Intermittent Preventive Treatment with DHA-piperaquine for malaria in pregnancy in areas with high sulphadoxine-pyrimethamine resistance in Africa
Lead Research Organisation:
European & Developing Countries Clinical Trials Partnership
Abstract
Context of the research
Each year over 30 million pregnancies occur in malaria endemic areas of sub-Saharan Africa. Malaria in pregnancy (MiP) has devastating consequences for the mother and unborn child. The control of malaria in pregnancy in parts of East and southern Africa is under threat. Pregnant women are often infected with malaria without showing any outward signs or symptoms which, if left undetected and untreated, can cause anaemia and interfere with the development of the foetus leading to loss of the pregnancy, or premature birth and low birth weight, which in turn increases the risk of early infant death. The World Health Organisation (WHO) therefore recommends a preventive strategy called 'intermittent preventive treatment in pregnancy' (IPTp) in which mothers receive a single dose of 3 tablets of medication called sulphadoxine-pyrimethamine (SP) at each scheduled antenatal visit starting in the 2nd and 3rd trimester. However, the effectiveness of this strategy is being compromised due to high levels of resistance to SP in the malaria parasite population.
The recent search for safe, effective and well-tolerated alternatives drugs has proven elusive because most of the new candidates tested were not tolerated well enough to be used for preventive purposes. Other trials evaluating test and treat strategies have also proven disappointing. All hopes are now pinned on an antimalarial called dihydroartemisinin-piperaquine (DP), which is known to be safe in the 2nd and 3rd trimester of pregnancy and highly effective for treatment of clinical malaria. The high profile journals Lancet and the New England Journal of Medicine recently published the results of two exploratory trials, completed in 2015 (including one by this research team in Kenya). These showed that DP, when taken as IPT by pregnant women, was well tolerated and much more effective than SP in preventing malaria. However these two trials were not big enough to be able to evaluate the impact on the pregnancy outcome and the health of the newborn. WHO reviewed the evidence in July 2015 and concluded that DP is indeed a promising alternative to SP and recommended that a larger, confirmatory, trial is needed, before it can consider whether to recommend this drug as an alternative to SP in areas of high resistance.
Study aims and objectives
This multi-centre trial will enrol about 3,000 pregnant women in six hospitals in Kenya and Malawi and compare the safety, tolerance and beneficial effects of IPTp with DP to the current strategy with sulphadoxine-pyrimethamine in reducing pregnancy loss, low birthweight, preterm birth and small-for-gestational-age babies, and early infant deaths. The trial will include sub-studies on health economics to determine the cost of the strategy in relation to its benefits, the acceptability of the intervention among pregnant women and health providers, paying particular attention to adherence to the 3-day regimen, and the operational feasibility of implementing the intervention in the routine health system.
Potential applications and benefits
After a decade of intensive multi-centre trials to find new prevention strategies for malaria in pregnancy, DP has been shortlisted as the only potential alternative to SP for IPTp, but evidence of its benefits on infant outcomes is needed. As an experienced network, specialised in malaria prevention trials in pregnancy, we are in a unique position to address these gaps in an expedited manner. The findings of this new trial will provide the definitive evidence for whether or not this drug should be recommended to replace SP in areas with high levels of resistance by the parasite to SP. A positive result may lead to a direct policy change by the WHO in countries experiencing these levels of parasite resistance, including most countries in East and southern Africa, benefiting women at risk of malaria in these regions resulting in healthier pregnancies and healthier newborns.
Each year over 30 million pregnancies occur in malaria endemic areas of sub-Saharan Africa. Malaria in pregnancy (MiP) has devastating consequences for the mother and unborn child. The control of malaria in pregnancy in parts of East and southern Africa is under threat. Pregnant women are often infected with malaria without showing any outward signs or symptoms which, if left undetected and untreated, can cause anaemia and interfere with the development of the foetus leading to loss of the pregnancy, or premature birth and low birth weight, which in turn increases the risk of early infant death. The World Health Organisation (WHO) therefore recommends a preventive strategy called 'intermittent preventive treatment in pregnancy' (IPTp) in which mothers receive a single dose of 3 tablets of medication called sulphadoxine-pyrimethamine (SP) at each scheduled antenatal visit starting in the 2nd and 3rd trimester. However, the effectiveness of this strategy is being compromised due to high levels of resistance to SP in the malaria parasite population.
The recent search for safe, effective and well-tolerated alternatives drugs has proven elusive because most of the new candidates tested were not tolerated well enough to be used for preventive purposes. Other trials evaluating test and treat strategies have also proven disappointing. All hopes are now pinned on an antimalarial called dihydroartemisinin-piperaquine (DP), which is known to be safe in the 2nd and 3rd trimester of pregnancy and highly effective for treatment of clinical malaria. The high profile journals Lancet and the New England Journal of Medicine recently published the results of two exploratory trials, completed in 2015 (including one by this research team in Kenya). These showed that DP, when taken as IPT by pregnant women, was well tolerated and much more effective than SP in preventing malaria. However these two trials were not big enough to be able to evaluate the impact on the pregnancy outcome and the health of the newborn. WHO reviewed the evidence in July 2015 and concluded that DP is indeed a promising alternative to SP and recommended that a larger, confirmatory, trial is needed, before it can consider whether to recommend this drug as an alternative to SP in areas of high resistance.
Study aims and objectives
This multi-centre trial will enrol about 3,000 pregnant women in six hospitals in Kenya and Malawi and compare the safety, tolerance and beneficial effects of IPTp with DP to the current strategy with sulphadoxine-pyrimethamine in reducing pregnancy loss, low birthweight, preterm birth and small-for-gestational-age babies, and early infant deaths. The trial will include sub-studies on health economics to determine the cost of the strategy in relation to its benefits, the acceptability of the intervention among pregnant women and health providers, paying particular attention to adherence to the 3-day regimen, and the operational feasibility of implementing the intervention in the routine health system.
Potential applications and benefits
After a decade of intensive multi-centre trials to find new prevention strategies for malaria in pregnancy, DP has been shortlisted as the only potential alternative to SP for IPTp, but evidence of its benefits on infant outcomes is needed. As an experienced network, specialised in malaria prevention trials in pregnancy, we are in a unique position to address these gaps in an expedited manner. The findings of this new trial will provide the definitive evidence for whether or not this drug should be recommended to replace SP in areas with high levels of resistance by the parasite to SP. A positive result may lead to a direct policy change by the WHO in countries experiencing these levels of parasite resistance, including most countries in East and southern Africa, benefiting women at risk of malaria in these regions resulting in healthier pregnancies and healthier newborns.
