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hiv and other infectious diseases

Current Projects

HIDRU has undertaken numerous clinical trials over the past 25 years (since 1996). The Unit has six established clinical research sites (CRSs) in the greater Durban area, which are approved by the Division of AIDS (DAIDS) and equipped to conduct large-scale clinical trials. Currently, the HIDRU conducts epidemiological, behavioural, basic science, and clinical research to investigate vulnerability to HIV and other infectious diseases as well as interventions (including vaccines and drugs) for prevention and treatment of these diseases.  All clinical research is conducted in partnership with stakeholders as part of the HIDRU community engagement programme which was established in the 90s.

In 2020, HIDRU partnered with CAPRISA and are part of the NIH funded  KwaZulu Natal Clinical Trials Unit (KZN CTU).

Historically, as the HIDRU was the only centre globally to test four out of five microbicide investigational products in five Phase III and three Phase II/IIb clinical trials. The excellent work produced by HIDRU gave the National Institutes of Health (NIH) the confidence to award HIDRU one of the largest grants, at three grant funding cycles, outside of the USA to undertake HIV prevention research.

Current Clinical Trials



IMPOWER (MK-8591-022) – HIV Prevention Phase II Clinical Trial

Protocol Title: A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir (ISL) Once Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection

Overall Study Design

This is a randomized, active-controlled, parallel-group, multisite, double-blind, double dummy study to evaluate the safety and efficacy of ISL administered orally once monthly (QM)) as PrEP in cisgender women who are at high risk for HIV-1 infection. The active comparator for this study, Truvada (FTC/TDF) will be administered orally QD (daily).

Primary Objectives and Primary Endpoints

  • To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the prevention of HIV-1 infection as assessed by the incidence rate per year of confirmed HIV-1 infections Hypothesis: ISL QM is superior to FTC/TDF QD as assessed by the incidence rate per year of confirmed HIV-1 infections 
  • To evaluate the safety and tolerability of oral ISL QM compared to oral FTC/TDF QD as assessed by review of the accumulated safety data

Secondary Objectives Secondary Endpoints

  • To evaluate the efficacy of oral ISL QM in reducing the incidence per year of HIV-1 infection relative to the background rate.

Hypothesis: ISL QM reduces the incidence rate of confirmed HIV-1 infections compared to the background incidence rate.

Approximately 4500 participants will be randomized (stratified by site and age) in a 1:1 ratio to receive either ISL or FTC/TDF for the duration of the study. Approximately 50% of the global study population will be <25 years of age. Women who are at high risk of acquiring HIV-1 infection will be enrolled in this study and is based upon the VOICE risk score tool

There are several sites across USA and Africa participating in the trial. There are 20 sites in South Africa and 20 sites in USA.  The Chatsworth site based in Durban is contributing to the sample size.

Eligible women will be enrolled over an approximate 12-month period with study intervention administered for approximately 1 year and up to 3 years, based on estimated accrual of primary endpoint cases.

The PI at the SAMRC Chatsworth Clinical Research Site is Dr. Logashvari Naidoo.

The study is currently in follow up stage.


PrEPVacc (2018)

A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomization to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.

National Clinical Trial Number: N/A

Principal Investigator(s): Dr Nishanta Singh (Verulam CRS)

PrEPVacc is a new African-led, European-supported HIV prevention study running in East and Southern Africa from 2018 to 2023.

The study is enrolling and in follow up stage

HPTN 084: (LIFE)
HPTN 084 (LIFE) (2018 and OLE in 2022) 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)

PedMAb: Phase I/II study to determine Safety & Pharmacokinetics of subcutaneous administration of potent & broad anti HIV-1 neutralizing monoclonal antibodies, given to HIV-1 exposed neonates and infants.

Dr Logashvari Naidoo (Chastworth CRS)

Screening and enrolling

CARES: A Phase 3b, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-Acting Cabotegravir Plus Long-Acting Rilpivirine From Current Antiretroviral Regimen in HIV-1 Infected, Virologically Suppressed Adults in Sub-Saharan Africa  

Dr Logashvari Naidoo (Chatsworth CRS)

Enrolling and follow up

Key Highlights

  • The DSMB halted the blinded part of the study in November 2020 because CAB LA was highly effective at HIV prevention. Participants in the study were informed of their study arm and continued dosing of their original product.
  • The team revised the protocol to develop the Open-Label Extension. “Open Label” means the participants would know what study products they were taking. During this part of the study, participants could now choose to take long-acting injectable cabotegravir (CAB-LA). All sites were required to get ethics approval for the protocol.
  • The OLE also includes a sub-study for pregnant and lactating women and their infants and incorporates feedback received from stakeholders during the consultation in May 2021.
  • The team began implementing the “Open Label Extension” (OLE) part of the study in January 2022. From early 2022 until now, all twenty study sites have transitioned all participants onto the OLE. 
  • In addition, participants enrolled in HPTN 084-01, an adolescent study, were also offered the option to join the HPTN 084 OLE so they could access CAB LA if they wanted to take it.
  • In November 2022, an amendment to the protocol extended the OLE period. The amendment adds 48 more weeks to the study. Participants will continue to have access to CAB-LA if they wish to take it. It also allows the choice for continued dosing on CAB-LA for expectant mothers and their infants throughout pregnancy and 48 weeks postpartum. Sites are actively working on local IRB/EC submissions. The amended protocol will begin implementation in early 2023.
  • At present, four countries have approved CAB-LA for PrEP (Australia, Uganda, the United States, and Zimbabwe). The study team is hopeful all countries involved in HPTN 084 will approve CAB-LA soon. If you have questions about the status of in-country approvals of CAB-LA, please reach out to ViiV directly.


