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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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Surviving endometriosis with natural remedies

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What is your professional background?
I am a medical officer at Princess Marina Hospital and have been working there for almost two years. I’m currently in the Obstetricians & Gynaecologist department working as a General Practitioner. It’s one of my areas of interest plus my boss is awesome and LOVES to teach.

What got you interested in food?
I went to a med school in China, and around the area I studied in, they were very passionate about their food intake, as it is with all Chinese but particularly in my city, Changsha. So we were blessed as students to be exposed to different remedies all the time. I got very ill whilst there, and they treated me with amazing methods. The only other people I know that use mother- nature as their healer are my grandparents in Lesotho. So I guess that’s where my motivation comes from, plus my mum practices alternative medicine all the time.

What is one of the wackiest nutrition myths you have heard of?
That swallowing gum may stay in your stomach for seven years. My mum loved saying that to me hence I am not a big fan of chewing gum.

What are some of the changes and trends you have observed in the food world over the last 20 years?
I am not a certified nutritionist, I’m just a person interested in using what earth has given us. It saved my life. The dependency of pills and a lot of pharmaceutical products scare me. The world has woken up to see that we don’t live as long as we used to. Take the Asians, they outlive us and are very active in their old age and their diet is a big factor to that.

You have been diagnosed with stage 3 endometriosis. Take us through that experience.
I was shocked but I was relieved at the same time, that at least I was not going crazy about my pain and the heavy menses. Plus, I had had a myomectomy, the surgical removal of uterine leiomyomas, also known as fibroids, done last year and that was horrible experience; so being diagnosed with Endometriosis was hard but a relief in the same breath.

How do nutrition and endo relate? Can diet improve the symptoms of endometriosis?
Honestly, regarding to this, there needs to be more information for the public. Since I’m not a nutritionist I cannot answer but can advise around it. There are so many theories of what causes endometriosis. So you need to understand your body first to derive a conclusion. In my case I first developed fibroids and did the necessary tests to try and find the cause. Then worked backwards from there.

In addition, research has shown that women with endometriosis often have higher levels of estrogen, and that estrogen can encourage tissue growth. Can an anti-inflammatory type of diet eliminate excess oestrogen from the body?
When attempting to relieve endometriosis symptoms naturally, begin by eliminating foods that lead to inflammation. This includes dairy, processed foods, refined sugars, caffeine and carbohydrates.
Eliminate these foods from your diet for at least three weeks, paying close attention to your body changing throughout the process.
Alcohol, soy and other high-estrogen foods should also be eliminated from your diet because of their estrogenic effects. Which means more super anti-inflammatory foods.

It is important to track symptoms so that potential triggers can be identified. Hence why journaling your progress is so important. Honestly those are some of the things I do which have been of big help. If you want more follow my page Dr. Tumie violet Mphusu. So we can discuss more.

Is there something specific that has made the biggest change in your health? A treatment plan you have formulated for yourself, maybe?
I am a big fan of natural remedies. When I get sick I always go to Mother Nature before seeking pills. So with my case, I realized that when explored the Daniel fast, follow my page for more details, my menstruation became normal. The first month, I remember thinking I was just lucky, but when I reintroduced certain foods in my life, the old horrific cycle returned.
The flow, my pain, my fatigue and other related symptoms. Diet is the key to how our lives will pan out in the future. You are what you eat.

Your last word?
Please remember there is no cure for endometriosis, and surgical or medical treatments remain the most effective methods of managing the condition. However, making dietary changes is a complementary approach that may help some women manage their symptoms. Keep in mind that just as symptoms of the disease vary from person to person, treatments that work best for one woman may not be right for another.  Take your time to experiment with different remedies to find the approach that’s right for you.

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Forgiveness is a virtue

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It’s hard to get through life without experiencing some resentment. Executive Director – Phronesis International College (PIC) and Counselling and Psychotherapist, Peacebuilding and Life Skills Education Specialist Dr Thelma Kgakgamatso Tlhaselo-Majela discusses forgiveness and why letting go is good for you.

What forgiveness?
Forgiveness is a process that positions one on a healing path by choice in an attempt to resolve the psychological stress and trauma one could be experiencing. These pains and emotional injuries may stagnate one into feelings of anger, bitterness and resentment and in worse cases depression, anxiety and post-traumatic stress disorders. If left for long, protracted unresolved psychological distress and or trauma could deepen one more into multiple losses.

It may generate hatred and desire to cause harm on the other and this can throw one into revenge and or vengeance. Forgiveness then starts from the cognitive ability to choose letting go of the emotional and cognitive baggage thus granting the self or inner being power to constructively open portals of intrapersonal empowerment. Moreover, a well-integrated process of forgiveness could shift one into an empathetic and compassionate psychological space filled with virtue and psycho-sociological attributes of restoration that accentuate positive benefits of healing.

In your experience,what are the common issues that need forgiveness?
Life by nature is riddled with so many issues and challenges characterised by diversity and complexity hence appropriate understanding is very important. People are social beings that co-exist through healthy connectedness and this may happen at the physical, personal, socio-cultural, psychological, financial, spiritual; political level to mention a few.
We all need a deepened awareness on how the intra-personal (within self), inter-personal (with others), inter-group (within groups) and international (nation to nation) relational connections play out in life. These healthy relationships deserve to be developed, nurtured and protected lest they become dysfunctional and corrosive.