Technical Summary
Malaria in pregnancy (MiP) has devastating consequences for the mother and unborn child. The intermittent preventive therapy with sulphadoxine-pyrimethamine (IPTp-SP) strategy recommended by WHO is threatened by high levels of parasite resistance. The search for safe, effective and well-tolerated alternatives drugs or strategies for IPTp-SP has proven elusive. However, two recent exploratory trials showed IPTp with dihydroartemisinin-piperaquine (DP) to be well tolerated and associated with marked reductions in malaria infection, but they were not powered to evaluate the impact on adverse pregnancy outcome. WHO reviewed the evidence in July 2015 and concluded that DP is a promising alternative to SP but that a larger confirmatory trial is needed before implementation of IPTp-DP could be recommended. We will determine the efficacy, safety and cost-effectiveness of IPTp-DP in a definitive trial to inform WHO policy decision makers whether or not this is a suitable alternative strategy in endemic areas with high SP resistance.
We will conduct a 24-month, multi-centre, 2-arm, double blind, placebo-controlled, individually randomised trial involving 2,942 women in 6 sites to determine if IPTp-DP (Eurartesim) is superior to the existing IPTp-SP strategy in areas in western Kenya (KEMRI) and Malawi (College of Medicine) with high SP resistance. The study has 80% power to detect a 20% reduction (RR=0.8) from 23% to 18.4% (a=0.05) in the primary outcome: 'adverse pregnancy outcome', a composite of foetal loss, live births born either small-for-gestational age, with low birthweight, or preterm, or neonatal death. It also provides 85% power to a prospective meta-analysis combining the evidence from this and previous trials to detect a 17% reduction in this outcome (a=0.05).
It also includes sub-studies on the antimicrobial activity of SP, including on the gut and vaginal microbiota, cardiac safety studies of monthly DP, and an operational feasibility component.
We will conduct a 24-month, multi-centre, 2-arm, double blind, placebo-controlled, individually randomised trial involving 2,942 women in 6 sites to determine if IPTp-DP (Eurartesim) is superior to the existing IPTp-SP strategy in areas in western Kenya (KEMRI) and Malawi (College of Medicine) with high SP resistance. The study has 80% power to detect a 20% reduction (RR=0.8) from 23% to 18.4% (a=0.05) in the primary outcome: 'adverse pregnancy outcome', a composite of foetal loss, live births born either small-for-gestational age, with low birthweight, or preterm, or neonatal death. It also provides 85% power to a prospective meta-analysis combining the evidence from this and previous trials to detect a 17% reduction in this outcome (a=0.05).
It also includes sub-studies on the antimicrobial activity of SP, including on the gut and vaginal microbiota, cardiac safety studies of monthly DP, and an operational feasibility component.
Planned Impact
Community: The ultimate beneficiaries will be mothers and their infants, especially those in east and southern Africa experiencing high levels of SP resistance. Malaria in pregnancy (MiP) has devastating consequences for the mother and unborn child. Without pregnancy-specific protection, it is estimated 12.4 million pregnant women (44.9% of all livebirths) would have been exposed to malaria infection each year in Africa, responsible for an estimated 900,000 low birthweight deliveries, and a quarter of these pregnancies occur in high SP resistant areas.
WHO and RBM: WHO, with its mandate to set global health policy, is a primary beneficiary of this research. Because the results of several recent trials with other antimalarials (mefloquine, amodiaquine and chloroquine-azithromycin) other strategies (intermittent screening and treatment) were disappointing, IPTp-DP now appears the only viable alternative that is being considered by WHO to replace SP in the near future. The results of this trial are therefore eagerly anticipated. All the senior investigators provide regular support to WHO's Evidence Review Group (ERG) for MIP (see 'Pathways to Impact'). Without guidance from WHO, national malaria control programs are hesitant to make changes to drug based policies in pregnancy because of concerns of the unknown safety profiles of new drugs. Thus, the role of WHO Geneva is critical to ensure germane research finding are translated into national policies, especially for malaria in pregnancy.
We are also active members of the Roll Back Malaria (RBM) MiP Working Group, responsible for generating consensus among RBM Partners on key strategic issues and best practices for ensuring effective delivery and scaling-up of interventions for the prevention and control of MiP.
National policy makers and stakeholders: MOH in Kenya and Malawi are key collaborators and have been involved in our previous trials in both countries. Both countries experience high levels of SP resistance and the MOH is under pressure to provide guidance on alternative preventive strategies for malaria in pregnancy. This trial will therefore provide essential evidence for the most promising alternative to the current strategy. The results will be disseminated at a stakeholders' meeting held at 36 months with key national policy makers and policy implementers in Kenya and Malawi, and representatives of local Health Offices and local communities. It is anticipated that policy impact occurs within 12 months of study completion, following recommendations by WHO.
Regional Level: WHO AFRO: The regional office of WHO is regularly called upon by African member states to provide guidance on malaria control in an ever changing context of drug resistance and transmission reduction. WHO-AFRO will be responsible for rolling out any policy formulated by WHO-HQ to other countries in the Africa region.
UK government: The UK Government has made tackling malaria a major priority, as described in the Malaria Framework for Results, which outlines DFID's strategic plans for malaria control until 2015. This research will contribute directly to UK policy and the UK's achievements will contribute directly to reaching international targets set out in the Global Malaria Action Plan 2016-2030 and the Sustainable Development Goals.
Impact on researcher and health worker capacity: Research capacity and leadership in the partner institutes in Kenya and Malawi will be enhanced by providing short- and long-term training and mentorship for research staff and students. Health worker capacity will also be strengthened through training on the administration of IPTp with DP, improving skills in drug administration, focused antenatal care, and routine recording and reporting.
Commercial private sector: Sigma Tau, Italy, and other manufacturers of DP, will also benefit from the results of the trial in terms of increased evidence for its safety, efficacy and application in pregnancy.
WHO and RBM: WHO, with its mandate to set global health policy, is a primary beneficiary of this research. Because the results of several recent trials with other antimalarials (mefloquine, amodiaquine and chloroquine-azithromycin) other strategies (intermittent screening and treatment) were disappointing, IPTp-DP now appears the only viable alternative that is being considered by WHO to replace SP in the near future. The results of this trial are therefore eagerly anticipated. All the senior investigators provide regular support to WHO's Evidence Review Group (ERG) for MIP (see 'Pathways to Impact'). Without guidance from WHO, national malaria control programs are hesitant to make changes to drug based policies in pregnancy because of concerns of the unknown safety profiles of new drugs. Thus, the role of WHO Geneva is critical to ensure germane research finding are translated into national policies, especially for malaria in pregnancy.
We are also active members of the Roll Back Malaria (RBM) MiP Working Group, responsible for generating consensus among RBM Partners on key strategic issues and best practices for ensuring effective delivery and scaling-up of interventions for the prevention and control of MiP.
