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• applications(array)
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    • Application(array)
      • id777
      • user_id360
      • trial_status_id5
      • abstract_of_study<p>\n This study, entitled Clinical Evaluation of the FilmArray Global Fever (GF) Panel, is sponsored by BioFire Defense, LLC and aims to evaluate the clinical sensitivity and specificity of the assays comprising the FilmArray Global Fever Panel when used to test whole blood collected from individuals with acute febrile illness, when compared to a well-validated molecular-based method, in the intended use setting (reference or diagnostic laboratory). The intention is to use these performance data to support classification of the FilmArray GF Panel as an in vitro diagnostic (IVD) device by the U.S. Food and Drug Administration (FDA) and other comparable regulatory agencies. Whole blood will be collected prospectively from patients attending outpatient and inpatient departments of the health care facilities at Kisumu District Hospital, Kombewa Sub-District Hospital, Kisii District Hospital, Marigat District Hospital, Gilgil District Hospital, and Kenya Armed Forces Memorial Hospital (Mbagathi, Nairobi), where only enrollment and specimen collection will be performed. The subjects will be consented for blood draw and testing of pathogens that are commonly associated with febrile illnesses such as malaria, leishmaniasis, anthrax, leptospirosis, plague, paratyphoid fever, typhoid fever, tularemia, Crimean-Congo hemorrhagic fever, chikungunya fever, dengue fever, lassa fever, ebola virus disease, marburg virus disease, West Nile fever and Yellow fever. The collected blood sample will be labeled with only a study code number (SCN) in order to protect subject identity. However, in the event a select agent is detected twice using the Global Fever Panel, the enrollment log which links the SCN to the subject may be used to identify the subject for follow-up. The samples will be secured in refrigerators and freezers at WRP/KEMRI facilities and only study investigators and their authorized staff will have access. All safeguards ensuring privacy that are in place during this study period will also continue to be in place for the long-term storage of samples. Some tests planned for this trial will be done with our collaborating laboratories abroad. Before shipment of samples to such collaborating laboratories, authority for sample shipment and testing will be sought from KEMRI SERU. The collected specimens will either be tested fresh or will be frozen and then tested at a later date. Freezing of specimens will allow for continued collection of specimens when immediate testing is not possible. Freezing and testing of specimens will be tracked on study-specific forms. Informed consent will be obtained from eligible participants prior to specimen collection. For the study, up to 500 patients will provide 2.5-3.0 mL of whole blood and the blood sample will be labeled with a study code number (SCN). Continuous enrollment and testing are expected to last for approximately 18 months in order to achieve a required number of valid specimens. All FilmArray testing and nucleic acid extraction will occur at the Basic Science Lab, KEMRI/WRP, Kisumu. Of the 2.5-3.0 mL of whole blood collected, 500 L will be archived at ≤-70°C immediately for discrepancy testing. A 200 L aliquot of the whole blood will be used for FilmArray GF Panel testing. In addition to FilmArray testing, 800 L of the whole blood will be used to purify nucleic acid, using the provided MagNA Pure Compact system (or equivalent). The purified nucleic acids will be shipped frozen to BioFire Defense for further testing (comparator testing). Comparator assays are designed to amplify and detect pathogen nucleic acid; no genetic testing or specific amplification of human nucleic acid will be performed. The residual blood specimen will be stored refrigerated until FilmArray testing and nucleic acid extraction is complete in the event that additional testing/extraction is required. Once the required testing is completed, remaining sample (up to 2.0 mL total, which includes the 500 µl aliquot archived for discrepancy testing), will be archived at ≤-70°C for at least two years after study completion. In order to conduct future research utilizing these samples, a new sub-protocol must be written, reviewed and approved by both the WRAIR IRB and the KEMRI SERU. To maintain patient confidentiality, blood samples, blood sample aliquots and specimen nucleic acid will only be labeled with a study code number (SCN). This study will be performed according to the approved multisite protocol (attached), laboratory-specific protocols and site-specific workflow procedures, and available product literature for the FilmArray instrument and the MagNA Pure Compact system. No deviation from this protocol will be implemented without the prior review and approval of BioFire Defense and the respective sites’ IRB(s), except where it may be necessary to eliminate an immediate hazard to a research subject. The results of the FilmArray GF Panel testing will not be provided to the patients or their healthcare providers, or in any way be used to affect their standard of care except in the event that a true positive select agent detection is confirmed (see 3.4 below for full description). This study is jointly funded by the U.S. Army Medical Materiel Development Activity (USAMMDA) through contracts with BioFire Defense and managed by the Joint Program Executive Office for Chemical and Biological Defense – Medical Countermeasure Systems (JPEO-CBD-MCS), the National Institute of Allergy and Infectious Diseases (NIAID) and BioFire Defense. The clinical evaluation outlined in this protocol will be administered and managed by BioFire Defense. The Sponsor contact person(s) for this study will be at BioFire Defense, and are listed above (page i).  </p>\n
      • study_title<p>\n Clinical Evaluation of the FilmArray Gobal Fever GF Panel</p>\n
      • laymans_summary<p>\n Diseases that are associated with increased body temperature (fever more than ≥ 38 °C) and other clinical signs like headache, tiredness and muscle pain are many. They can be caused by different microorganisms that are widespread in different regions, including Kenya. Sometimes these diseases can occur as outbreaks that make many people ill. One of the big problems with these types of diseases is determining the cause of the disease because symptoms such as high temperature, headache, tiredness and muscle pain are common signs of many diseases. A machine that can quickly and correctly identify microorganisms in blood of patients with elevated temperature would make treatment decisions easier for doctors. The FilmArray Global Fever (GF) Panel has the potential to detect many of these diseases. It is a machine that works by multiplying genetic material of an organism, making such materials easier to detect. The system is able to detect bacteria, viruses, and protozoa in a single blood sample. Unlike other methods that require human intervention, the machine performs all manipulations including extraction of genetic materials, multiplication of genetic materials, and identification of microorganism. The process is fully automated and gives final results in approximately one hour. The purpose of this study is to test how good this machine is in detecting the following microorganisms in patients with fever: Leptospira spp., Plasmodium spp., Plasmodium falciparum, Plasmodium vivax/ovale, chikungunya virus, and dengue virus. To do this, the machine will be tested using blood samples that will come from an ongoing study that collects blood samples from patients with fever (KEMRI SSC #1282 and WRAIR #1402). The FilmArray test results of Detected or Not Detected will be compared to validated molecular-based methods that are performed at BioFire Defense, LLC in Salt Lake City, Utah, US. Data obtained in this study will be used to support application to license the FilmArray GF Panel as an in vitro diagnostic (IVD) device for detection of microorganisms in blood from patients with fever. If the proposed study is successful, the FilmArray GF Fever Panel may provide an effective way to obtain a quick diagnosis. The study is sponsored by a company called BioFire Defense, LLC and the study will be performed at the Basic Science Lab of the Kenya Medical Research Institute/ Walter Reed Project (KEMRI/WRP) in Kisumu.</p>\n
      • short_titleBiofire FilmArray Gobal Fever GF Panel
      • protocol_noECCT/19/03/03
      • version_noREV 05
      • date_of_protocol21-02-2018
      • study_drugBiofire FilmArray Gobal Fever GF Panel-Device
      • disease_conditionACUTE FEBRILE ILLNESS
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameBiofire FilmArray Gobal Fever GF Panel-Device
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdotigondi3@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantJohn Waitumbi +254 733616548
      • declaration_date115-03-2019
      • declaration_principal_investigatorJohn Waitumbi +254 733616548
      • declaration_date215-03-2019
      • placebo_presentNo
      • study_objectives<p>\n The objective of this multi-center study is to evaluate the clinical sensitivity and specificity of the assays comprising the FilmArray GF Panel when used to test whole blood specimens. It is hypothesized that the FilmArray GF Panel assays will be highly specific and give no false detections of the bacteria, viruses, and protozoa included in the panel. These data will be used to support submissions to the FDA in support of the FilmArray GF Panel as an in vitro diagnostic device.</p>\n
      • principal_inclusion_criteria<p>\n Febrile patient (>38 °C) recruited at a health facility One year or older Able to give consent (guardian if lees than 18 years) and assent if >13 years</p>\n
      • principal_exclusion_criteria<p>\n Not able to give consent or assent if of appropriate age</p>\n
      • primary_end_points<p>\n N/A</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyDevice
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The KEMRI/USAMRD-K Basic Science Laboratory (BSL) at Kondele is a research laboratory that performs multi-disciplinary basic science research (molecular biology and immunology) in malaria and many other infectious diseases, including disease surveillance, diagnostic evaluations and developments. BSL has a well developed basic science research infrastructure for performing: 1) Surveillance for pathogens associated with febrile illness in diverse eco-regions of Kenya; 2) Determination of malaria parasites population structure prior and post vaccine and drug intervention; 3) Evaluation of multi-pathogen diagnostic platforms for infectious diseases of regional and global importance. To perform these functions, BSL has a well developed research infrastructure that includes state of art technologies such as: 1) Real-time and conventional PCR for diagnosis and genotyping; 2) MAGPIX for multiplexing pathogen detection, ideal for outbreak investigations and disease surveillance studies; 3) Sanger sequencer for sequence generation and fingerprinting; 4) MiSeq for unbiased sequence screening and pathogen characterization. The Lab has a workforce of 13 well trained scientist that includes: • two senior scientists with PhDs • 5 Research Officers with MScs • One certified QA/QC officer with appropriate professional certification • 4 Assistant Research Officers with BSc degree • One data entry clerk/curator with BA. To support patient recruitment, the Lab has surveillance sites in 9 hospitals, each staffed with a clinical officer or nurse and a Lab technician</p>\n
