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.
The University of Botswana Student Representative Council is disappointed by Minister Thapelo Olopeng’s remarks quoted in the media, and his failures to address issues faced by students. The Tertiarty Research Science and Technology Minister told reporters that the students are pulling political stunts.
This was after they were arrested for locking Department of Tertiary Education Funding (DTEF) employees in office some three weeks back as demand for student attachment allowance grows much greater than before. However, SRC vice president Tumelo Legase dismissed the minister’s remarks during a press briefing on Monday morning at the University.
“It’s disappointing to see the minister being petty instead of addressing pertinent issues that students face. It has been three months and students have not received their allowance, that’s the issue he should address,” he lashed out. The SRC’s endless scuffles with DTEF seem far from over. Legase said that DTEF has been inconsistent with crediting student allowances for the longest of times and they always have to ensure that they do their job. “We have proposed an advanced student allowance management system but they are still failing to take up such ideas.”
Following various engagements with the DTEF and UB Management that have failed to bear fruits, the SRC resolved to petition the DTEF Director and University of Botswana Student Welfare Director. According to Minister of Justice Carter Joseph the University Management has even failed to provide them with transportation to DTEF offices. “We are doing voluntary work for the students and management can’t even fulfil their duty of providing us with transportation,” he stressed.
For his part, UB SRC President Amogelang Mokwena said they are left with no option but to petition DTEF Director and UB Student Welfare Director. He said they will call a mass demonstration and petition these “two who are failing to do their job come August.” “We don’t encourage incompetency that’s why we want them to leave office so that someone befitting and capable goes into office, we will mobilise together with other SRCs across the country and we will get enough numbers to over throw them.”
The SRC has also expressed apprehension at the absence of University of Botswana Vice Chancellor Professor David Norris who is always available to give them an ear and extend a helping hand.
“We have a solid relationship with Professor Norris. It’s sad that he is outside the country and cannot be of any assistance.
“In his absence we have no one to run to. I can say we have no relationship with the Director of Student Welfare,” Mokwena lamented.
LIES AND DECEIT
On the surface it looks like a storm in a teacup but it is a brewing tornado which threatens to rent asunder the harmony subsisting between tribal leadership and politics.
And at the heart of it all seems to lie bits of dishonesty, lies and deceit. It all started with a luncheon meeting hosted at Maharaj Conference Centre for nine (9) Bangwaketse Dikgosana, supposedly called by Kgosikgolo Malope II. On the way to this luncheon from Kanye, the Ngawaketse capital, new information turned by one of the trip organisers revealed that the meeting was just a political gimmick by the Botswana Patriot Front (BPF) and its patron former president and Bangwato Kgosikgolo, Ian Khama.
Happening two weeks before the launch of the BPF in Kanye, the luncheon was a masterstroke by the party’s strategists to secure legitimacy amongst the tribe’s leadership as well as the much-needed numbers for the party’s launch and elective congress. But now some of the Dikgosana say they were tricked into participating in a partisan meeting whose motive they were never privy to.
The alleged association of Gangwaketse with BPF reportedly started with Khama’s visits to Kanye in search of a suitable venue for his party’s historic inaugural elective congress. This is where, according to emerging reports, officials of the BPF struck an association with one of the tribesmen who would later be used, amidst promises of money, to mobilise the other tribal leaders for the Maharaj meeting.
Last week Thursday, Bangwaketse Kgosi Malope II summoned all these Dikgosana to explain their actions. These Dikgosana are Gaonakgang Gaonakgang (Mmangwato ward); Thomson Ntsima (Tsima ward); Gaokgakala Monnathebe (Goo-Logaba); Frank Boakgomo (Boakgomo ward); Lewatle Kgosiyareng (Mongala ward); J. Ramoshane (Lotlhakane East); Kepatilwe Mafoko (Tlagae ward); Gaofenngwe Bome (Bome ward) and the Kgosana of Moshana village.
The meeting was attended by District Commissioner of Southern District Mmoloki Edward Raletobane as well as tribal administrators.Of these tribal leaders, it is Bome who reportedly met and agreed on the Maharaj meeting with the BPF patron. Both men are believed to have been contacting each other for some time and it appears they even spoke about how Khama could involve all Dikgosana in his grand political plan.
Following conclusion of the master plan, where two more tribal elders were brought into the plan, Bome is said to have then called all the other Dikgosana to inform them that Malope II – who at the time was in Gaborone attending Ntlo ya Dikgosi session – has invited them for lunch in Gaborone and would send a bus to collect them.
It was when the men were about to touch down in Gabs that Bome allegedly changed tune saying that they were in fact going to be meeting with Khama, not Malope. This allegedly brought worry and division among the Dikgosana but they nevertheless went ahead to Maharaja where they were met and welcomed by BPF interim President Biggie Butale. One of the dikgosana reveals that Butale would then request them to have patience because “Morena o etla” (The king will be coming), referring to Khama
And then Khama arrived
The common narrative from the elders is that upon arrival, Khama gave them the impression that he did not know anything about the purpose of the meeting, but that he had nonetheless come because he had been informed that they wanted to meet with him. Upon asking them why they had wanted to meet with him, it was Bome who curiously jumped to the opportunity to be the first to speak.