National policy makers and stakeholders: MOH in Kenya and Malawi are key collaborators and have been involved in our previous trials in both countries. Both countries experience high levels of SP resistance and the MOH is under pressure to provide guidance on alternative preventive strategies for malaria in pregnancy. This trial will therefore provide essential evidence for the most promising alternative to the current strategy. The results will be disseminated at a stakeholders' meeting held at 36 months with key national policy makers and policy implementers in Kenya and Malawi, and representatives of local Health Offices and local communities. It is anticipated that policy impact occurs within 12 months of study completion, following recommendations by WHO.
Regional Level: WHO AFRO: The regional office of WHO is regularly called upon by African member states to provide guidance on malaria control in an ever changing context of drug resistance and transmission reduction. WHO-AFRO will be responsible for rolling out any policy formulated by WHO-HQ to other countries in the Africa region.
UK government: The UK Government has made tackling malaria a major priority, as described in the Malaria Framework for Results, which outlines DFID's strategic plans for malaria control until 2015. This research will contribute directly to UK policy and the UK's achievements will contribute directly to reaching international targets set out in the Global Malaria Action Plan 2016-2030 and the Sustainable Development Goals.
Impact on researcher and health worker capacity: Research capacity and leadership in the partner institutes in Kenya and Malawi will be enhanced by providing short- and long-term training and mentorship for research staff and students. Health worker capacity will also be strengthened through training on the administration of IPTp with DP, improving skills in drug administration, focused antenatal care, and routine recording and reporting.
Commercial private sector: Sigma Tau, Italy, and other manufacturers of DP, will also benefit from the results of the trial in terms of increased evidence for its safety, efficacy and application in pregnancy.
Organisations
- European & Developing Countries Clinical Trials Partnership (Lead Research Organisation)
- Liverpool School of Tropical Medicine (Collaboration)
- Kilimanjaro Christian Medical Centre (KCMS) (Collaboration)
- University of California, San Francisco (Collaboration)
- Stanford University School of Medicine (Collaboration)
- PATH (Collaboration)
- Kenyan Institute for Medical Research (KEMRI) (Collaboration)
- National Institute for Medical Research, Tanzania (Collaboration)
- Intellectual Ventures (United States) (Collaboration)
- Bill & Melinda Gates Foundation (Collaboration)
- University College London (Collaboration)
- University of Copenhagen (Collaboration)
- University of Bergen (Collaboration)
- University of Tampere (Collaboration)
- Wellcome Trust (Collaboration)
- Centers for Disease Control and Prevention (CDC) (Collaboration)
- UNIVERSITY OF OXFORD (Collaboration)
- University of Melbourne (Collaboration)
- Banook Group (Collaboration)
- London School of Hygiene and Tropical Medicine (LSHTM) (Collaboration)
- University of Toronto (Collaboration)
- University of Massachusetts (Collaboration)
- University of Malawi (Collaboration)
- Ministry of Health (Project Partner)
- University of North Carolina System (Project Partner)
- Sigma Tau (Italy) (Project Partner)
- Centers for Disease Control and Prevention (Project Partner)
- Ministry of Health (Project Partner)
- University of Leicester (Project Partner)
People |
ORCID iD |
Publications
Weckman AM
(2021)
Neurocognitive outcomes in Malawian children exposed to malaria during pregnancy: An observational birth cohort study.
in PLoS medicine
Walker PGT
(2020)
Modelling the incremental benefit of introducing malaria screening strategies to antenatal care in Africa.
in Nature communications
Van Eijk AM
(2023)
Prevalence of and risk factors for microscopic and submicroscopic malaria infections in pregnancy: a systematic review and meta-analysis.
in The Lancet. Global health
Van Eijk AM
(2019)
Effect of Plasmodium falciparum sulfadoxine-pyrimethamine resistance on the effectiveness of intermittent preventive therapy for malaria in pregnancy in Africa: a systematic review and meta-analysis.
in The Lancet. Infectious diseases
Ter Kuile FO
(2021)
Towards Intermittent Preventive Therapy in Pregnancy with Dihydroartemisinin-Piperaquine?
in Clinical pharmacology and therapeutics
Samuels AM
(2022)
Diagnostic Performance of Loop-Mediated Isothermal Amplification and Ultrasensitive Rapid Diagnostic Tests for Malaria Screening Among Pregnant Women in Kenya.
in The Journal of infectious diseases
Roh ME
(2020)
Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis.
in The Lancet. Global health
Reddy V
(2023)
Global estimates of the number of pregnancies at risk of malaria from 2007 to 2020: a demographic study.
in The Lancet. Global health
Description | Contribution to new or Improved professional practice - WHO pre-meeting for agenda GDG malaria chemoprevention in pregnancy in Feb 2024 |
Geographic Reach | Africa |
Policy Influence Type | Participation in a guidance/advisory committee |
Impact | This is the first of a series of steps required by WHO before considering the results of our study for policy. The first step is very encouraging as WHO is moving it to the next step, which involves presenting the results to the guidelines development group (GDG) for malaria chemoprevention, which is likely to meet later in 2024. |
Description | Presentation of IMPROVE 1 & 2 results to national MOH for policy consideration |
Geographic Reach | National |
Policy Influence Type | Contribution to a national consultation/review |
Impact | The MoH decided to continue the use of the standard of care for the prevention of malaria in pregnancy in Kenya for HIV-negative women. |
Description | WHO meeting Preferred Product Characteristics of Medicines for Malaria Chemoprevention; Dec 15-16, 2020, Geneva |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Participation in a guidance/advisory committee |
Description | WHO-CDG malaria chemoprevention in pregnancy Jan 2022 |
Geographic Reach | Africa |
Policy Influence Type | Contribution to new or Improved professional practice |
URL | https://apps.who.int/iris/rest/bitstreams/1411121/retrieve |
Description | Anti-inflammatory effects of SP for intermittent preventive treatment |
Amount | $545,000 (USD) |
Funding ID | INV-002781 |
Organisation | Bill and Melinda Gates Foundation |
Sector | Charity/Non Profit |
Country | United States |
Start | 11/2019 |
End | 11/2023 |
Description | CDC-CoAg LSTM Malaria Operations Research to Improve Malaria Control and Reduce Morbidity and Mortality in Western Kenya |
Amount | $10,000,000 (USD) |
Funding ID | 1U01GH002290 |
Organisation | Centers for Disease Control and Prevention (CDC) |
Sector | Public |
Country | United States |
Start | 08/2020 |
End | 08/2025 |
Description | IDDO repositories - evidence for improving control policies and guidelines for malaria, visceral leishmaniasis and lymphatic filariasis |
Amount | $1,819,261 (USD) |
Funding ID | INV-004713 |
Organisation | University of Oxford |
Sector | Academic/University |
Country | United Kingdom |
Start | 11/2020 |
End | 10/2022 |
Description | Improved treatment and clinical management of poverty-related diseases |
Amount | € 3,200,000 (EUR) |
Funding ID | TRIA-2015-1076b |
Organisation | Sixth Framework Programme (FP6) |
Department | European and Developing Countries Clinical Trials Partnership |
Sector | Public |
Country | Netherlands |
Start | 06/2017 |
End | 11/2020 |
Description | Improved treatment and clinical management of poverty-related diseases |
Amount | € 7,389,049 (EUR) |
