Current Projects

Observational studies – Completed, closed and published

HVTN 910: (2018) A protocol to assess the persistence of HIV vaccine-induced seropositivity in participants who received vaccine in DAIDS-funded preventive HIV vaccine trials

Principal Investigator: Mrs Kubashni Woeber

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

PI: Dr. Marian Loveday

Aim
To document the treatment, pregnancy and outcomes of women treated for DR-TB during their pregnancy. 

Study methods

A descriptive cohort analysis

Status
Data collection ongoing

Collaboration

• Dr. Jennifer Hughes from the Desmond Tutu TB Centre (DTCC)
• Dr. James Seddon from Imperial College London and the Desmond Tutu TB Centre (DTCC)
• Clinicians at King Dinuzulu Hospital, eThekweni, KwaZulu-Natal.

Study outcomes

• Loveday M, Hughes J, Sunkari B, Master I, Hlangu S, Reddy T, Chotoo S, Green N, Seddon JA. Maternal and infant outcomes among pregnant women treated for multidrug/rifampicin-resistant tuberculosis in South Africa. 2020. https://doi.org/10.1093/cid/ciaa189.
• Presented pregnancy findings as WHO Guideline Development Group meeting. These findings have been included in the latest WHO guidelines on how pregnant women with RR-TB should be managed.

Nested study within the DR-TB during pregnancy study:

Title: To explore maternal and infant concentrations of second-line TB drugs in pregnant women and their infants

PI: Dr. Gary Maartens (UCT) and Dr Catriona Waitt (Liverpool University)

PI MRC: Marian Loveday

Aim
To explore maternal and infant concentrations of the second-line TB drugs in these women and their infants.

Study methods

All recruited participants who have not yet delivered will be screened for eligibility into the pharmacokinetic (PK) analysis to enhance the understanding of drug exposure in pregnant women on therapy for DR-TB. Two PK sampling occasions will be scheduled, the first will be prior to delivery preferably in the third trimester, on a date, which is convenient for the mother and the second at 6 weeks post-delivery to compare drug levels in the pregnant and non-pregnant state.

Status
Recruitment has started and is ongoing.

Collaboration

Prof Gary Maartens, Prof Helen Mclleron, Dr Richard Court: UCT

Second nested study within the DR-TB during pregnancy study:

PI: Dr Grant Theron (US)

PI MRC: Dr. Marian Loveday

Aim

To explore whether microbiomes of mothers (airways, breastmilk, vagina, gut) and babies (gut) are potentially affected by treatment, and if so, are any microbiome changes associated with infant outcomes and drug exposure?

Study methods

All recruited participants who have not yet delivered will be screened for eligibility into the microbiome study. Vaginal, gut, breastmilk and sputum samples will be collected from the mother in the 3^rd trimester and 6 weeks, 6 months and 12 months after delivery. Microbiome estimates in each specimen type will be correlated with PK data and clinical outcomes (in mothers and babies).

Status

Recruitment has started and is ongoing.

MRC PI: Dr. Marian Loveday

PI: Prof Helen Cox (UCT)

Aim
To document survival and the recurrence of TB after successful drug-susceptible- and rifampicin-resistant TB treatment

Study methods

A mixed methods cohort study design: We will identify a similar number of patients with TB in Umzinyathi and Khayelitsha, matching for age and gender with MDR-TB patients in the same area.  Patients co-infected with HIV and with co-morbid conditions (eg. Diabetes) will be included.

Status
Data collection for Umzinyathi is complete. The qualitative data component has been analysed and submitted for publication. We have been unable to extract quantitative data for Khayelitsha from the PDSA.

Collaboration
Mr Johnny Daniels and Dr. Erika Mohr from Medicins san Frontier (Khayelitsha, South Africa)
Dr. Helen Cox and Dr. Andrew Boulle from UCT

PI: Dr. Marian Loveday

Aims
The aims of the implementation component are:

• To develop and implement a targeted screening approach for diabetes, hypertension, and other diseases and conditions utilizing existing community-based and facility-based health service infrastructure in eThekwini, using an improved diagnostic algorithm aligned with national guidelines. This builds on existing screening efforts against other diseases such as tuberculosis.
• To develop an algorithm alongside our partners that is based on peer-reviewed evidence and in line national guidelines. Subsequently, implement it for treatment, support, and education for these patients and their families. Work with public health and where appropriate private health delivery partners to implement and improve this program in subsequent years in a large, targeted area of the municipality.
• To support the National health services integration initiative by sharing practical operational research in a timely manner, avoiding duplication or parallel, “vertical” disease efforts (HIV, TB, hypertension, diabetes, etc.), improving existing and new health worker capacity in public and private sectors, and implementing a clear sustainability plan at the end of the grant period

The aims of the evaluation component:

1. Document the opportunities and models for improved integration and health service delivery implemented by AA&D and local partners at PHC facilities, schools and in the community.
2. Through the lens of a non-communicable disease (NCD) diabetes and an infectious disease TB document the functioning of the different levels of the health system, the interface and relationship between these layers and the inputs needed to optimize health system functionality across all levels.
3. Document the strategies and interventions required to improve integration and for effective patient-centered services including active case finding, linkage to care, effective education and quality management of both non-communicable and infectious diseases.
4. Monitor the integration of both non-communicable and infectious disease services at a community level, together with the linkages to PHC facility level care. 
5. Using the platform created for the Zero TB Cities Initiative, pilot a program of decentralized, community-based screening and referral for diabetes, hypertension and other conditions (as the basis for using this approach for integrated PHC delivery).
6. Monitor the impact of the introduction of new, complex interventions at a district level and how these impact on and are integrated into existing services. This may include the provision of MDR-TB services, Test and Treat and adolescent HIV prevention.

Study methods

Implementation research

Status
Ongoing

Collaboration
Advance Access & Delivery (AA&D)

eThekweni Metro Health Services

Provincial TB and NCD directorates

PI: Marian Loveday

Aim

To describe the treatment journeys of PLHIV with sub-optimal retention in care to gain a better understanding of the complexities around HIV disease, its management and the contribution of health system failures to sub-optimal retention in care. (We have defined poor retention in care as a PLHIV who has not taken ART for 30 days in the last two months.)

The specific objectives of the study are:

1. to describe the treatment journey of PLHIV with sub-optimal poor retention in care;
2. to explore the social, structural, economic and cultural factors that influence retention in care;
3. to identify health systems factors which are facilitators or barriers to retention in care. 

Methods

Setting: RK Khan hospital and Don Mackenzie ART clinic for adolescents which are both in eThekwini district in KwaZulu-Natal.

Study design: A mixed methods study design will be used. This will include interviews, participant-generated visual methodologies (PVM) and a review of medical records.

Data collection: Data will be collected using semi-structured interviews in PLHIV ≥ 25 years of age and PVM in those 16 - 24 years old.

