Current Projects

HPRU has undertaken numerous clinical trials over the past 20 years. The Unit has five  established clinical research sites (CRSs) in the greater Durban area, which are approved by the Division of AIDS (DAIDS) and equipped to run large-scale clinical trials. Currently, the HPRU is conducting HIV injectable and vaccine trials several observational and behavioural research at the  CRSs,. All clinical research is conducted in partnership with stakeholders as part of the HPRU community engagement programme  Historically, the HPRU was the only centre globally to test four out of five microbicide investigational products in five Phase III and 3 Phase II/IIb  microbicide clinical trials. The excellent work produced by HPRU gave the National Institutes of Health (NIH) the confidence to award HPRU one of the largest grants, at three grant funding cycles, outside of the USA to undertake HIV prevention research.

Current
PHASE II AND III CLINICAL TRIALS
2020
COVID-19 Prevention Network
A clinical trial called CoVPN 5001 will help the newly formed COVID-19 Prevention Network (CoVPN) 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.
2020
STI_Zoli001 Study - A multi-center, randomized, open-label, noninferiority 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
National Clinical Trial Number: pending
Principal Investigator(s): Dr Elizabeth Spooner (Botha’s Hill CRS), Dr Vimla Naicker (Tongaat CRS)
Sponsor: Global Antibiotic Research and Development Partnership (GARDP)
2020
COVID-19 in children website
We invite practitioners, researchers, and others, who have an interest in, and are contributing to, the body of science about COVID-19 in children to visit our website. This website aims to promote the collaboration and sharing of resources and knowledge, specifically related to COVID-19 in children, amongst: South African clinicians working in child health and paediatrics; Researchers working in maternal and child health; and Virologists and epidemiologists interested in the epidemiology of COVID-19 in children.
 
You will find information and contact details of the following on our website: Research projects; The latest research evidence; Reports from the World Health Organisation and relevant institutions; Funding opportunities; Diagnostic and treatment guidelines
2018
PrEPVacc - 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.
2018
HVTN 703/HPTN 081 (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)
2018
HPTN 084(LIFE) - 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 Mammekwa Mirriam Mokgoro (Botha’s Hill CRS)  
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
2018
HVTN 705: (Imbokodo)  - 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.
2017
HVTN 702(Uhambo) - 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)
2016
MTN 025(HOPE): A Phase 3b Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
PHASE I CLINICAL TRIAL
2017
HVTN108: 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)
2015
HVTN 100: 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.
2015
HVTN 111: 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.
BIOLOGICAL CLINICAL RESEARCH
2018
HVTN 702 Mucosal sampling sub-study: 
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
2018
HVTN 910: A protocol to assess the persistence of HIV vaccine-induced seropositivity in participants who received vaccine in DAIDS-funded preventive HIV vaccine trials
National Clinical Trial Number: N/A
Principal Investigator: Mrs Kubashni Woeber
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
2010
MTN 016: (EMBRACE): 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)
2009
MTN 015: 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)
SOCIO-BEHAVIOURAL TRIALS
2018
Registration CohortDevelopment 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)
2017
SHIOP - 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
2016
MTN 032: (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)
2016 Hotspots: 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
2012
MTN 020: Qualitative Study (component of MTN 020)
Site Investigator: Mrs Kubashni Woeber (Isipingo CRS)
Network: Microbicide Trials Network (MTN)
2007
PEER study: Implementation and Evaluation of a Peer Education Programme in Communities  
Principal Investigator: Ms. Neetha Morar
Sponsor: SAMRC and Trial sponsors

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

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 2019-2021  - click to view information

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
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 for mothers and use of neutralizing antibody-based immunotherapy for infants.

Methods
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.

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)
  • 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: Data collection and laboratory analyses conducted and completed in September 2019 to February 2020. Data analyses and manuscript writing currently underway.

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

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

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 22 July 2020, more than 15 million confirmed cases across 118 countries and over 617 000 deaths have been reported; South Africa reported over 382 000 confirmed COVID-19 cases with 5 173 death.

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:

  • To assess the effect of the COVID-19 pandemic on the service utilization and quality of routine non-COVID-19-related SRMNH services in the public sector;
  • To assess the effect of the COVID-19 pandemic on the Mphatlalatsane Initiative intervention delivery;
  • To assess the contextual and implementation process factors that shape the effectiveness of the Mphatlalatsane Initiative, which will include a specific focus on how COVID-19 affects the delivery of SRMNH services, and health workers’ and managers’, who respectively deliver and manage these services, experiences and perceptions of COVID-19.