      • other_details_explanation<p>\n n/a</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n The study has been submitted to anumber of countries and the RA in the respective countries have approved the study and the study is already ongoing in those countries. These include RA in Tanzania, Thailand , Cambodia, Uganda:Peru</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration18Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Walter Reed Project USAMRD A/K Kisumu
      • single_site_physical_addressBeside New Nyanza provincial Hospital
      • single_site_contact_personDr John Waitumbi
      • single_site_telephone+254 733616548
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3 Africa , Asia and America
      • number_of_sites
      • multi_country_listMoshi, Tanzania\nSt Louis, USA\nBangkok, Thailand\nKampong Cham, Cambodia\nKampala, Uganda\nIquitos, Peru\n\nTegucigalpa, Honduras\nWashington, DC, USA\nNavrongo, Ghana\nTbilisi, Georgia\n
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide1500
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJOHN
      • investigator1_middle_name
      • investigator1_family_nameWAITUMBI
      • investigator1_qualificationPhD
      • investigator1_professional_addressP.O BOX 54 KISUMU CODE 40100
      • investigator1_telephone+254 733616548
      • investigator1_emailjohn.waitumbi@usamru-k.org
      • organisations_transferred_No
      • number_participants500
      • notification<p>\n None</p>\n
      • approval_date16-05-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-09-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This study, entitled Clinical Evaluation of the FilmArray Global Fever (GF) Panel aimed to evaluate the clinical sensitivity and specificity of the assays comprising the FilmArray Global Fever Panel when used to test whole blood collected from individuals with acute febrile illness, when compared to a well-validated molecular-based method, in the intended use setting (reference or diagnostic laboratory). The intention was to use these performance data to support classification of the FilmArray GF Panel as an in vitro diagnostic (IVD) device by the U.S. Food and Drug Administration (FDA) and other comparable regulatory agencies.</p>\n
      • implication_results<p>\n The Clinical Evaluation of the FilmArray Global Fever Panel in Kisumu Kenya was initiated July 10-18, 2019. A total of six (6) collections sites were trained to participate in the study as well as laboratory personnel to perform FilmArray testing and nucleic acid extractions. The last participant was recruited on 30th September 2019 bringing to a total of 163 subjects, of which 158 were enrolled and tested on FilmArray at Kisumu site. All eligible nucleic acids samples were shipped to BioFire Defense Laboratories after obtaining permission from KEMRI SERU. Comparator testing and analysis at BioFire Defense Laboratories has been completed. The first submission of Global Fever Panel results from all the participating sites was made to the FDA. The second submission with all the GFP analytes was made to FDA in October 2021. Full GFP analylates includes: Chikungunya virus, dengue virus (serotypes 1-4), Leptospira spp., Plasmodium spp., P. falciparum, and P. ovale/vivax. Crimean Congo Hemorrhagic Fever virus, Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, and Leishmania donovani complex. A manuscript titled “Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study by Manabe et al., The Lancet Infectious Diseases, 2022, https://doi.org/10.1016/S1473-3099(22)00290-0</p>\n
      • quantity_imported3 Film Arrays Global Fever (GF) Panel
      • quantity_dispensedN/A
      • quantity_destroyedN/A
      • quantity_exported 1 was returned to the sponsor because it was faulty
      • balance_site2 were donated to the site
      • final_date0000-00-00
      • modified2025-07-15 14:11:19
      • created2019-03-15 11:24:51
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id485
        • application_id777
        • given_nameJOHN
        • middle_name
        • family_nameWAITUMBI
        • qualificationPhD
        • professional_addressP.O BOX 54 KISUMU CODE 40100
        • telephone+254 733616548
        • emailjohn.waitumbi@usamru-k.org
        • created2019-03-15 12:18:07
        • modified2020-09-28 17:09:52
    • SiteDetail(array)
      • 0(array)
        • id631
        • application_id777
        • county_id(null)
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        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-03-15 12:18:07
        • modified2020-09-28 17:09:52
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id378
        • application_id777
        • sponsorBioFire Defense, LLC
        • sponsor_typeIndustry
        • contact_personCynthia Phillips
        • address79 West 4500 South, Suite 14,
        • telephone_number(801) 262-3592 ext.1370
        • fax_number
        • cell_number(801) 262-3592 ext.1370
        • email_addressCynthia.Phillips@biofiredefense.com
        • created2019-03-15 12:18:07
        • modified2020-09-28 17:09:52
  • 1(array)
    • Application(array)
      • id1035
      • user_id353
      • trial_status_id2
      • abstract_of_study<p>\n Background: Several subpopulations, including adolescent girls and young women (AGYW, ages 15-24), lag behind the 3rd 90-90-90 UNAIDS goal of viral suppression, particularly in resource-limited settings (RLS).1 AGYW living with HIV (AGYWLHIV) face unique challenges in persistence to anti-retroviral therapy,2 and overcoming barriers such as stigma and poverty that hinder achieving viral suppression among AGYW.5 Long-acting (LA) antiretroviral therapy (ART), such as injectable cabotegravir and rilpivirine, has been receiving global clinical approvals and has the potential to address these barriers and improve patient adherence and persistence to treatment. LA ART regimens can potentially also increase options for patients and providers to individualize treatment plans, provide a powerful treatment option for those experiencing adherence issues related oral treatment options, and may ease the burden of health systems in RLS. Another major threat to AGYW’s health is unintended pregnancies,3 and AGYWLHIV also face unique challenges in uptake and continuation of LA contraceptives. Use of LA ART may foster synergy in usage of LA contraceptives among AGYWLHIV.</p>\n<p>\n Methods: This proposed research study has three main components: 1) a prospective, non-randomized, parallel-group pharmacokinetic (PK) study among a sentinel cohort of five distinct groups of AGYW, and will leverage existing control groups from the PARVI study (Aim 1a); 2) a qualitative study that will conduct individual interviews with four different subgroups of AGYWLHIV from the sentinel cohort from the PK study, as well as focus group discussions with providers, policy makers, and other stakeholders for health systems readiness for wider scale-up (Aim 1b); and 3) an open-label, mixed methods, 48-week type I hybrid trial randomizing AGYW with viral suppression on their current ART regimen to switch to 1:1 cabotegravir/ rilpivirine (intervention arm) vs. continue their oral ART regimen (Aim 2a), with a component also evaluating implementation outcomes of acceptability, feasibility, and fidelity (Aim 2b). The proposed study will be conducted in HIV treatment facilities in western Kenya within the regional Moi Teaching and Referral Hospital (MTRH).</p>\n<p>\n Impact: This study will provide foundational data for future studies and implementation plans related to addressing barriers and will critically inform follow-up studies of LA ART in other priority subpopulations. Providing an array of method options for both HIV treatment and pregnancy prevention has the potential to revolutionize personal decision-making and improve long-term outcomes for AGYWLHIV. Our real-world experiences of co-delivery will also inform future considerations for co-formulations of antiretrovirals and contraceptives for both HIV treatment and prevention. This study also directly addresses the need to find interventions that will and achieve the UNAIDS 90-90-90 goals.</p>\n
      • study_title<p>\n Co-benefits of co-delivery of long-acting antiretrovirals and contraceptives</p>\n
      • laymans_summary<p>\n Layman’s Summary</p>\n<p>\n Adolescent girls and young women (AGYW) lag behind older women in viral suppression. Long-acting antiretroviral therapy (LA ART) can increase options, patient adherence and persistence to treatment. In resource-limited settings (RLS), LA ART regimens may also ease the burden on health systems by decreasing refill visits or easing supply chain management. Unintended pregnancies greatly affect AGYW. Long-acting contraceptives (e.g., LARCs and injectables) can prevent unintended pregnancies. RLS have decades of investments in contraceptive delivery. LA ART can leverage LA contraceptive delivery platforms. We speculate that using L ART will increase the demand for LAC among AGYW, using LARCs will increase the demand for L ART among AGYW (advantages will be on both sides), that taking advantage of the LARCs platforms to provide the LART to AGYW will be highly acceptable, feasible, and deliverable to all stakeholders (e.g. the AGYW, the healthcare workers, the management and policy makers).</p>\n<p>\n Study objectives:</p>\n<p>\n 1 (a): To find out more about how the body responds to L AART (Pharmacokinetic (PK) study). This will include assessing the blood levels of the LAART, as well as the blood level of the LARCs and seeing if the two are affecting each other’s blood levels. Low blood levels of any drug in the body that is needed may reduce the effectiveness of the drug. High blood levels that is needed may increase the unexpected medical problems of the drug. Other studies have found that these two are safe when used together, as well as effective. We intend to do this so that AGYW can benefit from both drugs 1 (b): To find out what stakeholders think about the L ART (Qualitative study). This will include what stakeholders think are the strengths and challenges of providing LART to AGWY. For LART to be included for routine use, all stakeholders need to be on board. We hope to provide information for policy makers to use when planning to roll out LART for routine use by AGYW 2 (a): To compare the outcomes of using LART compared to those HIV negative but on contraceptives (comparing the contraceptive drug levels in blood) and those HIV positive but not on hormonal contraceptive (comparing HIV outcomes such as drug adherence, viral loads etc. This is the Hybrid type I effectiveness-implementation trial. 2 (b): To evaluate the impact providing L ART to AGYW: We will assess, after implementing the study, how acceptable and feasible it is providing both drugs. Study site: The proposed study will be conducted in HIV treatment facilities in western Kenya within the regional Moi Teaching and Referral Hospital (MTRH).</p>\n
      • short_titleKuwa Free! - Live free!
