizing training on responsible research conduct, which involves the ordinary research ethics that IREC does, mentorship on ensuring data and reporting integrity, and promoting inclusive publication for all involved in research projects.

WHAT FUTURE GOALS DO YOU HAVE PERSONALLY AND RELATED TO THE AMPATH RESEARCH PROGRAM?

The AMPATH Research Program has grown quite a lot, as it should, and has gone to multiple disciplines, programs and areas. The program achieves a lot because it utilizes working groups that act as internal peer review processes that nurture research conceptualization and development. In my view, we need to continue incorporating more people into the AMPATH Research Program way of doing things. Some people think that if they are not working in mainstream AMPATH, then they cannot be in the AMPATH Research Program. This can be tackled through awareness creation and letting people know everybody is welcome to use the AMPATH Research Program's structure to nurture ethical research.

WHAT MAKES THE AMPATH PARTNERSHIP SPECIAL?

If you ask me, AMPATH, in the research setting, embodies and exemplifies the fair benefits framework. The fair benefits framework recommends that to avoid exploitation of the research participant who are exposed to research risks, however small, some benefit must go to the participant. This could be through training, infrastructure or the improvement of the community regardless of the research results. AMPATH research is the fair benefit framework in action because, within AMPATH's mandates of care, training, and research, AMPATH always leads with care. So, whether there is research or not, the care infrastructure has been developed and is still being supported continuously. Additionally, many health professionals and students continue to receive care and research training through the AMPATH collaboration, and I am a beneficiary. So, when you layer in research and the specific research does not bring out a positive outcome, as was expected by the hypothesis, you already have the community benefiting in multiple ways through better health care, jobs and training.

This makes me happy, and I can sleep easy knowing that despite working with significantly better resourced partners, the framework at AMPATH harnesses that power to develop our community so that everyone benefits from the work: the researcher, the community and the health sector.