Paediatric programme - HIV and other diseases of poverty
Lead Research Organisation:
MRC Clinical Trials Unit
Abstract
Our studies aim to improve management of children with severe illnesses of poverty (predominantly HIV, Malaria, bacterial infections, TB) worldwide. We have 20 years experience of HIV in children, inintially in Europe, now mainly in Africa. In Europe, prevention of mother-to-child HIV transmission has reduced new infections in babies, but many children are now entering adolescence. Our research is finding out the best medicines with the fewest longterm side-effects, as children have to take treatment for life. In UK, we are starting a new study (AALPHI) to find out how HIV and its treatment affects young people entering adulthood. |Rollout of HIV treatment in Africa is increasing, bringing many questions about how best to do this in countries with few trained staff or health infrastructure. HIV-infected children have many other problems including malnutrition, tuberculosis, bacterial infections, malaria; without treatment, ~50% die before their second birhtday. We are undertaking large studies with colleagues in south/east African countries aimed at providing ways to enable more children to access HIV treatment. |Throughout Africa, death from malaria and other severe infections is unacceptably high, most occurring <24 hours after admission to hospital. Little attention has been paid to resuscitation with fluids. We are working with colleagues in Kenya to find out the best way to resuscitate these very sick children, particularly with malaria.
Technical Summary
The CTU paediatric programme of trials and cohorts of childhood diseases of poverty - HIV, malaria, tuberculosis and sepsis - aims to generate evidence to inform policy and practice in both well-resourced and resource-limited countries worldwide, particularly Africa. |The PENTA (Paediatric European Network for treatment of AIDS, www.pentatrials.org) program (funding EU 1990-2015) undertakes cohorts and trials in ~15 countries in Europe, South America, Asia(Thailand) and Africa (Uganda) addressing questions on HIV-infection in children which cannot be extrapolated or assumed from adult studies. New trials aimed at older children/adolescents focus on strategies to maximise efficacy and adherence to antiretroviral therapy (ART) while minimising longterm toxicity (PENTA 16, 18 & 20 trials). Two trials recently completed: (1)PENTA 11, a trial of CD4-guided treatment interruptions (AIDS 2010) has 5 year follow-up ongoing; (2)PENPACT1: a 5-year trial of what treatment to start and when to switch will be presented at World AIDS 2010. |Individual patient meta-analyses of European cohort data address multiple questions, including informing trial design, facilitating recruitment and longterm follow-up during/after trials, comparisons between adults and children and pharmcovigilance information for the EMEA. The Childrens HIV Paediatric Study (CHIPS, a UK/Irish paediatric HIV cohort, www.chipscohort.org, DOH funding 1990-), contributes to the above and also provides annual feedback to inform national paedaitric HIV services. Recently (2012) a new cohort study of HIV-infected adolescents and HIV-negative controls has started recruitment. It will evaluate long-term health outcomes in these two groups, with a particular focus on neurodevelopment, quality of life and growth. |In Africa, large ongoing trials in Uganda, Zambia, Zimbabwe and South Africa (total ~2,500 children) are addressing multiple management questions including: when to start ART in children; when and whether ART can be stopped after early treatment; how to monitor children on ART; simplification of ART using fixed dose combination baby pills and once-daily dosing; whether cotrimoxaozole prophylaixs can be stopped in children on ART. Several trials have 2 or more randomisations (in factorial design), have multiple substudies (e.g. pharmacokinetics, adherence, co-morbidities tuberculosis, sepsis, malnutirition) and include additional social science and economic components. A new trial addressing ways to reduce early mortality in HIV-infected adults and children is planned. |In collaboration with Wellcome Trust centre, Kilifi, Kenya, FEAST (www.Feast.org, 2009-2011) is a large (3,600) pragmatic trial evaluating fluid resuscitation strategies in sick children in Uganda, Tansania and Kenya, predominantly due to malaria and sepsis. CTU plays a key role in design, analysis and mentoring. A new trial evaluating transfusion, antibiotic and prophylaxis strategies in sick anaemic children coming into hospital is in the planning stages (TRACT trial).
Organisations
- MRC Clinical Trials Unit (Lead Research Organisation)
- National Institutes of Health, United States (Collaboration)
- University of Padova (Collaboration)
- Arthur Davison Children's Hospital (Collaboration)
- Cipla (Collaboration)
- Wellcome Trust, LONDON (Collaboration)
- Drugs for Neglected Diseases initiative (DNDi) (Collaboration)
- University Medical Centre Nijmegen (Collaboration)
- Imperial College London, United Kingdom (Collaboration)
- University of Cape Town (Collaboration)
- Mpilo Central Hospital (Collaboration)
- University of York, United Kingdom (Collaboration)
Publications

Abongomera G
(2017)
Improved Adherence to Antiretroviral Therapy Observed Among HIV-Infected Children Whose Caregivers had Positive Beliefs in Medicine in Sub-Saharan Africa.
in AIDS and behavior

American Academy Of Pediatrics Committee On Pediatric AIDS, Section On International Child Health
(2007)
Increasing antiretroviral drug access for children with HIV infection.
in Pediatrics

Babiker AG
(2006)
Considerations in the design of randomized controlled trials evaluating the optimal time to initiate antiretroviral therapy in previously untreated HIV-1-infected patients.
in Current opinion in HIV and AIDS

Bastiaans DE
(2014)
Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands.
in The Pediatric infectious disease journal

Bienczak A
(2017)
Effect of diurnal variation, CYP2B6 genotype and age on the pharmacokinetics of nevirapine in African children.
in The Journal of antimicrobial chemotherapy

Bienczak A
(2016)
The impact of genetic polymorphisms on the pharmacokinetics of efavirenz in African children.