      • protocol_noECCT/21/09/01
      • version_no1.0
      • date_of_protocol13-04-2021
      • study_drugInjectable cabotegravir/rilpivirine
      • disease_conditionHIV/AIDS
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameStandard of care, ART that concurrently contains combinations of nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ritonavir, or integrase inhibitors
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresschakieunice@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantEdwin Were
      • declaration_date107-09-2021
      • declaration_principal_investigatorEdwin Were
      • declaration_date207-09-2021
      • placebo_presentNo
      • study_objectives<p>\n Aim 1: To collect foundational data to better inform design of an effectiveness implementation trial.</p>\n<p>\n Aim 1a: To determine if combined cabotegravir/rilpivirine injectable use has bidirectional drug-drug interactions with injectable (depot medroxyprogesterone acetate [DMPA]) or implantable (etonogestrel or levonorgestrel) contraceptives.</p>\n<p>\n Aim 1b: To qualitatively explore points of convergence and divergence, preferences and values, and health systems readiness around wider-scale codelivery of LA ART and contraceptives.</p>\n<p>\n Aim 2: To evaluate the impact of clinic-provided, co-delivery of LA ART and contraceptives among AGYWLHIV.</p>\n<p>\n Aim 2a: To evaluate the impact on effectiveness outcomes of HIV treatment (viral suppression and adherence/persistence) and contraception (uptake and continuation rates).</p>\n<p>\n Aim 2b: To evaluate the impact on implementation outcomes of acceptability, feasibility, and fidelity.</p>\n
      • principal_inclusion_criteria<p>\n PK study: • Female sex, • HIV-positive (for PK groups #1-4 and hybrid trial) or HIV-uninfected (for PK group #5 only), • Age 15-24 years at the time of enrollment, • Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study screening, • Have been on the study oral drug for at least 4 weeks for the PK groups #1-4, • Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively, • Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period • Able to consent or assent (with parental consent) for study participation in English or Kiswahili.</p>\n<p>\n Hybrid trial: • Female sex, • HIV-positive, • Age 15-24 years at the time of enrollment, • Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study screening, • Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period, • Able to consent or assent (with parental consent) for study participation in English or Kiswahili</p>\n
      • principal_exclusion_criteria<p>\n PK study:</p>\n<p>\n • Already be on ART that concurrently contains combinations of nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir • Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively, • Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing, • Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen, • Current or planned concomitant use of other hormonal contraceptives, • Be obese (BMI≥30), • Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded). • Serum ALT>5x ULN at the time of screening, • Serum creatinine >2.5x ULN at the time of screening.</p>\n<p>\n Hybrid trial:</p>\n<p>\n • Already be on ART that concurrently contains combinations of nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir. • Currently pregnant or intends to become pregnant or breastfeeding within the next one year, • Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing, • Use or anticipated use of drugs for the duration of the study period known to interact with the study ART regimen, • Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded). • Serum ALT>5x ULN at the time of screening, • Serum creatinine >2.5x ULN at the time of screening.</p>\n
      • primary_end_points<p>\n The primary endpoint for the PK study is the hormone concentrations at 12 or 24 weeks after hormonal contraception initiation.</p>\n<p>\n The primary endpoint for the hybrid trial is the proportion of participants with viral suppression ( via HIV viral load <40 copies/mL) 48 weeks after study enrollment (primary outcome) in the intervention vs. control arms (primary exposure; Aim 2a).</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImplementation effectiveness
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:153px;\">\n <p>\n NAME  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:184px;\">\n <p>\n ROLE</p>\n </td>\n <td style=\"width:168px;\">\n <p>\n QUALIFICATION                                     </p>\n </td>\n <td style=\"width:133px;\">\n <p>\n START DATE</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Prof. Edwin Were</p>\n </td>\n <td style=\"width:184px;\">\n <p>\n Site Principal Investigator</p>\n </td>\n <td style=\"width:168px;\">\n <p>\n MBChB, MMed, MPH</p>\n </td>\n <td style=\"width:133px;\">\n <p>\n April 2021</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Prof. Rena Patel</p>\n </td>\n <td style=\"width:184px;\">\n <p>\n Study Principal Investigator</p>\n </td>\n <td style=\"width:168px;\">\n <p>\n MD, MPH, MPHIL</p>\n </td>\n <td style=\"width:133px;\">\n <p>\n April 2021</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Dr. Beatrice Jakait</p>\n </td>\n <td style=\"width:184px;\">\n <p>\n Study Pharmacist</p>\n </td>\n <td style=\"width:168px;\">\n <p>\n B Pharm, PharmD,  MSc                     </p>\n </td>\n <td style=\"width:133px;\">\n <p>\n April 2021</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Dr. Edith Apondi</p>\n </td>\n <td style=\"width:184px;\">\n <p>\n Study Clinician  </p>\n </td>\n <td style=\"width:168px;\">\n <p>\n MBChB, MMed,                                     </p>\n </td>\n <td style=\"width:133px;\">\n <p>\n April 2021</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Eunice Kaguiri</p>\n </td>\n <td style=\"width:184px;\">\n <p>\n Study Coordinator</p>\n </td>\n <td style=\"width:168px;\">\n <p>\n BSc, MPH</p>\n </td>\n <td style=\"width:133px;\">\n <p>\n April 2021</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:638px;\">\n <p>\n Other facilities and resources</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n IEC/IRB</p>\n </td>\n <td colspan=\"3\" style=\"width:485px;\">\n <p>\n Moi University/Moi Teaching and Referral Hospital Institutional Research and Ethics Committee (MU/MTRH IREC) has been mandated to review and approve protocols on behalf of the National Council of Science and Technology (the national regulatory authority).</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Study facility &Equipment</p>\n <p>\n  </p>\n </td>\n <td colspan=\"3\" style=\"width:485px;\">\n <p>\n The study offices are located at the Partners House along Lumumba Road. The available space includes Coordinator’s Office, the staff offices, Data room, Counseling/Consenting rooms, and a reception/waiting area. The facility is equipped with reliable internet, desktop & laptop computers, printers, photocopiers, and filing cabinets.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Site Laboratory</p>\n <p>\n  </p>\n </td>\n <td colspan=\"3\" style=\"width:485px;\">\n <p>\n AMPATH Reference Laboratory will provide access to all required laboratory facilities for this study.  The laboratory is staffed by appropriately trained personnel ensuring that IATA regulations for the shipping of biological samples are adhered to.  A Quality Control system is in place that ensures all procedures are performed according to GCLP & GLP standards. The laboratory provides services to the AMPATH program and all clinical trials under Moi University College of Health Sciences.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Study Pharmacy</p>\n </td>\n <td colspan=\"3\" style=\"width:485px;\">\n <p>\n The MUCRC study   pharmacy is located at Chandaria Centre within MTRH. It is well equipped to ensure that all study medications are stored, dispensed and returned in accordance with study requirements.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n MTRH Rafiki Center for Excellence in Adolescent Health</p>\n <p>\n  </p>\n </td>\n <td colspan=\"3\" style=\"width:485px;\">\n <p>\n MTRH Rafiki Center for Excellence in Adolescent Health  is a combined adolescent medicine, adolescent HIV care and research clinic that provides a one stop shop for free reproductive health, mental health, management of chronic diseases, HIV prevention and treatment services, and life skills for adolescents in Eldoret, Kenya.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:153px;\">\n <p>\n Emergency Facilities</p>\n <p>\n  </p>\n </td>\n <td colspan=\"3\" style=\"width:485px;\">\n <p>\n A comprehensive emergency service is accessible at Moi Teaching & Referral Hospital. The hospital has a bed capacity of 1020 specialized beds with an average number of 1300 of inpatients at any time and 1500 outpatients per day. The hospital has doctors specialized in various fields of medicine, pediatrics, obstetrics and gynecology, surgery, psychiatry, critical care and medical research.</p>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n This research is proposed to take place in Kenya for several reasons. First, most AGYW living with HIV reside in resource-limited settings, where the burden of HIV is disproportionately high. Therefore, it is only appropriate to conduct such a study in high HIV-burden settings, such as Kenya or other parts of sub- Saharan Africa. Furthermore, we are conducting this study within a region of Kenya with one of the highest prevalence and burden of pediatric and adult HIV within Kenya. Second, the study is more feasible to conduct in Kenya than, for example, in the US, because both the prevalence of HIV and the lack of viral suppression are more common in Kenya than in the US among AGYW. Third, we are proposing this research in the context of existing research and programmatic work, namely integration of contraception provision within routine HIV care, already underway in Eldoret, Kenya. Therefore, leveraging the considerable resources for the study site to conduct the proposed study is crucial for feasibility. For all these reasons, conducting this research in Kenya is the most appropriate, feasible, and timely way to answer the proposed research questions.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyThe hybrid trial is randomized whereas the PK study is non- randomized
      • design_controlled_comparatorCurrent ART regimen
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMoi Teaching and Referral Hospital
      • single_site_physical_addressNandi Road, Eldoret
      • single_site_contact_personProf. Edwin Were
      • single_site_telephone+254 705756103