Some in the group reveal they were shocked when Bome told Khama that they had come to seek his assistance against President Mokgweetsi Masisi whom they alleged was making them lead miserable lives. Bome allegedly stressed that since Khama left the presidency, they suffered under Masisi who was forcing them to pledge allegiance to him. Khama was further told by some of the tribal elders that they were not comfortable with the oppression and sought his advice on how they could petition Masisi to Queen Elizabeth.
It is said that Khama advised them to rather take their petition to the British High Commission in Gaborone. One of the Dikgosana, Kepatilwe Mafoko, is said to have chipped in to add that Government was refusing to promote him even though he had served the morafe for long a long time. Records however show that the same Mafoko had long been brought to the Kgotla years back, just to help with a few things, and that he has remained there since. The other Kgosana who spoke was Lewatle Kgosiyareng, a former political activist for both ruling BDP and opposition BNF but has since quit politics. In his response, Khama is said to have told them that he too is suffering under president Masisi (Le nna Masisi o a ntshwenya) even as he is the one to have chosen him to succeed him when he retired.
Khama allegedly then told the Dikgosana that he too would love it if they give him support in removing Masisi through the ballot in October. “I therefore request you all to mobilise people to come in numbers for the BPF launch,” he allegedly said. In his address to Dikgosana, Khama allegedly told them that he was currently talking to other Dikgosi throughout the country seeking their support for this cause. Some of the elders reveal that after deliberations of the day, two of their colleagues would later have a private meeting with Khama. The Midweek Sun has established that the two were Bome and Mafoko. There is suspicion that the two received some monetary incentives as what would transpire later in the village gave rise to those suspicions. A source close to the village’s development committee – VDC – revealed that one of the two would later that day arrive pay back the P3000-00 debt he had had for some time.
Reports say Bome and Mafoko, from their side meeting, arrived to tell the others that they had been promised that transport would be organised and each of them would be paid P6000 to mobilise Bangwaketse for the BPF launch and efforts to remove Masisi. As it turned out, not all Dikgosana could hold the secret for long, and soon the secret meeting reached the ears of Kgosi Malope and a meeting was called for Wednesday, where the concerned Dikgosana were advised to stay away from politics. Malope and his administrators would then call another meeting with Dikgosana on Thursday and asked them to explain their actions to other village elders. This is where some of the issues were revealed. It is at the same meeting that Bome allegedly confessed and exonerated Malope, saying he never gave them permission to attend a meeting with Khama.
Instead, he confessed that before the Maharaj meeting, he had gone to Malope to tell him Khama had invited him for lunch, to which Malope only said he didn’t find anything wrong with him dining with Khama if they are friends.
Word was already spreading in the village that Ngwaketse royals had been given huge sums of money to mobilise morafe for the Saturday launch of BPF. But after this clarification by Bome on Thursday, Malope then called a Kgotla meeting on Friday in order to clear the air for the villagers. The meeting was addressed by deputy Chief, Kebapetswe Telekelo.
Efforts by this publication to speak to Khama proved futile, but The Monitor quoted him this week denying that he ever sought to meet with the Dikgosana. “They are the ones who had asked to see me on that day, but unfortunately I was not available in the morning and they had to come for lunch,”Khama is quoted to have said, adding that the Ngwaketse royals then complained that Masisi was forcing them to support him.
What Bome told The Midweek Sun
Kgosi Bome also denied most of the allegations against him but confirmed that they indeed travelled to have lunch with Khama and were provided with transport although he says he does not know whose vehicle it was.
“It is true we travelled to Gaborone at the invitation of former president Khama who invited us for lunch. We accepted the invitation as we did not see anything wrong with it,” Bome said.
“But we have since apologised to Kgosikgolo Malope for having attended lunch without having followed proper channels, so questions on this matter are not necessary.” But then again, Bome denies ever organising transport or calling other Dikgosana to attend the lunch meeting with Khama. Yet his colleagues contend he did. “I did not organise the transport for Dikgosana as they claim. Our transport came with Kgosi Lewatle Kgosiyareng.
He told us that they were coming from Letlhakane where there was a donation for a wheelchair.” Bome said it should be noted that this is election time and people are bound to lie about others. “There is nothing more I can say. We called Bangwaketse to clarify our position on Friday. I also confirm that I have heard stories that Khama offered us money. The Morafe continues to ask me about this and some close to me tease me for a share,” he told this publication. And then he added: “The fact is we never talked politics with Khama – even the law is very clear that we have to remain apolitical as our major role is arbitration and uniting the tribe.
Instead he only told us he is retired and only wanted to spend time with us as he has done with other Dikgosi.” District Commissioner – Southern, Mmoloki Raletobane confirmed being aware of the matter. “I was informed by the tribal administration and know everything by virtue of my position. We allowed the chieftainship to resolve the issue in the best way possible,” he said. The contradicting versions on what really transpired have not been helped much by the refusal of other Dikgosana to speak to this publication. Kgosi Malope II could neither be drawn into discussing the matter as he said the matter had been successfully resolved.
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