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      • id1359
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      • abstract_of_study<p>\n Respiratory syncytial virus (RSV) is the most important cause of severe acute lower respiratory illness in infants and children and the most common cause of severe pneumonia requiring hospital admission in children worldwide. According to global estimates, RSV caused approximately 33 million cases of lower respiratory illness and approximately 118,000 deaths in children < 5 years of age in 2015.Infants and young children are at increased risk for RSV infections because of their maturing immune system and lack of prior exposure to RSV.</p>\n<p>\n A genetically stable live-attenuated RSV ΔNS2/Δ1313/I1314L vaccine has been shown to be safe and immunogenic in RSV-seronegative children in Phase I studies with further research ongoing in RSV-seropositive children. Sanofi is conducting clinical studies with a similar RSV ΔNS2/Δ1313/I1314L vaccine, referred to as RSVt vaccine, as part of the Phase III development of the RSVt vaccine (the VAD00004 study).</p>\n<p>\n The VAD00004 study, is a Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers. The study is designed to evaluate the efficacy, immunogenicity, and safety of RSVt vaccine administered by intranasal route and compared to placebo.</p>\n<p>\n Overall, a global sample size of approximately 6300 participants 6 months to < 22 months of age will be enrolled in the study. Kenya site will enroll approximately 1500 participants. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo.Study duration will be 24months for each participant. The safety evaluation will start after the first vaccination and up to the end of the study. The trial will target recruitment of people from different races and ethnic groups that at a minimum will be representative of the countries in which the trial will be conducted.</p>\n
      • study_title<p>\n Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)</p>\n
      • laymans_summary<p>\n <strong>Respiratory Syncytial Virus (RSV)</strong> is a contagious virus (germ) that circulates particularly during the winter months and throughout the year in some parts of the world. It is transmitted through droplets containing the virus when someone infected sneezes or coughs. In most infants, the RSV infection will be a mild illness similar to a cold, with symptoms such as fever, runny nose, sore throat, ear infection, cough, and croup (barky cough with hoarseness). In some cases, RSV can cause serious lung illnesses such as pneumonia and bronchiolitis (an infection of small airways in the lung called bronchioles), which may lead to hospitalization. At this time, there is no approved vaccine to prevent RSV illness.</p>\n<p>\n Sanofi Pasteur is developing a vaccine called the RSVt vaccine. The study is called VAD00004 and is a Phase III trial, with two study arms, multiple research sites in multiple countries. in Kenya there are a total of 7 sites. It will be conducted in infants and toddlers 6 months to less than 22 months of age to evaluate if the vaccine works, how safe it is and how the human body responds to protect itself following vaccination of 2 intranasal spray of RSVt vaccine. The trial is designed to demonstrate how the vaccine works in preventing the occurrence of respiratory syncytial Virus.</p>\n<p>\n The investigational RSVt vaccine in this study contains a live, weakened form of the virus (that is, attenuated) and is given as a nasal spray. It is made to help a person’s body respond in a way that will protect them from getting sick from the virus. The vaccine has been tested in humans before, and other live attenuated RSV vaccines very similar to this one has also been tested in both adults and children.</p>\n<p>\n A total of 6300 children are planned to be enrolled worldwide. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations 56 days apart of either the RSVt vaccine or placebo at day 1 and day 57 of the study. Additional illness visits may occur during the study for those who develops RSV like symptoms. Each participant will be followed for 24 months in the study. It is anticipated that approximately 1500 participants could be enrolled by local sites in Kenya.</p>\n<p>\n The trial will target recruitment of people from different races and ethnic groups that at a minimum will be representative of the countries in which the trial will be conducted.</p>\n
      • short_titlePEARL RSVt Vaccine Study
      • protocol_noECCT/23/12/02
      • version_noVersion 2.0
      • date_of_protocol30-06-2023
      • study_drugRSVt_Dr. Maricianah Onono
      • disease_conditionRespiratory syncytial virus (RSV)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
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      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countriesn/a
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
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      • declaration_applicantMillicent Aketch
      • declaration_date108-12-2023
      • declaration_principal_investigatorDr Fredrick Sawe
      • declaration_date208-12-2023
      • placebo_presentYes