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site105 participants in the Pharmacokinetic study (aim 1a) and 550 in the Hybrid trial(aim 2a)
      • total_participants_worldwide105 participants in the Pharmacokinetic study (aim 1a) and 550 in the Hybrid trial(aim 2a)
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specify15-17 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameEdwin
      • investigator1_middle_name
      • investigator1_family_nameWere
      • investigator1_qualificationProfessor
      • investigator1_professional_addressMoi University
      • investigator1_telephone+254 705756103
      • investigator1_emaileowere@gmail.com
      • organisations_transferred_No
      • number_participants105 participants in the Pharmacokinetic study (aim 1a) and 550 in the Hybrid trial(aim 2a)
      • notification
      • approval_date16-09-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-09-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
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      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-11-16 12:52:00
      • created2021-06-30 11:51:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id705
        • application_id1035
        • given_nameRena
        • middle_name
        • family_namePatel
        • qualificationAssistant Professor, Department of Medicine, Division of Allergy and Infectious Diseases
        • professional_addressUniversity of Washington
        • telephone+16503530718
        • emailrcpatel@uw.edu
        • created2021-08-05 11:43:33
        • modified2021-09-07 20:32:58
      • 1(array)
        • id709
        • application_id1035
        • given_nameEdwin
        • middle_name
        • family_nameWere
        • qualificationProfessor
        • professional_addressMoi University
        • telephone+254 705756103
        • emaileowere@gmail.com
        • created2021-08-27 12:14:11
        • modified2021-09-07 20:32:58
    • SiteDetail(array)
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        • created2021-08-05 11:43:33
        • modified2021-09-07 20:32:58
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        • id528
        • application_id1035
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personRena Patel
        • addressUniversity of Washington
        • telephone_number+16503530718
        • fax_number
        • cell_number+16503530718
        • email_addressrcpatel@uw.edu
        • created2021-08-05 11:43:33
        • modified2021-09-07 20:32:58
  • 2(array)
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      • abstract_of_study<div>\n <strong>Title:</strong> Delivery strategies for malaria chemoprevention in the post-discharge management of hospitalised children with severe anaemia or severe malaria: cluster and individually randomised controlled implementation trials with nested economic evaluation in Kenya and Benin.</div>\n<div>\n Short Title: PDMC-Saves Lives (PDMC-SL)</div>\n<div>\n <strong>Background and rationale:</strong> In June 2022, the World Health Organization (WHO) recommended PDMC for the post-discharge management of children with severe anaemia in settings with moderate to high perennial malaria transmission to reduce hospital readmissions and deaths after discharge. However, there is no obvious delivery platform for PDMC, unlike for intermittent preventive treatment in infants (IPTi) or pregnant women (IPTp). Furthermore, a potential limitation of PDMC is adherence to the 3-day dosing regimen, which is provided monthly three times after discharge. Therefore, implementation research is urgently needed to support the introduction and scale-up of PDMC. We propose to conduct two implementation trials to evaluate delivery strategies to optimise adherence to PDMC in different contexts: one in East Africa (Kenya) and one in West Africa (Benin). The actual interventions to be evaluated differ between the two trials as they have been co-designed with national stakeholders during an initial formative research stage, conducted under a separate protocol (LSTM Protocol #23-053, KEMRI-SERU #480/4870).</div>\n<div>\n <strong>Aim:</strong> To conduct implementation trials, co-designed with national stakeholders, to evaluate different delivery strategies to optimise health system delivery of PDMC drugs and adherence to PDMC to provide evidence-based data including acceptability, feasibility and cost-effectiveness that are useful to decision-makers.</div>\n<div>\n Study Type: Kenya: A multi-centre, 2-arm, cluster-randomised trial evaluating two health system delivery strategies and a 3-arm nested individually randomised trial evaluating two new intervention strategies to enhance end-user adherence to PDMC compared to the standard of care without adherence strategies. Benin: A multi-centre, 3-arm, individually randomised trial evaluating two intervention strategies to enhance end-user adherence to PDMC compared to a control arm of PDMC without specific adherence support strategies.</div>\n<div>\n <strong>Sites: </strong>Health facilities with blood transfusion services in malaria-endemic areas in Benin and western Kenya.</div>\n<div>\n <div>\n Study Population:</div>\n <div>\n <strong>Clusters (Kenya only) inclusion criteria:</strong> health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria. Exclusion criteria: primary health facilities without subservient lower-level health facilities. Individuals (Kenya and Benin) inclusion criteria: convalescent children aged <10 years, weighing ≥5 kg admitted with severe anaemia (haemoglobin<5g/dL) or severe malaria; clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL. Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell disease, known hypersensitivity to study drug, known heart conditions, non-resident in the study area, previous participation in the study, known need at enrolment for prohibited medication and scheduled surgery during the 4-month course of the study. HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.</div>\n <div>\n <strong>Study Interventions:</strong></div>\n <div>\n Cluster randomised trial (Kenya only): Hospitals will be randomised to one of two delivery platforms for PDMC (A or B). The choice of the two delivery strategies to be evaluated has been informed by formative research conducted under a separate standalone protocol (LSTM Protocol #23-053, KEMRI-SERU #480/4870) and stakeholder engagements. Strategy A comprises delivery of the initial PDMC course at the primary admitting facility two weeks after discharge during a post-discharge follow-up clinic visit. The subsequent 2 courses will be dispensed monthly at the closest health facility. Strategy B comprises delivery of all 3 PDMC courses at the primary admitting facility two weeks after discharge during a post-discharge follow-up clinic visit.</div>\n <div>\n Individually randomised trial (Kenya and Benin): The final choice of the adherence support strategies to be evaluated has been informed by formative research conducted under the same separate standalone protocol. In Kenya, these include: Arm a - SMS reminders to caregivers, Arm b - Community Health Promoter (CHP) support through monthly home visits and Arm c - no reminders (control). In Benin, these include: Arm a- a telephone reminder to the community health worker (CHW)/qualified community health worker (ASCQ); Arm b - regional social mobilisation research and support officer (CRAMS) reminder through monthly visits to CHW/ASCQ; and Arm c - no reminder (control).</div>\n <div>\n All participating children will receive standard in-hospital care for severe anaemia or severe malaria (blood transfusion, often combined parenteral artesunate, followed by a 3-day course of AL whether they initially had malaria or not), which will be started in-hospital as soon as they are able to take oral medication. Many children are likely to receive parenteral antibiotics as well as part of the standard of care.</div>\n <div>\n <strong>Endpoints:</strong> Cluster randomised trial (Kenya only): The primary endpoint will be the proportion of eligible participants who were not prescribed the full 3 courses of dpoints:PDMC. Individually randomised trial (Kenya and Benin): Primary endpoint: proportion of children with incomplete adherence to the 9 doses of PDMC (three courses of 3-day treatments 3x3=9). Secondary endpoints include 1) clinical effectiveness (all-cause and malaria-specific sick-child clinic visits, all-cause and cause-specific readmissions and all-cause mortality by the end of week 14 after discharge, 2) safety (incidence of serious adverse events), 3) cost-effectiveness, and 4) acceptability and feasibility.</div>\n <div>\n <strong>Follow-up procedures:</strong> Children will be followed for 14 weeks (i.e., four weeks after the last PDMC course) through passive surveillance of clinic visits and hospitalisations. Each child will then be seen for an end-of-study visit towards the end of week 14. Children will also be visited at home for unannounced home visits one to three days from the last day of the last dose of each 3-day course of PDMC medication to assess adherence.</div>\n <div>\n Sample size: Cluster randomised trial (Kenya only): Approximately 60 participants per cluster (cluster size will vary between clusters), or approximately 600 overall (300 in each of the two study arms) is estimated to provide over 80% power to detect a risk difference of 20% from 35% in the control arm to 15% in the intervention clusters (RR=0.43), using a two-sided alpha of 0.05, and assuming an intra-cluster correlation coefficient (ICC) of 0.03, a coefficient of variation of 0.39,15% loss to follow-up and small-sample correction to account for the small number of clusters. Individually randomised trial (Kenya and Benin): A sample size of 147 participants in the control arm (c) and 147 in each of the two intervention arms (a and b), totalling 441 participants, would provide 90% power to detect a 50% reduction in the primary endpoint (proportion of children with incomplete adherence to the 9 doses of PDMC) from 36.8% in the control arm to 18.4% (RR=0.50) in any of the two intervention arms using a 1:1:1 allocation after accounting for the multiple comparisons (α = 0.025). A total of 519 participants (173 per arm) will be recruited to allow for a 15% loss to follow-up.</div>\n <div>\n <strong>Data Analysis:</strong> Risk ratios and corresponding 95% confidence intervals will be computed to compare treatment effects using multi-level mixed models (Kenya) or mixed models (Benin) accounting for clustering effects.</div>\n <div>\n <strong>Partners institutions</strong>: IRCB, Benin; KEMRI Kisumu, Kenya; LSTM, UK; Epicentre, France; IRD, France; Centers for Disease Control and Prevention, US; TRUE, Malawi.</div>\n</div>\n<div>\n  </div>\n
