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Dr. Emily Shava explains the Antibody-Mediated Prevention (AMP) study

DR Emily Shav

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Enrolment is ongoing in the Antibody-Mediated Prevention (AMP) study. Tell us about that. What is AMP and how exactly does it work?

AMP is a multicentre study being conducted in different countries by two global networks known as HIV Prevention Trials Network (HPTN) and HIV Vaccine Trials Network (HVTN). The AMP study in Sub-Saharan Africa is enrolling women and is also known as HVTN 703/HPTN081 Study. Women because in Africa they are among those at highest risk of HIV infection because of their physiology and gender based imbalances. In this study broadly neutralising antibodies (Bnabs) known as VRC 01 are being studied to see to what extent they can prevent acquisition of HIV-1(efficacy) and to what extend VRC01 can be tolerated by participants (safety).

This is a follow up of previous studies which showed that VRC01 is generally safe and well tolerated (HVTN 104).
It is a double blind randomised placebo controlled trial. This means that participants do not choose which group they are to be on. The study has 3 groups, high dose VRC01, low dose VRC01 and a placebo group. They will NOT know which group they are in and the clinicians consulting them will also not know which group the participants are in. Only the site pharmacy personnel are unblended – they know which product is which. This is important to prevent bias. BHP has engaged and continues to engage various stakeholders (including Ministry of Health and Wellness, DHMT, clinics) and communities through the BHP community advisory board since 2015 when we were selected to take part in this important study. The success we are talking about now would not have been possible had the different stakeholders and communities not been on board.

What is your role in the Study?
I am the study coordinator for the project, responsible for day to day running of the study clinic. The person with overall responsible for the study in Botswana is the site investigator, Dr Joseph Makhema.

Who are the participants in the study? How many people are required and how many have you enrolled so far?
The participants are healthy HIV negative women at risk of acquiring HIV, aged between 18 and 40 years and willing to take part in the study. They should not be pregnant or breastfeeding and should be willing to use effective contraception to prevent pregnancy since the effect of VRC01 on pregnancy is unknown. In Sub-Saharan Africa a total of 1900 participants will be enrolled from Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania and Zimbabwe. 1555 participants have been enrolled as of the end of April. From Botswana a total of 150 participants will be enrolled.In Botswana the AMP study was activated in July, 2016. The first participant was enrolled on August 16, 2016. To date 236 participants have been screened/checked for eligibility to participate in the study and from these, 122 women have been enrolled and are on study as of May 4, 2018.

Willing participants provide written informed consent after discussion of all procedures, and their risks. The informed consent forms together with the protocol (document that explains how the study is conducted) and other pertinent documents for study conduct are submitted for approval by the Ministry of Health and Wellness, Institutional Review Board (IRB) known as Health Research and Development Committee (HRDC). This is the committee responsible for approval of research conducted in country.

What are the fundamental questions about HIV prevention that the AMP Study is designed to answer?
Are people able to “tolerate” the antibody without becoming too uncomfortable? Does the antibody lower people’s chances of getting infected with HIV? If the antibody does lower people’s chances of getting infected with HIV, how much of it is needed to provide protection from HIV?
When did it begin and when is it expected to end?
In Botswana the study started in July 2016.Total duration of study is 5 years. Each participant stays on study for about two years.

What HIV preventive care do volunteers receive and how are you ensuring the safety of study participants?
Participants come for study visits monthly. During these visits, we do what is called “history taking” from the participants to find out how they are feeling and have been feeling. We examine them and we conduct laboratory tests to ensure safety. To prevent HIV infection, we provide risk reduction counselling and HIV prevention package per Botswana Standard of care

What impact will this study have in the future of HIV prevention?
We generally liken HIV prevention options to a tool box. We currently have various behavioural modification options in this tool box, including abstinence, use of condoms effectively and consistently. It is therefore important to also add more biomedical interventions in this tool box. bNabs would then be an important addition if proven to be effective. This would lead to more combination prevention options. The idea of a toolbox with more tools in it is important because we know that when people have more choices, it increases the chances that an individual will find one tool that fits their needs and circumstances. Those decisions can be influenced by many factors – cost, ease of use, availability/easy access, partner agrees to use, etc. –so having more tools will mean increasing the chance of serving more people’s needs for HIV prevention.