in British journal of clinical pharmacology

Bienczak A
(2017)
Determinants of virological outcome and adverse events in African children treated with paediatric nevirapine fixed-dose-combination tablets.
in AIDS (London, England)

Bourke CD
(2019)
Cotrimoxazole reduces systemic inflammation in HIV infection by altering the gut microbiome and immune activation.
in Science translational medicine

Bunupuradah T
(2013)
Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions.
in AIDS (London, England)

Burger D
(2010)
Limited sampling models to predict the pharmacokinetics of nevirapine, stavudine, and lamivudine in HIV-infected children treated with pediatric fixed-dose combination tablets.
in Therapeutic drug monitoring
Description | Antiretroviral Therapy of HIV Infection in infants and Children in Resource-Limited Setttings: Towards Universal Access. Recommendations for a public health approach |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Participation in advisory committee |
Guideline Title | PENTA 2009 guidelines for the use of antiretroviral therapy in paediatric HIV-1 infection |
Description | Citation in PENTA guidelines |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Impact | CHIPS data contributed evidence to the section describing testing strategies for children newly arriving within the EU and presenting to health services |
URL | http://www.pentatrials.org/guide09.pdf |
Guideline Title | Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. August 16, 2010. Department of Health and Human Services, USA. |
Description | Citation in US guidelines |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Impact | CHIPS data contributed epidemiological data to assess the general nature of problems in clinical management of HIV in paediatrics, as well as specifically contributing evidence to inform guidance on the use of tenofovir in paediatrics; PENTA trials have contributed to evidence for firstline therapy;cohort collaborations including CHIPS and PENTA data form the mainstay of when to start treatment according to age-related CD4 counts and percentages for US guidelines, as well as PENTA and WHO guidelines. |
Description | Core Member of WHO consolidated ARV Guidelines 2013 |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Membership of a guidance committee |
Description | DART Trial Film |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Influenced training of practitioners or researchers |
Impact | Provides evidence that toxcicity monitoring is not required for ARV's in WHO 2010 ARV Guidelines. |
Guideline Title | Draft recommendations for management of children with severe febrile illness and impaired circulation without signs of severely impaired circulation |
Description | East Africa Guidelines Panel Recommendations |
Geographic Reach | Africa |
Policy Influence Type | Citation in clinical guidelines |
Description | FEAST Trial Film |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Influenced training of practitioners or researchers |
Impact | Although WHO Guidelines have not yet changed, practice has changed in the centres who participated in the trial and there ahs been widespread international discussion about these results. |
Guideline Title | Antiretroviral Therapy of HIV Infection in infants and Children in Resource-Limited Setttings: Towards Universal Access. Recommendations for a public health approach. |
Description | Generating evidence for when to start treatment for HIV-infected children |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Impact | Formed the basis of when to start ART in guidelines in US, WHO, Europe and then National guidelines. CHER trial results (2007) informed WHO 2008 guidelines on early treatment of infants. results of HPPMCS cohort collaboration informed start treatment guidelines for children after infancy |
URL | http://www.who.int/hiv/pub/guidelines/WHOpaediatric.pdf |
Guideline Title | WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach |
Description | Influence on WHO ART guidelines 2013 |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Guideline Title | Management of circulatory failure in normally nourished children |
Description | MSF shock algorithms |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Description | Member of WHO Maternal and Child Health Guideline Development Group |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Membership of a guidance committee |
Description | Membership of PENTA Guidelines |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Membership of a guidance committee |
Impact | referred to by practitioners and national paedaitric guideline bodies worldwide |
Description | Paediatric Medicines Expert Advisory Group to the MHRA |
Geographic Reach | National |
Policy Influence Type | Participation in advisory committee |
Impact | Advises about paediatric medicines for the MHRA |
Description | WHO 2006, 2007, 2008, 2010 World Health Organisation Guidelines Committee for Paedaitric Antiretroviral therapy |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Membership of a guidance committee |
Impact | WHO guidelines set the standard for HIV treatment in resource-limited settings |
Description | WHO Expert advisory group on formulations of antiretroviral drugs for children |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Participation in advisory committee |
Impact | Development of weightband-based dosing tables of antiretroviral drugs, including fixed dose combination drugs for HIV-infected children in resource-limited countries. Used to approach generic companies to make these products and widely used in resource-limited settings. We have provided much of the evidence on which these recommendations are based from pharmacokinetic and other studies |
Description | WHO expert consultation for global recommendations on cotrimoxazole prophylaxis for HIV infection in adults and children, Geneva |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Membership of a guidance committee |
Impact | accepted as the evidence base for cotrimoxazole prophylaxis in adults and children with HIV infection in resource-limited settings worldwide. incorporated into most national guidelines |
Guideline Title | WHO consolidated guidelines 2013 |
Description | WHO guidelines - health economics and modelling |
Geographic Reach | Africa |
Policy Influence Type | Citation in clinical guidelines |
URL | http://apps.who.int/iris/bitstream/10665/93523/1/WHO_HIV_2013.61_eng.pdf |