      • study_title<p>\n Delivery strategies for malaria chemoprevention in the post-discharge management of hospitalised children with severe anaemia or severe malaria: cluster and individually randomised controlled implementation trials with nested economic evaluation in Kenya and Benin</p>\n
      • laymans_summary<div>\n <strong>Background:</strong> The World Health Organization (WHO) recommended post-discharge malaria chemoprevention (PDMC) in June 2022 for managing children with severe anaemia in areas with moderate to high perennial malaria transmission. The goal is to reduce hospital readmissions and deaths after discharge. However, there is no clear delivery platform for PDMC, and adherence to the 3-day dosing regimen, provided monthly three times after discharge, is a potential limitation. Implementation research is necessary to support the introduction and scale-up of PDMC.</div>\n<div>\n <strong>Aim: </strong>Implementation trials in Kenya and Benin will be co-designed with national stakeholders to evaluate alternative health system delivery strategies for optimizing delivery of PDMC drugs and adherence to PDMC. The trials will provide evidence on the acceptability, feasibility, and cost-effectiveness of each strategy to inform effective implementation and scale-up of PDMC in different country and health system contexts.</div>\n<div>\n <strong>Methods:</strong> The project involves two separate trials, one in each country. Formative research with the Ministries of Health in the two countries and their stakeholders has informed the delivery strategy interventions selected to be evaluated in each trial. In Kenya, a multi-centre, 2-arm cluster randomised trial will compare two “delivery strategies” for the 3 courses of monthly PDMC with dihydroartemisinin-piperaquine (DP). The trial will randomize 10 hospitals (the clusters) to one of two delivery platforms (A and B) in a 1:1 ratio, with the final choice of intervention informed by formative research. The primary endpoint will be the proportion of eligible participants prescribed with incomplete courses of PDMC. A nested 3-arm individually randomised trial involving 600 children ( 200 per arm) will evaluate 3 different “adherence support” strategies, including SMS reminders to caregivers, Community Health Worker (CHW) support through home visits, and a control arm comprising of provision of all 3 PDMC courses by the hospital where the child was admitted i.e. standard of care. The primary endpoint will be the proportion of children with incomplete adherence (i.e. not receiving all 9 doses of PDMC).</div>\n<div>\n Secondary endpoints include clinical effectiveness, cost-effectiveness, acceptability and feasibility, provision of adherence support mechanisms, and linkage to subsequent levels of service provision along the PDMC delivery continuum. All participating children will receive standard in-hospital care for severe anaemia or severe malaria and a 3-day course of artemether-lumefantrine (AL), started in-hospital as soon as they can take oral medication.</div>\n<div>\n In Benin, a 3-arm individually randomised trial involving 519 children (173 per arm) will be conducted to evaluate different “adherence support” strategies only, including: mobile phone reminders to CHW/ASCQ , monthly reminder visits to CHW/ASCQ by the regional social mobilisation research and support officer (CRAMS), and a control arm without any reminder intervention.</div>\n<div>\n LSTM-UK will act as the legal sponsor of the trials in Kenya. The Institut de Recherche Clinique du Bénin (IRCB) will act as the sponsor for the trial in Benin.</div>\n
      • short_titlePDMC-Saves Lives (PDMC-SL)
      • protocol_noECCT/24/12/01
      • version_no1.3
      • date_of_protocol06-09-2024
      • study_drugDihydroartemisinin-piperaquine
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDihydroartemisinin-piperaquine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressruth.njoroge@ke.lstmed.ac.uk
      • applicant_covering_letter1
      • applicant_protocol1
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      • applicant_approval_letter1
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      • declaration_applicantDr. Ruth Njoroge - Pharmacist
      • declaration_date105-12-2024
      • declaration_principal_investigatorDr. Juliet Otieno Awori - Principal Investigator
      • declaration_date205-12-2024
      • placebo_presentNo
      • study_objectives<div>\n <div>\n <strong>Primary Objectives</strong></div>\n</div>\n<div>\n <strong>1. Cluster RCT of health systems delivery mechanism:</strong></div>\n<div>\n - To determine the effectiveness of different delivery strategies to optimise health system delivery of PDMC</div>\n<div>\n <div>\n <strong>2. Individually RCT of end-user adherence support</strong></div>\n <div>\n - To determine the effectiveness of different adherence support strategies to optimise end-user adherence to PDMC</div>\n <div>\n  </div>\n <div>\n <strong>Secondary Objectives</strong></div>\n</div>\n<div>\n <strong>1. Cluster RCT of health systems delivery mechanism:</strong></div>\n<div>\n - To evaluate the adoption of the health system delivery mechanisms and adherence support mechanisms for the 3 courses of PDMC</div>\n<div>\n <div>\n <strong>2. Individually RCT of end-user adherence support:</strong></div>\n <div>\n To determine the clinical effectiveness of the different PDMC delivery strategies (all-cause and malaria-specific readmissions and sick-child clinic visits, all-cause mortality).</div>\n <div>\n 3. To evaluate the effectiveness of the linkage mechanisms between the various health facility levels along the PDMC delivery continuum</div>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. Aged <10 years of both sexes</div>\n<div>\n 2. Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin <5.0 g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection</div>\n
      • principal_exclusion_criteria<div>\n 1. Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)</div>\n<div>\n 2. Sickle cell anaemia/sickle cell disease</div>\n<div>\n 3. Body weight <5 kg</div>\n
      • primary_end_points<div>\n 1. The proportion of participants receiving an incomplete set of PDMC courses</div>\n<div>\n 2. The proportion of participants with incomplete adherence to the 9 doses of PDMC</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <strong>INVESTIGATORS AND INSTITUTIONS</strong></div>\n<div>\n <strong>Chief Investigators</strong></div>\n<div>\n Dr Jenny Hill, PhD - Liverpool School of Tropical Medicine (LSTM)</div>\n<div>\n Prof Feiko ter Kuile, MD, PhD - KEMRI/CDC and LSTM</div>\n<div>\n <strong>Country Principal Investigator</strong></div>\n<div>\n Dr Juliet Otieno Awori, MBChB, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n <strong>Country Co- Principal Investigator</strong></div>\n<div>\n Dr Simon Kariuki, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n <strong>Co-Investigators</strong></div>\n<div>\n Dr Titus Kwambai, MBChB, PhD - Centers for Disease Control and Prevention, Kenya (CDC-Kenya), KEMRI Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n Dr. Ruth Njoroge, BPharm, Dr Prisca Oria, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n Dr Eve Worrall, PhD, Carole Khairallah, Jenna Hoyt, Dr Tao Chen, MD, MSc, PhD, Amanda McCoy, MSc - Liverpool School of Tropical Medicine (LSTM)</div>\n<div>\n <strong>Collaborators</strong></div>\n<div>\n Dr. Sammy Mahugu, MBChB, MPH,MBA, Ms. Regina Kandie, MSc - Ministry of Health Kenya, National Malaria Control Programe</div>\n<div>\n Dr Valérie Briand, Dr Adrian Luty - Epicentre, Paris, France</div>\n<div>\n Prof Kamija Phiri, MD, PhD; Dr Lucinda Manda-Taylor - Training Research Unit of Excellence, Blantyre, Malawi</div>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration17 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorDiff. delivery strategies
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaHealth facilities with blood transfusion services in malaria-endemic areas in Western Kenya
      • single_site_physical_addressKEMRI-CGHR P.O. Box 1578-40100, Kisumu, Kenya.
      • single_site_contact_personJuliet Otieno Awori
      • single_site_telephone+254721432548
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listKenya\nBenin
      • data_monitoring_committeeYes
      • total_enrolment_per_site600
      • total_participants_worldwide1119
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren aged under 10 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFeiko
      • investigator1_middle_nameter
      • investigator1_family_nameKuile
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
      • investigator1_telephone+254708739228
      • investigator1_emailFeiko.terkuile@lstmed.ac.uk
      • organisations_transferred_No
      • number_participants600
      • notification
      • approval_date16-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-12-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted05-12-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have ben addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-08-06 12:20:54
      • created2024-11-18 15:41:01
      • total_sites1
      • ecitizen_invoice330507
    • InvestigatorContact(array)
      • 0(array)
        • id1202
        • application_id1489
        • given_nameJuliet
        • middle_nameOtieno
        • family_nameAwori
        • qualificationMBChB
        • professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
        • telephone+254721432548
        • emailJuliet.Otieno@lstmed.ac.uk
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
      • 1(array)
        • id1203
        • application_id1489
        • given_nameSimon
        • middle_name
        • family_nameKariuki
        • qualificationPhD
        • professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
        • telephone+254725389246
        • emailskariuki1578@gmail.com
        • created2024-12-05 11:57:10
        • modified2025-02-03 10:22:51
    • SiteDetail(array)
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        • id1825
        • application_id1489
        • county_id(null)
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        • misc(null)
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id795
        • application_id1489
        • sponsorLiverpool School of Tropical Medicine (LSTM
        • sponsor_typeResearch Institution
        • contact_personProf Feiko ter Kuile, MD, PhD
        • addressPembroke Place, Liverpool L3 5QA, UK.