The common issues for forgiveness are varied and highly individualised. One person may look at what another is struggling with and may consciously or unconsciously belittle it because for them it appears an easy or small matter but people are unique and this deserves respect. The relational betrayals, emotional injuries, corrosive conflicts and intractable may result in residual emotions that can cause people to drift into anger and bitterness. In such accounts, people may find themselves responding through avoidance or seeking revenge which has the potential to cycle one back into deeper pain.

The complexity of forgiveness may originate from the nature and quality of the relationship one had, the nature of the wrong committed with the cognitive interpretations one ascribes to the event. This includes significant others such as spouses (couples), children, family relatives, colleagues, bosses and subordinates in the work place.

Sometimes, it may be people we do not know that have hurt us such as a murderer, rapist or an abuser and may not even acknowledge that they have done anything wrong to us. It may also be about the symbolic losses where the people and or situations to forgive do not physically exist such as a dead person or a geographic disconnection. In such cases, the existential reality of the phenomenon remains true, real and alive in the psyche of the emotionally injured person and requires a healing process.

Is it possible to forgive when one is still angry and can you forgive someone who does not think they have done anything wrong?
Forgiveness is a process that one does by choice for oneself and not for the perpetrator because one understands that the pain and suffering one is experiencing has a direct injurious effect on one’s life. Similarly, revenge and vengeance which for long has been one of the rudimentary human responses can only promote increased pain as it stagnates one into more hurt and pain.

It often cycles one back into psychological trauma hence one needs to perceive value addition in engaging in forgiveness because it can be logically and rationally incomprehensible when one is caught up in this quagmire. A bitter-angry person may grapple with cognitive dissonance which is an internal struggle to understand why they have to release someone who according to them deserves a punishment or better still refuses to acknowledge that they have done anything wrong.

But irrespective of the reason, holding on to anger, bitterness and resentfulness within the inner self can only grant one false gratification that they are holding the perpetrator to ransom. Needless to say, we have no control on how the other person thinks and feels and we may actually be subjecting ourselves to increased injury and punishment from the very issue we are contending with.

Seeking professional help will assist one to work through the psychological defence mechanisms such as denial, repression, rationalisation, reaction formation, regression to mention a few that may promote dysfunctional tendencies in un/forgiveness processes. Notwithstanding, people need to be assisted with respect for human dignity within them and never be forced and or coerced into forgiveness when they are not ready to do so. Given that anger will consume the person already holding the pain and hurt whether it is perceived or real, working on forgiveness can be a desirable option to open the healing process.

Can you discuss the rewards or benefits of forgiveness?
As can be seen, it often pays to work through forgiveness hence the concept of working it out because people respond to pain and trauma differently. The rewards and benefits shared in this context are not by any means exhaustive because there are several psycho-social models for assisting people to process forgiveness issues and this requires well trained service providers.

*People who are angry and bitter are often not desirable in social contexts because they may consciously or unconsciously spill this negative energy on other people and this tends to repel instead of attract social connections. At intra-personal level, we are likely not to find our inner life peaceful and enjoyable if we are ever stuck psychosocially on anger and bitterness because it may promote self-hate, poor self-concept and negative self-esteem. So it pays to be gentle to love yourself enough to desire good emotions about and towards other people for that will rub corrosively on your personal well-being. The benefits of forgiveness include enabling one to circumvent these psychological pains and trauma that can affect quality of life with self and others which may compound stress levels.

In extreme cases people may sink into depression and anxiety which could ripple into other areas of life such as sexual dysfunction, eating disorders, substance use and abuse, relational conflicts and psychosomatic illness. Forgiveness builds a healthy mindset and that attracts a healthy personality which consequently leads to healthy social and physical well-being. Forgiveness fills the inner space with good attributes and this is shared with others. We then by addressing forgiveness issues reduce on maladaptive tendencies and lift on psychosocial protection thus leading to safeguarding the intra-personal, familial, corporate and societal communities from effects such as divorce and relational stressors.

At corporate and industrial level, a socio-psychological space that is riddled with un/forgiveness is a breeding ground for visible and invisible costs. For instance, a huge cost can emanate from a collective environment that is unproductive because of collective stress and restlessness. A workplace where people are transparent and honest and regard others with respect to deserve forgiveness often tends to promote healing communities where others feel safe and do not fear hence they can work to the optimum level of their potential.

We also benefit as a nation when we are characterised by forgiveness because we have a strategic desire to promote a knowledge-based community as the foundation for transformational change. Botswana considers people as a reservoir for knowledge and wisdom to lead as change agents and if we are a community that is unable to work through issues of forgiveness, we may create or nurture a psycho-sociological space that disempowers collective construct for healing communities.

A Motswana who is able to forgive is likely to live with people from other backgrounds and has a healthy and broader capacity of dealing with diversity and differences with virtue and competencies for the 21st century to advance the nation at local, regional and international level.

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