Intermittent Preventive Treatment with DHA-piperaquine for malaria in pregnancy in areas with high sulphadoxine-pyrimethamine resistance in Africa

Lead Research Organisation: EDCTP

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 sulphadoxinepyrimethamine
(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 dihydroartemisininpiperaquine
(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.

Publications

10 25 50
 
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 European Union (EU)
Start 07/2017 
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 European Union (EU)
Start 12/2016 
End 11/2020
 
Description Cardiabase 
Organisation Banook Group
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 Georgia 
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 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 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 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 Private 
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 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 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 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