Study outcomes

By describing the treatment journeys of PLHIV with sub-optimal retention in care we will get a better understanding of the complexities around HIV disease, its management and the contribution of health system failures to sub-optimal retention in care. 

Status

A manuscript reporting the findings of the adult study component has been written and is currently under review. A manuscript on the adolescent study is currently being written up.

Collaboration

Dr. Jennifer Furin (Department of Global Health and Social Medicine, Harvard Medical School)

PI: Nobubelo Ngandu, Ameena Goga

Overview
Several clinical trials are currently underway in search for neutralizing antibody candidates that can effectively prevent HIV infection including prevention of vertical HIV transmission. It is important to understand which neutralizing antibody combinations would be ideal for use in preventing HIV transmission during breastfeeding in the South African context.

Aims
This is study aims to assess the feasibility of using broadly neutralizing antibodies as prophylaxis to protect infants from postnatal HIV infection through breastfeeding, in a South African population dominated by HIV-1 subtype C which has a broad intra-subtype genetic diversity spectrum.

Methods
A facility-based proof-of-concept cross-sectional study is being conducted at Kalafong Provincial Tertiary Hospital. A pilot sample of 12-24 mothers with a current plasma viral load >400 copies/mL will be targeted. Sensitivity to second generation neutralizing antibodies will be assessed in-vitro on viruses isolated from the mother’s breastmilk and compared to viruses isolated from autologous blood plasma. One to three antibodies with good potency and breadth will be identified and used to plan a Phase IIb clinical trial in similar settings.

Collaboration

• South African Breastmilk Reserve
• National Institute for Communicable diseases (NICD)/ National Health Laboratory Services (NHLS)
• University of Pretoria
• Ospedale San Rafaelie
• University of Montpellier

Project status: Phase I (data collection) completed, currently in Phase II

Contact
Dr. Nobubelo Ngandu (Nobubelo.Ngandu@mrc.ac.za), Prof. Ameena Goga (Ameena.Goga@mrc.ac.za

PI: Nobubelo Ngandu, Ameena Goga

Overview
The sub-regional variation in maternal HIV exposure and vertical transmission rates are the current stumbling blocks against progress towards meeting the targets for eliminating mother-to-child transmission of HIV (MTCT) at national level in South Africa. High impact and context-specific district-level interventions in districts with vertical HIV transmission higher than the national average are needed. Ehlanzeni district in Mpumalanga province is one of such high-risk regions. However, routine data is either incomplete or of poor quality making it difficult to accurately identify gaps and opportunities for improving HIV care to mother-infant pairs.

Aims
PHASE I: In order to design an effective intervention(s) to assist Ehlanzeni district lower its MTCT rate, we will measure the distribution and correlates of: Maternal viral load, Maternal HIV incidence, Infant prophylaxis uptake and Infant feeding practices. We will also explore the feasibility and acceptability of use of pre-exposure prophylaxis.

PHASE 2: To evaluate the effect of COVID-19 pandemic and lockdown on uptake of viral load testing, HIV diagnosis testing, and viral load suppression amongst mothers and infants who participated in this study.

Methods
PHASE I: A quantitative cross-sectional study conducted at district level. The inclusion criterion is HIV-positive pregnant women and HIV-positive postnatal women with infants aged 0-24 months. Data collection will involve(i) face-to-face interviews (ii) review of patient clinic records (iii) collection of whole blood samples to measure HIV viral load (iv) collection of DBS samples from HIV-exposed uninfected infants for HIV diagnoses.

PHASE 2: A prospective longitudinal cohort conducted using routine programmatic HIV and PCR test data of study participants, from the National Health Laboratory Service’s Data Warehouse, between March 2020 through to September 2021.

Collaboration

• National department of Health
• Ehlanzeni district PMTCT management
• Right to Care (district partner)
• Academy for Quality Healthcare (AQUAH) (district partner)
• National Institute for Communicable diseases (NICD)/ National Health Laboratory Services (NHLS)
• Wits Health Consortium
• Montpellier University France
• University of Bergen Norway
• Queen Mary University of London UK
• Zvitambo Institute for MCH Research Zimbabwe
• Unviersity of Liverpool UK

Project status:  PHASE 1: Primary study was completed in March 2022 and the primary objective findings have been published in BMJ-Open (https://bmjopen.bmj.com/content/12/3/e058347).  The district report with a full summary of study findings can be found here. Data analyses and manuscript writing currently underway.

PHASE 2: Data collection, extraction and cleaning have been completed. Data analyses is currently in progress.

Contact
Dr. Nobubelo Ngandu (Nobubelo.Ngandu@mrc.ac.za),  ; Prof. Ameena Goga (Ameena.Goga@mrc.ac.za)

PI: Prof. Ameena Goga, Dr Terusha Chetty and Prof. Helen Schneider

Overview

The National Department of Health (NDoH) is implementing an integrated sexual, reproductive, maternal and newborn health (SRMNH) initiative to improve sexual, reproductive, maternal and neonatal health outcomes in South Africa.  This initiative called “Mphatlalatsane” (meaning “the last star before the dawn”) seeks to reduce unplanned pregnancies, maternal and neonatal mortality, and stillbirths, by testing a potentially replicable quality improvement (QI) model for national scale-up through government adoption and funding. The Mphatlalatsane Initiative embraces QI interventions to make small facility-based changes that the system can absorb and sustain if they work.  The SAMRC, in partnership with the SAMRC Health Services to Systems Research Unit, School of Public Health, University of the Western Cape, is responsible for evaluating the impact and implementation processes of the Mphatlalatsane Initiative in the QI-intensive sites. The evaluation will only focus on the maternal and newborn components.

On 30 January 2020, the World Health Organization (WHO) declared COVID-19 a public health emergency of international concern (PHEIC).  As of 06 June, 2022, more than 528 million confirmed cases across 118 countries and over 617 000 deaths have been reported; South Africa reported over 3.9 million confirmed COVID-19 cases with 101,250 deaths.

In March 2020, the South African government declared a state of disaster and implemented several measures to prevent the spread of the disease, restricting face-to-face interactions and allowing only essential activities.  The effect that COVID-19 has had/will have on the uptake, continuity and quality of maternal and neonatal healthcare services is still uncertain; much depends on whether South Africa’s efforts to prevent further spread of the virus are effective. Generating research evidence on the impact of COVID-19 on SRMNH services is of utmost importance as it will inform policies and practises on how to mitigate some of that impact. The evaluation of Mphatlalatsane offers an ideal opportunity to add specific COVID-19 research questions.

Aims
The overall evaluation aim is to determine whether a system-level, complex, patient-centred QI intervention reduces institutional maternal mortality ratio, stillbirth rate and neonatal mortality rate by 50% in five years.