        • telephone_number+44 0151 7053794
        • fax_number
        • cell_number+44 0151 7053794
        • email_addresslstmgov@lstmed.ac.uk
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
  • 3(array)
    • Application(array)
      • id1516
      • user_id667
      • trial_status_id1
      • abstract_of_study<p>\n Many low- and middle-income countries (LMICs) countries are facing a double burden of acute infections (malaria, HIV, TB) and chronic non-communicable diseases (diabetes, hypertension). Rapid diagnostic tests (RDTs) can be used for a range of health conditions outside clinic-based settings, including self-administered testing at home, community health worker-facilitated testing, or testing facilitated by other health workers. When paired with mobile health services and geospatial mapping, testing with RDTs may further improve health outcomes, reduce health care costs, and enhance patient care satisfaction. Several novel RDTs are available for either screening or diagnostic testing, but few studies have evaluated and compared testing strategies for accelerated diagnosis and treatment for infections. Our primary aim is to conduct a randomized controlled trial to evaluate two on-demand testing strategies using RDTs for accelerated linkage to care and treatment. Overall, we expect to demonstrate that on-demand RDT testing with mobile health service linkage through community health workers can increase case identification, accelerate time to care and treatment initiation, and improve health outcomes in resource-limited regions. Results of this study will inform a proposal for a larger randomized clinical trial</p>\n
      • study_title<p>\n Diagnostic Access to Self-Care & Health Services in Low- and Middle-Income Countries (DASH) – Phase II Study</p>\n
      • laymans_summary<p>\n In many low- and middle-income countries, like Kenya, people are struggling with both infectious diseases such as malaria, HIV, and TB, and chronic conditions like diabetes and high blood pressure. Rapid diagnostic tests (RDTs) are simple tests that can quickly identify these diseases and can be used outside hospitals, including at home or by community health workers.This study focuses on how using RDTs, along with mobile health services and mapping technology, can improve health outcomes, reduce costs, and increase patient satisfaction. New types of RDTs are available, but not many studies have compared different ways of using these tests for quick diagnosis and treatment.</p>\n<p>\n The main goal of this research is to test two different strategies using RDTs to see which one helps people get diagnosed and treated faster. By doing this, we hope to show that these tests, combined with mobile health services and support from community health workers, can help more people get the care they need quickly and improve their overall health.</p>\n<p>\n The results of this study will help design a larger trial to further test and refine these strategies.</p>\n
      • short_titleDASH II Study
      • protocol_noECCT/25/02/09
      • version_no1.2
      • date_of_protocol05-09-2024
      • study_drugN/A
      • disease_conditionMalaria, HIV, Diabetes and Hypertension
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameAbbott Ag P.f/Pan Rapid Diagnostic Kit
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@kemri.go.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Greshon Rota
      • declaration_date118-02-2025
      • declaration_principal_investigatorProf Elizabeth Anne Bukusi
      • declaration_date218-02-2025
      • placebo_presentNo
      • study_objectives<p>\n Our long-term objective is to evaluate the best use case scenarios and implementation of community-based rapid testing to enhance testing adoption and case detection, accelerate linkage to care and treatment, and improve overall health outcomes. In this study, our primary objective is to determine if on-demand, home-based rapid diagnostic testing or community health worker (CHW)-facilitated rapid diagnostic testing may improve testing adoption and access to care for select infectious diseases and non-communicable diseases in Kenya, Zambia, and South Africa. This will be completed by conducting a randomized controlled trial to evaluate two testing strategies using RDTs, as compared to the standard of care.</p>\n<p>\n  </p>\n<p>\n The specific aims of this study are the following:</p>\n<p style=\"margin-left:36pt;\">\n ·       <strong>Aim #1 (Primary)</strong> – To evaluate whether on-demand, home-based rapid diagnostic testing or community health worker (CHW)-facilitated rapid diagnostic testing improve testing adoption per event (or indication) for malaria or HIV in Kenya, Zambia, and South Africa.</p>\n<p style=\"margin-left:36pt;\">\n ·       <strong>Aim #2</strong> - To evaluate whether on-demand, home-based rapid testing or community health worker (CHW)-facilitated rapid testing improves the percentage of people or households receiving a test result, improving access to care, or accelerating time to diagnosis/treatment for malaria or HIV in Kenya, Zambia, and South Africa.</p>\n<p style=\"margin-left:36pt;\">\n ·       <strong>Aim #3</strong> – To evaluate whether household screening for hypertension and diabetes with appropriate referral for confirmatory testing and treatment may decrease the median blood pressure (hypertension) or hemoglobin A1c level (diabetes) during a 6-month observational period in Kenya, Zambia, and South Africa.</p>\n
      • principal_inclusion_criteria<p>\n <span lang=\"EN-US\" style=\"color: rgb(0, 0, 0); font-size: 11pt; font-family: Arial, sans-serif;\">The study team will visit each of these priority houses to determine if the household is eligible and willing to participate in the study. If the household is available, eligible, or willing to participate, the study team will offer study participation. Households will be considered enrolled after at least one member of a household has provided written, informed consent</span></p>\n
      • principal_exclusion_criteria<p>\n <span lang=\"EN-US\" style=\"color: rgb(0, 0, 0); font-size: 11pt; font-family: Arial, sans-serif;\">If the household is not available, ineligible, or not  willing to participate, the study team will choose the next house within the designated cluster to offer study participation. </span></p>\n
      • primary_end_points<p>\n <strong>Primary Outcomes (Testing Adoption) for Priority Conditions</strong>:</p>\n<p style=\"margin-left:21.25pt;\">\n ·    <strong><em>Malaria:</em></strong>  Participant self-report of testing for malaria (measured as ever tested between baseline and exit).</p>\n<p style=\"margin-left:21.25pt;\">\n ·    <strong><em>HIV:</em></strong>  Participant self-report of testing for HIV (measured as ever tested after baseline).</p>\n<p>\n <strong><em>Composite:</em></strong>  Participant self-report of testing for malaria or HIV (measured as ever tested after baseline).</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifySelf test
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>PERSONNEL</strong></p>\n<p>\n <strong>Site Principal Investigator: Professor Elizabeth Bukusi. </strong>As the Site Principal Investigator of this study, Prof Bukusi’s role will be oversight of research development and implementation in Kenya. She will facilitate collaboration between UW, HSRC, Akros, Audere and KEMRI, serve on the Scientific Steering Committee with the MPI’s, oversee all phases of study development and implementation in the field, and assure for feasibility and cultural appropriateness of study procedures and materials. She will be the chief liaison with the local HIV implementing partners, local government, and KEMRI leadership</p>\n<p>\n <strong>Co-Investigator: Norton Sang.</strong></p>\n<p>\n He will be responsible for overseeing the day-to-day study activities, managing the study staff, tracking study progress, and will communicate closely with the KEMRI investigators and MPIs. He will be responsible for facilitating study training, managing the local regulatory submissions, and ensuring for protocol compliance</p>\n<p style=\"margin-left:2.15pt;\">\n <strong>Co-Investigator: Dr. Zachary Kwena</strong></p>\n<p style=\"margin-left:2.15pt;\">\n He will lead and supervise implementation of qualitative activities including focus group and individual interview guide development, conduct, coding/analysis, integration into intervention refinement and results dissemination.</p>\n<p>\n <strong>Finance Manager: Kevin Okoth. </strong>The Finance Manager at 5% effort is based in Nairobi. He will be instrumental in budget management, fast tracking of project payments to suppliers, and facilitating staff contracts and subcontracts. He will be key in processing invoices and cash transfer requests to the donor. He will also provide overall supervision to the study administrator and support on all financial matters related to the project.</p>\n<p>\n <strong>Study Coordinator; Felix Okoth. </strong>He will be responsible for overseeing the day-to-day study activities, managing the study staff, and reporting to the PIs on the study progress. He will supervise the Assistant Coordinator and study team. He will conduct site level visits to assess, for, mentor, and consistently ensure for protocol and standard operating procedure compliance. He will be responsible for managing study human resource needs, facilitating study training, and managing the local regulatory submissions and reporting.  He will be in frequent communication with the local PIs and work closely the non-Kenyan -based investigator team, project coordinator, local data manager, and local administrator to ensure for smooth and compliant study operations. He will work closely with the co-investigator, Dr. Kwena, to carry out the qualitative research activities including workplan development, FGD and interview organization and facilitation, and support transcript coding.</p>\n<p>\n <strong>Assistant Study Coordinator;</strong> <strong>TBD. </strong>He/She will report to the study coordinator and be responsible for supervising study activities at the three clinic sites. She will provide key support to study implementation. She will mentor study staff on recruitment, screening, informed consent, enrollment, data collection and patient follow up. She will generate study reports to facilitate daily tracing and study management, provide written reports on site progress and performance as may be required. She will help train and support Research Assistants on study protocol and standard operating procedure compliance.</p>\n<p>\n <strong>Data Manager/Analyst; (TBD) </strong>The Data Manager/Analyst will manage the local data system, ensure data is transmitted securely and efficiently to the central server ensure for high quality study data and develop and generate preliminary findings for review. He/she will spear head preparation of standard operating procedures for data management, including quality control procedures and verification processes, and prepare data source documentation. He/she will program and test study surveys, train the study team on data entry procedures, troubleshoot data issues that may arise, respond to data queries, and generate routine data reports. He/she will report to the local PIs, supervise the Assistant Data Manager, work closely with the Programmer and ICT Officer, coordinators and the US Analyst.</p>\n<p>\n <strong>Assistant Data Manager; (TBD). </strong>The Assistant Data Manager will assist the Data Manager in preparation of standard operating procedures for data management, including quality control procedures to review source documentation for completion, respond to data queries and quality control reports, and ensure overall high-quality data at the site.</p>\n<p>\n <strong>Driver (TBN) </strong>Responsible for the project vehicle and driving of project staff and participants as required. He will be based in Kisumu. The driver will also double up as a cleaner/messenger at the study office. He will report to the administrator.</p>\n<p>\n <strong>ICT Officer; (TBN) </strong>The IT support will work in tandem with the programmer to network, test, monitor, and maintain the study data system. He/she will provide support to the programmer and end users on system utilization, as well as troubleshoot and resolve data issues that may arise. He/she will also help develop and maintain IT documentat</p>\n
      • other_details_explanation<p style=\"margin-left:21.6pt;\">\n 1        <strong>Migori County</strong><strong>, Kenya.  </strong>Migori County is in southwestern Kenya and borders Lake Victoria and Tanzania. The multi-ethnic province has a population of about 5.5 million, mostly living in rural areas. The province faces high burdens of HIV, malaria, early pregnancy, and a growing burden of type II diabetes and hypertension.</p>\n<p style=\"margin-left:21.6pt;\">\n 2        <strong>KwaZulu-Natal Province, South Africa.  </strong>The study will take place around the Greater Edendale and Vulindlela area, KwaZulu-Natal, South Africa. The Greater Edendale and Vulindlela area includes rural and peri-urban areas and has a population of approximately 600,000 predominantly isiZulu-speaking people. Primary healthcare clinics (PHCs), Community Healthcare Centers (CHCs), and public hospitals in the area care for the community’s healthcare needs. The community has a high burden of HIV, STIs, early pregnancy, and type II diabetes.</p>\n<p style=\"margin-left:21.6pt;\">\n 3        <strong>Copperbelt Province, Zambia.  </strong>In Zambia, roughly half of the population resides along the main transport corridors between the urban centers of Lusaka and the Copperbelt Province in the north. Zambia faces a high burden of HIV/AIDS and malaria, both of which are leading causes of hospitalization and death, as well as chronic NCDs. There are roughly 2,800 healthcare facilities in Zambia, and CHWs and a network of Community Health Assistants (CHAs) provide much of the delivery of care and treatment in more rural areas.</p>\n<p style=\"margin-left:18pt;\">\n  </p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n NACOSTI 20TH Sept 2024</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration18 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyThe study design will be a three-arm household-randomized controlled implementation trial (RCT) comparing two community-based intervention strategies for rapid diagnostic screening or testing, as compared to passive standard-of-care clinic-based screening
      • design_controlled_comparatorThe study design will be
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMigori County
      • single_site_physical_addressMigori County Hospital
      • single_site_contact_personNorton Sang
      • single_site_telephone+254 715778930
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites
      • multi_country_listKenya, Zambia and South Africa
      • data_monitoring_committeeNo
      • total_enrolment_per_site750 participants
      • total_participants_worldwidethe study will include ~2,250 people.
