Dr Emily Shava is a medical doctor (MBChB from University of Zimbabwe 2004) with a Master of Science in Clinical Trials (London School of Hygiene and Tropical Medicine 2016.)
She has been involved in clinical research in Botswana through Botswana Harvard AIDS Institute Partnership, since November 2009. Thus she has had the opportunity to work with different stakeholders and communities in the country since then.
Here she tells RACHEL RADITSEBE about the ongoing AMP Study Enrolment is ongoing in the Antibody-Mediated Prevention (AMP) study.
Tell us about that. What is AMP and how exactly does it work? AMP stands for Antibody Mediated Prevention. This 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 randomized 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 18-40 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 that 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 organizations 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 HIV 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.
Batswana’s sorry lives
For scores of Batswana, life is a mundane routine of trying to make ends meet. An economist once indicated that many Batswana are a meal away from poverty.
In fact the 2016/17 report of Botswana Statistics indicates that most Batswana in urban areas live below the poverty line. Meanwhile, unemployment among youth stands at 23%. The report also indicates that a great number of Batswana earn on average of P4000 while a lot more still live in one-room dwellings. The gap between the poor and the rich is ever widening and incomes are not enough to cover the high cost of living while prospects are few and wide apart.
Thabiso Makatse came to Gaborone in search of greener pastures but has been disappointed. “After two years of unsuccessfully applying for jobs, I decided to move to Gabs from my home village. I did odd jobs – from store cashier to petrol attendant. I also dabbled in entrepreneurship, selling car parts and clothes.”
Faced with taking care of his younger siblings, parents and child, he had to try everything to make ends meet and he is still riding that boat. Makatse says that the stress of being anxious about an income and being unemployed with nothing stable in the horizon had a negative effect on him. “In the world we live in, you only make sense when you have money. Even in relationships it is difficult because women don’t like broke men who cannot take them out or give them money. It can be stressful when a woman expects money for nails, hair or clothes while you are worried about where your next meal will come from.”
Depression brought on by socio-economic stress is widespread in the country. A source at the Sbrana Psychiatric Hospital in Lobatse says that in the past decade, the hospital has registered a higher number of patients, most of who come with stresses related to money, work and other issues affecting their socio-economic status. “Issues such as retrenchment, debt and bad financial decisions in business can land one on their back. We see more people struggling to keep in the socio-economic landscape, and it affects their psychological well-being and brings on mental illness brought on by compounded stress.”
Psychologist Thelma Tlhaselo-Majela concedes that unemployment or inability to generate an income can have a negative effect on individuals. “The most significant is the realisation that one may have all it takes to find a job including wishes and desires to do so nonetheless are unable to work because of circumstances beyond their control. In some instances, the situation may push one to opt for jobs that are far below one’s qualifications thus compromising potential and inner capacity simply because they want to be engaged.
When one realises that they cannot get meaningfully engaged, this may provoke residual effects because employment has some invaluable benefits in balancing the equilibrium for quality life.” She further says that it is crucial to recognise that gainful and fulfilling employment contributes to shaping the foundational state of the socio-psychological and economic well-being at individual, familial and national level.
“It is in our work, job or occupation that we willingly spend long hours of our time and this grounds structural patterns for daily routine hence people deriving corresponding fulfilment for purpose and existence. The disruption of this patterned routine has potential to throw one in a state of chaos and disorientation especially if one is not well-prepared to adjust and handle the situation well.”
Majela explains that when these stressors set on, no matter the existing savings, the financial resources are bound to witness a gradual decline and depletion. The struggle begins in meeting basic needs while lifestyle orientation demands corresponding alterations. The key indicator in the family lifestyle change often impacts on children because some may not fully comprehend what is going on. Lifestyle reorientation may demand moving from large to smaller houses, private to public schools, smaller cost effective cars, humble meals and clothing and these new dynamics may shake the familial structure into diverse difficulties and conflicts.”
Majela explains that our occupations and work spaces constitute the inseparable nature of our psychological identities due to the intra-inter-personal development that happens especially if one loves and enjoys what they do.