The study objectives are as follows:

• The evaluation primarily aims to measure the effectiveness of the Mphatlalatsane Initiative on iMMR, neonatal mortality rate and stillbirth rate (Objective 1). We also assess whether patients’ experience of care (Objective 2); and quality of maternal (Objectives 3a) and neonatal care (Objective 3b) was affected by the pandemic.  Objective 4a explores the macro (regional/national) and meso (sub-district/district) level factors, and Objective 4b, the micro (facility) level process and contextual factors, including COVID-19, to explain variation in QI uptake and programme outcomes. Partner interviews (Objective 4a) commenced early 2020, and data collection for Objective 4b in May 2021. Patient interviews commenced in October 2021.

Collaboration
The NDoH, in collaboration with the South African Medical Research Council, Clinton Health Access Initiative (CHAI), the SAMRC-University of Pretoria Maternal and Infant Health Strategies Unit (SAMRC-UP), the University of Limpopo Trust-Limpopo Initiative for New-born Care, and the University of Western Cape.

Project status
The study is funded by ELMA Philanthropies. We received ethical approval from the University of the Western Cape to commence with assessing contextual and implementation processes and has produced a report on the first round of interviews we conducted with the collaboration partners. A revised proposal (necessitated by COVID-19 restrictions) has received ethical approval from the South African Medical Research Council and the data collection is currently ongoing.  Interim evaluation reports on the contextual and implementation processes are currently disseminated to the participating catchment areas. These reports include an Objective 4a technical report.

Contact person
Dr Terusha Chetty (terusha.chetty@mrc.ac.za)

PI: Prof Prakash Jeena

PI MRC: Prof. Ameena Goga, Dr Terusha Chetty

PI UP: Prof Jeane Cloete, Dr Maria Karsas

PI University of Witswatersrand: Prof David Moore

PI UKZN: Prof Moherndran Archary, Dr Ashendri Pillay

Overview
In South Africa, antimicrobial usage, and the prevalence of paediatric community-acquired infections (CAI) and healthcare-associated infections (HAI) are mostly unknown. More robust evidence is required, given the current context of the COVID-19 pandemic.  A cross-sectional point prevalence survey will be conducted in 2021 over two consecutive months at three tertiary/quaternary health care hospitals in South Africa, namely, Chris Hani Baragwanath Academic Hospital (CHBAH), Inkosi Albert Luthuli Central Hospital (IALCH) and Steve Biko Academic Hospital (SBAH).

Objective

To evaluate the antimicrobial usage and prevalence of neonatal and paediatric CAI and HAI at three regional/tertiary centres in South Africa.

Collaboration
The study is a collaborative effort between the South African Medical Research Council, Steve Biko Academic Hospital, University of Pretoria, and Chris Hani Baragwanath Hospital, University of Witwatersrand.

Project status

The proposal has received ethical approval and we completed data collection.

Contact person
Dr. Terusha Chetty (Terusha.Chetty@mrc.ac.za)

PIs: Dr Vundli Ramokolo and Dr Wanga Zembe-Mkabile

Aim

To measure the impact of the COVID-19 pandemic on child morbidity including nutritional status, household food security, and dietary diversity, and access to health services

Methods

Cross-sectional follow-up of participants enrolled in a pregnancy cohort study. Consenting mothers/caregivers will be interviewed on the child’s dietary intake and morbid outcomes, grant access and utilization and other factors. Child anthropometry will be measured and data from the previous cohort study will be used as a baseline.

Project status

Data collection underway.

Contact person: Dr Vundli Ramokolo (vundli.ramokolo@mrc.ac.za)

Principal investigators: Dr Terusha Chetty and Dr Vundli Ramokolo

Co-investigators: Vuyolwethu Magasana, Duduzile Nsibande, Trisha Ramraj, Ameena Goga, Tarylee Reddy, Nada Abdelatif, Carl Lombard

Aim: To determine the best model for PrEP delivery in pregnant and postpartum women attending health facilities in KwaZulu-Natal.

Methods:

Cluster randomised trial among pregnant or postpartum women attending primary health care and community health centres for antenatal or well-baby care in the iLembe and eThekwini Districts, KwaZulu-Natal, South Africa.  Health facilities will be randomised to either an intervention group with universal PrEP (opt-out) or control group with PrEP opt-in based on risk stratification following standardized counselling. Outcomes include PrEP uptake, and provider and participant acceptance of PrEP use following telephonic interviews.

Contact: Dr Chetty (terusha.chetty@mrc.ac.za), Dr Ramokolo (vundli.ramokolo@mrc.ac.za)

Aim

To assess the nutritional status and dietary patterns of recipients and non-recipients of the CSG in Langa Township, Western Cape

Methods

Community-based prospective pregnancy cohort study conducted in Langa township between. Mother-child pairs were recruited during pregnancy and followed until 2 years postpartum. Data on access to the CSG, child feeding practices and anthropometry were collected. 

Status

Data collected between March 2016 and March 2020. Data analysis and manuscript writing underway.

PIs

Dr Wanga Zembe-Mkabile and Dr Vundli Ramokolo

Contact: Dr Wanga Zembe-Mkabile (wanga.zembe@mrc.ac.za), Dr Vundli Ramokolo (vundli.ramokolo@mrc.ac.za)

PI: Prof. Ameena Goga

Overview
In 2015 South Africa adopted PMTCT Option B+ which recommends lifelong antiretroviral therapy for all pregnant and lactating women regardless of CD4 cell count.

Aim
To document the processes and models used for PMTCT Option B+ implementation, to measure the effects of PMTCT Option B+ on health services for mothers and children and to evaluate early effectiveness of PMTCT Option B+ in the initial 1-2 years post-implementation.

Collaboration
National Department of Health, Centers for Disease Control and Prevention, UNICEF, National Institute for Communicable Diseases

Project status
The project has been completed.  The detailed survey report  is available here.  Research papers for peer reviewed publication are currently being written.

Contact person
Prof. Ameena Goga (ameena.goga@mrc.ac.za)

Publications:

1. Ngandu, N. K., Nsibande, D. F., Magasana, V., Chirinda, W., Mbira, T., Sherman, G. G., & Goga, A. E. (2021). Quality and turnaround times of viral load monitoring under prevention of mother-to-child transmission of HIV Option B+ in six South African districts with a high antenatal HIV burden. South African Medical Journal, 111(8), 759-767.

PI: Prof. Ameena Goga and Dr. Witness Chirinda

Overview
There are few studies assessing the long-term outcomes, at approximately 3-4 years of age of HIV exposed and HIV unexposed children. These data are critical for monitoring the impact of the national PMTCT programme and the fourth millennium development goal.

Aim
To assess the survival of mothers and their HIV exposed uninfected (HEU) or HIV unexposed infants, previously enrolled in the 2012-14 South African PMTCT Evaluation (SAPMTCTE), at 2-3 years postpartum. Peer-reviewed paper submitted for publication.