How will the findings benefit Batswana?
I would say that it is too soon to say what direct benefit there may be to Batswana. This trial is about proving the concept that bNabs can prevent HIV. More trials will be needed to find the best antibody, or combination of antibodies, how to best administer them as a public health strategy amongst other things.

We know the strides science has made in the war against HIV/AIDS. There are very effective drugs and that is great news. But what do you say to young people that would say to you that it’s no big deal to get HIV and that there are already good drugs to control the disease as if it’s diabetes?
Prevention is ALWAYS better than cure. We are truly grateful for the strides that have been made in science to avail great treatments for HIV treatment. We do not yet have all the answers about the various great treatments available, time generally brings things to light. Additionally, prevention is more cost effective than treatment or a cure. (Note that in the question, diabetes isn’t cured – it is treated as a chronic illness.) That is important to individuals, and to countries/public health systems.

From your experience, do you believe that there will be an effective vaccine and/or cure for HIV in our lifetime? Is that an achievable objective you think?
Please note that in AMP study, the study agent VRC01 is NOT a vaccine but broadly neutralising antibodies (bNabs). This study could help us develop a safe and effective HIV vaccine more quickly. An HIV vaccine developed more quickly because of this study could essentially teach the body to make antibodies like VRC01 (without getting the VRC01-like antibody through an IV/drip). To develop a vaccine like that we need to understand more about how VRC01 may work, and how much is needed to “work” (to prevent HIV infection). This study should help us learn that. My answer on vaccine in our lifetime would be YES. The Thai Trial, RV144, showed us a vaccine regimen could reduce new infections by about 32%. That wasn’t strong enough to license, but it paved the way for a great deal of additional research. There are 2 efficacy trials currently underway in sub-Saharan Africa testing different vaccine strategies (one of which builds on the Thai results), so we have come farther than ever before.There are various international organisations with scientists whose main focus is the development of the HIV vaccine such as the HVTN, International AIDS Vaccine Initiative(IAVI) etc.

I understand that the HI virus lives not in the blood but lymph nodes and some organs. Is there any research
currently being done to try and flush out HIV from these compartments so that it can be killed by the antiretroviral drugs?
To clarify, when a person is on antiretroviral therapy, the amount of virus also known as viral load in blood will reduce. Generally, if a person is not on treatment the viral load will remain high. For people on treatment with low/undetectable viral load, scientists are looking into ways of flushing out HIV from its hiding places like the lymph nodes termed the “shock and kill” strategy.Currently I am not aware of any such study being conducted in Botswana.

HIV was around for decades before it was discovered and diagnosable and infecting humans during that period. Has anything been learnt from that to prevent a recurrence with another type of retrovirus?
This is a difficult question, yes human beings are capable of learning to better themselves in the future, to what extent, time will tell.

What good news can you give readers of this interview who are living with HIV/AIDS?
If someone knows they are living with HIV, it means they have been responsible enough to take the test and know their status. This needs to be commended. Currently we have available in this country potent antiretroviral treatment with minimal side effects, which means that people living with HIV can have improved quality of life, including sexual reproductive health and live longer.
I would also like to take the opportunity to highlight the importance of universal test and treat and for all HIV infected people to be on treatment and to take the treatment diligently. This is important because a persistently undetectable virus is not transmissible.

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Know Your Specialist

Caroline Gartland speaks on Children and Mental Health

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Tell us about yourself and your background
I’m originally from the UK but have been in Botswana for eight years so this is now home! I have a Combined Honours degree in Psychology an MSc in Mental Health and have had a pretty varied career.
I started off working with offenders doing rehabilitation programmes; went on to support the victims of domestic violence then ended up working in Child and Adolescent Mental Health Services for the National Health Service.
I’ve done a lot of work, mainly voluntary, in different fields since being in Botswana but my passion is now Early Childhood Mental Health.

What does your work entail?
Early childhood mental health is mainly working with parents, caregivers and teachers to help them understand how children develop and the best ways to support their mental health and brain development as they grow. It’s about providing training and opportunities for families to bond with their children and introducing new ways of playing and interacting.