Guideline Title | WHO consolidated ART guidelines |
Description | WHO guidelines 2013 - health economics and modelling |
Geographic Reach | Africa |
Policy Influence Type | Citation in clinical guidelines |
URL | http://apps.who.int/iris/bitstream/10665/91043/1/WHO_HIV_2013.60_eng.pdf |
Guideline Title | WHO consolidated ART guidelines 2013 |
Description | WHO guidelines 2013 - health economics and modelling |
Geographic Reach | Africa |
Policy Influence Type | Citation in clinical guidelines |
URL | http://apps.who.int/iris/bitstream/10665/93524/1/WHO_HIV_2013.56_eng.pdf |
Description | WHO: Programmatic Management of Latent TB Infection |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Membership of a guideline committee |
Description | A multi-centre randomised controlled trial of volume expansion in children with severe malaria (FEAST) |
Amount | £2,144,054 (GBP) |
Funding ID | G0601027 |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 01/2007 |
End | 01/2012 |
Description | A randomized controlled trial of shorter course treatment for uncomplicated minimal childhood tuberculosis (SHINE) |
Amount | £3,217,996 (GBP) |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 10/2014 |
End | 10/2018 |
Description | Adolescents and Adults Living with Perinatal HIV cohort (AALPHI)/ Monument Trust (Sainsbury Family) |
Amount | £850,000 (GBP) |
Organisation | The Sainsbury Family Charitable Trusts |
Department | Monument Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 08/2011 |
End | 12/2015 |
Description | Alexander Flemming Dissemination Grant (FEAST) |
Amount | £30,000 (GBP) |
Organisation | Medical Research Council (MRC) |
Department | Medical Research Foundation |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 01/2011 |
End | 01/2012 |
Description | Audit of Tenofovir in HIV infected children in UK/Gilead |
Amount | £36,637 (GBP) |
Organisation | Gilead Sciences, Inc. |
Department | Gilead |
Sector | Private |
Country | United Kingdom |
Start | 06/2006 |
End | 09/2009 |
Description | CHAPAS 3: Expanding the Availability of Fixed Dose Combination Antiretroviral Formulations for First-line Treatment of HIV-infected Children - the Children with HIV in Africa Pharmacokinetics and Acceptability/Adherence of Simple Antiretroviral Regimens |
Amount | € 4,617,034 (EUR) |
Organisation | Sixth Framework Programme (FP6) |
Department | European and Developing Countries Clinical Trials Partnership |
Sector | Public |
Country | Netherlands |
Start | 01/2010 |
End | 01/2014 |
Description | Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS-1 trial) |
Amount | £319,534 (GBP) |
Organisation | Sixth Framework Programme (FP6) |
Department | European and Developing Countries Clinical Trials Partnership |
Sector | Public |
Country | Netherlands |
Start | 01/2006 |
End | 01/2010 |
Description | Children with HIV in Africa Pharmacokinetics and Acceptability/Adherence of Simple Antiretroviral Regimens CHAPAS-3 Trial/EDCTP |
Amount | £683,863 (GBP) |
Organisation | Sixth Framework Programme (FP6) |
Department | European and Developing Countries Clinical Trials Partnership |
Sector | Public |
Country | Netherlands |
Start | 01/2009 |
End | 06/2013 |
Description | Collaborative HIV Paediatric Study (CHIPS) |
Amount | £870,000 (GBP) |
Organisation | NHS England |
Sector | Public |
Country | United Kingdom |
Start | 04/2010 |
End | 03/2020 |
Description | DART Substudy: Follow-up of infants born to HIV infected women in the DART study/Gilead Sciences |
Amount | £52,800 (GBP) |
Organisation | Gilead Sciences, Inc. |
Department | Gilead |
Sector | Private |
Country | United Kingdom |
Start | 09/2006 |
End | 12/2009 |
Description | Development of Antiretroviral Therapy in Africa (Medical Research Fund - Alexander Fleming Dissemintion Scheme) |
Amount | £30,000 (GBP) |
Organisation | Medical Research Council (MRC) |
Department | Medical Research Foundation |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 11/2009 |
End | 06/2010 |
Description | Does short cycle antiretroviral therapy impact on inflammation, immune activation, thrombogenesis and CD4 cell dynamics? |
Amount | £60,773 (GBP) |
Funding ID | 11/136/108 |
Organisation | National Institute for Health Research |
Department | Health Technology Assessment Programme (HTA) |
Sector | Public |
Country | United Kingdom |
Start | 06/2013 |
End | 06/2015 |
Description | European Network Treatment AIDS Laboratory Network (PENTA LABNET) |
Amount | £75,000 (GBP) |
Funding ID | 201057 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 01/2007 |
End | 01/2012 |
Description | Joint Global Health Trials (H-PRIME trial) |
Amount | £4,375,063 (GBP) |
Funding ID | MR/P74363/1 |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 07/2020 |
End | 06/2025 |
Description | MRC Training Fellowship - Felicity Fitzgerald |
Amount | £205,907 (GBP) |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 09/2013 |
End | 09/2016 |
Description | Network of Excellence: Task Force in Europe for Drug Development for the Young, (TEDDY) 4.4m euros across 18 participants |
Amount | £44,577 (GBP) |
Funding ID | 5216 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 06/2005 |
End | 06/2010 |
Description | Networking Grant for Clinical Pharmacology in Sub Saharan Africa/The European & Developing Countries Clinical Trials Partnership |
Amount | £30,000 (GBP) |
Organisation | Sixth Framework Programme (FP6) |
Department | European and Developing Countries Clinical Trials Partnership |
Sector | Public |
Country | Netherlands |
Start | 01/2007 |
End | 01/2014 |
Description | Networking grant: Identifying the common learning needs of investigators working in poverty-related diseases in African settings, areas of project and data/The European & Developing Countries Clinical Trials Partnership |
Amount | £30,000 (GBP) |
Organisation | Sixth Framework Programme (FP6) |
Department | European and Developing Countries Clinical Trials Partnership |
Sector | Public |
Country | Netherlands |
Start |
Description | ODYSSEY qualitative substudy - how does moving to second line HIV treatment affect young people's treatment engagement - additional funding |
Amount | £47,678 (GBP) |
Organisation | Viiv Healthcare |
Sector | Private |
Country | United Kingdom |
Start | 11/2019 |
End | 09/2020 |
Description | ODYSSEY substudy: Folate and vitamin B12 status among children and adolescents in the ODYSSEY trial |