Collaboration
UNICEF, National Department of Health

Project status
Data collection completed, analysis and write up in progress.

Contact person
Dr. Witness Chirinda (witness.chirinda@mrc.ac.za)

Protocol chair: SAMRC: Prof. Ameena Goga

Protocol co-chairs: University of the Witwatersrand - Dr David Moore; University of Pretoria - Prof Jeané Cloete and Prof Ute Feucht; Sefako Makgatho Health Sciences University: Prof Dini Mawela; University of Cape Town- Prof Liesl Zühlke; University of Stellenbosch - Prof Helena Rabi; University of KwaZulu-Natal - Dr Moherdran Archery; University of the Free State - Dr Nomakhuwa Tabane; Limpopo - Dr Ntsako Gabaza Tiva

Overview

Given the risk of respiratory infections, and high exposure to HIV, TB and malnutrition in South Africa, the course that COVID-19 disease will take in hospitalised South African children is not known. This study aims to describe the epidemiology, clinical characteristics and outcome of hospitalised children with COVID-19 at academic and non-academic hospitals in South Africa. Data from hospitalised children with COVID-19 will be extracted from medical notes and laboratory records and entered into a surveillance database that is an expansion of the national DATCOV surveillance platform – this is a data platform developed by the National Institute for Communicable Diseases (NICD) in response to COVID-19. This expanded database will form the national paediatric COVID-19 Registry.

Primary Objective

To describe the epidemiology and clinical characteristics and outcome of paediatric SARS-CoV-2 infection amongst children hospitalised at academic and non-academic hospitals.

Secondary Objectives

1. To describe immunological responses in a subset of children with COVID-19 (confirmed on PCR or by clinical suspicion and including cases of multi-system inflammatory syndrome in children (MIS-C) admitted to academic or non-academic hospitals.
2. To gather data on co-morbidities amongst SARS-CoV-2 positive hospitalised children and cases of multi-system inflammatory syndrome in children (MIS-C)  
3. To document COVID-19-related complications amongst SARS-CoV-2 positive hospitalised children and children with MIS-C at academic hospitals in the South African context, including cardiac, autoinflammatory/autoimmune, rheumatological, dermatological etc.
4. To determine the proportion of SARS-CoV-2 positive hospitalised children who present with respiratory symptoms.
5. To determine the proportion of SARS-CoV-2 positive hospitalised children who need admission to an intensive care unit.
6. To determine the proportion of SARS-CoV-2 positive hospitalised children who are HIV positive

Collaboration: The study is a collaborative effort between the South African Medical Research Council,  University of the Witwatersrand, Chris Hani Baragwanath Hospital, Nelson Mandela Children’s Hospital, Charlotte Maxeke Hospital, Rahima Moosa Hospital, University of  Pretoria, Steve Biko Academic Hospital, Sefako Makgatho Health Sciences University George Mukhari Academic Hospital, University of Cape Town, Red Cross Children’s Hospital, University  of Stellenbosch, Tygerberg Hospital, University of KwaZulu-Natal, Inkosi  Albert Luthuli Hospital,  King Edward Hospital, University of Free State, Universitas, Pelanomi, Bongani Regional Hospital, Dihlabeng Regional Hospital, Boitumelo Regional Hospital, University of Limpopo, Mankweng Hospital and Polokwane hospital, National Institutes of Communicable Diseases, Perinatal HIV Research Unit, Wits Reproductive Health and HIV Institute

Project status

Data collection in progress

Contact person: Prof. Ameena Goga (ameena.goga@mrc.ac.za)

Protocol chair: SAMRC: Prof. Ameena Goga

Protocol co-chairs: University of the Witwatersrand: Prof David Moore, Dr Firdose Nakwa, Dr Shannon Cawood, Prof Debbie White, Dr Gary Reubenson; University of Pretoria: Prof Jeané Cloete, Prof Ute Feucht; Sefako Makgatho Health Sciences University: Prof Dini Mawela; University of Cape Town: Prof Kate Webb, Prof Chris Scott, Prof Heather Zar, Prof Liesl Zühlke; University of KwaZulu Natal: Dr Kogie Chinniah, Dr Moherndren Archary; University of the Free State: Dr Michael Pienaar and Dr Nomakhuwa Tabane

Overview

In children, severe acute respiratory syndrome corona virus type 2 (SARS-CoV2) related disease includes both acute COVID-19 disease and post-acute Multisystem Inflammatory Syndrome in Children (MISC). There is very little information about acute COVID-19 disease and MISC in children presenting to hospital in low and middle-income countries. The aim of this study is to understand the clinical characteristics of SARS-CoV2 related disease in neonates, children and adolescents aged 0-19 years presenting to hospital in LMICs. The study will be set in a network of 20 children’s and maternity hospitals in four countries in Africa and Asia (Ethiopia, India, Pakistan, South Africa). SAMRC is the coordinating centre in South Africa with network hospitals existing within regional clusters. Network hospitals will be supported to improve their diagnostics, therapies, data collection systems, and clinical guidelines for best practice management and therapy. Testing processes will follow the local hospital standard operating procedures for each site. There are three components to the study: (i) prospective surveillance; (ii) prospective case control study; and (iii) retrospective data extraction.

Our objectives are to use hospital network surveillance systems to:

• Describe clinical presentations, comorbidities, diagnostic and laboratory features, currently available therapies, and long-term outcomes
• Understand the association between severity of SARS-CoV2 related disease and comorbidities in LMIC children

Collaboration

The study is a collaborative effort between the South African Medical Research Council,  University of the Witwatersrand, Chris Hani Baragwanath Hospital, Nelson Mandela Children’s Hospital, Charlotte Maxeke Hospital, Rahima Moosa Hospital, University of  Pretoria, Steve Biko Academic Hospital, Sefako Makgatho Health Sciences University, George Mukhari Academic Hospital, University of Cape Town, Red Cross Children’s Hospital, University of KwaZulu-Natal, Inkosi  Albert Luthuli Hospital,  King Edward Hospital, Mahatma Gandhi Memorial Hospital, Greys Hospital, University of Free State, Universitas, Pelanomi Hospital

Project status

Data collection in progress

Contact person: Prof. Ameena Goga (ameena.goga@mrc.ac.za)

PI: Prof. Ameena Goga

Co-PI: Vuyolwethu Magasana, Trisha Ramraj, Witness Chirinda, Duduzile Nsibande, Terusha Chetty, Vundli Ramokolo

Overview
The project aims to explore how HIV incidence amongst pregnant and lactating women can be reduced. Specifically, we aimed to test the feasibility and effectiveness of Pre-exposure prophylaxis (PrEP) and reasons for withdrawal amongst HIV negative pregnant women enrolled in a PrEP study in KZN. Additionally, we sought to develop a risk score to identify young pregnant or lactating women at highest risk of HIV acquisition. Our deliverables include reports, peer reviewed publications, policy briefs, data that could guide policy makers on whether to invest in additional work to test the role of PrEP in HIV negative pregnant women.