HVTN 139

Title: A phase 1 clinical trial to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult participants

Phase: 1

Site: Isipingo CRS

Protocol Chair: Prof Ameena Goga

Site PIs: Drs Reshmi Dassaye and Villeshni Asari

Study in enrollment and follow up phase

STI_Zoli001 Study

STI_Zoli001 Study (2020)

A Phase 3 multi-center, randomized, open-label, non-inferiority trial to evaluate the efficacy and safety of a single, oral dose of Zoliflodacin compared to a combination of a single intramuscular dose of Ceftriaxone and a single oral dose of Azithromycin in the treatment of patients with uncomplicated Gonorrhoea

Principal Investigator(s): Dr Elizabeth Spooner (Botha’s Hill CRS), Dr Vimla Naicker (Tongaat CRS)

Sponsor: Global Antibiotic Research and Development Partnership (GARDP)

Study enrolling and in follow up stage

COVID-19 Trials


SHERPA - Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S. Open-label, phase 3 study to evaluate the effectiveness of heterologous mRNA-1273 boosting of the single or two dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa.

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

Dr Vimla Naicker (Tongaat CRS)

Screening and Enrolling


A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

CRSs includes Chatsworth, Tongaat, Bothas Hill.

PIs : Logashvari Naidoo, Vimla Naicker, Mammekwa Mokgoro.

The study is currently in follow up.

Biological Clinical Research

COVID T cell immune Escape

Predicting and monitoring T cell immune escape mutations found in SARS-CoV-2 epitopes from genomes isolated in South Africa and sub-Saharan Africa, 2022-2023 

PI: Nobubelo Ngandu

CD8+ T cell immune response plays a role in controlling the pathogenesis of SARS-CoV-2 infection. However, the extent to which it exerts selective pressure on the virus proteins during evasion of the immune response leading to emergence of new variants is still under investigation.

This study aims to take advantage of large open-source genomic data to investigate the potential role of CD8+ T cell immune response as well as CD4+ T-cell dependent antibody immune response in the emergence of SARS-CoV-2 variants.

Open-source SARS-CoV-2 genomic data will be analyzed to identify immune escape mutations potentially associated with CD8+ and CD4+ T cell immune response pathways, using bioinformatics prediction methods.


  • University of Cape of Cape Town, South Africa
  • South African National Bioinformatics Institute, UWC, South Africa
  • Simon Fraser University, Canada

Funding: The study is funded by the SAMRC Grants, Innovation & Products Development.

Project status: The study has received ethics approval and data mining has commenced. 

Contact: Dr. Nobubelo Ngandu (

HVTN 702 Mucosal sampling sub-study
HVTN 702 Mucosal sampling sub-study: (2018)
Mucosal systems in vaccine responses and HIV infection risk in a subset of participants enrolled in HVTN 702
National Principal Investigator: Mrs Kubashni Woeber
Sponsor: SAMRC

Observational Studies & Social Behavioral Studies

Registration Cohort: (2018)

Registration Cohort(2018) Development of an HIV-negative registration cohort for future participation in an HIV vaccine study

Principal Investigator(s): Ms. Samantha Siva (Phoenix CRS, Verulam CRS)

Sponsor: European Developing Country Clinical Trial Partnership (EDCTP)

 Study in follow up 

PEER study

PEER study: (2007) Implementation and Evaluation of a Peer Education Programme in Communities  

Principal Investigator: Ms. Neetha Morar

Sponsor: SAMRC and Trial sponsors

Socio-Behavioural Trials

SHIOP (2017)   - A Study to investigate Sexual health, HIV and co-morbidity with non-communicable infections among Older Persons
Principal Investigator(s): Dr Makandwe Nyirenda (Botha’s Hill CRS and Chatsworth CRS)
Sponsor: SAMRC
MTN 032
MTN 032: (2016) (AHA): Assessment of ASPIRE and HOPE Adherence
National Clinical Trial Number: NCT02702895
Principal Investigator: Ms. Neetha Morar (Botha’s Hill CRS)
Network: Microbicide Trials Network (MTN)
MTN 020
MTN 020: (2012) Qualitative Study (component of MTN 020)
Site Investigator: Mrs Kubashni Woeber (Isipingo CRS)
Network: Microbicide Trials Network (MTN)
Hotspots: (2016) To describe in detail, the social economic, behavioural context of women residing within HIV ‘hot spot’ areas compared to women residing in HIV ‘cold spots’
Principal Investigator: Prof Gita Ramjee
Sponsor: SAMRC

