WHC News Journal - November 2023

NEWS JOURNAL November 2023 Edition

Dear colleagues, Welcome to the November 2023 edition of our Wits Health Consortium online news journal.

In this edition we congratulate and celebrate the appointment of our esteemed colleague at Wits VIDA, Professor Shabir Madhi, as an honorary Commander of the Most Excellent Order of the British Empire (CBE) by King Charles III. This is a most outstanding achievement by Professor Madhi who is truly a pioneer in his field!

We also have an article from our colleagues at the Clinical HIV Research Unit (CHRU) on the REPRIEVE trial, which is the first large-scale trial to test a heart disease prevention strategy in people living with HIV, the results of which were recently presented at the International AIDS Society Conference on HIV Science in Australia.

Then we have a piece from Professor Mags Beksinska at the MatCH Research Unit, who shares some of the innovative work that they have been doing there. Similarly, there is an article from Professor Benita Olivier about her Wits Cricket Research Hub.

And finally we have a couple of stories from our colleagues at Wits RHI who share some good news about Project PrEP and the official launch of the CATALYST (Catalyzing Access to New Prevention Products to Stop HIV) Study, after months of preparation.

I hope that you enjoy the content.

Regards

Alf

Alfred Farrell

Executive Director and Chief Executive Officer of WHC

CONTENTS 01

World-renowned vaccinologist awarded CBE by King Charles III

02

A statin a day keeps cardiac trouble away for those with HIV

03

Working together to improve sexual and reproductive health outcomes

04

The very first game of Women’s Cricket took place in 1745

05

Providing the Dapi-ring as a new PrEP choice in South Africa

Professor Shabir Madhi has been appointed as an honorary Commander of the Most Excellent Order of the British Empire (CBE) by King Charles III.

WMRU has established itself as a global leader in the conduct of barrier method trials and has an ongoing of programme of condom research aiming to test new more acceptable male and female condoms.

The results of the first large-scale trial to test a heart disease prevention strategy in people living with HIV were presented recently.

The Women’s Cricket Science, Medicine and Leadership Conference was held on 5 February 2023 with the Wits Cricket Research Hub playing a central role in its initiation and organisation.

The Maria Rantho Clinic in Soshanguve, Tshwane became the first Department of Health healthcare facility in South Africa to offer the Dapi-ring as an additional choice for HIV prevention.

Acknowledgements

We would like to thank the following people for their contributions to this issue: Ms Zurayda Hendricks

Project Manager

Clinical HIV Research Unit

zhendricks@witshealth.co.za

Professor Mags Beksinska

Executive Director

MatCH Research Unit

mbeksinska@mru.ac.za

Ms Deshni Naidoo

Communications Manager (Comms)

Wits RHI

dnaidoo@wrhi.ac.za

Professor Benita Olivier

Director

Wits Cricket Research Hub

benita.olivier@wits.ac.za

If you would like to share any information or news that may be considered for inclusion in future issues of our news journal or any suggestions on how we may improve this communication platform, please direct them to:

Bradley Aigner

baigner@witshealth.co.za

Inspiring Excellence

World-renowned vaccinologist awarded CBE Professor Shabir Madhi has been appointed as an honorary Commander of the Most Excellent Order of the British Empire (CBE) by King Charles III. Madhi led South Africa and the continent’s first Covid-19 vaccine trials in 2020/2021 as founder and Director of the South African Medical Research Council (SAMRC) Wits Vaccines and Infectious Diseases Analytics (Wits VIDA) Research Unit.

An internationally recognised leader in his field, the National Research Foundation A-rated scientist was involved in multiple clinical and serology epidemiology studies on Covid-19, in addition to his research on vaccines against other life-threatening diseases.

The first of (subsequently two) Wits University-led South African Covid-19 vaccine trials, Madhi led the Oxford/AstraZeneca Covid-19 vaccine clinical trials in South Africa, in association with the University of Oxford.

Professor Sir Andrew Pollard, Director of the Oxford Vaccine Group, University of Oxford, and Madhi’s UK counterpart in these Covid-19 vaccine trials, said of Madhi’s CBE appointment: “I am delighted that Professor Shabir Madhi CBE has been honoured by King Charles for his remarkable contributions to global public health and particularly for his extraordinary leadership in the midst of a global pandemic. It has been a huge privilege for me to work alongside him and his team on the development of the globally impactful OxfordAstraZeneca vaccine.”