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) is currently under Scientific Review and will be submitted to the SAMRC Ethics Committee at the next sitting.

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

Preventing HIV incidence in pregnant and lactating young women: 2018 ongoing

PI: Prof. Ameena Goga

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

  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.
  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
  4. To write a proposal to test an intervention aimed at reducing HIV incidence in young pregnant and lactating women

Collaboration
Prof Dhayendre Moodley, University of KwaZulu-Natal.

Project status

  • Research papers for peer reviewed publication on the secondary analysis and desk review have been drafted
  • A formative assessment on the feasibility and acceptability of PrEP amongst HIV negative pregnant women was conducted in 3 provinces (North West, Gauteng and Limpopo). Data for this work is being analysed to inform how the proposals are framed.
  • Two proposals are currently being written: (1) to understand perceptions of women and their partners currently enrolled in a PrEP study in KZN and (2) to explore the plausibility of on-demand PrEP in pregnant and lactating women

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

Process evaluation of PMTCT Option B+: 2018

PI: Prof. Ameena Goga and Dr. Witness Chirinda

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
Field work has been completedto commence mid-2017, Data management, analysis and write-up are currently underway.

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

A proof of concept feasibility study of an outreach mentorship approach for disseminating the updated 2016 WHO HIV and Infant feeding guidelines: 2018

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

Field work has been completed. Two papers have been published and one is in press.

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

Publications:

  1. 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
  2. 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
Barriers to integrated family planning and HIV care services in South Africa: data collection 2017

PI: Dr Witness Chirinda

Overview
In South Africa, high rates of unplanned pregnancies remain a major public health concern.  Studies have reported prevalence of unplanned pregnancies ranging between 60-85% in HIV infected women and in the general population.  Integrating family planning into HIV service has been shown to; reduce rate of unplanned pregnancy; increase uptake, coverage and reach of FP; reach both men and women; increase ART uptake and adherence; and reduction of HIV-related stigma. Despite recognition that service integration is important for patient care and that integration reinforces HIV prevention and FP goals, the literature is unclear on how best to integrate SRH and HIV services, leaving service providers with uncertainty regarding the most effective model. In South Africa, little is known about the extent of service integration particularly at the level of policy making, and interventions are necessary to be targeted at this level.

Overall aim
This study aims to explore the (policy and operational) barriers to FP/HIV service integration and identify strategies to overcome them.

The key questions are:

  • What is the extend of FP/HIV care integration in selected contexts
  • What is the understanding of service integration among policy makers and programme managers?
  • What are the barriers to FP/HIV care service integration at policy and operational levels?
  • How can these barriers be overcome?

Collaboration
UNICEF

Project status
Data analysis in progress. An expert meeting to be held before end-June 2019

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

Utility of routine PMTCT data for monitoring antenatal HIV prevalence: data collection: 2017

PI: Prof. Ameena Goga

SAMRC co-investigator: Duduzile Nsibande

Overview
This study aims 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 is to assess the utility of PMTCT program (DHIS) data for HSS among pregnant women.

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

Project status
Data collection has been completed. The detailed survey report can be found here and policy brief here. Research papers for peer reviewed publication are currently being drafted.

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

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

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

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)

Evaluation of the effectiveness of the South African Prevention of Mother - to - Child Transmission of HIV (PMTCT) Programme on Infant HIV, periodically at six weeks postpartum (data collection: 2010, 2011, 2012), and until 18 months of age (data collection: 2012-2014) (SAPMTCTE)

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, 20th edition. Epub 2017 May.
Very Early Infant Diagnosis Study: data collection: 2014-2016

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 focuses 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 are:

  • 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 test 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 and two papers have been accepted for publication thusfar.

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

Historical completed - Key Clinical Trials
1 MTN 020: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women
2 MTN 003: Phase IIB Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/ Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV infection in Women
3 HPTN 035: Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel for the Prevention of HIV Infection in Women
4 CONRAD: Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission (Phase III)
5 Phase III Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women
6 MIRA (Phase III) : Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
7 MDP 301 PHASE III: An international multi-centre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 0.5% and 2% PRO 2000/5 gels for the prevention of vaginally acquired HIV infection
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