Amount | £32,476 (GBP) |
Organisation | Viiv Healthcare |
Sector | Private |
Country | United Kingdom |
Start | 06/2019 |
End | 05/2020 |
Description | Optimising Clinical Care, Treatment Strategies and Use of laboratories for ART Roll Out in Africa: The Lab-Lite Project |
Amount | £1,896,304 (GBP) |
Organisation | Government of the UK |
Department | Department for International Development (DfID) |
Sector | Public |
Country | United Kingdom |
Start | 05/2011 |
End | 05/2015 |
Description | PENTA 16 Trial: Short-Cycle Therapy (SCT) (5 days on/2 days off) in young people with chronic HIV-infection/Health Technology Assessment |
Amount | £531,261 (GBP) |
Funding ID | HTA/08/53/25 |
Organisation | National Institute for Health Research |
Sector | Public |
Country | United Kingdom |
Start | 01/2011 |
End | 01/2015 |
Description | Paediatric European Network Treatment AIDS and European Collaborative Study on HIV infected pregnant women and their children: renewal of the PENTA Concerted Action |
Amount | £463,158 (GBP) |
Funding ID | 18865 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 01/2006 |
End | 01/2010 |
Description | Reduction of Early mortaLITY in HIV-infected African adults and children starting antiretroviral therapy: REALITY trial |
Amount | £3,986,746 (GBP) |
Funding ID | MC_EX_G1100693 |
Organisation | Wellcome Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 11/2012 |
End | 03/2018 |
Description | Research Collaboration Agreement - PENTA/EPPICC |
Amount | £1,556,696 (GBP) |
Organisation | PENTA Foundation |
Sector | Academic/University |
Country | France |
Start | 06/2011 |
End | 12/2017 |
Description | Severe Malaria Africa - A consortium for Research and Trials (SMAART) |
Amount | £4,028,013 (GBP) |
Funding ID | 209265/Z/17/Z |
Organisation | Wellcome Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 06/2019 |
End | 06/2023 |
Description | Support for UK clinical centres enrolling in PENTA trials |
Amount | £67,648 (GBP) |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | |
End | 03/2009 |
Description | Support for enrolment of additional children into joint PENTA/PACTG Penpact 1 Trial/National Institute of Child Health and Human Development, USA |
Amount | £129,636 (GBP) |
Organisation | National Institutes of Health (NIH) |
Sector | Public |
Country | United States |
Start | 01/2003 |
End | 01/2009 |
Description | The Cost Effectiveness of Antiretroviral Therapy in the CHAPAS Trials/Development Corporation Ireland |
Amount | £60,000 (GBP) |
Organisation | Government of Ireland |
Department | Development Corporation Ireland (DCI) |
Sector | Public |
Country | Ireland |
Start |
Description | The Cost Effectiveness of Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected African children in the CHAP trial/Development Corporation Ireland |
Amount | £60,000 (GBP) |
Organisation | Government of Ireland |
Department | Development Corporation Ireland (DCI) |
Sector | Public |
Country | Ireland |
Start | 01/2006 |
End | 01/2010 |
Description | Trial of Cotrimoxazole prophylaxis in HIV Infected Children in Zambia (CHAP) - including extension for microbiology and after-trial follow-up |
Amount | £479,000 (GBP) |
Organisation | Government of the UK |
Department | Department for International Development (DfID) |
Sector | Public |
Country | United Kingdom |
Start |
Description | Wellcome Trust Fellowship Helen Payne (Immunology substudies in CHER Trial) |
Amount | £314,606 (GBP) |
Funding ID | 095182/Z/10/Z |
Organisation | Wellcome Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 09/2011 |
End | 07/2015 |
Description | Wellcome Trust Fellowship Julia Kenny (CHAPAS 3 Trial & Substudies) |
Amount | £371,694 (GBP) |
Organisation | Wellcome Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 09/2012 |
End | 07/2016 |
Description | Young Lives: the Social Contexts of Paediatric Anti-Retroviral Therapy. A DFID Social Science programme in Uganda and Zimbabwe |
Amount | £788,800 (GBP) |
Organisation | Government of the UK |
Department | Department for International Development (DfID) |
Sector | Public |
Country | United Kingdom |
Start | 01/2011 |
End | 01/2015 |
Title | PENTA biobank |
Description | central repository with web access and virtula database in France for all PENTA samples |
Type Of Material | Database/Collection of Data/Biological Samples |
Provided To Others? | No |
Impact | ensuring rapid use of valuable clinical trial linked samples |
Title | PENTA trials database |
Description | Data collected for the ongoing trials |
Type Of Material | Database/Collection of Data/Biological Samples |
Year Produced | 2008 |
Provided To Others? | Yes |
Impact | Data used in meta-analyses and in modelling |
Description | Arthur Davison Children's Hospital |
Organisation | Arthur Davison Children's Hospital |
Department | Department of Paediatrics |
Country | Zambia |
Sector | Hospitals |
PI Contribution | This is a recruiting site to the CHAPAS-4 study |
Collaborator Contribution | This is a recruiting site to the CHAPAS-4 study |
Impact | This is a recruiting site to the CHAPAS-4 study |
Start Year | 2019 |
Description | Cipla |
Organisation | Cipla |
Country | India |
Sector | Private |
PI Contribution | MRC CTU coordinated the CHAPAS 1,2,3 trials. |
Collaborator Contribution | Cipla have donated antiretroviral drugs for the children participating in these trials. |
Impact | The results of the CHAPAS 1 trial were used towards the licensing by the FDA of Triomune Baby/Junior Fixed Dose Formulations for children. CHAPAS 2 & 3 trials will provide data for licensing these important formulations for children in Africa. |
Start Year | 2006 |
Description | DNDI (Drugs for Neglected Diseases Initiative) |
Organisation | Drugs for Neglected Diseases initiative (DNDi) |
Department | Paediatric Programme |
Country | Switzerland |
Sector | Charity/Non Profit |
PI Contribution | MRC CTU co-ordinates the CHAPAS-2 trial. |
Collaborator Contribution | DNDI has funded the second cohort of the CHAPAS 2 trial and discussions are underway with Dr Marc Lallemant (Head of Paediatric HIV Programme) for further collaboration. |
Impact | Prof A Kekitiinwa, Principal Investigator at one of the Uganda sites for CHAPAS 2, was an invited speaker in a DNDI sponsored satelitte meeting on formulations for children at the AIDS 2012 Conference. |
Start Year | 2011 |
Description | EPPICC (European Paediatric and Pregnancy HIV Cohort Collaboration) |
Organisation | University of Padova |