Objectives and Status

1. To explore the acceptability and feasibility of PrEP, and reasons for study withdrawal amongst HIV negative pregnant or lactating women enrolled in CAP016: Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women: An Open-Label Randomised Control Study, a study currently funded by the SAMRC and led by Prof Dhayendre Moodley, University of KwaZulu-Natal. Collaboration: Prof Dhayendre Moodley, University of KwaZulu-Natal. Lead: Vuyolwethu Magasana; peer-reviewed publication being drafted
2. To conduct a desk review on the legislative and regulatory framework around PrEP in pregnant and lactating women
3. To develop a simple risk measurement tool to identify which young pregnant or lactating women are at risk of HIV infection. This paper has been completed and submitted for publication. Lead author: Trisha Ramraj
4. To write a proposal to test an intervention aimed at reducing HIV incidence in young pregnant and lactating women. Lead: Terusha Chetty and Vundli Ramokolo: Funder: UNICEF; the proposal has been submitted for Scientific review.

Contact person
Prof. Ameena Goga (ameena.goga@mrc.ac.za), Vuyolwethu.Magasana@mrc.ac.za, Duduzile.Nsibande@mrc.ac.za, Trisha.Ramraj@mrc.ac.za, Terusha.Chetty@mrc.ac.za; Vundli.Ramokolo@mrc.ac.za

PI: Prof. Ameena Goga, Prof Tanya Doherty and Dr Christiane Horwood

Overview
In 2017 HIV and infant feeding guidance was updated in South Africa, in response to the 2016 WHO update.

Aim
We sought to determine whether a participatory mentorship approach to guidelines dissemination increases knowledge, attitude and skills of health workers.

Collaboration
UKZN, WHO, University of Bergen

Project status

This study has been completed and papers have been published.

Publications:

1. Goga A, Doherty T, Manda S, et al. Translating new evidence into clinical practice: a quasi-experimental controlled before–after study evaluating the effect of a novel outreach mentoring approach on knowledge, attitudes and confidence of health workers providing HIV and infant feeding counselling in South Africa. BMJ Open 2020;10:e034770. doi:10.1136/bmjopen-2019-034770
2. Horwood C, Haskins L,Goga A,Doherty T, John V, Engebretsen IMS, Feucht U, Rollins N, Kroon M,Sanders D, Tylleskar T. An educational intervention to update health workers about HIV and infant feeding. Maternal & Child Nutrition. https://doi.org/10.1111/mcn.12922
3. Doherty T, Horwood C, Magasana V, Goga A, Feucht U, Sanders D, Tylleskar T, Kauchali S, Rollins N, Kroon M, Engebretsen IMS.  Breastfeeding advice for reality: women’s perspectives on infant feeding support received in primary health care settings in South Africa. Accepted by Maternal and Child Nutrition: https://doi.org/10.1111/mcn.12877

Contact person
Prof. Ameena Goga (ameena.goga@mrc.ac.za),  Prof Tanya Doherty (Tanya.Doherty@mrc.ac.za)

PI: Prof. Ameena Goga

SAMRC co-investigator: Duduzile Nsibande

Overview
This study aimed to answer the following questions: Can routine PMTCT data be used for antenatal HIV surveillance in the South African context?  What value will such an approach add? Could such an approach replace the SAANCHSS?

Aim
The overall objective of the study was to assess the utility of PMTCT program (DHIS) data for HSS among pregnant women.

Collaboration
The study was a collaborative effort between the Medical Research Council, National Department of Health, CDC and NICD/NHLS, Epicentre and UNAIDS.

Project status
The project has been completed. The detailed survey report can be found here and policy brief here. A research paper for peer reviewed publication has been accepted (May 2022).

Contact person
Prof. Ameena Goga (ameena.goga@mrc.ac.za)

PI: MRC: Prof. Ameena Goga co-PIs UWC: Prof Debra Jackson CDC: Dr Thu-Ha Dinh

Co-investigators: South African Medical Research Council:  Prof Carl Lombard, Dr Selamawit Woldesenbet, Ms Vundli Ramokolo  National Department of Health:  Dr Yogan Pillay, NICD/NHLS Prof Gayle Sherman, Prof Adrian Puren.

Overview
Within seven years of implementing the national PMTCT program, South Africa had successfully scaled up its PMTCT services. Interventions to prevent mother-to-child transmission of HIV were offered in more than 95% of antenatal clinics and maternity institutions country-wide. In 2008, 2010 and 2013 the South African National Department of Health (NDOH) updated its PMTCT policy to include more efficacious interventions to reduce mother-to-child transmission of HIV. These efforts are to meet the National Strategic Plan (NSP 2012-2016) targets of reducing the MTCT rate of HIV to less than 2% by six weeks and < 5% by 18-months.

The South African PMTCT Evaluation was implemented in 2010, 2011 and 2012 to track population-level impact of the national PMTCT programme. These data were (critically important to monitor progress towards meeting the targets set in the South African National Strategic Plan (of reducing vertical transmission to less than 5% at 18 months by 2016), and the 4th and 6th millennium development goals (i.e. ‘reduce under-five mortality rate by two thirds, between 1990 and 2015, and halt the spread of HIV/AIDS’).

Aim
To periodically conduct facility-based surveys to monitor the effectiveness of the South African National PMTCT programme until 18 months postpartum.

Collaboration
The survey was a collaborative effort between the Medical Research Council, University of the Western Cape, National Department of Health, Centers for Disease Control and Prevention, Atlanta, NICD/NHLS, Wits Infant HIV Diagnostics, UNICEF and Provincial Departments of Health. All findings were reported to all stakeholders to improve implementation of the national PMTCT programme.

The SAPMTCTE was funded predominantly by the Centers for Disease Control and Prevention, Atlanta, with contributions from the National Department of Health, NICD/NHLS, Global Fund and UNICEF.

Project status

The 2010 situational assessment, conducted to document systems for early infant diagnosis at primary health care level, has been completed and can be obtained here. The 2010 survey has been completed. Results were presented at numerous conferences including SAAIDS 2011, IAS 2011, APHA 2011 and Perinatal priorities 2011. The detailed 2010 survey report can be found here.

The 2011 SAPMTCTE-6 weeks has been completed. Results were released by the Minister of Health and at the International AIDS Conference 2012. The Executive Summary with preliminary 2011 results can be found here. 

The 2012 survey has been completed and the report can be found here. The six weeks results were presented to the Minister of Health on the 28th August 2014. All HIV exposed infants were subsequently followed up at 3, 6, 9, 12, 15 and 18 months. The 18-month follow-up was completed by 12th September 2014 and  results were released at the AIDS 2016 Conference.