Over the course of the pandemic (2020-2022), Madhi had been an outspoken, articulate, and ardent advocate of Covid-19 vaccination as well as for increased access to these and other vaccines in Africa.

Professor Shabir Madhi On his appointment as CBE, Madhi said: “The privilege of being conferred this honour is credit to the tremendous effort of the incredible Wits VIDA research team that I have the privilege of leading at Wits University – before, during and beyond the Covid-19 pandemic. As a collective, and together with colleagues at the University of Oxford and in South Africa, we are proud to have contributed scientifically to informing the public health response to the Covid-19 pandemic in South Africa and globally.”

Madhi’s royal appointment as CBE follows extensive recognition and accolades in South Africa. In 2021/22 he was awarded the National Science and Technology Forum (NSTF)-South32 Lifetime Achiever Award, which acknowledges his leadership in researching vaccines against life-threatening diseases in Africa and globally, and for being at the cutting-edge of research in this area since 1997.

That same year, the Academy of Science of South Africa (ASSAf) awarded Madhi the Science for Society Gold Medal for outstanding achievement in scientific thinking to the benefit of society. And a decade before the pandemic, the SAMRC awarded Madhi its most prestigious accolade, the Lifetime Achievement Award (Platinum Medal).

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1

A statin a day keeps cardiac trouble away for those with HIV study reveals The results of the first large-scale trial to test a heart disease prevention strategy in people living with HIV were presented at the International AIDS Society Conference on HIV Science held recently in Australia.

The REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial found that a statin reduced the risk of heart attack, stroke and other major cardiovascular events by 35%.

Participants were then followed to determine whether they experienced major cardiovascular disease or safety events. The researchers followed participants for about five years, but ended the trial early when they discovered the treatment benefits outweighed potential risks.

Pitavastatin was effective in both men and women.

Pitavastatin was well tolerated by most trial The Clinical HIV Research Unit (CHRU) together with participants, and very few participants stopped the clinical research sites from 12 countries that took part in study early due to adverse events.

this double blinded phase 3 trial, screening 169 and enrolling 144 of the over 7 760 trial participants.

CHRU’s principal investigator for the study, Dr Sharlaa Badal-Faesen, explains, “REPRIEVE was designed to address the increased risk of heart disease experienced by people living with HIV by testing a daily statin medication.”

The medication, pitavastatin, can lower LDL or ‘bad’ cholesterol and reduce inflammation in the body.

Participants with HIV infection who received the statin had a lower risk of a major adverse cardiovascular event than those who received a placebo. The incidence rate of major heart disease events was lowered by 35% for Dr Sharlaa Badal-Faesen is CHRU’s principal investigator participants taking pitavastatin compared to placebo. for the REPRIEVE study.

“Having HIV increases the risk of heart disease, but The findings of the study, entitled ‘Pitavastatin to

until now there has been no proven treatment to prevent heart disease in this population,” says BadalFaesen. “It is a significant moment for South Africa’s clinical research sector to have played a role in informing global guidelines to prevent heart disease in people living with HIV.”

Prevent Cardiovascular Disease in HIV Infection’ were also published in The New England Journal of Medicine.

In addition to South Africa, clinical research units from Botswana, Brazil, Canada, Haiti, India, Peru, Spain, Thailand, Uganda, United States and Zimbabwe were involved in the trial.

Trial participants were people living with HIV aged between 40 and 75 who had low-to moderate traditional risk for heart disease. All participants were randomly assigned to take either daily pitavastatin or a placebo.

REPRIEVE (A5332) was funded by the National Heart Lung and Blood Institute of the NIH with additional support from the National Institutes of Allergy and Infectious Diseases (NIAID) and supplemental funding from the Office of AIDS Research. NIAID was the regulatory sponsor and IND holder.

www.witshealth.co.za

2

Working together to improve sexual and reproductive health outcomes Wits MRU (WMRU) is a Research Unit in the Department of Obstetrics and Gynaecology. The Unit is based in central Durban, KwaZulu-Natal where we conduct research at our site and in the surrounding communities. WMRU aims to answer priority questions that will translate into improving sexual and reproductive health outcomes through expanding access to appropriate and acceptable health technologies and services. Our core research areas include HIV prevention, contraception including barrier methods, safer conception, menstrual management, postpartum depression and other areas of sexual and reproductive health.