Country | Italy |
Sector | Academic/University |
PI Contribution | We co-lead this network of paediatric observational HIV cohorts along with the Institute for Child Health. We have co-written the strategic plan for this network for the next 5 year period and have contributed to the EuroCoord bid which has secured funding for this network for the next 5 years. |
Collaborator Contribution | We are leading a new collaborative project (EPPICC infants) for this network, and the network has provided us with data to make the project feasible. The network also contributes epidemiological and clinical expertise to the project. |
Impact | Goetghebuer T, Haelterman E, Le Chenadec J, Dollfus C, Gibb D, Judd A, et al. Effect of early antiretroviral therapy on the risk of AIDS/death in HIV-infected infants. AIDS 2009,23:597-604. European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC). Fosamprenavir use in children in the European Union. A report to the European Medicines Agency (EMA), August 2009 (and repeated August 2010). London: MRC Clinical Trials Unit. European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC). Early antiretroviral therapy in HIV-1 infected infants in Europe, 1996-2008: treatment response and duration of first line regimens. AIDS. 2011;25:2279-2287. |
Start Year | 2007 |
Description | Imperial College, London |
Organisation | Imperial College London |
Department | Department of Paediatrics |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Scientific leadership designing the TRACT (awarded £3,497,084 not yet started) and FEAST trials in collaboration with Professor Kath Maitland (Imperial College and KEMRI Wellcome Trust). Analysis and writing up of the FEAST trial; oversight of trial management and mentoring the trial team in Kilifi. |
Collaborator Contribution | Collaborators of the trial monitoring network in East Africa. The FEAST trial monitors also monitored the VITA trials in Tanzania. Dr Hermione Lyall was a Trial Steering Committee (TSC) member of the ARROW trial and is chair of the EndPoint Review Committe for CHAPAS 3. Dr Gareth Tudor-Williams is chair of the EndPoint Review Committee for ARROW. Clinical trial site for REALITY. |
Impact | The FEAST trial paper in NEJM, follow up papers ongoing. BMJ paper of the year 2012. |
Start Year | 2009 |
Description | Kemri Wellcome Trust, Kilifi Kenya |
Organisation | Wellcome Trust |
Department | KEMRI-Wellcome Trust Research Programme |
Country | Kenya |
Sector | Academic/University |
PI Contribution | Scientific leadership designing the TRACT and FEAST trials in collaboration with Professor Kath Maitland (Imperial College and KEMRI Wellcome Trust). Analysis and writing up of the FEAST trial; oversight of trial management and mentoring the trial team in Kilifi. Chair of Trial Steering Committe of Cotrimoxizole trial for Jay Berkley. |
Collaborator Contribution | the CTU lead network of trial monitoring in East Africa. The FEAST trial monitors also monitored the VITA trials in Tanzania. Trial sites for REALITY Trial |
Impact | The FEAST trial paper in NEJM, follow up papers ongoing. BMJ paper of the year 2012. |
Start Year | 2009 |
Description | Mpilo Hospital, Bulawayo, Zimbabwe |
Organisation | Mpilo Central Hospital |
Country | Zimbabwe |
Sector | Hospitals |
PI Contribution | This is a recruitment site in the CHAPAS-4 trial. |
Collaborator Contribution | This is a recruitment site in the CHAPAS-4 trial. |
Impact | This is a recruitment site in the CHAPAS-4 trial, trial is still actively recruiting. |
Start Year | 2019 |
Description | National Institute of Health |
Organisation | National Institutes of Health (NIH) |
Country | United States |
Sector | Public |
PI Contribution | Provide scientific input in to all aspects of desgin, analysis and write up of the CHER trial (Prof Diana Gibb and Prof Abdul Babiker). With Prof Lynne Mofenson at NIAID we have worked on PENPACT-1 trial and cohort collaborations (HPPMCS). |
Collaborator Contribution | We have collaborated with NIH who funded the CHER trial in South Africa through a CIPRA grant. NIH have contributed funding and collaboration on the PENPACT-1 trial |
Impact | Papers from the CHER trial and PENPACT-1 trial, papers from HPPMCS. |
Description | Radboud University Nijmegen Medical Centre, the Netherlands |
Organisation | Radboud University Nijmegen Medical Center |
Country | Netherlands |
Sector | Academic/University |
PI Contribution | The research team at the MRC co-ordinates the ARROW, CHAPAS-1,2,3 and PENTA trials and provides scientific input and analysis of EDCTP funded VITA 1 and 2 trials. |
Collaborator Contribution | Long standing nesting of key pharmacokinetic studies within larger trial programmes. Contributed to several PhD studentships (all Dutch), PK data resulted in licensing of new appropriate antiretroviral formulations for children in resource limited settings. |
Impact | Radbound University has been involved in the analysis and writing up of the pharmacokinetics data from ARROW, PENTA 18 and the CHAPAS trials which has resulted in presentations at international conferences, peer review publications, FDA and EMA approval of drugs and Clinton Foundation and UNITAID dissemination in Africa. |
Start Year | 2007 |
Description | University of Cape Town |
Organisation | University of Cape Town |
Department | Division of Clinical Pharmacology |
Country | South Africa |
Sector | Academic/University |
PI Contribution | MRC CTU coordinates the CHAPAS 3, PENTA 17 (SMILE) and PENTA 20 (ODYSSEY) clinical trials. |
Collaborator Contribution | Dr Helen McIlleron's team designed, coordinate and analyse pharmacokinetic studies in collaboration with Prof David Burger from Nimejgen. Collaboration between MRC CTU at UCL, Harvard University and University of Cape Town to be Data Center for CIPHER global cohort collaboration. Clinical site for PENTA 17 (SMILE) and PENTA 20 (ODYSSEY) clinical trials |
Impact | Analyses of CHAPAS 3 data are currently in progress |
Start Year | 2010 |
Description | University of York |
Organisation | University of York |
Department | York Health Economics Consortium (YHEC) |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | MRC CTU coordinates programmes of trials and implementation projects. |
Collaborator Contribution | The Health Economics team led by Professor Mark Sculpher collaborate on cost effectiveness analyses linked to clincal trials and economic evaluations including equity and modelling for medical decision makers in health |
