Looking at the link

Can you speak to why you chose to focus on AIDS/HIV?
My final years of pharmacy school coincided with the peak of the HIV pandemic in Zimbabwe; it was also the year when we had the opportunity to do clinical rotations at the teaching hospital. So, I worked with a lot of patients with HIV and AIDS. Antiretroviral (ARV) therapy wasn’t widely available in Zimbabwe, so most patients weren’t on treatment. Many were suffering severe HIV and dying. I researched a lot around HIV, AIDS, ARVs, and other treatment modalities. For my final-year honours project, I studied the known chemistry and pharmacology of herbal medicines, commonly used by HIV patients at the time.

Getting to practice, my pre-registration training supervisor relied on me whenever any ARV prescriptions would come through the pharmacy because he completed his studies before the era of ARVs. As a result, my interest in HIV management grew. I saw opportunities and funding for training and research in the area. During my pre-registration training year, my undergraduate research supervisor facilitated a research training position for me at the University of California San Francisco (UCSF), where I began my work with herb-antiretroviral drug interactions using preclinical cell and animal models. There has always been lots to do in the area since then. I have never looked back.

You earned an MSc in Clinical Trials with the University of London. Why did you decide to embark upon the programme?
Upon my return from my stint at UCSF, I realised the work I had done, being preclinical, didn’t have immediate clinical relevance to our patients as was my ambition. So, my attention was drawn to the field of Clinical Trials. Because of the challenges I faced in getting a clinical trial I proposed for my PhD studies approved by the national drug regulatory authority, I sought training in clinical trials.

The main challenge was that my intervention was a traditional herbal medicine, which didn’t have a standardised or approved formulation. I wanted an in-depth understanding of the science of clinical trials so that I could design a robust trial that had good risk-benefit balances, was credible, and appropriate for assessing the effects of herbal medicine in people living with HIV (PLWH).

How did the programme prepare you for your work?
The programme was extremely helpful. I applied literally every module of the MSc Clinical Trials programme during my PhD studies: from redesigning the clinical trial to addressing the safety and ethical concerns raised by the regulatory authority, to managing the project costs and quality, and publishing my findings. The trial became the first regulatory-approved clinical trial with an herbal intervention in Zimbabwe. Publications from this work were instrumental in the establishment of regulatory frameworks for herbal trials and herbal medicine evaluation in Zimbabwe.

Since then, I’ve served as a clinical trials specialist in various capacities. I help colleagues strengthen their trial designs, I assist the national and institutional ethics committees in assessing applications proposing clinical trials. I sit on a paediatric trial steering committee. I also mentor postgraduate students in conducting clinical research.

Because I took the online version of the programme, I didn’t meet classmates or faculty until graduation. However, I appreciate the high level of engagement and detailed feedback as well as the faculty’s commitment.

You are interested in the relationship between conventional medicine and herbal treatment. Why is this important when looking at ways of treating people living with AIDS?
Initially, when I became interested in herbal medicines, as much as 93% of our patients were turning to herbal medicine because of the limited access to ARVs. Many of the patients were using herbs to manage their symptoms of AIDS. But even as ARVs became more available, the trend declined, but did not disappear.

In fact, since the pandemic, this trend has been growing as many people turned to herbs for the prevention and treatment of COVID-19 in the absence of approved treatments. These findings show that the use of herbal medicines is a legitimate medical practice. We cannot afford to turn a blind eye to the interplay between conventional medicine and herbal treatment.

Many patients believe that because herbs are natural, they’re safe; on the other hand, clinicians cite herbal medicines as one of the causes of liver and kidney damage among patients. PLWH are typically on multi-drug ARV treatments already, so they’re at a higher risk of medication safety issues. We need more research in this area. We see a growing evidence base for screening and other type of non-clinical studies, however, we need more development of clinical evidence.

Our research group, Research Unit for the Safety of Herbs and Drugs (RUSHeD), works with PLWH to evaluate adverse effects and potential interactions of widely used herbal medicines with ARVs and medicines used for managing non-communicable diseases. It’s important to know which herbs are safe, which have potential for interaction, which are effective and which are not.

The biggest challenge has been that clinicians shy away from engaging with patients on the issue because they aren’t equipped to deal with it; as a result, what’s recorded in the health records doesn’t capture the wide-spread use and any resultant effects, leaving us with very little to work with, in terms of research. We secured funding from the Fogarty International Centre and worked with HIV clinicians to develop an herbal medicine-use documentation tool. The hypothesis was the tool would assist HIV clinicians to gather and record herbal medicine use data consistently, in a standardised way. We’re currently incorporating it into electronic medical records at two HIV clinics.

The vision is to mine the database for any safety issue (e.g. drug interactions, adverse reactions) and to spot any potential efficacy associated with herbal medicine use, which would be further investigated in well-designed clinical trials.

Alongside the medical side of AIDS/HIV, is the policy and social side. What are some challenges you’ve seen during your career, in terms of stigma surrounding AIDS/HIV education, and how did you and your colleagues try to combat that stigma? 
We have come a long way in terms of stigma. I think our health care professionals are generally well informed and advocate for PLWH. We still have issues on the social side. Between 2017 and 2020, I managed the teaching Hospital HIV Clinic Pharmacy. We noticed that at the end of the day, our bathrooms would be full of empty medicine bottles and packets. When we engaged the patients, we realised that many had not disclosed their status even to the people they lived with. They would prefer to transfer their medication into tissue or plastic paper so that when they reached out to take their medication in the dark, the tablets would not make noise. Apparently that noise is associated with being on ARVs and comes with a lot of stigma, even from close family members.

Obviously, the practice has lots of product stability and effectiveness issues, and we had to devise alternative packaging and ask patients to speak up if they needed alternative packaging. So we still have a long way to go in educating communities and patients on the issue of stigma.

Finally, do you see some cause for optimism when it comes to AIDS/HIV in Zimbabwe, as well as globally?
We have made significant milestones in the management of HIV in Zimbabwe. My earliest memories of HIV, prevalence was one in every four. The latest ZIMPHIA 2020 statistics indicates that this has come down to 12.9% in those 15 years and older. That is almost a 50% reduction. Even in terms of the UNAIDS targets, 86.8% of people living with HIV know their status, 97% of those diagnosed on treatment and 90.3% of those on ARVs virally suppressed. We have transitioned over 90% of our adults on the national ARV program to dolutegravir-based regimen which has shown to be potent and has a high barrier to resistance.

Globally, I believe the more recent longer acting antiretroviral formulations will be the game changers. ARVs are now very effective and acceptably safe. A formulation that you can inject at home or at the local pharmacy once every three months will simplify treatment and solve a lot of the adherence and access challenges. This is in terms of both prevention and treatment. As a nation, we have been involved in several HIV prevention and treatment trials with these newer formulations, which I believe has already set the groundwork for good uptake.

We will need to work more to deal with the vaccine hesitancy we are observing with COVID-19, but there definitely is a reason to be optimistic!

Dr Tsitsi Monera-Penduka is a researcher and pharmacist, and senior lecturer at the University of Zimbabwe.

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