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.
‘Cancer took away my boobs, not my life’
Sun Health: What events led up to your diagnosis, or, how did you discover that you were suffering from cancer?
Mpho Kgaodi:My journey with Breast cancer started in 2012. Around April I felt a lump on my right breast. It was not painful at all, just slightly itchy. It was on the upper part of my breast. I ignored it for about three days but it kept nagging me and then I decided to go see my doctor. He also confirmed that there was a lump on my breast He sent me for mammogram that confirmed an abnormality on the structure of my right breast. I then went to see him with the results and he informed me that there are two ways to test that lump – Biopsy, which meant that he will be taking a piece of that lump to send it to the laboratory for examination and the other option was to totally remove the lump, Lumpectomy. I decided that he removes the whole lump, because I really didn’t want that Lump on my breast.
SH: We know that about 10% of all breast cancers are hereditary. Are there other women affected in your family?
MK: I don’t know of any other woman or even man in my family who has had cancer, though it is hereditary.
SH: What were your first thoughts when you received the diagnosis?
MK: I cried for a brief moment. I was overwhelmed with emotions, fear of death. I quickly recovered from that dreadful thought and remembered that I have a great husband and three boys. I felt that I had so much to live for.The doctor informed me about the options I had regarding treatment and he gave me time to think about it. I drove back home to Lobatse and by the time I arrived at my house, I had already made up my mind that I am going for total removal of the breast. I broke the news to my family and they were just as shocked as I was when the doctor broke the news to me. I explained to them my decision to go for surgery and they were very supportive. Few weeks later, I went for a mystectomy.
SH: How long were you in treatment
MK: The surgery was followed by Chemotherapy. The first time I walked into the oncology centre, I found so many people there already. I then realised that I am not the only person with cancer, it is so many of us. It gave me strength and courage. I had heard that the side effects of chemo are brutal, seeing those people made me realise that if others can do it so can I. I decided to go for it as I had so much will and spirit to stay alive and raise my kids. After the second session of chemo, I started losing my hair, nail beds turned black. I was never discouraged though, despite my aching body and the constant nausea after chemo. I had six cycles of it. In 2013 around April again, I experienced severe pain on my left breast, but with no Lump. My doctor again recommended I go for a mammogram. It confirmed cancer which was still at stage 1. I then insisted that they remove the breast. I would lose both my breasts but I knew staying alive for my boys was more important. Other people thought the pain was psychological, and I knew what I felt and my mind was made up. I had the second mastectomy and had to go through another cycle of chemo which I completed. I am now on oral medication. I take my tablet daily. It is recommended that I take it for ten years. I have just started on my year 6 on the tablet. I do go for regular check ups, to establish if the cancer is not back.
SH: What helped keep your spirits up and gave you support during this period?
MK: A good friend of mine and colleague told me about Journey of Hope Botswana. He introduced me to them, and I had tremendous support from them. I also went to Cancer Association Botswana to introduce myself. My family has also been my backbone, supporting me through it all. I am so greatful. On days that my spirits are low, I always take my mind to positive thoughts. I try to remind myself of the good times, sometimes I even find myself laughing out loud.
SH: How has this affected you at a psychological level?
MK: My life has not really changed for the worst. Like the saying “when life gives you lemons, make lemon aid out of them”. I lost my job after the second diagnosis of cancer. While this affected my family financially I never got discouraged, as this gave me time to take care of my family. I am a full time stay home mom. I walk this journey with my family. My boys understand that I had Cancer but now I am okay. They sometimes check if I have taken my medication, and they would even ask about my next appointment. I am blessed to have them.
SH: Facing the diagnosis of breast cancer is one of the most feared experiences in our society. What has been your experience as you worked with communities through Cancer Association of Botswana (CAB)?
MK: Working with CAB has been eye opening. Through motivational talks and other actives like the annual stiletto walk, the message has been positively received. There is still a lot to be done though, especially to make people understand that breast cancer is NOT a death sentence. So many lives can be saved.
SH: Amongst raising awareness, cancer awareness month is about celebrating individuals like yourself and their triumphs over cancer. Is there anything you would like to say to the community of cancer survivors and women in general?
MK: I have learnt so much from being diagnosed with cancer. I appreciate life more. I never used go and see a doctor without any pains or any thing “wrong” with my body. Now I do it regularly and so far I always get a clean bill of health. I encourage everybody to do regular self -breast examination. It is easy, convenient, cost-effective and can really help with early detection. I believe there is a lot to be done as far as breast cancer awareness. Remember men can also have breast cancer.
To all those who are going through cancer at the moment, remember you are not alone. Let’s walk this journey together. Let’s walk with Hope, Courage and Strength. There is life after cancer. Cancer took away my boobs it did not take my life. As October is breast cancer awareness, let’s support those affected, honour the survivors and remember the fallen.
PINK RIBBON ALWAYS
Caroline Gartland speaks on Children and Mental Health
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!