Recent trials have indicated that the drug Truvada® is effective in preventing the acquisition of HIV. However, the participants of one such trial consisting of serodiscordant couples conducted in Kisumu, Kenya, do not have post trial access (PTA) to Truvada®. Who is responsible for post-trial access for the participants?
That is the question that Dr. Stella Njuguna is trying to answer through her mentored research project for Fordham University’s HIV Prevention Research Ethics Training Institute (RETI). Dr. Njuguna is the recipient of this year’s Fordham Center for Ethics Education/Santander Universities International Scholarship, which provided her with the funds to travel from Kenya to New York City in July to attend the HIV Prevention Research Ethics Training Institute. Her mentor for the project is Dr. Sean Philpott, of Union Graduate College.
Dr. Njuguna is a Research Officer at Kenya Medical Research Institute (KEMRI). She earned her pharmacy degree from the University of Nairobi, Kenya and a MPH in Epidemiology from the University of California, Berkeley. Currently, she is a Co-Investigator for the HIV- Neurology in Kenya Study 2 (THINK-2) and a pharmacist and epidemiologist for Sustainable East Africa in Community Health (SEARCH) study. Her main research interests include: HIV prevention care and treatment as well as socio-behavioral research especially within HIV discordant couples.
As mentioned above, Dr. Njuguna’s RETI mentored research project examines post-trial access to Truvada® amongst HIV-1 discordant couples enrolled in the pre-exposure prophylaxis (PrEP) study in Kisumu, Kenya. Specifically, she seeks to (1) explore participants’ views about post-trial access to Truvada®, and (2) identify potential delivery to Truvada® to the couples.
Dr. Njuguna notes that although recent studies have shown that Truvada® is effective in preventing HIV infections in most at risk populations, it was not made available to the participants of the PrEP study that took place in Kisumu, Kenya. She chose this as the topic of her mentored research project because it “is a critical ethical issue embodied in the principle of distributive justice that needs to be addressed.”
Q&A with Dr. Stella Njuguna
1) How did you first become interested in HIV research?
One particular case, from my time working as a clinical pharmacist in charge of the HIV clinic at Lugari District Hospital in Western Province, left a mark in my life. In 2006, a mother came to the clinic for routine HIV counseling and testing. Unfortunately the test confirmed her worst fears; she was infected with the HIV. She started coming for regular clinic visits and I advised her to get her children tested as well. At first she was reluctant, but with intensive counseling she agreed. Her youngest was infected and had to start care immediately as her health had deteriorated. I made sure the mother understood the gravity of her daughter’s condition. Initially, the child was responsive to treatment but after three months she took a turn for worse; she was infected with Cryptococcal meningitis and was rendered bed-ridden. This took a toll on her mother who had no source of income and an alcoholic husband who was oblivious of what was happening. The woman sacrificed her own health and stopped coming to the clinic so that she could take care of her child. I decided to pay a home visit to the family since the mother had missed several clinic visits. I pleaded with her to come to the clinic for routine tests and medication reinitiating. Her cd4 levels had dropped probably due to non- adherence to her antiretroviral medication.
Unfortunately, in July 2009 the mother succumbed to HIV-related complications and died; after futile effort the child died too because there was no other care-giver to look after her except for the alcoholic father. For a while, my erstwhile enthusiasm to join the healthcare system was dampened. However, I was convinced that there had to be a positive contribution, albeit small, I could still make. This prompted me to venture into HIV research.
2) How did you first become involved in HIV research?
In 2008, after a very competitive interview process, I was offered an opportunity to work in HIV research as the Lead Pharmacist in Kisumu, Nyanza Province, located in western Kenya. This was at the Couples Intervention Study which is affiliated with Kenya Medical Research Institute (KEMRI). The study works in collaboration with University of California, San Francisco and the University of Washington. The aim of the study was to evaluate the effect of anti-retroviral treatment to prevent HIV-1 transmission among sero-discordant couples. Nyanza is Kenya’s hardest hit area by the HIV pandemic with 15% prevalence. I was determined to find out whether through well-designed clinical trials in our local settings new interventions can be found that may help eradicate some of the constraints. I saw this as an opportunity to learn more about the HIV / AIDS and how research findings are translated into policies. This was my first experience in clinical research and a few months into the program I knew with certainty that I wanted to pursue a career in clinical research.
3) Are there any challenges in HIV prevention that are specific to Kenya?
44% of married/cohabiting HIV-infected persons have an uninfected partner. This population of sero-discordant couples contributes significantly to the incidence of HIV infections in the country. Therefore, since the majority of HIV-1 transmissions to adults in Africa occur within stable, HIV-1 discordant couples, PrEP would be a beneficial intervention for this high-risk heterosexual population. However, the continuing global financial and economic downturn threatens future HIV funding so our greatest challenge is whether available funds can be diverted from provision of HIV treatment to cater for HIV prevention? Is this realistic or even feasible? How we will sustain PrEP provision to potential end users? How will we improve our health infrastructure to form a well-targeted program that is vital for PrEP delivery? Furthermore, Kenya is now moving toward a devolved government for health service delivery, therefore we need to ensure that service provision is adequate to respond to the health needs of the citizenry within each county. In my opinion, these are some of the questions we need to answer and provide solutions in order to successfully implement PrEP.
4) Do you expect the findings of your research will be applicable/generalizable in other parts of Africa/the world?
To some extent I do. PTA is not implemented in most resource limited countries where numerous ground breaking studies are conducted and yet these are the populations with the greatest need for the new intervention under investigation. Therefore, the participants views elicited from my studies will probably reflect the same sentiments shared by study participants in similar settings. I am very excited about this study as this will be a platform for the study participants to air their views as well as a resource for investigators to think about PTA and discuss this with their sponsors and formulate a roll out plan if the intervention is successful before study implementation. Furthermore, most guidelines are silent on the issue of PTA so I hope the findings will catalyze change.
5) What, in your opinion, is the future of HIV prevention?
It’s bright and exciting. Although a HIV vaccine is not yet a reality, we need to implement a mix of HIV prevention strategies that have the greatest impact for a specific community based on the profile of their local epidemic and an assessment of the gaps in current HIV prevention programs. For example, in SSA women of reproductive age bear the greatest burden of HIV infection. They have a need for the prevention of STIs including HIV and therefore, as efforts toward new biomedical HIV prevention options are ongoing, scientists need to consider more efficacious contraceptive methods that would be germane to this population. Developing products that can be useful for dual purposes (MPTs) with a single mode of delivery is a critical need. In the words of Sharon Camp-President and CEO Guttmacher Institute, “Women want contraceptive methods that can protect against both pregnancy and disease without unpleasant side effects, which do not interfere with sex, require little or no medical supervision and are effective when used post-coitally”.