What sparked your interest in early childhood mental health?
Quite simply, having my own children! My daughter was born five years ago and I was fascinated watching her develop and grow. It occurred to me that the younger you begin to consider mental health and provide tools for resilience against life’s adversities, the better outcomes you are likely to have.
I began reading everything I could get my hands on, and completed a diploma in Infant Mental Health. I’ve worked down the lifespan but I feel I’m now where I belong, working with babies and young children.

What mental health issues have you observed in children in Botswana?
Mental Health is still stigmatised around the world and Botswana is no exception. Most people immediately think of mental illness, but mental health is about so much more; we all have mental health and some days we are fine and able to deal with life’s challenges and some days we need more support and tools under our belt to help us cope.

Young children can experience mental health problems. Anxiety is a common one, but we are more likely to focus on the behaviour we see rather than how the child is feeling. An anxious child who refuses to go to school may be labelled as ‘difficult’ or ‘naughty’ but what they are expressing is a painful emotion that they need help dealing with.

Describe one thing you find fulfilling and challenging about working in this industry.
Working with children and families is a pleasure and a privilege. To make life a little bit easier for someone is all that matters, you don’t have to be out there saving the world to make a difference.
My major challenge is time. I would love to do more, I’d love to do an MSc in play therapy and a couple of other therapeutic techniques I’ve come across in Europe but that gets put on hold as I focus on my own family and business.

Can you share an anecdote about how mental health consultation works?
I think that education, understanding and connection are the three keys to giving a child the best start in life. Led by that, SensoBaby provides classes in the community for parents and caregivers to connect with their infants.

We offer workshops on parenting and play to foster understanding of child development and wellbeing and we are available to troubleshoot specific problems an individual or agency has with the young children in their care or the systems they have in place. When it comes to individual parents, mostly what they need is to feel heard, supported and guided in their parenting choices.
You can read all the baby books in the world but they won’t give you the answers you need for your child, through responsive parenting and connection, you’ll find you have the solutions you need.

What advice do you have for child-care providers or early childhood teachers who are at their wits’ end over a child’s challenging behaviour but don’t have access to a consultant?
Empathy is an important and undervalued skill – the ability to consider another’s viewpoint. What is that child feeling? Their behaviour might be challenging and hard to deal with but often the root cause is an unmet need. There’s a famous quote from an American Clinical Psychologist, “The children who need love the most, will ask for it in the most unloving ways.”

Does a mother’s mental health affect her foetus? How important would you say is paying attention to women’s well being during pregnancy as with their physical well being?
100% yes. It is so important to support a woman’s wellbeing during pregnancy. As an example, if the mother experiences significant stress and rising levels of cortisol (the stress hormone) during pregnancy, the foetus will be affected and in some cases will be more sensitive to stress in childhood or later in life.

Pregnant women and new families (Dads as well!) deserve nurturing care themselves and shouldn’t be afraid to ask for support. SensoBaby run FREE monthly coffee mornings to support pregnant and new mothers because we understand the importance of maternal wellbeing.

Do smart phones and television make our children mentally ill as is often purported?
I don’t think technology is always the villain it’s made out to be. The key is in the relationship with that technology. Moderate use of TV’s and smart phones are fine, as long as they aren’t a substitute for outdoor play, imaginative play and meaningful interactions. If a child is crying or upset and we hand them a device to keep them quiet then we have missed an important opportunity for connection, helping them process what is going on and supporting them to calm down and settle themselves.

Now, I know you are involved in an exciting programme that helps caregivers and children to bond and get the children off to the best start in life through play. Can you say a little bit about that work and just how you are seeing it play out?
SensoBaby is our baby; a project born from passion and a desire to support families in Botswana. We offer play-based classes for children and their caregivers that are underpinned by the principles of child wellness as well as early foundations for learning.

When you provide developmentally appropriate opportunities to play, you learn so much about your child. That understanding and observation builds strong connections, which will form the basis of that child’s future relationships and self esteem. Play is so much more than ‘a fun activity.’

We offer a number of trainings and workshops for parents, nannies and community stakeholders and hope to increase our offerings this year. Our community partnerships and voluntary programmes have been successful so far and we hope to see more impact in 2018.