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_name
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics) Senior Principal Clinical Research Scientist CMR-KEMRI Co-Director, Research Care Training Program (RCTP)
      • investigator1_professional_addressKEMRI-RCTP, KEMRI CIS Building, Lumumba Sub-County Hospital, Along Ondiek Highway, P.O Box 614-40100, Kisumu, Kenya
      • investigator1_telephone0733617503
      • investigator1_emailebukusi@kemri.go.ke
      • organisations_transferred_No
      • number_participants750 participants
      • notification
      • approval_date23-05-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-04-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted18-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-06-16 07:37:55
      • created2025-02-18 10:18:15
      • total_sites1
      • ecitizen_invoice356772
    • InvestigatorContact(array)
      • 0(array)
        • id1230
        • application_id1516
        • given_nameELIZABETH
        • middle_nameANNE
        • family_nameBUKUSI
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics) Senior Principal Clinical Research Scientist CMR-KEMRI Co-Director, Research Care Training Program (RCTP)
        • professional_addressKEMRI-RCTP, KEMRI CIS Building, Lumumba Sub-County Hospital, Along Ondiek Highway, P.O Box 614-40100, Kisumu, Kenya
        • telephone0733617503
        • emailebukusi@kemri.go.ke
        • created2025-02-18 10:18:15
        • modified2025-04-22 17:57:13
    • SiteDetail(array)
      • 0(array)
        • id1844
        • application_id1516
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
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        • misc(null)
        • created2025-02-18 11:12:32
        • modified2025-04-22 17:57:13
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id809
        • application_id1516
        • sponsorMelinda and Gates Foundation
        • sponsor_typeIndustry
        • contact_person
        • address500 Fifth Avenue North Seattle, WA 98109 USA
        • telephone_number+1 206-709-3100
        • fax_number
        • cell_number+1 206-709-3400
        • email_addressmedia@gatesfoundation.org
        • created2025-02-18 11:12:32
        • modified2025-04-22 17:57:13
  • 4(array)
    • Application(array)
      • id1239
      • user_id32
      • trial_status_id6
      • abstract_of_study<div>\n <p>\n <em>Title: </em>Dihydroartemisinin-piperaquine and azithromycin for the post-discharge management of children with severe anaemia in Malawi, Kenya and Uganda; A multicentre, parallel-group, two-arm, randomised, double-blind superiority trial</p>\n <p>\n <em>Short Title: </em>Post-discharge Malaria Chemoprevention - II (PDMC-II) study</p>\n <p>\n <em>Background and rationale:</em> Severe anaemia is associated with significant post-discharge morbidity and mortality in children in malaria-endemic Africa. A recent trial in areas with moderate to intense malaria transmission in Kenya and Uganda showed that three months of post-discharge malaria chemoprevention (PDMC) with monthly dihydroartemisinin-piperaquine (DP) in recently transfused children with severe anaemia prevented 35% of deaths or all-cause readmissions by six months post-discharge. The protective effect was restricted to the 3-month PDMC intervention period. PDMC-DP did not affect non-malarial causes of readmissions; 45% and 80% of the remaining readmissions and sick-child clinic visits (SCCV) were due to other causes. We hypothesise that the beneficial effect of PDMC can be boosted further by combining DP with azithromycin (AZ), a potent broad-spectrum antibiotic known to reduce all-cause mortality in African children.</p>\n <p>\n <em>Primary efficacy objective: </em>To determine if PDMC with four courses of monthly AZ treatment courses (given monthly) in combination with four months of weekly DP is superior to PDMC with weekly DP-alone in reducing non-malaria SCCV by six months post-discharge in children aged <5 years admitted with severe anaemia (Hb<5g/dl) who are ready to be discharged and are clinically stable and able to switch to oral medication.</p>\n <p>\n <em>Hypothesis: </em>An addition of four monthly AZ courses to a four months of malaria chemoprevention with weekly treatment courses with DP provided during the post-discharge period to children recently admitted with severe anaemia is superior to reduce all-cause sick-child visits rates by 6 months compared to a placebo (AZ-placebo).</p>\n <p>\n <em>Study Type: </em>Multi-centre, 2-arm, placebo-controlled, individually randomized, trial of 4 courses of monthly AZ added to PDMC-DP in Malawi, Uganda and Kenya, using randomisation stratified by age and study centre.</p>\n <p>\n <em>Sites: </em>6 hospitals, 2 in Malawi, 2 in western Kenya and 2 in Uganda, in areas with moderate to intense malaria transmission. The number of hospitals will be expanded during recruitment if so required.</p>\n <p>\n <em>Study Population:</em> Inclusion criteria: convalescent children aged less than 5 years and weighing ≥5 kg admitted with severe anaemia (haemoglobin<5g/dL or Ht<15%); clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL. Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell disease, known hypersensitivity to study medication, known heart conditions, non-resident in study area, previous participation in study, known need at enrolment for prohibited medication (including cotrimoxazole prophylaxis) and scheduled surgery during the 6-month course of the study.</p>\n <p>\n <em>Study Interventions:</em> Children in both arms will receive standard in-hospital care for severe anaemia (blood transfusion, often combined with quinine or artesunate IV/IM). All children will then receive a 3-day course of DP (whether they initially had malaria or not), which will be started in-hospital as soon as they are able to take oral medication, and will be completed at home after discharge. They will further take weekly doses of DP for 16 weeks (approximately 4 months). At 1 week after enrolment surviving children will be randomized to receive either a standard 3-day courses of AZ 10mg/kg body weight (Fosun Pharmaceuticals, China) or an identical placebo regimen at 1, 5, 9 and 13 weeks after enrolment.</p>\n <p>\n <em>Outcome Measures: </em>Primary: Non-malaria sick-clinic visits (SCCV) by 6 months from randomization. Key secondary: 1) all-cause SCCV, 2) readmissions due to non-severe anaemia or non-severe malaria, 3) readmissions due to severe anaemia (requiring a blood transfusion), 4) all-cause hospital readmission, 5) All-cause mortality.</p>\n <p>\n <em>Follow-up procedures: </em>Children will be followed for 6 months by passive case detection in 3 phases: Pre-intervention (1 week between discharge and randomisation); Intervention (1-17 weeks post-discharge); post-intervention (extended follow-up period from 18 to 26 weeks post-discharge).</p>\n <p>\n <em>Sample size: </em>958 participants (479 per arm) to allow the detection of ≥25% reduction in the incidence of all-cause SCCV from 147 to 110 per 100 child years, allowing for 15% loss to follow-up (power 90%, α=0.05). There will be one interim analysis half-way the study.</p>\n <p>\n <em>Data Analysis:</em> Primary analysis will be by intention to treat. Incidence rates will be calculated and rate ratios estimated using Poisson regression, stratified by country, with treatment (as randomised) as the only co-variate. One interim analysis is planned. A Lan-DeMets α spending function with O’Brien-Fleming type of boundaries will be used to preserve the overall type I error rate (α=0.05). To assess how long any initial beneficial effect of the intervention is sustained, the observation time will also be divided into a) PDMC period (1-16 weeks); and b) Extended follow-up period (17-26 weeks post-discharge).</p>\n <p>\n <em>Partners institutions: </em>Training and Research Unit of Excellence; University of Bergen; Makerere University; Global Health, Uganda; KEMRI-CDC, Kenya; Indiana University; Liverpool School of Tropical Medicine; University of Amsterdam; US Centers for Disease Control and Prevention, Kenya.</p>\n</div>\n
      • study_title<p>\n Dihydroartemisinin-piperaquine and azithromycin for the post-discharge management of children with severe anaemia in Malawi, Kenya and Uganda; A, multicentre, parallel-group, two-arm, randomised, double-blind superiority trial.</p>\n
      • laymans_summary<p>\n Severe anaemia is associated with many under five-year-old children being unwell and some resulting in deaths after hospital discharge, especially in malaria-prone areas. Previous studies have shown that providing three months of long-acting antimalarial dihydroartemisinin-piperaquine (DP) treatment among children recently blood transfused prevented 35% of deaths and reduced hospital readmissions by six months. However, this benefit did not stop other non-malarial causes of readmissions among these children. In this study, we want to combine DP with a wide-spectrum antibiotic, azithromycin (AZ), and we expect this will reduce non-malarial causes of readmissions. There will be two groups, Group 1 will receive azithromycin (3 days each month) for four months and weekly DP for 16 weeks, while Group 2 will receive azithromycin placebo (3 days each month) for four months and weekly DP for 16 weeks. The assignment to either group will be decided by chance (random). The azithromycin placebo is an inactive substance that looks like the azithromycin drug. Only children who are under 5 years old, admitted with severe anaemia and who are able to take oral medication will be eligible to join this study. The study is being done in Kenya, Uganda, and Malawi and will enrol 958 participants in total, who will be followed for 26 weeks after enrolment. Written informed consent will be sought before enrolment in the study. Within the 26-week period, we will collect biological samples and conduct ECGs. Participants will also be regularly monitored free of charge, improving the likelihood that any malaria infection or anaemia will be detected and treated. The study is designed to generate the information required to assess whether long-acting DP and AZ should be recommended as a cost-effective strategy for the post-discharge management of children with severe anaemia in malaria-endemic areas. It is anticipated the trial results will increase the effectiveness of the management of severely ill children and reduce the health care costs associated with high readmission rates post-discharge, thereby also reducing associated costs to poor households.</p>\n
      • short_titlePDMC-II
      • protocol_noECCT/23/03/06
      • version_no1
      • date_of_protocol08-12-2022
      • study_drugDihydroartemisinin-piperaquine plus azithromycin/azithromycin placebo
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDihydroartemisinin-piperaquine plus azithromycin/azithromycin placebo
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressruthwambuinjoroge1@gmail.com