Funding ID | TRIA-2015-1076-IMPROVE |
Organisation | Sixth Framework Programme (FP6) |
Department | European and Developing Countries Clinical Trials Partnership |
Sector | Public |
Country | Netherlands |
Start | 12/2016 |
End | 11/2020 |
Description | MRC Global Maternal & Neo Natal Health Full Application - MR/T038489/1 |
Amount | £956,277 (GBP) |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 01/2021 |
End | 08/2023 |
Description | Pharmacovigilence and drug safety |
Amount | € 432,867 (EUR) |
Funding ID | PO17/00456 |
Organisation | Medicines for Malaria Venture (MMV) |
Sector | Charity/Non Profit |
Country | Switzerland |
Start | 08/2017 |
End | 06/2019 |
Description | Pregnancy Registry |
Amount | £3,883,530 (GBP) |
Funding ID | PO19/01469 |
Organisation | Medicines for Malaria Venture (MMV) |
Sector | Charity/Non Profit |
Country | Switzerland |
Start | 02/2020 |
End | 02/2024 |
Title | Birthweight reference for birthweight taken more than 24 hours after birth |
Description | We developed prediction maps and reference charts that can be used by researchers in low-resource settings to retrospectively estimate birthweights using weights collected up to 168 h after delivery, thereby maximizing data utilization. Clinical practitioners can also use the prediction maps to retrospectively classify newborns as low birthweight or small for gestational age. |
Type Of Material | Physiological assessment or outcome measure |
Year Produced | 2023 |
Provided To Others? | Yes |
Impact | Identification of low birthweight and small for gestational age is pivotal in clinical management and many research studies, but in low-income countries, birthweight is often unavailable within 24 h of birth. Newborn weights measured within days after birth and knowledge of the growth patterns in the first week of life can help estimate the weight at birth retrospectively. This study aimed to generate sex-specific prediction maps and weight reference charts for the retrospective estimation of birthweight for exclusively breastfed newborns in a low-resource setting. MATERIAL AND METHODS: This was a prospective cohort study nested in the IMPROVE clinical trial of intermittent preventive treatment in pregnancy for malaria with either dihydroartemisinin-piperaquine with/without azithromycin or sulfadoxine-pyrimethamine in Korogwe District, north-eastern Tanzania (Clinicaltrials.gov: NCT03208179). Newborns were weighed at birth or in the immediate hours after birth and then daily for 1 week. Reference charts, nadir, time to regain weight, and prediction maps were generated using nonlinear mixed-effects models fitted to the longitudinal data, incorporating interindividual variation as random effects. Predictions and prediction standard deviations were computed using a linear approximation approach. The data were used to generate prediction maps with 1-h time intervals and 0.05 kg weight increments showing the predicted birthweights and weight-for-age and weight-change-for-age reference charts depicting variation in weight loss from <1 to >10%. CONCLUSIONS: The prediction maps and reference charts can be used by researchers in low-resource settings to retrospectively estimate birthweights using weights collected up to 168 h after delivery, thereby maximizing data utilization. Clinical practitioners can also use the prediction maps to retrospectively classify newborns as low birthweight or small for gestational age. |
URL | https://obgyn.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/aogs.14323?download=true |
Description | CDC-Malaria Branch |
Organisation | Centers for Disease Control and Prevention (CDC) |
Department | Division of Parasitic Diseases and Malaria |
Country | United States |
Sector | Public |
PI Contribution | Our team at LSTM were 2nd and last author on the report. We conducted the analysis in collaboration with the CDC partners. We all provided significant input to the WHO report and were part of a team of 3 (two from my team, including myself) who presented this to WHO's guidelines development group for malaria chemoprevention |
Collaborator Contribution | wrote the first draft of the report and presented part of the results to WHO. Our team at LSTM presented the other parts |
Impact | Report presented to WHO of a meta-analysis combining all trials that compared intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine vs DHA-piperaquine |
Start Year | 2020 |
Description | Cardiabase |
Organisation | Banook Group |
Country | France |
Sector | Private |
PI Contribution | We provide for the generation of data through conducting ECGs on the clinical trial participants as part of the safety component of the trial. |
Collaborator Contribution | Cardiabase provides discounted equipment for rental and end user purchase at the end of the trial. As part of a commercial service, Cardiabase provide interpretation of the ECGs and technical support including quality assurance of recordings. |
Impact | No Outputs noted yet |
Start Year | 2017 |
Description | Centres for Disease Control, Atlanta |
Organisation | Centers for Disease Control and Prevention (CDC) |
Department | Division of Parasitic Diseases and Malaria |
Country | United States |
Sector | Public |
PI Contribution | We work collaboratively with the CDC by providing expertise and facilities on a research area of common interest. |
Collaborator Contribution | The CDC provides technical expertise in the conduct of the trial and technical support including quality assurance of laboratory evaluations for primary endpoints of the trial such as placental histopathology. |
Impact | No outputs reported yet. |
Start Year | 2016 |
Description | College of Medicine, Blantyre, Malawi |
Organisation | University of Malawi |
Department | College of Medicine |
Country | Malawi |
Sector | Academic/University |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. The clinical trials are managed by a trial management group headed by Prof ter Kuile and the site PIs. Within this academic collaboration, we provide a platform for career development for postgraduate trainees. The trainees are embedded in facets of the study in tandem with shared objectives of the trial and the trainee's research interests. We also provide mentorship and career development of the trainees. |
Collaborator Contribution | CoM provides one of four field sites in the IMPROVE trial, and one of two sites for the IMPROVE-2 trial. The CoM site PI for both trials, Dr Madanitsa, is responsible for the day-to-day management of the trials, and is the overall trial coordinator for the multicentre IMPROVE trial. CoM provides academic collaboration that will lead to peer reviewed publication. CoM has been a recipient or collaborator on 8 previous EDCTP grants and hosts several other collaborative projects, this expertise and infrastructure also benefiting this trial. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | Kenyan Institute for Medical Research (KEMRI) |
Department | KEMRI/CDC Research and Public Health Collaboration |
Country | Kenya |
Sector | Charity/Non Profit |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | Kilimanjaro Christian Medical Centre (KCMS) |
Country | Tanzania, United Republic of |
Sector | Hospitals |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | National Institute for Medical Research, Tanzania |
Country | Tanzania, United Republic of |
Sector | Public |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | University College London |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | University of Bergen |
Country | Norway |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | University of Copenhagen |
Country | Denmark |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | University of Malawi |
Country | Malawi |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-1 Consortium |