Using a range of methodologies, we conduct behavioural, operations and clinical research, actively partnering and involving communities and local structures. We also provide technical assistance, partnering with various stakeholders including the Department of Health and other NGOs to affect policy change and enhance best practice. We work with diverse partners, collaborators and donors, including local and internationally based universities and research centres.

The leadership team of Mags Beksinska, Nzwakie Mosery, Jenni Smit and Keri Singh have worked together for over a decade and have put Wits on the map in KwaZulu Natal! Despite the distance from Johannesburg, we continue to collaborate with many other WHC Research Units in a range of research activities. WMRU staff also supervise Wits PhD and MMed students, and participate in Wits Research Days.

Research Highlights Depot Medroxyprogesterone Acetate also known as DMPA or Depo Provera is a commonly used threemonthly injectable contraceptive in South Africa and the region. A previous study has shown that DMPA stopped women from ovulating (for at least 6 months when it was given under the skin (instead of the muscle). To evaluate its safety and contraceptive efficacy as a 6-monthy injection Wits MRU commenced a contraceptive efficacy trial:-DMPA-XT: A Phase 3, Open-Label, Multicenter Study to Evaluate Contraceptive Efficacy and Safety of Depot Medroxyprogesterone Acetate (150 mg/mL) Injected Subcutaneously Every Six Months. This study funded by USAID via FHI 360 is being conducted in five sites globally and WMRU is the only African site.

Women’s Day Celebration, August 2023

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3

WMRU has established itself as a global leader in the conduct of barrier method trials and has an ongoing of programme of condom research aiming to test new more acceptable male and female condoms.

We are currently involved in several Pre-exposure prophylaxis (PrEP) for HIV Prevention studies:- Firstly the PURPOSE-1 PrEP trial is a Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection.

Secondly, project ENGAGE, a Phase II Acceptability Study of Oral emtricitabine/tenofovir alafenamide (F/ TAF) vs emtricitabine/tenofovir disoproxil fumarate (F/ TDF) for the Prevention of HIV Acquisition in Adolescent Girls and Young Women (AGYW) and a third study:- A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women. Two of these studies are mixed methods with qualitative components built in to explore young women’s PrEP use experience.

We also recently completed an evaluation of a simple urine point-of-care test for adherence of F/TAF and F/ TDF.

The Unit conducts acceptability, function and contraceptive efficacy trials. Recently completed studies include a function study which compared two new male condoms to a standard latex male condom. Later this year several female condom trials will commence.

WMRU has collaborated with a team from Massachusetts General Hospital for over a decade and currently working together on a NIH funded study which is developing a resiliency intervention to support nurses engaged in the provision of HIV care. This study will adapt, refine, and pilot test an existing stress management and resiliency-enhancing intervention (the Relaxation Response Resiliency Program; 3RP) for nurses providing HIV care in the public sector in SA. We will identify the ways in which the 3RP requires adaptation to meet the needs of nurses based on data collected from focus group discussions (FGDs) and adapt the intervention accordingly.

WMRU hosted its Research Dissemination day in February this year. The meeting was attended by the Department of Health at provincial level and clinic staff; local research organisations including the MRC, HSRC, CAPRISA, EpiCentre and the Clinical HIV Research Unit (CHRU); NGOs; educational institutions and other key stakeholders including UNFPA. The dissemination was also attended by representatives of WHC, Wits faculty of Health Sciences and our adult and adolescent Community Advisory boards (CAB/ACAB) who gave their input and experience on their role as CAB members at WMRU.

Research Dissemination Day, February 2023

Adolescent CAB presenting at the WMRU Dissemination day

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4

The very first game of Women’s Cricket took place on 26 July 1745 in England.

Over the years, Women’s Cricket has grown from strength to strength through efforts and contributions made by passionate individuals who pool their forces to create something spectacular.