We currently serve the Gaborone community but would like to expand throughout Botswana as opportunities arise. The response to SensoBaby has been fantastic so far and we can’t wait to see how far we can go with the concept!

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Know Your Specialist

Terence Mohammed explains intricacies of clinical trials

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What does a lab manager do?
As BHP laboratory manager, I am responsible for providing an oversight in the technical operations of the laboratory, including the clinical trials processing and testing labs. As part of the laboratory management, I also provide leadership in planning, implementing and completion of research activities and to ensure that laboratory operations and data generated is in accordance with Good Clinical Laboratory Practice. The lab manager is also expected to provide an oversight on the laboratory quality management system and laboratory expenditure.

Describe your career trajectory. How did you get to where you are now?
I joined BHP in 2007 as a laboratory research assistant. I worked for two years in various BHP clinical trials for diagnosing and monitoring of HIV/AIDS in clinical trials participants. In 2009, I got transitioned to the BHP research laboratory to work as a research fellow where I got assigned to work on various basic science projects. In 2014, I worked as a research laboratory coordinator where I was mainly involved in day to day routine management of the research laboratory activities including; conduct of research projects, preparation of education activities and mentoring of new research fellows, students and interns. In 2015, I got promoted to the position of deputy laboratory manager where I assisted the lab manager in overseeing the technical operations of the lab. In 2017, I got promoted to the position of lab manager.

What’s a typical day/week at the Botswana Harvard Partnership (BHP) for you?
I participate in a lot of weekly meetings; laboratory management and departmental meetings. I am also expected to attend meetings for the various clinical trials which we provide laboratory services to. These include local site meetings and international conference calls with study principal investigators and sponsors. I also review and authorise laboratory orders ensuring continuous operation of laboratory work and within allocated budgets. In addition, I also allocate time to walk around the different laboratory departments on a regular basis in order to interact with staff and learn more about their challenges. This facilitates discussions on how to improve our laboratory operations and working environment.

What are the main health and safety issues for lab technologists?
Exposure to blood, bodily fluids and tissues, which may contain infectious agents and also exposure to ultra-cold materials such as liquid nitrogen and dry ice. However, all necessary laboratory safety trainings are mandatory and staff has access to personal protective equipment including lab coats and gloves which are a requirement for certain tasks.

What aspects of your role do you enjoy the most?
I enjoy the daily interaction with researchers in the field of HIV/AIDS, both locally and internationally. It makes me proud to be part of a team that is working towards ending the HIV/AIDS pandemic in our region as it has decimated the population for over two decades now. With our work, I hope Batswana become increasingly cognisant of the task ahead of us and unify to bring an end to the pandemic.

What would you say the biggest challenge in your field is? Discuss one thing in particular?
Supply of laboratory reagents and consumables can be challenging as sometimes we experience supply stock-out and delays in delivery.

On a basic level, what skills does your job demand?
A lab manager should be able to organise and run effective meetings. It is important to set up an effective meeting agenda and be able to assign key action items to staff
-To be able to communicate effectively and create a positive atmosphere in the working environment. It is also important for the lab manager to be able to motivate staff and also be approachable to staff whenever required.
-A lab manager is expected to have leadership skills in order to provide direction to team members and ensure that the institution goals are effectively met.
-To be able to manage budgets and always be alert to ensure that the laboratory current spend does not exceed target spend.

You have done some research on HIV-1c gp120 in recently and chronically infected individuals in Botswana. For starters what is HIV-1c gp120? A brief background on the research and what the findings were?
Gp 120 stands for glycoprotein 120. This is a protein found on the outer surface of HIV and it used by the virus to enter human cells thereby causing infection. Previous research has shown that gp120 characteristics and properties could be susceptible to change overtime during the progression of the disease. Therefore, we used two groups of study participants at various stages of disease progression (i.e. recently and chronically infected) to see if there are changes in structure and properties of gp120 during the course of the disease. This research highlighted the need to further investigate gp120 in order to get information that maybe useful in the development and designing of an effective vaccine

What advice would you give someone interested in becoming a research fellow?
I would advise them to read a lot in their field of interest and also be aggressive enough to seek opportunities of attachment to a relevant institution. Furthermore, they should seek to interact with experts in the field in order to keep themselves in the loop should a research fellowship become available.

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