Organisation | University of Tampere |
Country | Finland |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. The Consortium consists of a highly experienced network of 11 institutions from Africa, Europe and the US with extensive experience in pregnancy trials. It also includes 4 African PhD-studentships and a Post-Doctoral fellowship. Additionally, we will ensure results are shared with WHO for policy impact. |
Collaborator Contribution | The consortium partners provide facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings.For individual contributions, see entries for each partner institution. |
Impact | No outputs have been generated at this time. |
Start Year | 2016 |
Description | IMPROVE-2 Consortium |
Organisation | Kenyan Institute for Medical Research (KEMRI) |
Country | Kenya |
Sector | Public |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE 2 trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. |
Collaborator Contribution | The consortium provides facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | IMPROVE-2 Consortium |
Organisation | Liverpool School of Tropical Medicine |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE 2 trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. |
Collaborator Contribution | The consortium provides facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | IMPROVE-2 Consortium |
Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE 2 trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. |
Collaborator Contribution | The consortium provides facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | IMPROVE-2 Consortium |
Organisation | University of Malawi |
Department | College of Medicine |
Country | Malawi |
Sector | Academic/University |
PI Contribution | We provide a platform, through administrative and technical expertise, for coordinated interactions between the several collaborating institutions of the IMPROVE 2 trial. This ensures standardisation of practice across the partners and efficiency in delivering of the outputs for the trial. |
Collaborator Contribution | The consortium provides facilities and expertise of the conduct of the trial, collection of data, analysis of the data and publication of the results. Additionally, the consortium will enable the dissemination of the results to a wider arena of stakeholders across geographical settings for impact on policy and practice within those settings. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | Intellectual Ventures Lab, Washington |
Organisation | Intellectual Ventures |
Country | United States |
Sector | Private |
PI Contribution | We provide a platform for the evaluation of their prototype high sensitive malaria rapid diagnostic test (HS-RDT) and prototype commercial malaria diagnostic test photothermal reader. |
Collaborator Contribution | IVL have provided industrial-academia collaborative platform in their R and D process. The y have provided intellectual training input to staff collaboration for academic investigators on the outcomes of the prototype evaluations. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | KEMRI |
Organisation | Kenyan Institute for Medical Research (KEMRI) |
Country | Kenya |
Sector | Public |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. The clinical trials are managed by a trial management group headed by Prof ter Kuile and the site PIs. |
Collaborator Contribution | KEMRI provides one of four field sites in the IMPROVE trial, and one of two sites for the IMPROVE-2 trial. The KEMRI site PI is responsible for the day-to-day management of the trial, and provides academic collaboration that will lead to peer reviewed publication. Within this academic collaboration, we provide a platform for career development for postgraduate trainees. The trainees are embedded in facets of the study in tandem with shared objectives of the trial and the trainee's research interests. We also provide mentorship and career development of the trainees. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | Kilimanjaro Christian Medical Centre |
Organisation | Kilimanjaro Christian Medical Centre (KCMS) |
Country | Tanzania, United Republic of |
Sector | Hospitals |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. The clinical trials are managed by a trial management group headed by Prof ter Kuile and the site PIs. |
Collaborator Contribution | KCMC (in Moshi, Tanzania) provides one of four field sites in the IMPROVE trial. The KCMC site PI is responsible for the day-to-day management of the trial, and provides academic collaboration that will lead to peer reviewed publication. KCMC has conducted clinical trials with LSHTM for over 20 years, including a cardio-safety trial of DP among pregnant women at Handeni District Hospital (ongoing) and an IPTp trial comparing SP vs. azithromycin + chloroquine. KCMC has state-of-the art laboratory facilities for STI diagnostics at NIMR-Amani Tanzania funded by the UK Medical Research Council through a grant to LSHTM. Within this academic collaboration, we provide a platform for career development for postgraduate trainees. The trainees are embedded in facets of the study in tandem with shared objectives of the trial and the trainee's research interests. We also provide mentorship and career development of the trainees. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | Liverpool School of Tropical Medicine |
Organisation | Liverpool School of Tropical Medicine |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | LSTM is the recipient of the IMPROVE and IMPROVE-2 awards co-funded by the MRC/DFID/WT JGHT scheme and EDCTP. LSTM provides effective project management and communication among the network partners to ensure that collectively we achieve the project's objectives, and effective dissemination to key stakeholders and beneficiaries. An Executive Committee comprised of a representative from each project partner and chaired by the grant Chief Investigator, Professor Feiko ter Kuile, and WP leads (WP2-6) is the main decision-making body, supported by a Secretariat at LSTM led by a project manager (Dr Jenny Hill), responsible for the overall administration and financial management for the project duration (4 years). |
Collaborator Contribution | LSTM as the trial sponsor is responsible for research governance, project management, financial management, communication among partners, quality control, trial monitoring, reporting to funders and support for the clinical trials in each site. |
Impact | No outputs yet |
Start Year | 2016 |
Description | London School of Hygiene and Tropical Medcine |
Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | We provide access through the IMPROVE and IMPROVE-2 trials to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. |
Collaborator Contribution | LSHTM provides academic collaboration that will lead to peer reviewed publication and capacity development for staff from our participating institutions in the countries where the trial will be conducted. Specifically, LSHTM investigators bring a range of institutional experience and capacity to investigate the treatment effect on STIs/RTIs, intestinal and vaginal microbiomes, and macrolide resistance; on the economics of malaria in pregnancy and its control, and on acceptability and feasibility studies of trial interventions in pregnant women. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | Malawi-Liverpool Wellcome Trust, Blantyre, Malawi |
Organisation | Wellcome Trust |
Department | Malawi-Liverpool Wellcome Trust Clinical Research Programme |
Country | Malawi |
Sector | Academic/University |
PI Contribution | Within this academic collaboration, we provide a platform for career development for postgraduate trainees from the Malawi-Liverpool Wellcome Trust. The trainees are embedded in facets of the study in tandem with shared objectives of the trial and the trainee's research interests. We also provide mentorship and career development of the trainees. |