      • applicant_covering_letter1
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      • declaration_applicantDr Ruth Njoroge - Pharmacist
      • declaration_date120-03-2023
      • declaration_principal_investigatorDr Simon Kariuki - Principal Investigator
      • declaration_date220-03-2023
      • placebo_presentYes
      • study_objectives<h2>\n <span style=\"font-size:16px;\">Objectives</span></h2>\n<h2>\n <span style=\"font-size:16px;\">Primary objective</span></h2>\n<p>\n To determine if PDMC with four courses of monthly AZ treatment in combination with four months of weekly DP is superior to PDMC with weekly DP-alone in reducing non-malaria SCCV by six months post-discharge in children aged <5 years admitted with severe anaemia (Hb<5g/dl) who are ready to be discharged and are clinically stable and able to switch to oral medication.</p>\n<p>\n <span style=\"font-size:16px;\"><strong>Secondary objectives</strong></span></p>\n<p style=\"margin-left:36.0pt;\">\n a)       To determine the cost-effectiveness of PDMC DP+AZ compared to PDMC DP-alone.</p>\n<p style=\"margin-left:36.0pt;\">\n b)      To assess cardiotoxicity with the combined administration of piperaquine and AZ as part of PDMC.</p>\n<p style=\"margin-left:36.0pt;\">\n c)       To monitor the development of macrolide-resistant <em>Streptococcus pneumoniae</em> and the enrichment of resistant organisms in the gut microbiome.</p>\n
      • principal_inclusion_criteria<div>\n Pre-study screening</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Haemoglobin <5.0 g/dl or PCV < 15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Aged less than 59.8 months</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Body weight ≥5 kg</div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>Resident in catchment area</div>\n<div>\n Enrolment in study(t=0)</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Fulfilled the pre-study screening eligibility criteria</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Aged < 59.8 months</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Clinically stable, able to take oral medication </div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>participant completed blood transfusion(s) or became clinically stable without transfusion</div>\n<div>\n 5.<span style=\"white-space:pre\"> </span>Able to feed (for breastfeeding children) or eat (for older children) </div>\n<div>\n 6.<span style=\"white-space:pre\"> </span>Absence of known cardiac problems</div>\n<div>\n 7.<span style=\"white-space:pre\"> </span>Provision of informed consent by parent or guardian</div>\n<div>\n Randomisation (t=1 weeks)</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Fulfilled enrolment eligibility criteria and was enrolled during recent admission</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Aged <60 months</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Still clinically stable, able to take oral medication, able to feed (for breastfeeding children) or eat (for older children) and able to sit unaided (for older children who were already able to do so prior to hospitalisation)</div>\n<div>\n  </div>\n
      • principal_exclusion_criteria<div>\n Pre-study screening</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Known sickle cell disease.</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Anticipated to reach the 5th birthday (60 months of age) within 1 week from enrolment (i.e. prior to randomization)</div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>Child will reside for more than 25% of the 6 months study period (i.e. 6 weeks or more) outside of catchment area</div>\n<div>\n Enrolment in study (t=0)</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Previous enrolment in the present study</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Known hypersensitivity to study medication</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Known sickle cell disease</div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>Use or known need at the time of enrolment for concomitant prohibited medication (see section 8.5.7.2, page 35) during the 17 weeks intervention period (see section 8.5.7.2, page 35) </div>\n<div>\n 5.<span style=\"white-space:pre\"> </span>Ongoing or planned participation in another clinical trial involving ongoing or scheduled treatment with prohibited medicinal products or active follow-up during the course of the study (6 months from enrolment)</div>\n<div>\n 6.<span style=\"white-space:pre\"> </span>A known need at the time of enrolment for scheduled surgery during the subsequent course of the study (6 months from enrolment)</div>\n<div>\n 7.<span style=\"white-space:pre\"> </span>Suspected non-compliance with the follow-up schedule</div>\n<div>\n 8.<span style=\"white-space:pre\"> </span>Known heart conditions, or family history of congenital prolongation of the QTc interval.</div>\n<div>\n 9.<span style=\"white-space:pre\"> </span>Taking medicinal products that are known to prolong the QTc interval</div>\n<div>\n Randomisation (t=1 weeks)</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>Used AZ since enrolment</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Use or known need at the time of randomisation for concomitant prohibited medication (see section 8.5.7.2, page 35) during the 17 weeks PMC treatment period (see section 8.5.7.2, page 35). </div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Enrolled, or known agreement to enrol into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months from enrolment)</div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>A known need at the time of randomisation for scheduled surgery during the subsequent course of the study (6 months from enrolment)</div>\n<div>\n 5.<span style=\"white-space:pre\"> </span>Suspected non-compliance with the follow-up schedule</div>\n<div>\n 6.<span style=\"white-space:pre\"> </span>Withdrawal of consent since enrolment</div>\n<div>\n  </div>\n
      • primary_end_points<p>\n Non-malaria sick-child clinic visits (SCCV) by 26 weeks from randomization </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
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      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study will be conducted in Kisumu and Busia for a start and later expand to Siaya county. Each of these towns has a county paediatric ward on which this study will be based, and the adjacent facilities will act as satellite sites for recruitment and referral.</p>\n<p>\n  </p>\n<p>\n The key study staff will include the following:</p>\n<ul>\n <li>\n Chief Investigator – Prof Kamija S. Phiri, PhD</li>\n</ul>\n<p>\n •                    Co-PI - Prof Feiko ter Kuile, PhD</p>\n<p>\n •                    Co-PI - Dr Simon Kariuki, PhD</p>\n<p>\n •                    CO-Investigator-Dr Titus Kwambai, MD, PhD</p>\n<p>\n •                    Study Pediatrician Officer - Dr Martina Oneko, MD, MMed</p>\n<p>\n •                    Pharmacist - Dr Ruth Njoroge, BPharm</p>\n<p>\n  </p>\n<p>\n Additionally, each of the sites will have the following personnel:</p>\n<p>\n ·       Clinical Officers - 2</p>\n<p>\n ·       Lab Technicians/ Phlebotomist -1</p>\n<p>\n ·       Field workers- 2</p>\n<p>\n ·       Data Officers -1</p>\n<p>\n ·       QA/QC officers -1</p>\n<p>\n  </p>\n<p>\n Site capacity</p>\n<p>\n All three sites have the requisite capacity to conduct clinical trials. In addition, these sites are also KEMRI/CDC research sites in which we have invested in capacity development, infrastructure and have existing Memorandum of Understanding (MoUs) over the years.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration4 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorAzithromycin placebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaJaramogi Oginga Odinga Teaching and Referral Hospital
      • single_site_physical_addressKisumu-Kakamega Road, Kisumu
      • single_site_contact_personDr. Titus Kwambai
      • single_site_telephone0722207281
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites
      • multi_country_listKenya\nUganda\nMalawi
      • data_monitoring_committeeYes
      • total_enrolment_per_site958
      • total_participants_worldwide958
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren blow 60 months of age
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFeiko
      • investigator1_middle_name
      • investigator1_family_nameter Kuile
      • investigator1_qualificationMD,PhD
      • investigator1_professional_addressP.O. Box 1578, Kisumu, 40100
      • investigator1_telephone+254 708 739 228
      • investigator1_emailfeiko.terkuile@lstmed.ac.uk
      • organisations_transferred_No
      • number_participants958
      • notification
      • approval_date16-08-2023
      • submitted1
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      • deleted_date(null)
      • deactivated0
      • date_submitted20-03-2023
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      • initial_date_submitted(null)
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      • approved2
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      • final_date(null)
      • modified2025-06-19 14:24:19
      • created2023-03-17 09:26:32
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      • ecitizen_invoice(null)
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        • id912
        • application_id1239
        • given_nameSimon
        • middle_name
        • family_nameKariuki
        • qualificationPhD
        • professional_addressP.O. Box 1578, Kisumu, 40100
        • telephone+ 254 725 389 246
        • emailskariuki1578@gmail.com
        • created2023-03-17 10:29:25
        • modified2023-03-20 12:03:07
      • 1(array)
        • id913
        • application_id1239
        • given_nameTitus
        • middle_name
        • family_nameKwambai
        • qualificationMD, PhD
        • professional_addressCenters for Disease Control and Prevention Kenya Malaria Program
        • telephone+254 722207281
        • emailqbb5@cdc.gov
        • created2023-03-17 13:09:37
        • modified2023-03-20 12:03:07
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        • application_id1239
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        • created2023-03-17 10:29:25
        • modified2023-03-20 12:03:07
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      • 0(array)
        • id650
        • application_id1239
        • sponsorTraining and Research Unit of Excellence (TRUE)
        • sponsor_typeResearch Institution
        • contact_person
        • addressP.O. Box 30538, Blantyre, Malawi
        • telephone_number+265 881222672
        • fax_number
        • cell_number+265 881222672
        • email_addresstrue@true.mw
        • created2023-03-17 10:29:25
        • modified2023-03-20 12:03:07
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  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php