Contact person
Prof. Ameena Goga
ameena.goga@mrc.ac.za

The following papers have been published as a result of our association with this work

Journal Articles

2014/15 Financial Year

1. Goga AE, Dinh TH, Jackson DJ, Lombard C, Delaney KP, Puren A, Sherman G, Woldesenbet S, Ramokolo V, Crowley S, Doherty T, Chopra M, Shaffer N, Pillay Y. First population-level effectiveness evaluation of a national programme to prevent HIV transmission from mother to child, South Africa. Journal of Epidemiology and Community Health. 2015 Mar;69(3):240-8. Epub 2014 Nov 4. DOI: 10.1136/jech-2014-204535 [Original]
2. Woldesenbet SA, Jackson D, Goga AE, Crowley S, Doherty T, Mogashoa MM, Dinh TH, Sherman GG. Missed opportunities for early infant HIV diagnosis: results of a National Study in South Africa. Journal of Acquired Immune Deficiency Syndromes. 2015 Mar 1;68(3):e26-32. Epub 2014 Dec 2. DOI: 10.1097/QAI.0000000000000460 [Original]

2015/16 Financial Year

1. Dinh TH, Delaney KP, Goga A, Jackson D, Lombard C, Woldesenbet S, Mogashoa M, Pillay Y, Shaffer N. Impact of maternal HIV seroconversion during pregnancy on early Mother to Child Transmission of HIV (MTCT) measured at 4-8 weeks postpartum in South Africa 2011-2012: a National Population-Based Evaluation. PLoS One. 2015 May 5;10(5):e0125525. DOI: 10.1371/journal.pone.0125525 [Original]
2. Woldesenbet S, Jackson D, Lombard C, Dinh TH, Puren A, Sherman G, Ramokolo V, Doherty T, Mogashoa M, Bhardwaj S, Chopra M, Shaffer N, Pillay Y, Goga A. Missed opportunities along the prevention of mother-to-child transmission services cascade in South Africa: uptake, determinants, and attributable risk (the SAPMTCTE). PLoS One. 2015 Jul 6;10(7):e0132425. DOI: 10.1371/journal.pone.0132425 [Original]

2016/17 Financial Year

1. Goga AE, Dinh TH, Jackson DJ, Lombard CJ, Puren A, Sherman G, Ramokolo V, Woldesenbet S, Doherty T, Noveve N, Magasana V, Singh Y, Ramraj T, Bhardwaj S, Pillay Y; South Africa PMTCT Evaluation (SAPMCTE) Team. Population-level effectiveness of PMTCT Option A on early mother-to-child (MTCT) transmission of HIV in South Africa: implications for eliminating MTCT. Journal of Global Health. 2016 Dec;6(2):020405. Epub 2016 Sep 16. DOI: 10.7189/jogh.6.020405 [Original]
2. Woldesenbet SA, Jackson DJ, Lombard CJ, Dinh TH, Ramokolo V, Doherty T, Sherman GG, Pillay Y, Goga AE. Structural level differences in the mother-to-child hiv transmission rate in South Africa: a multilevel assessment of individual-, health facility-, and provincial-level predictors of infant HIV transmission. Journal of Acquired Immune Deficiency Syndromes. 2017 Apr 15;74(5):523-530. Epub 2017 Jan 18. DOI: 10.1097/QAI.0000000000001289 [Original]

2017/18 Financial Year

1. Hamilton E, Bossiky B, Ditekemena J, Esiru G, Fwamba F, Goga AE, Kieffer MP, Tsague LD, Van De Ven R, Wafula R, Guay L. Using the PMTCT cascade to accelerate achievement of the global plan goals. Journal of Acquired Immune Deficiency Syndromes. 2017 May 1;75 Suppl 1:S27-S35. Epub 2017 Apr 12. DOI: 10.1097/QAI.0000000000001325 [Review]
2. Sherman GG, Mazanderani AH, Barron P, Bhardwaj S, Niit R, Okobi M, Puren A, Jackson DJ, Goga AE. Toward elimination of mother-to-child transmission of HIV in South Africa: how best to monitor early infant infections within the prevention of mother-to-child transmission program. Journal of Global Health. 2017 Apr 12;7(1):010701. DOI: 10.7189/jogh.07.010701 [Original]
3. Ramokolo V, Goga AE, Lombard C, Doherty T, Jackson DJ, Engebretsen IMS. In-utero ART exposure and birth and early growth outcomes among HIV-exposed uninfected infants attending immunization services: results from National PMTCT Surveillance, South Africa. Open Forum Infectious Diseases. 2017 Oct;4(4):ofx187-ofx. Epub 2017 Aug 30. DOI: 10.1093/ofid/ofx187 [Original]
4. Ngandu NK, Van Malderen C, Goga A, Speybroeck N. Wealth-related inequality in early uptake of HIV testing among pregnant women: an analysis of data from a national cross-sectional survey, South Africa. BMJ Open. 2017 Jul;7(7):e013362. DOI: 10.1136/bmjopen-2016-013362 [Original]
5. Goga A, Chirinda W, Ngandu NK, Ngoma K, Bhardwaj S, Feucht U, Davies N, Ntloana M, Mhlongo O, Silere-Maqetseba T, Moyo F, Sherman G. Closing the gaps to eliminate mother-to-child transmission of HIV (MTCT) in South Africa: Understanding MTCT case rates, factors that hinder the monitoring and attainment of targets, and potential game changers. South African Medical Journal. 2018 Mar 03;108(3 Suppl1):s17-s24. DOI: 10.7196/SAMJ.2017.v108i3b.12817 [Editorial]
6. Ramraj T., Jackson, D., Dinh, TH., Olorunju, S., Lombard, C., Sherman, G., Puren, A., Noveve, N., Singh, Y., Magasana, V., Bhardwaj, S., Cheyip, M., Mogashoa, M., Pillay, Y., Goga, AE. Adolescent access to care and risk of early mother-to-child HIV transmission.Journal of Adolescent Health.https://doi.org/10.1016/j.jadohealth.2017.10.007
7. Larsen L, Cheyip M, Aynalem G, Dinh TH, Jackson D, Ngandu N, Chirinda W, Mogashoa M, Kindra G, Lombard C, Goga A. Uptake and predictors of early postnatal follow-up care amongst mother-baby pairs in South Africa: Results from three population-based surveys, 2010-2013. 2017 Journal of Global Health. Dec;7(2):021001. doi: 10.7189/jogh.07.021001.
8. Sherman GG, Haeri Mazanderani AF, Barron P, Bhardwaj S, Niit R, Okobi M, Puren D, Jackson DJ, Goga AE. Towards eMTCT of HIV in SA: How best to monitor the PMTCT Program. 2017 JoGH. Published April 2017 online. http://www.jogh.org/documents/issue201701/jogh-07-010701.XML
9. Woldesenbet S, Jackson D, Lombard C, Dinh T, Ramokolo V, Doherty T. Goga A. Structural Level Differences in the Mother-to-Child HIV Transmission Rate in South Africa: A Multilevel Assessment of Individual-, Health facility-, and Provincial- Level Predictors of Infant HIV Transmission. J Acquir Immune Defic Syndr. 2017. Published online January 2017. Available from: https://www.pubfacts.com/fulltext/28107227/