Collaborator Contribution | Dr Dianna Terlouw (MD, PhD), is a lecturer in malaria epidemiology from the LSTM, based at the Malawi-Liverpool Wellcome Trust Clinical Research Programme, Malawi. She will support the activities in the Chikwawa site in Malawi and linkages with the MLW program. |
Impact | No outputs to report at this time. |
Start Year | 2017 |
Description | National Institute Medical Research |
Organisation | National Institute for Medical Research, Tanzania |
Department | NIMR Dar Es Salaam |
Country | Tanzania, United Republic of |
Sector | Public |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. The clinical trials are managed by a trial management group headed by Prof ter Kuile and the site PIs. |
Collaborator Contribution | NMRI (in Tanga, Tanzania) provides one of four field sites in the IMPROVE trial. The NMRI site PI is responsible for the day-to-day management of the trial, and provides academic collaboration that will lead to peer reviewed publication. NIMR has conducted clinical trials and observational studies for over two decades including the RTS,S malaria vaccine trials, STOPPAM studies and FOETALforNCD study of foetal programming. The NIMR-Tanga Korogwe Field station has a GCLP compliant laboratory facility including a microbiology section. Within this academic collaboration, we provide a platform for career development for postgraduate trainees. The trainees are embedded in facets of the study in tandem with shared objectives of the trial and the trainee's research interests. We also provide mentorship and career development of the trainees. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | PATH |
Organisation | PATH |
Country | Global |
Sector | Charity/Non Profit |
PI Contribution | We have provided PATH with a platform for the evaluation of a reformatted RDT prototype and the generation of data on it's performance. |
Collaborator Contribution | PATH provide collaboration between a Not-for-Profit and an academic institutions. They have provided intellectual training input to staff collaboration for academic investigators on the outcomes of the prototype evaluations. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | SP-Inflam |
Organisation | Bill and Melinda Gates Foundation |
Country | United States |
Sector | Charity/Non Profit |
PI Contribution | Funding from the Bill and Melinda Gates Foundation to determine if SP has non-malaria effects |
Collaborator Contribution | Bill & Melinda Gates Foundation provide the funding The University of Melbourne and the University of Toronto support the laboratory-based assays |
Impact | No products yet |
Start Year | 2018 |
Description | SP-Inflam |
Organisation | University of Melbourne |
Country | Australia |
Sector | Academic/University |
PI Contribution | Funding from the Bill and Melinda Gates Foundation to determine if SP has non-malaria effects |
Collaborator Contribution | Bill & Melinda Gates Foundation provide the funding The University of Melbourne and the University of Toronto support the laboratory-based assays |
Impact | No products yet |
Start Year | 2018 |
Description | SP-Inflam |
Organisation | University of Toronto |
Country | Canada |
Sector | Academic/University |
PI Contribution | Funding from the Bill and Melinda Gates Foundation to determine if SP has non-malaria effects |
Collaborator Contribution | Bill & Melinda Gates Foundation provide the funding The University of Melbourne and the University of Toronto support the laboratory-based assays |
Impact | No products yet |
Start Year | 2018 |
Description | Stanford Center for Human Systems Immunology |
Organisation | Stanford University School of Medicine |
Country | United States |
Sector | Academic/University |
PI Contribution | The trial provides blood samples to Stanford Center for Human Systems Immunology for further analysis of the impact of malaria and of different antimalarials on the immune responses to malaria and other infectious diseases in pregnancy |
Collaborator Contribution | Stanford Center for Human Systems Immunology will run a set of 60 assays with additional funding from the Bill and Melinda Gates Foundation |
Impact | None yet. The samples have been selected and MTA are being prepared |
Start Year | 2020 |
Description | UCSF |
Organisation | University of California, San Francisco |
Department | School of Medicine (UCSF) |
Country | United States |
Sector | Academic/University |
PI Contribution | Our team were last author and the overall coordinates of these analyses. The results were shared with WHO |
Collaborator Contribution | The group shared their data on previous completed trials for meta-analyses. The first author on some of the analysis (Michelle Roh) is from UCSF |
Impact | several meta-analyses (other analyses are ongoing) 1. Fernandes S, Were V, Gutman J, Dorsey G, Kakuru A, Desai M, Kariuki S, Kamya MR, Ter Kuile FO, Hanson K, 2020. Cost-effectiveness of intermittent preventive treatment with dihydroartemisinin-piperaquine for malaria during pregnancy: an analysis using efficacy results from Uganda and Kenya, and pooled data. Lancet Glob Health 8: e1512-e1523. 2. Chan XHS, Win YN, Haeusler IL, Tan JY, Loganathan S, Saralamba S, Chan SKS, Ashley EA, Barnes KI, Baiden R, Bassi PU, Djimde A, Dorsey G, Duparc S, Hanboonkunupakarn B, Ter Kuile FO, Lacerda MVG, Nasa A, Nosten FH, Onyeji CO, Pukrittayakamee S, Siqueira AM, Tarning J, Taylor WRJ, Valentini G, van Vugt M, Wesche D, Day NPJ, Huang CL, Brugada J, Price RN, White NJ, 2020. Factors affecting the electrocardiographic QT interval in malaria: A systematic review and meta-analysis of individual patient data. PLoS Med 17: e1003040. 3. Roh ME, Kuile FOT, Rerolle F, Glymour MM, Shiboski S, Gosling R, Gutman J, Kakuru A, Desai M, Kajubi R, L'Ianziva A, Kamya MR, Dorsey G, Chico RM, 2020. Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis. Lancet Glob Health 8: e942-e953. 4. Gutman J, Kovacs S, Dorsey G, Stergachis A, Ter Kuile FO, 2017. Safety, tolerability, and efficacy of repeated doses of dihydroartemisinin-piperaquine for prevention and treatment of malaria: a systematic review and meta-analysis. Lancet Infect Dis 17: 184-193. |
Start Year | 2019 |
Description | University College London |
Organisation | University College London |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. |
Collaborator Contribution | UCL provides academic collaboration that will lead to peer reviewed publication and capacity development for staff from our participating institutions in the countries where the trial will be conducted. Specifically investigators will provide expertise to examine the effect of SP and AZ on the intestinal and vaginal microbiomes of mothers, and the intestinal microbiomes of neonates relative to DP alone, and of multiple doses of AZ on the prevalence of macrolide resistance in the pneumococcus. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | University of Bergen |
Organisation | University of Bergen |
Country | Norway |
Sector | Academic/University |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. |
Collaborator Contribution | The University of Bergen provides academic collaboration that will lead to peer reviewed publication and capacity development for staff from our participating institutions in the countries where the trial will be conducted. Specifically, UiB will lead the economic evaluation, and is the main supervisor for the PhD project. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | University of Copenhagen |
Organisation | University of Copenhagen |
Country | Denmark |
Sector | Academic/University |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. |