Impact | Paul Revill has led a cost effectiveness analysis of the ARROW data which is in the process of being published, he also leads a team of African economists (including capacity building working on the DFID funded Lablite project). |
Start Year | 2010 |
Title | BREATHER - PENTA 16 |
Description | All young people enrolled in this clinical trial evaluating the role of Short Cycle Therapy (5 days on, 2 days off) in the management of HIV infection will be followed until July 2014. Young people continued to be followed on their randomised treatment, where appropriate, in a 2 year extended follow-up period until July 2016. Results were presented at CROI 2017 |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Late clinical evaluation |
Year Development Stage Completed | 2010 |
Development Status | Closed |
Clinical Trial? | Yes |
Impact | Results were presented at CROI 2017. A further trial is planned to look at the possibility of a short course therapy in settings where viral loads are measured annually. |
URL | http://pentatrials.org |
Title | CHAPAS 1 Trial - Triomune Baby/Junior |
Description | Fixed Dose Combination Tablet of 3 antiretrovrials (Stavudine, Lamivudine, Nevirapine) |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2007 |
Development Status | Closed |
Clinical Trial? | Yes |
Impact | Trial results contributed to tentative approval by FDA, which allowed use by Clinton foundation and other treatment programmes in Africa |
Title | CHAPAS 2 Kaletra minitabs |
Description | Lopinavir/Ritonavir in a novel minitabs sprinkle formulation have been developed by CIPLA Ltd. |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2011 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
Impact | CHAPAS 2 showed that minitabs were comparable with syrup in terms of pharmacokinetics and were more acceptable than syrups for younger children who are unable to take tablets. |
URL | http://www.controlled-trials.com/ISRCTN01946535 |
Title | CHAPAS 3 - Efavirenz double scored tablets |
Description | Efavirenz 600mg tablets scored once on one side and twice on the other side have been developed by CIPLA Ltd to enable dosing using one tablet from childhood through to adulthood. These tablets have been evaluated in the CHAPAS 3 trial using weight band based dosing for pharmacokinetics and their acceptability to children and carers. These tablets are also now being used in the REALITY trial to treat both children and adults. |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Late clinical evaluation |
Year Development Stage Completed | 2012 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
Impact | This product has the potential to greatly simplify ART provision to both adults and children |
URL | http://www.controlled-trials.com/ISRCTN69078957 |
Title | CHAPAS 3 ABC/3TC 120/60mg |
Description | Abamune Junior 120/60mg is in the updated WHO 2013 guidelines for children as an urgently needed formulation. This product has been used in the CHAPAS 3 trial in which data on pharmacokinetics, adherance and acceptability has been collected |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Late clinical evaluation |
Year Development Stage Completed | 2010 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
Impact | This product will simplify dosing in children |
URL | http://www.controlled-trials.com/ISRCTN69078957 |
Title | Children with HIV Early Antiretroviral Therapy (CHER) |
Description | evaluated early antiretroviral therapy in HIV infected infants in South Africa |
Type | Management of Diseases and Conditions |
Current Stage Of Development | Late clinical evaluation |
Year Development Stage Completed | 2011 |
Development Status | Closed |
Clinical Trial? | Yes |
Impact | changed WHO guidance on when to start ART (2010) |
Title | Children with HIV antibiotic prophylaxis |
Description | randomised trial of Cotrimoxazole prophylaxis in Zambian children |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Late clinical evaluation |
Development Status | Closed |
Clinical Trial? | Yes |
Impact | changed WHO guidelines on Cotrimoxazole prophylaxis |
Title | PENTA 11 - TICCH |
Description | 5 year follow-up is continuing of children enrolled in PENTA 11 - a randomised study to evaluate CD4 driven planned treatment interruptions in children with HIV infection. |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Late clinical evaluation |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
Impact | PENTA 11 and the CHER trial have provided randomised data for the possibility of planned treatment interruptions in HIV treatment. |
URL | http://pentatrials.org |
Title | PENTA 18 - Once daily Kaletra 100/25ml |
Description | Currently being analysed Kaletra 100/25ml paediatric tablets once daily in the KONCERT (PENTA 18) in process of submission to FDA |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Late clinical evaluation |
Year Development Stage Completed | 2009 |
Development Status | Closed |
Clinical Trial? | Yes |
Impact | If lopinavir is shown to be non-inferior when taken once daily rather than twice daily in terms of virological suppression, we expect this will become the standard of care for this drug. |
URL | http://www.pentatrials.org |
Title | SHINE Fixed dose combination TB treatment for children |
Description | Fixed dose combination scored dispersable tablet, containing Isoniozid 50mg, rifampicin 75mg and pirozinamide 150mg for the intensive phase and an FDC tablet of isoniazid 50mg and rifampicin 75mg for the continuation phase. These are currently being evaluated in a bio equivalent study in healthy volunteers. If bioequivalent these will be used in SHINE. |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Initial development |
Year Development Stage Completed | 2013 |
Development Status | Under active development/distribution |
Impact | Still under development |
Description | ARROW Cotrimoxazole film |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | Film about the ARROW cotrimoxazole results released on YouTube. 161 views so far from the YouTube website. Unsure how many views from the MRC CTU website. |
Year(s) Of Engagement Activity | 2014 |
URL | https://www.youtube.com/watch?v=D1n_We7x8Do |