The Women’s Cricket Science, Medicine and Leadership Conference was held on 5 February 2023 at Laborie Estate in the beautiful town, Paarl, in the Western Cape, with the Wits Cricket Research Hub playing a central role in its initiation and organisation. A total of 93 delegates registered to attend the event in person, and another 364 for online attendance – researchers, healthcare practitioners, coaches, managers and leaders in women’s cricket came together in a quest to strengthen Women’s Cricket. View the highlights of this spectacular event here: https://youtu.be/ mvOz1RsX1Zs?si=EKY3JdLyaUS0zM4U

The Women’s Cricket Science, Medicine and Leadership Conference, February 2023

Professor Benita Olivier Bowling Analysis Benita Olivier, Director of the Wits Cricket Research Hub, has been contracted to analyse the bowling actions of Cricket South Africa’s Elite Fast Bowling Group. Together with her team, Mmathapelo Thotse, Jolandi Jacobs and Prudence Phalandwa, they travelled to the various provinces to perform bowling analysis at the home grounds of the Warriors, Cape Cobras, Knights, Norther Cape Heat, Dolphins, Titans, and the Lions. Each bowler’s bowling action gets analysed individually using three- and two-dimensional recordings.

Three-dimensional movement analysis takes place through an inertial measurement system, and two-dimensional analysis through video capturing using GoPro cameras. Cricket South Africa then arranges a feedback session a few weeks later where the findings produced in the report gets interpreted, explained and turned into practical recommendations. Through this initiative, we are using our research expertise to create an impact in the lives of others.

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5

Providing the Dapi-ring as a new PrEP choice in South Africa On August 18, 2023, history was made as Maria

CATALYST Launch

Rantho Clinic in Soshanguve, Tshwane became the first Department of Health healthcare facility in South

MOSAIC South Africa announced the official launch of

Africa to offer the revolutionary Dapi-ring as an

the CATALYST (Catalyzing Access to New Prevention

additional choice for HIV prevention.

Products

to

Stop

HIV)

Study

after

months

of

preparation and anticipation. The launch was held at In 2016 South Africa was one of the first countries in

the Wits RHI Key Populations clinic in Johannesburg

the world to approve and begin the rollout of oral PrEP

on 11 August 2023 and was attended by clients

for populations at significant risk of HIV. Since then,

seeking services, representatives from the civil society

South Africa has made significant progress with over a

organization, Sisonke, Department of Health, and the

million individuals having been initiated on oral PrEP. In

USAID South Africa Mission.

2021, WHO recommended that the dapivirine ring (PrEP ring) may be offered as an additional HIV

Speaking during the launch, Dr Letitia Robinson,

prevention choice for women.

Acting

USAID

Bilateral

Health

Office

Director,

emphasized the importance of having real-world In 2022, SAHPRA approved this monthly vaginal ring for

actionable data to maximize the impact that new PrEP

use by adult women (18 years and older) to protect

products may have on reducing new HIV infections.

against sexual transmission of HIV. Project PrEP, an

Participants

initiative funded by Unitaid and implemented by Wits

activities including the ‘Drive with Sasha’ and a game

RHI, announced the addition of the PrEP ring as an

called ‘pop it’ that allowed participants to showcase

additional PrEP choice at Maria Rantho Clinic in

their HIV prevention knowledge prowess. The first

Soshanguve, Tshwane and in other provinces.

two study participants were enrolled whilst the launch

were

engaged

through

interactive

event was underway.

The study will generate real-world data on integrating a new PrEP method the Dapi-ring, in addition to oral PrEP,

CATALYST

and

will

address

a

global

gap

in

evidence

is

implemented

through

the

MOSAIC

on

(Maximizing Options to Advance Informed Choice for

understanding choice and patterns of use of different

HIV Prevention) project, a five-year global project

PrEP methods.

funded by the U.S. President’s Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID).

The study is designed to generate evidence to accelerate access to a choice-based HIV prevention package that supports PrEP choice; addresses needs at the individual, provider, facility, and community levels; and uses quality improvement methods to refine the components of the services provided.

Learn

more

about

CATALYST

www.prepwatch.org/catalyst/

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Study:

https://