Collaborator Contribution | The University of Copenhagen provides academic collaboration that will lead to peer reviewed publication and capacity development for staff from our participating institutions in the countries where the trial will be conducted. Specifically, investigators will contribute expertise in molecular makers of antimalarial drug resistance and has undertaken similar studies over the past 15 years under the umbrella of the Joint Malaria Programme, which built research capacity to conduct molecular studies with funding from Danida. Investigators will also support capacity development activities. CMP has been involved in research capacity building as part of the ACT, MiP and MCDC Consortia and the Danida-funded Building Stronger Universities initiative, with extensive experience in providing training on research methodology, research ethics, scientific writing and knowledge management and communication. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | University of Massachusetts, Worcester, USA |
Organisation | University of Massachusetts |
Department | University of Massachusetts Medical School |
Country | United States |
Sector | Academic/University |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and maternal antibody, trans-placental antibody transfer and multi-pathogen neonatal cell mediated immune responses. |
Collaborator Contribution | The University of Massachusetts provides academic collaboration that will lead to peer reviewed publication and capacity development for staff from our participating institutions in the countries where the trial will be conducted. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | University of Melbourne, Australia |
Organisation | University of Melbourne |
Country | Australia |
Sector | Academic/University |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on an evaluation of the interaction between intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and maternal immune modulation. |
Collaborator Contribution | The University of Melbourne provides academic collaboration that will lead to peer reviewed publication and capacity development for staff from our participating institutions in the countries where the trial will be conducted. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | University of Tampere |
Organisation | University of Tampere |
Country | Finland |
Sector | Academic/University |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. |
Collaborator Contribution | The University of Tampere provides academic collaboration that will lead to peer reviewed publication and capacity development for staff from our participating institutions in the countries where the trial will be conducted. Specifically UTA have conducted pioneering investigations of intestinal and vaginal microbiomes using microarrays in pregnancy trials in Africa. |
Impact | There are no outputs available yet. |
Start Year | 2016 |
Description | University of Toronto, Canada |
Organisation | University of Toronto |
Country | Canada |
Sector | Academic/University |
PI Contribution | We provide access to data generation and facilities for the collection of biological samples and data on evaluation of the impact of intermittent preventive treatment in pregnancy for the prevention of malaria in pregnancy and placental function. |
Collaborator Contribution | The University of Toronto provides academic collaboration that will lead to peer reviewed publication and capacity development for staff from our participating institutions in the countries where the trial will be conducted. |
Impact | No outputs have been generated at this time. |
Start Year | 2017 |
Description | WWARN-University of Oxford |
Organisation | University of Oxford |
Department | Oxford Hub |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | I lead the malaria in pregnancy module of the World Wide Antimalarial resistance network. We conduct individual participant data meta-analysis of trials of malaria in children and pregnant women (including those funded by UKRI). |
Collaborator Contribution | WWARN is hosted by the University of Oxford and provides the platform for investigators to share their trial data. They also provide data curation services and statistical support. |
Impact | 1. Fernandes S, Were V, Gutman J, Dorsey G, Kakuru A, Desai M, Kariuki S, Kamya MR, Ter Kuile FO, Hanson K, 2020. Cost-effectiveness of intermittent preventive treatment with dihydroartemisinin-piperaquine for malaria during pregnancy: an analysis using efficacy results from Uganda and Kenya, and pooled data. Lancet Glob Health 8: e1512-e1523. 2. Chan XHS, Win YN, Haeusler IL, Tan JY, Loganathan S, Saralamba S, Chan SKS, Ashley EA, Barnes KI, Baiden R, Bassi PU, Djimde A, Dorsey G, Duparc S, Hanboonkunupakarn B, Ter Kuile FO, Lacerda MVG, Nasa A, Nosten FH, Onyeji CO, Pukrittayakamee S, Siqueira AM, Tarning J, Taylor WRJ, Valentini G, van Vugt M, Wesche D, Day NPJ, Huang CL, Brugada J, Price RN, White NJ, 2020. Factors affecting the electrocardiographic QT interval in malaria: A systematic review and meta-analysis of individual patient data. PLoS Med 17: e1003040. 3. Roh ME, Kuile FOT, Rerolle F, Glymour MM, Shiboski S, Gosling R, Gutman J, Kakuru A, Desai M, Kajubi R, L'Ianziva A, Kamya MR, Dorsey G, Chico RM, 2020. Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis. Lancet Glob Health 8: e942-e953. 4. Gutman J, Kovacs S, Dorsey G, Stergachis A, Ter Kuile FO, 2017. Safety, tolerability, and efficacy of repeated doses of dihydroartemisinin-piperaquine for prevention and treatment of malaria: a systematic review and meta-analysis. Lancet Infect Dis 17: 184-193. 5. Kwambai TK, Mori AT, Nevitt S, Anna Maria van Eijk AM, Samuels AM, Robberstad B, Phiri KS, ter Kuile FO, 2022 (in press). Post-discharge morbidity and mortality in children admitted with severe anaemia andor other health-conditions in malaria-endemic settings in Africa: a systematic review and meta-analysis. Lancet Child Adolesc Health. 6. Phiri KS, Khairallah C, Kwambai TK, Bojang K, Dhabangi A, Opoka R, Idro R, Stepniewska K, Robberstad B, Greenwood B, ter Kuile FO, 2022. Post-discharge Malaria Chemoprevention in Children Admitted with Severe Anaemia in Malaria-Endemic Settings in Africa: A Systematic Review and Meta-Analysis. for WHO. 7. Gutman JR, Khairallah C, Stepniewska K, Tagbor H, Madanitsa M, Cairns M, L'Lanziva A J, Kalilani L, Otieno K, Mwapasa V, Meshnick S, Kariuki S, Chandramohan D, Desai M, Taylor SM, Greenwood B, Ter Kuile FO, 2021. Intermittent screening and treatment with artemisinin-combination therapy versus intermittent preventive treatment with sulphadoxine-pyrimethamine for malaria in pregnancy: a systematic review and individual participant data meta-analysis of randomised clinical trials. EClinicalMedicine 41: 101160. 8. van Eijk AM, Larsen DA, Kayentao K, Koshy G, Slaughter DEC, Roper C, Okell LC, Desai M, Gutman J, Khairallah C, Rogerson SJ, Hopkins Sibley C, Meshnick SR, Taylor SM, Ter Kuile FO, 2019. Effect of Plasmodium falciparum sulfadoxine-pyrimethamine resistance on the effectiveness of intermittent preventive therapy for malaria in pregnancy in Africa: a systematic review and meta-analysis. Lancet Infect Dis 19: 546-556. |
Start Year | 2018 |
Description | 21st College of Medicine Research Dissemination Conference, 24th-25th November, 2017, Blantyre |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | The annual scientific research dissemination conference provides a platform for presentation of policy relevant evidence to a wide audience of policy stakeholders including funders and implementing institutions. An opportunity to disseminate policy relevant evidence from previous and upcoming research activities was provided through the parallel session on Malaria. The IMPROVE trials were presented, outlining the need for novel interventions for the control of malaria in pregnancy in HIV infected and uninfected women as alternative to the current regimens in practice. There was a significant interest in the policy review recommendations for malaria in pregnancy of which the results would be informative to the National Malaria Control Programme, HIV and AIDS Department, Reproductive Health Unit and the Parliamentary Committee on Health. |