Description | ARROW Cotrimoxazole policy brief |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | The policybrief was distributed to policymakers in the Ministry of Health in Uganda and Zimbabwe (where the trial took place). It has also been more widely distributed at meetings, and is available on the MRC CTU website. Feedback from policymakers at the Ministry of Health was very positive about the policy brief. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.ctu.mrc.ac.uk/12602/13009/children_on_art_in_africa_need_to_continue_cotrimoxazole_prophy... |
Description | Aids Treatment Information Centre (ATIC) Newsletter on Development of New Paediatric Antiretroviral Formulations. CHAPAS-1 was used as a case study |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | Yes |
Primary Audience | Health professionals |
Results and Impact | A newsletter that was distributed to healthcare providers throughout Uganda The article was well received in Ugandan audience. |
Year(s) Of Engagement Activity | 2008 |
Description | Anatomy of a clinical trial film |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Type Of Presentation | Keynote/Invited Speaker |
Geographic Reach | International |
Primary Audience | Health professionals |
Results and Impact | A film was developed, targeted at healthworkers, explaining the importance of clinical trials, using FEAST as an example. This film has been shown at a conference in South Africa, as well as being made available on YouTube and the MRC CTU website. The film has had almost 500 views online. Health workers watching the film reported finding the interviews with the trial team before they found out the results, and watching them learn the results, to be very persuasive. |
Year(s) Of Engagement Activity | 2013 |
URL | http://www.youtube.com/watch?v=GdMMuURsZQg&list=UUxUK9Zn4Es5SxMbAYeTSO2g |
Description | CHAPAS-1 participants meetings |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Primary Audience | Public/other audiences |
Results and Impact | The CHAPAS-1 centre held a participants day/celebration after the final Trial Steering Committee to feedback the results of the trial to participants. Presentations were done by trial staff. Participants were very appreciative of being told results early in the dissemination process. Throughout the trial, regular meetings with participants enabled researchers to become aware of concerns and issues before these developed into major problems. |
Year(s) Of Engagement Activity | 2008 |
Description | CHAPAS-1 policy briefs |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | Yes |
Primary Audience | Policymakers/politicians |
Results and Impact | A policy brief describing the main results of CHAPAS-1 and the advantages of fixed dose combination tablets for children. The case studies were well received in Zambia and by African audience. |
Year(s) Of Engagement Activity | 2010 |
Description | CHER long-term results press release |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Type Of Presentation | Paper Presentation |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | A press release was issued regarding the long-term results of CHER. This was covered by an article on the AFP News wire. |
Year(s) Of Engagement Activity | 2013 |
Description | CHIVA |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | Yes |
Type Of Presentation | Keynote/Invited Speaker |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Twice yearly contribution of lay text on the CHIPS study to the CHIVA Newsletter; yearly presentation of key findings from the CHIPS and AALPHI studies at the CHIVA national conference. Updating on results and ongoing PENTA trials Improved reporting of patients to CHIPS, and general understanding of the CHIPS data and its importance. Recruitment of patients into PENTA trials |
Year(s) Of Engagement Activity | 2006,2007,2008,2009,2010,2011,2012,2013,2014,2015,2016,2017 |
Description | CHIVA Annual Conference: Invited Speaker |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Invited speaker to the annual CHIVA conference in London. Title of talk: PENTA - A global Update |
Year(s) Of Engagement Activity | 2019 |
URL | https://www.chiva.org.uk/professionals/previous-conferences/2019-annual-chiva-conference/ |
Description | CTU Seminar Series: Invited Speaker |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Professional Practitioners |
Results and Impact | About 80 people attended the seminar which was highlighting the impact of the CHAPAS HIV trials that have been conducted from the CTU and led by Prof Gibb over the past 20 years. The seminar sparked questions around the future of the CHAPAS trials and the international collaborations. Title of talk: Impact of the CHAPAS trials |
Year(s) Of Engagement Activity | 2019 |
Description | Communication Strategy for stakeholders (FEAST) |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Type Of Presentation | Workshop Facilitator |
Geographic Reach | International |
Primary Audience | Health professionals |
Results and Impact | Communication Strategy was developed for the main stakeholders - including health professionals, policy makers and public. Primarily designed to raise awareness of the existance and potential impact of the trial. Communities and hospitals were anxious to know the outcome of the study when published |
Year(s) Of Engagement Activity | 2009,2010,2011,2012 |
Description | ESPID Plenary Lecture |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | I as invited and gave the plenary lecture at ESPID (European Society for Paediatric Infectious Diseases) which is an international conference addressing clinicians and policymakers. The talk ws well recieved to an audience of over 100 and which discussed the trials run from CTU, SHINE/CHAMP/SURE/STREAM/REALITY/CAPIT/ODYSSEY/ARROW Title of the talk: New ways of doing clinical trials in infectious diseases to maximise evidence generation |
Year(s) Of Engagement Activity | 2019 |
Description | FEAST engagement with media over BMJ paper |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | The story was covered by the Today Programme, BBC World Service, BBC News website, Guardian. The World Health Organisation responded, saying they would release updated guidelines by the end of the year. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.ctu.mrc.ac.uk/news/2014/current_septic_shock_treatment_guidelines_are_putting_childrens_l... |
Description | FEAST information pack |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Health professionals |