TB and HIV studies

HVTN 405/HPTN1901

Observational studies – Completed, closed and published

HVTN 910

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)

MTN 016: (EMBRACE): (2010) Evaluation of Maternal and Baby Outcome Registry after Chemoprophylactic Exposure (EMBRACE)
National Clinical Trial Number: NCT01209754
Principal Investigator: Ms. Samantha Siva (Botha’s Hill, Isipingo, Verulam, Tongaat and Chatsworth CRS)
Network: Microbicide Trials Network (MTN)
MTN 015
MTN 015: (2009) An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials
National Clinical Trial Number: NCT00514098
Principal Investigator: Mr. Zakir Gaffoor (Botha’s Hill, Isipingo, Verulam, Tongaat and Chatsworth CRS)
Network or Sponsor: Microbicide Trials Network (MTN)
What are the maternal treatment outcomes, pregnancy outcomes and infant outcomes in women treated for DR-TB during pregnancy.

PI: Dr. Marian Loveday

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

Study methods

A descriptive cohort analysis

Data collection ongoing


  • 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.
  • 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

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.

Recruitment has started and is ongoing.


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


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 3rd 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).


Recruitment has started and is ongoing.

Survival and TB recurrence after successful drug-susceptible- and rifampicin-resistant TB treatment

MRC PI: Dr. Marian Loveday

PI: Prof Helen Cox (UCT)

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.

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.

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

Exploring opportunities and models for improved integration and health service delivery at a community and primary health care level in eThekweni metro, KwaZulu-Natal, South Africa

PI: Dr. Marian Loveday

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


Advance Access & Delivery (AA&D)

eThekweni Metro Health Services

Provincial TB and NCD directorates

The treatment journey of People Living with HIV (PLHIV)

PI: Marian Loveday


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. 


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. 


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.


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

Maternal, Family, Child Health, Nutrition (MFCHN) studies

Sensitivity of HIV-1 virus isolates in breastmilk to broadly neutralizing antibodies: 2021-2022

PI: Nobubelo Ngandu, Ameena Goga

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.

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.

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.


  • 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

Dr. Nobubelo Ngandu (, Prof. Ameena Goga (

PHANGISA study: Key risk factors for peripartum and postpartum vertical HIV transmission in the context of PMTCT Option B+ in a rural district in South Africa 2019 - 2023 

PI: Nobubelo Ngandu, Ameena Goga

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.

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.

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.


  • 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 (  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.

Dr. Nobubelo Ngandu (,  ; Prof. Ameena Goga (

Evaluation of the Mphatlalatsane Initiative: An Integrated Quality Improvement Approach to Improve Sexual, Reproductive, Maternal and Neonatal Health Outcomes: 2018 ongoing

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


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.

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.

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.

In 2019 we also drafted a Reader (a resource document on quality improvement literature for maternal, neonatal, and child health), and a Mphatlalatsane newsletter with interviews with Project management staff.

Contact person
Dr Terusha Chetty (

A point prevalence survey of paediatric antimicrobial use and healthcare-associated infections in three acute care tertiary/ quaternary hospitals in South Africa; Chris Hani Baragwanath Academic Hospital, Inkosi Albert Luthuli Central Hospital and Steve Biko Academic Hospital

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

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).


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

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 (

COVID-19 and Nutrition Study

PIs: Dr Vundli Ramokolo and Dr Wanga Zembe-Mkabile


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


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 (

A cluster randomized study of models of delivery of Pre-Exposure Prophylaxis for pregnant and breastfeeding women at public health facilities in KZN

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.


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 (, Dr Ramokolo (

The Child Support Grant (CSG) and Child Nutrition: A birth cohort assessing the utilisation of the CSG and its link to dietary diversity, food security and child growth


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


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. 


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


Dr Wanga Zembe-Mkabile and Dr Vundli Ramokolo

Contact: Dr Wanga Zembe-Mkabile (, Dr Vundli Ramokolo (

Implementation evaluation of PMTCT Option B+ in South Africa, : 2018: A mixed methods multi-level evaluation of health care provision and user experiences.

PI: Prof. Ameena Goga

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

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.

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 (


  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 Journal111(8), 759-767.
Long-term health outcomes of mothers and infants enrolled in the 2012-13 SAPMTCT evaluation: data collection 2016

PI: Prof. Ameena Goga and Dr. Witness Chirinda

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.

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.

UNICEF, National Department of Health

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

Contact person
Dr. Witness Chirinda (

SARS-CoV-2 Infection in Hospitalised South African Children: A multi-centre collaborative study to develop a COVID-19 Paediatric Registry SA COVID KIDS Study

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


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 (

Severe SARS-CoV-2 related disease in low and middle - income country children aged 0 - 19 years: a multi-country observational study in a network of hospitals (WHO COVID KIDS study)

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


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


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 (