2018/19 Financial Year

1. Goga A. Birth HIV testing and paediatric treatment programmes. Lancet HIV. 2018 Dec;5(12):e675-e6. Epub 2018 Nov 8. DOI: 10.1016/s2352-3018(18)30291-1 [Letter]
2. Goga A, Singh Y, Jackson D, Mukungunugwa S, Wafula R, Eliya M, Ng'ambi WF, Nabitaka L, Chirinda W, Bhardwaj S, Essajee S, Hayashi C, Pillay Y. How are countries in sub-Saharan African monitoring the impact of programmes to prevent vertical transmission of HIV? British Medical Journal. 2019 Mar 26;364:l660. Epub 2019 Mar 26. DOI: 10.1136/bmj.l660 [Original]
3. Ramraj T, Goga AE, Larsen A, Ramokolo V, Bhardwaj S, Chirinda W, Jackson D, Nsibande D, Ayalew K, Pillay Y, Lombard CJ, Ngandu NK; South Africa PMTCT Evaluation (SAPMCTE) Team. Completeness of patient-held records: observations of the Road-to-Health Booklet from two national facility-based surveys at 6 weeks postpartum, South Africa. Journal of Global Health. 2018 Dec;8(2):020901. Epub 2018 Sep 15. DOI: 10.7189/jogh.08.020901 [Original]

2019/20 Financial Year:

1. Jackson DJ, Swanevelder S, Doherty D, Lombard C, Bhardwaj S, Goga A. Changes in rates of early exclusive breastfeeding in South Africa from 2010 to 2013: before and during implementation of a change in national breastfeeding policy. BMJ Open 2019;9:e028095. http://dx.doi.org/10.1136/bmjopen-2018-028095
2. Hunt GM, Ledwaba J, Salimo A, Kalimashe M, Dinh TH, Jackson D, Sherman G, Puren A, Ngandu NK, Lombard C, Morris L, Goga A. Prevalence of HIV-1 drug resistance amongst newly diagnosed HIV-infected infants age 4–8 weeks, enrolled in three nationally representative PMTCT effectiveness surveys, South Africa: 2010, 2011–12 and 2012–13. BMC Infectious Diseases, 16 September 2019. https://bmcinfectdis.biomedcentral.com/articles/supplements/volume-19-supplement-1.
3. Jackson DJ, Dinh TH, Lombard CJ, Sherman GG and Goga AE. An approach for evaluating early and long term mother-to-child transmission of HIV (MTCT) in low and middle income countries: a South African experience. BMC Infectious Diseases, 16 September 2019. https://bmcinfectdis.biomedcentral.com/articles/supplements/volume-19-supplement-1.
4. Kuhn L and Goga AE. Moving towards elimination: findings from the South Africa prevention of mother to child transmission evaluation (SAPMTCTE). BMC Infectious Diseases, 16 September 2019. https://bmcinfectdis.biomedcentral.com/articles/supplements/volume-19-supplement-1.
5. Larsen A, Magasana V , Dinh TH , Ngandu N , Lombard C , Cheyip M , Ayalew K , Chirinda W , Kindra G , Jackson D and Goga A. Longitudinal adherence to maternal antiretroviral therapy and infant Nevirapine prophylaxis from 6 weeks to 18 months postpartum amongst a cohort of mothers and infants in South Africa. BMC Infectious Diseases, 16 September 2019. https://bmcinfectdis.biomedcentral.com/articles/supplements/volume-19-supplement-1.
6. Mathivha E, Olorunju S, Jackson D, Dinh TH, du Plessis N and Goga A. Uptake of care and treatment amongst a national cohort of HIV positive infants diagnosed at primary care level, South Africa. BMC Infectious Diseases, 16 September 2019. https://bmcinfectdis.biomedcentral.com/articles/supplements/volume-19-supplement-1.
7. Ngandu NK, Jackson D, Lombard C, Nsibande DF, Dinh TH, Magasana V, Mogashoa M and Goga AE. Factors associated with non-attendance at scheduled infant follow-up visits in an observational cohort of HIV-exposed infants in South Africa, 2012–2014. BMC Infectious Diseases, 16 September 2019. https://bmcinfectdis.biomedcentral.com/articles/supplements/volume-19-supplement-1.
8. Ngandu NK, Maduna V, Sherman G, Noveve N, Chirinda W, Ramokolo V, Lombard C and Goga AE. Infrastructural and human-resource factors associated with return of infant HIV test results to caregivers: secondary analysis of a nationally representative situational assessment, South Africa, 2010. BMC Infectious Diseases, 16 September 2019. https://bmcinfectdis.biomedcentral.com/articles/supplements/volume-19-supplement-1.
9. Singh Y, Jackson D, Bhardwaj S, Titus N, Goga A. National surveillance using mobile systems for health monitoring: complexity, functionality and feasibility

2020/21 Financial Year

1. Goga AE. Impact of breastfeeding, maternal antiretroviral treatment and health service factors on 18-month vertical transmission of HIV and HIV-free survival: Results from a nationally representative HIV-exposed infant cohort, South Africa. In press. Journal of Epidemiology & Community Health
2. Nsibande D, Goga A, Laubscher R, Lombard C, Cheyip M, Jackson D, Larsen A, Mogashoa M, Dinh T-H, Ngandu N.The long journey towards optimal uptakeUptake of antenatal care in high HIV -prevalence settings: an exampleResults from three population-based surveys in South Africa. South African Medical Journal 2020;110(7):671-677. DOI:10.7196/SAMJ.2020.v110i7.14325

Book Chapters

2017/18 Financial Year

1. Goga A, Sherman G, Chirinda W, Ng`oma K, Bhardwaj S, Doherty T, Pilly Y, Barron P. Eliminating mother-to-child transmission of HIV in South Africa, 2002–2016: progress, challenges and the last mile plan. Chapter 13. In: Padarath A, Barron P (eds).  South African Health Review 2017. Durban: Health Systems Trust; 2017 Aug 23. P137-146, 20^th edition. Epub 2017 May.

PI: University of Pretoria (UP) Dr Nicolette du Plessis MRC co-PI Prof Ameena Goga

Co-investigators: UP: Prof Theunis Avenant  NHLS/UP: Dr Ahmad HaeriMazanderani

Overview
This study focused on the public health impact and feasibility of universal versus targeted very early infant diagnosis. The Mississippi baby, Visconti cohort and Berlin patient have raised optimism regarding the benefits of very early diagnosis and treatment initiation in functional HIV cure. Since the reported initial apparent functional cure in the Mississippi baby several debates about the optimal timing of early infant diagnosis have occurred in South Africa and Internationally.