Year(s) Of Engagement Activity | 2017 |
Description | ASTMH symposium |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | We organised a symposium at the ASTMH meeting in 2021 to present the results of our JGHT-funded trial on malaria in pregnancy. The results have important policy implication and implications for future research |
Year(s) Of Engagement Activity | 2021 |
URL | http://mesamalaria.org/resource-hub/astmh-2021-annual-meeting-virtual-day-5 |
Description | Annual General Meeting, Malawi |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Study participants or study members |
Results and Impact | The annual investigators meeting took place in Blantyre, Malawi from the 23rd to 24th of May 2017. Twenty-eight participants from IMPROVE and IMPROVE-2 trials attended the meeting in person and remotely (via Skype/telephone), including our EDCTP Project Officer. Discussions focused on the trial protocols, embedded studies, roles and responsibilities of Work package leads and a summary of all other activities planned to be undertaken. Four newly appointed PhD students presented their research projects, development of the students was discussed at length and plans put in place for their research activities and cross linkages. |
Year(s) Of Engagement Activity | 2017 |
Description | Expert Scientific Advisory Committee (ESAC), Medicine for Malaria Venture (MMV), ad hoc advisor, malaria in pregnancy |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Third sector organisations |
Results and Impact | Invited speaker for use of antimalarials for malaria in pregnancy. Expert Scientific Advisory Committee (ESAC), Medicine for Malaria Venture (MMV), ad hoc advisor, malaria in pregnancy Invited contributor to MMV meeting: MiMBa workshop: Development of a new non-teratogenic product for the treatment of malaria in pregnancy which will virtually take place on the 7th of December 2021, from 14:00 - 17:00 CET. |
Year(s) Of Engagement Activity | 2018,2021,2022 |
URL | https://www.mmv.org/newsroom/publications/mimba-malaria-mothers-and-babies |
Description | Global Excellence Research Symposium II; "New Wine in old Bottles and Old Wine in new Bottles", Past, present and future use of antimalarial and other drugs in the control of malaria: applications and dilemmas, Celebrating the 25 Year Anniversary of Centre for Medical Parasitology; Copenhagen, Denmark, 17 Oct 2019 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Ter Kuile FO, 2019. Invited speaker: Treatment and Pevention of Malaria in pregnancy: New wine in old bottles. Global Excellence Research Symposium II; "New Wine in old Bottles and Old Wine in new Bottles", Past, present and future use of antimalarial and other drugs in the control of malaria: applications and dilemmas, Celebrating the 25 Year Anniversary of Centre for Medical Parasitology; Copenhagen, Denmark, 17 Oct 2019. |
Year(s) Of Engagement Activity | 2019 |
URL | https://malariaworld.org/blog/event-global-excellence-research-symposium-ii-%E2%80%9Cnew-wine-old-bo... |
Description | Invited Lecture, Malaria in Pregnancy |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | ter Kuile FO, 2018. Invited Lecture, Malaria in Pregnancy. Médecins Sans Frontières (MSF) UK, Diploma for Tropical Medicine and Hygiene. |
Year(s) Of Engagement Activity | 2018 |
Description | Invited Speaker: An aggregated meta-analysis will be presented of the efficacy of intermittent preventive therapy for the control of malaria in pregnancy in HIV-uninfected women combining the results of two completed trials in Kenya and Uganda |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | ter Kuile FO, 2018. Invited Speaker: An aggregated meta-analysis will be presented of the efficacy of intermittent preventive therapy for the control of malaria in pregnancy in HIV-uninfected women combining the results of two completed trials in Kenya and Uganda. 7th MIM Pan African Malaria Conference: MMV Symposium, The potential of dihydroartemisinin-piperaquine (DP) for intermittent preventive therapy (IPTp) to prevent malaria in pregnancy: results from recent trials in Africa. Dakar, Senegal. |
Year(s) Of Engagement Activity | 2018 |
URL | https://www.mmv.org/newsroom/events/7th-mim-pan-african-malaria-conference |
Description | Invited Speaker: Malaria in pregnancy, implication of sulphadoxine-pyrimethamine resistance and overview of studies seeking alternative options to IPTp with SP |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | ter Kuile FO, 2018. Invited Speaker: Malaria in pregnancy, implication of sulphadoxine-pyrimethamine resistance and overview of studies seeking alternative options to IPTp with SP. 7th MIM Pan African Malaria Conference: EDCTP Symposium, Malaria in pregnancy programmes: challenges and priorities in antimalarial drug development for African pregnant women Dakar, Senegal. |
Year(s) Of Engagement Activity | 2018 |
URL | https://www.mmv.org/newsroom/events/7th-mim-pan-african-malaria-conference |
Description | Invited speaker: The safety, tolerability and efficacy of repeated doses of dihydroartemisinin-piperaquine for the prevention and treatment of malaria: A systematic review and meta-analysis |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | ter Kuile FO, 2016. Invited speaker: The safety, tolerability and efficacy of repeated doses of dihydroartemisinin-piperaquine for the prevention and treatment of malaria: A systematic review and meta-analysis. WHO, Evidence Review Group (ERG) Meeting on cardiotoxicity of antimalarials, 13-14 October 2016. Varembé Conference Centre, Geneva, Switzerland. |
Year(s) Of Engagement Activity | 2016 |
URL | https://www.who.int/malaria/mpac/mpac-mar2017-erg-cardiotoxicity-report-session2-presentation.pdf?ua... |
Description | Presentation Dr Hellen Barsosio ASTM 2022, Delivery mechanism study IMPROVE 1&2 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presented the preliminary results of the nested delivery mechanism study of IMPROVE 1& 2 |
Year(s) Of Engagement Activity | 2022 |
URL | https://www.lstmed.ac.uk/news-events/news/lstm-phd-student-hellen-barsosio-recognised-with-american-... |
Description | Presentation IMPROVE trial update, at MoH Kenya malaria in pregnancy meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | Presented the IMPROVE malaria in pregnancy study update to the MoH in Kenya |
Year(s) Of Engagement Activity | 2020 |
Description | WHO Technical Consultation on research requirements to support policy recommendations on highly sensitive malaria diagnostic tests, WHO/UNAIDS Building D, Geneva, Switzerland, 4-6 June 2018 |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Ter Kuile FO, 2018. Invited speaker: impact of sub-patent malaria infections in pregnancy. WHO Technical Consultation on research requirements to support policy recommendations on highly sensitive malaria diagnostic tests, WHO/UNAIDS Building D, Geneva, Switzerland, 4-6 June 2018 |
Year(s) Of Engagement Activity | 2018 |
Description | WHO-GDG malaria chemoprevention in pregnancy Jan 2022 |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | WORLD HEALTH ORGANIZATION GUIDELINE DEVELOPMENT GROUP (GDG) FOR REVISION OF THE MALARIA CHEMOPREVENTION GUIDELINE DEVELOPMENT GROUP MEETINGS VIRTUAL MEETINGS, 15-17 February & 1-2 March 2022 I presented the results of a meta-analysis that included the JGHT-funded trial in of malaria in pregnancy. |
Year(s) Of Engagement Activity | 2022 |
URL | https://apps.who.int/iris/rest/bitstreams/1411121/retrieve |