Results and Impact | The information pack has been distributed to international policymakers including the World Health Organisation, international NGOs such as Medicins Sans Frontiers, and representatives of paediatric associations from ten African countries. The implications of FEAST have been discussed by the paediatric associations of several African countries. A small group is being convened to work on revising the ETAT and ETAT+ guidelines |
Year(s) Of Engagement Activity | 2012 |
Description | Fluid Resuscitation Meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Type Of Presentation | Keynote/Invited Speaker |
Geographic Reach | International |
Primary Audience | Health professionals |
Results and Impact | Working with Kenya Paediatric Association we convened a workshop with representations from the paediatric associations of ten sub-Saharan African countries. This meeting looked at the evidence on fluid resuscitation of children, including that from the FEAST trial, and discussed the implications for policy and practice. It was agreed that a small group would work on revising the ETAT and ETAT+ guidelines incorporating the evidence from FEAST. Participants in the meeting would also raise the issue with their national paediatric associations, with the aim of updating national policy. |
Year(s) Of Engagement Activity | 2012 |
Description | Invited speaker at PENTA HIV Training |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Invited speaker at the international HIV paediatric training programme run by PENTA ID. Title of talk; TB Research Update/Research and adolescents, trials and their involvement |
Year(s) Of Engagement Activity | 2019 |
Description | Lablite briefing paper 1: prioritising improving laboratory monitoring or scaling up ART |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | Briefing paper developed based on results of modelling study. . |
Year(s) Of Engagement Activity | 2013 |
URL | http://www.ctu.mrc.ac.uk/13706/13710/prioritising_increasing_access_to_art_or_improving_monitoring_o... |
Description | Lablite briefing paper: Access to lab tests |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | Policy brief developed based on results of Lablite baseline survey. Currently being distributed. Too early to say. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.ctu.mrc.ac.uk/13706/13710/Access_to_lab_testing_at_primary_health_facilities |
Description | Lablite briefing paper: Children's access to ART |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Briefing paper developed based on results of Lablite baseline survey. Currently being distributed. Currently being distributed. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.ctu.mrc.ac.uk/13706/13710/Childrens_access_to_art |
Description | London Specialised Commissioning Group |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | Yes |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | Annual production of a newsletter (annual report) and slide set which presents CHIPS data in lay language. Presentation of data at twice yearly London HIV Consortium meetings CHIPS data are now used as the basis for commissioning paediatric HIV services across England, and are being developed to measure quality of services within new designation schemes. |
Year(s) Of Engagement Activity | 2006,2007,2008,2009,2010,2011,2012,2013,2014,2015,2016 |
Description | PENTA Website |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Primary Audience | Health professionals |
Results and Impact | Includes detials of trials, updated news, publications, guidelines for antiretroviral therapy in children, links to HPPMCS risk calculator for clinicians, links to the CHIVA website, regular traffic of emails asking questions and indicating appreciation |
Year(s) Of Engagement Activity | 2006,2007,2008,2009,2010 |
Description | PENTA newsletters for participants |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Primary Audience | Participants in your research and patient groups |
Results and Impact | regular newsletters update about ongoing trials and results Appreciated by participants |
Year(s) Of Engagement Activity | 2006,2007,2008,2009,2010 |
Description | Policy brief: Challenging fluid resuscitation for critically sick children in Africa (FEAST) |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | The policy brief, summarising the results of the FEAST trial, has been distributed to healthworkers and policymakers from ten African countries, and international agencies such as the World Health Organisation and Medicins Sans Frontiers. Further copies of the policy brief have been requested (and sent) for distribution to Zambia Paediatric Association. The implications of FEAST have been discussed by the paediatric associations of several African countries. |
Year(s) Of Engagement Activity | 2012 |
Description | Visit to WHO (FEAST) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | Yes |
Primary Audience | Policymakers/politicians |
Results and Impact | WHO awaiting results of trial. They would like to use the results and our expertise to advise of fluid management of the severely ill child WHO are the key policy maker who advise on guidelines for management of children in LED countries including Africa. FEAST will direct inform policy. |
Year(s) Of Engagement Activity | 2010 |
Description | WB-PK1 results in children 20-<25kg (Bollen et al. CROI 2019, poster #830) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | WB-PK1 results in children 20-<25kg (Bollen et al. CROI 2019, poster #830) presented at CROI 2019, informing WHO guidelines. |
Year(s) Of Engagement Activity | 2019 |
Description | talks/workshops to adolescents with HIV infection about research including understanding of clinical trials |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Type Of Presentation | Workshop Facilitator |
Geographic Reach | National |
Primary Audience | Participants in your research and patient groups |
Results and Impact | eg workshop of >100 young people with HIV; resulting in more active participation of young people with HIV in thinking about reserach |
Year(s) Of Engagement Activity | 2009,2010 |
Description | • WB-PK1 results in children on dispersible tablets (Waalewijn et al. AIDS 2019, oral # WEAB0401LB) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | • WB-PK1 results in children on dispersible tablets (Waalewijn et al. AIDS 2019, oral # WEAB0401LB) informing WHO guidelines |
Year(s) Of Engagement Activity | 2019 |