“The psychological identity connects with the socialisation processes where we received messages, positive or negative, early in life from people around us. In our daily social activities, the purpose and meaning of life is then shaped by and through the communication we internalise through our social space.” She further points out that being ‘judged’ can worsen the situation in people who are already struggling to make ends meet.
“Anyone who receives verbal and non-verbal communication that undermines their inner worth contributes to the onset of anxiety and depression. The psychological state of rejection, discouragement, coupled with deterioration in hope, pride and self-esteem impacts on mental well-being.” Majela points out that a deep sense of depression expressed through hopelessness and helplessness can throw one into psychological damage expressed through self-harming behavioural patterns such as self-cutting, hair pulling, addiction to alcohol and drugs, sexual and eating disorders to mention just a few. “The loss of employment on the other hand provokes psychological pain leading to grief and bereavement, which can be just as real and actual as loss of death of a loved one.”
She adds that it is not uncommon for people to begin to experience mental health issues because often their thought patterns may become irrational and distorted and may dig into suicidal ideation.
Majela suggests several ways that people with depression related to their socio-economic situation can be assisted that include acceptance of situation. “When people are thrown into chaotic states of life, they unconsciously engage psychological defence mechanisms which often work on short term basis and can be detrimental when applied on long term basis.
These defence mechanisms include denial, repression, reaction formation and intellectualization. The quick psychological acceptance helps to propel one to shift into being open to seeking, receiving and committing to the necessary and available intervention support.” She also recommends seeking counselling and psycho-social support. Majela also suggests transformational thinking with cognitive reordering.
“Any new life orientation bringing change in our lives tends to provoke discomfort and often people are tempted to resist the change. It is necessary for people to challenge their thinking patterns by redirecting, refocusing and re-establishing new ways of processing information. Transformational thinking influences us in relooking at situations sometimes with the ability to let go and forgive which requires a new mindset in looking at situations of life,” she said. She also recommends regular physical exercise, journaling, and spiritual connection.
Majela notes that a stress free life may not be a reality hence it is necessary to have a proactive, systemic and holistic approach to managing socio-economic landscape and its associated challenges to reduce the bumpy impact of life stressors.
BDP elections in doubt
Botswana Democratic Party (BDP) is a party in disarray at the moment, and uncertainty reigns over what the future really holds at Tsholetsa as the 2019 general election looms large.
Tensions abound within the party, with glaring factionalism taking centre stage and prompting a call by some, for the party’s elective congress to proceed without election of a new Central Committee. The BDP’s Secretary General Mpho Balopi has since revealed that party members will use the impending National Council to deliberate whether to hold an elective congress or not.
As per its constitution, the party holds an elective congress every two years. Already, some democrats have shown interest to challenge the current Central Committee members for office.
Even though the party has not given the green light for campaigns, democrats vying for office have started speaking to fellow party members to lobby for votes. The divided party’s break or make elective congress is expected in the month of July at a venue and date yet to be decided.
There have been calls by some democrats for the party not to hold an elective congress, even at their other structures. This year the party is expected to have a Youth Wing elective congress, Women Wing elective congress and a National Elective Congress. This publication has established that there is a lobby for a compromise, but chances of the compromise deal succeeding are very slim, inside sources say.
This is because despite Balopi’s assertions that the party emerged united from the Palapye retreat, there is a strained relationship between the current leadership and some members of the party including ministers, Members of Parliament and Councillors.
Those who believe the current central committee has failed the party are pushing for the elective congress while those sympathetic to the leadership want a compromise. Their contention is that since it is election year, they have to focus on general elections to win with large numbers instead of being distracted by inner party elections.
However the opposing side has stood by the party constitution and wants it to be followed to the letter and respected above all else. In the past, compromise deals were made and elections were avoided at the request of then President Ian Khama.
Balopi told members of the media in Palapye after the party’s retreat that the National Council which traditionally is held in March, would deliberate on the question of the elective congress. “We have tradition as BDP that during election year we avoid elections internally and focus on general elections.
The issue of the youth wing, women wing and national congress will be discussed during our national council,” he said. Balopi stated that the democrats who attended the in-house meeting were on the same page that the matter should be taken seriously because of the impact it could have on the performance of the party in the general elections.
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