The key questions were:

• In the context of PMTCT Option B what testing approach should be used to identify HIV infected infants as early as possible so that treatment can be initiated?
• What would be the impact and added benefit of universal versus targeted very early infant diagnosis?
• If a targeted approach is used, which combination of criteria would have the highest sensitivity and positive predictive value for infant HIV infection?
• What is the optimal treatment to use once a neonate has been identified as being HIV infected?
• Can universal or targeted birth infant diagnosis be incorporated into routine health care settings?

In this study we tested all participating HIV exposed infants for HIV infection within 72 hours of birth and initiate all HIV infected neonates on treatment.

Aim
To investigate the public health impact and feasibility of universal versus targeted very early infant diagnosis (VEID). Specifically we are investigating the impact of VEID on (i) early treatment initiation amongst HIV exposed infants and on (ii) infant outcomes at birth, 6 weeks, 10 weeks, 14 weeks, 6 months and 9 months and on the health system.

Collaboration
The study is a collaborative effort between the Medical Research Council, Department of Paediatrics and Child Health, Kalafong hospital, University of Pretoria, and Rahima Moosa Mother and Child Hospital (RMMH) University of Witwatersrand, National Health Laboratory system and National Department of Health.

Project status
Data collection started in August 2014 at Kalafong hospital and ended in December 2016. Two PhD students have graduated.

Publications

1. Mazanderani AH, Murray TY, Sherman GG, Snyman T, George J, Avenant T, Goga AE, Pepper MS, du Plessis N. Non-nucleoside reverse transcriptase inhibitor levels among HIV-exposed uninfected infants at the time of HIV PCR testing – findings from a tertiary healthcare facility in Pretoria, South Africa. JIAS. 22(6):e25284. doi: 10.1002/jia2.25284.

2. Du Plessis NM, Muller CJB, Avenant T, Pepper MS, Goga AE. An Early Infant HIV Risk Score for Targeted HIV Testing at Birth. Pediatrics. 2019 Jun;143(6). pii: e20183834. doi: 10.1542/peds.2018-3834. Epub 2019 May 17.

Contact person
Prof. Ameena Goga (ameena.goga@mrc.ac.za)

A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

PI at Verulam CRS : Nishanta Singh

The study is closed to follow up

An international, Bayesian platform adaptive, randomized, placebo-controlled trial assessing the effectiveness of candidate interventions in preventing COVID-19 disease in adults.

PI: Reshmi Dassaye; Co-Principal Investigator: Dr Villeshni Asari

The study is closed to follow up

OPEN LABEL TRIAL: Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa (VAC31518COV3012), Version 2.0

Principal Investigators (HPRU sites, Chatsworth, Bothas Hill, Tongaat CRSs)

Dr E Spooner - Elizabeth.Spooner@mrc.ac.za
Dr L Naidoo - Logashvari.Naidoo@mrc.ac.za
Dr V Naicker - Vimla.Naicker@mrc.ac.za

This open label COVID-19 vaccine trial was managed by Nivriti Hurban, Pharmacist of Record at Chatsworth CRS and Pharmacist Coordinator  

SAMRC PI - Prof Glenda Gray
SAMRC Co-PI - Prof Ameena Goga

Sisonke (Together) Websites

• Sisonke Study - Protecting Healthcare Workers 
• Sisonke2 Study - Protecting Healthcare Workers

• Press Releases

The trial is completed and published.

CoVPN 5001 - A prospective study of acute immune responses to SARS CoV-2 infection

The study will help the understand early SARS-CoV-2 infection and the body’s early immune responses to the virus that causes COVID-19 illness. Gathered from diverse populations worldwide, the data obtained through this study will describe viral progression and immunological characteristics of early infection with SARS-CoV-2. Information about the clinical course of SARS-CoV-2 infection, especially during its early stage, is needed to close knowledge gaps and will potentially suggest markers of protection that could be used in evaluating the efficacy of future COVID-19 vaccine candidates.

CRSs includes Chatsworth,Isipingo, Tongaat, Bothas Hill.

PIs – Elizabeth Spooner, Brodie Daniels

The study is close to follow up

HPTN 084: (LIFE) (2018) A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

National Clinical Trial Number: NCT03164564

Principal Investigator(s): Dr Nishanta Singh (Verulam CRS), Dr Dishiki Jenny Kalonji (Isipingo CRS), Dr Elizabeth Spooner (Botha’s Hill CRS)  

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Completed and published

HVTN 703/HPTN 081 (2018)

(AMP) -A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa

National Clinical Trial Number: NCT02568215

Principal Investigator(s): Dr Mammekwa Mirriam Mokgoro (Botha’s Hill CRS), Dr Logashvari Naidoo (Chatsworth CRS)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

The study is closed to follow up and published

HVTN 705: (Imbokodo)  (2018) A multicenter, randomized, double-blind, placebo-controlled phase 2b efficacy study of a heterologous prime/boost vaccine regimen of Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 in preventing HIV-1 infection in women in sub-Saharan Africa

National Clinical Trial Number: NCT03060629

Principal Investigator(s): Dr Logashvari Naidoo (Chatsworth CRS), Dr Vimla Naicker (Tongaat CRS)

Sponsor: Janssen Vaccines & Prevention B.V.       

The study is closed and published

HVTN 702: (Uhambo) - (2017) A pivotal phase 2b/3 multi-site, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in preventing HIV-1 infection in adults in South Africa

National Clinical Trial Number: NCT02968849

Principal Investigator(s): Dr Nishanta Singh (Verulam CRS), Dr Dishiki Jenny Kalonji (Isipingo CRS)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

MTN 025: (HOPE): (2016) A Phase 3b Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

IPM’s Dapivirine Ring for Women’s HIV Prevention Receives WHO Prequalification, International Partnerships for Microbicides, 30 November 2020

HVTN 405/HPTN1901: Characterizing SARS-CoV-2-specific immunity in convalescent individuals (PIs: Elizabeth Spooner and Brodie Daniels)

Study closed

HVTN108: (2017) A phase 1/2a clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA, and of MF59®- or AS01B-adjuvanted clade C Env protein in various combinations, in healthy, HIV-uninfected adult participants

National Clinical Trial Number: NCT02915016

Principal Investigator(s): Dr Vimla Naicker (Verulam CRS)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

HVTN 100: (2015) A phase 1-2 randomized, double-blind, placebo-controlled clinical trial of clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59^® in HIV-uninfected adults at low risk of HIV infection.

HVTN 111: (2015) A phase 1 clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA and of MF59-adjuvant clade C Env protein, in heathy, HIV-uninfected adult participants.