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.
PHASE II AND III CLINICAL TRIALS
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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)
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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
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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.
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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)
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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)
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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.
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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)
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2016
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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
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PHASE I CLINICAL TRIAL
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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)
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2015
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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.
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2015
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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.
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BIOLOGICAL CLINICAL RESEARCH
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2018
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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
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OBSERVATIONAL STUDIES
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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)
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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)
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2009
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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)
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SOCIO-BEHAVIOURAL TRIALS
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2018 |
Registration Cohort: 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)
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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
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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)
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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
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2012
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MTN 020: Qualitative Study (component of MTN 020)
Site Investigator: Mrs Kubashni Woeber (Isipingo CRS)
Network: Microbicide Trials Network (MTN)
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2007
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PEER study: Implementation and Evaluation of a Peer Education Programme in Communities
Principal Investigator: Ms. Neetha Morar
Sponsor: SAMRC and Trial sponsors
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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 Aims Methods Collaboration
Project status: Data collection and laboratory analyses conducted and completed in September 2019 to February 2020. Data analyses and manuscript writing currently underway. Contact |
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 study objectives are as follows:
Collaboration Project status Contact person |
Preventing HIV incidence in pregnant and lactating young women: 2018 ongoing |
PI: Prof. Ameena Goga Overview Objectives
Collaboration Project status
Contact person |
Process evaluation of PMTCT Option B+: 2018 |
PI: Prof. Ameena Goga and Dr. Witness Chirinda Overview Aim Collaboration Project status Contact person |
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 Aim Collaboration Project status Field work has been completed. Two papers have been published and one is in press. Contact person Publications:
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Barriers to integrated family planning and HIV care services in South Africa: data collection 2017 |
PI: Dr Witness Chirinda Overview Overall aim The key questions are:
Collaboration Project status Contact person |
Utility of routine PMTCT data for monitoring antenatal HIV prevalence: data collection: 2017 |
PI: Prof. Ameena Goga SAMRC co-investigator: Duduzile Nsibande Overview Aim Collaboration Project status Contact person |
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 Aim Collaboration Project status Contact person |
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 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 Collaboration 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 The following papers have been published as a result of our association with this work Journal Articles 2014/15 Financial Year
2015/16 Financial Year
2016/17 Financial Year
2017/18 Financial Year
2018/19 Financial Year
2019/20 Financial Year:
2020/21 Financial Year
Book Chapters 2017/18 Financial Year
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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 The key questions are:
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 Collaboration Project status Contact person |
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 |