      • study_objectives<p>\n <strong>Primary Objective Efficacy</strong></p>\n<p>\n 1. To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after 2 doses, over RSV Season 1.</p>\n<p>\n <strong> Secondary Objective </strong></p>\n<p>\n <strong>Efficacy</strong></p>\n<p>\n 1. To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV URTD after2 doses over RSV Season† 1</p>\n<p>\n 2. To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV associated with the occurrence of LRTD, leading to hospitObjectives Endpoints</p>\n<p>\n 3. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV severe LRTD after 2 doses over RSV Season 1</p>\n<p>\n 4. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after 2 doses over RSV Season 1, necessitating urgent care 5. To describe the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV ARD after 2 doses over RSV Season 1</p>\n<p>\n 6. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 1, leading to hospitalization</p>\n<p>\n 7. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 1, necessitating urgent care 8. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD, by RSV strain after 2 doses over RSV Season 1</p>\n<p>\n 9. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV URTD, by RSV strain after 2 doses over RSV Season 1</p>\n<p>\n 10. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD, by RSV strain after 2 doses over RSV Season 1 11. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after at least one dose, over RSV Season 1</p>\n<p>\n 12. To describe the clinical efficacy of RSVt vaccine for the Pharmaceutical form Route of administration Composition, apart from active substance(s) Is it otherwise identical to the INDP? If not, specify major ingredients 1 Liquid for nasal spray Intranasal Histidine-based formulation buffer (including monosodium glutamate, sodium chloride and L-histidine) Yes prevention of RT-PCR confirmed RSV URTD after at least one dose, over RSV Season 1</p>\n<p>\n 13. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after at least one dose, over RSV Season 1</p>\n<p>\n 14. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after 2 doses over RSV Season 2</p>\n<p>\n 15. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV URTD after 2 doses over RSV Season 2</p>\n<p>\n 16. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 2</p>\n<p>\n <strong>Safety</strong></p>\n<p>\n 17. To describe the safety profile of the RSVt vaccine</p>\n<p>\n <strong>Immunogenicity</strong></p>\n<p>\n 18. To describe the RSV A and B serum neutralizing and RSV serum anti-F IgA and IgG antibody responses to the study intervention</p>\n<p>\n <strong>Exploratory Efficacy Efficacy</strong></p>\n<p>\n 1. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV URTD after 2 doses over RSV Season 1, leading to outpatient medical care, urgent care, or hospitalization.</p>\n<p>\n 2. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV URTD after 2 doses over RSV Season 1, leading to outpatient medical care</p>\n<p>\n 3. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 1, leading to outpatient medical care</p>\n<p>\n 4. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after 2 doses over RSV Season 2, leading to hospitalization 5. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV severe LRTD after 2 doses over RSV Season 2</p>\n<p>\n 6. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 2, leading to hospitalization</p>\n<p>\n 7. To describe the clinical efficacy of RSVt vaccine for the prevention of all-cause acute otitis media (AOM) after 2 doses over RSV Season 1 and Season 2.</p>\n<p>\n <strong>Long-Term Immunogenicity</strong></p>\n<p>\n 8. To describe the RSV A and B serum neutralizing and RSV serum anti-F IgA and IgG antibody responses to the study intervention at 3 months, 6 months, 1 year and 1.5 years after dose 2</p>\n<p>\n <strong>Immunogenicity</strong></p>\n<p>\n 9. To estimate an immunological correlate of protection against RT-PCR confirmed RSV LRTD</p>\n<p>\n <strong>Safety</strong></p>\n<p>\n 10. To assess the evidence of vaccine-enhanced RSV disease upon natural infection during both RSV Season 1 and RSV Season 2 10. Presence of Grade 1, 2, and 3 LRTD or ARD episodes (during both RSV Season 1 and RSV Season 2) associated with any RT-PCR confirmed RSV strain Other</p>\n<p>\n 11. To describe in each study intervention group the following events that are associated with cases of RT-PCR confirmed RSV ARD, associated with any RSV strain, over Season</p>\n<p>\n 1: â–ª recurrent wheezing</p>\n<p>\n â–ª pneumonia</p>\n<p>\n â–ª bronchiolitis</p>\n<p>\n â–ª AOM</p>\n<p>\n â–ª febrile illness </p>\n
      • principal_inclusion_criteria<p>\n <strong>Inclusion Criteria </strong></p>\n<p>\n Participants are eligible for the study only if all of the following criteria are met: AGE 1. Aged 6 months to < 22 months on the day of inclusion </p>\n
      • principal_exclusion_criteria<p>\n <strong>MEDICAL CONDITION</strong>S </p>\n<div>\n <p>\n E01. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) </p>\n <div>\n E02. Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances </div>\n <div>\n  </div>\n <div>\n E03. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completionc</div>\n <div>\n  </div>\n <div>\n E04. History of medically diagnosed wheezing</div>\n <div>\n  </div>\n <div>\n E05. Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.</div>\n <div>\n  </div>\n <div>\n E06. Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.</div>\n <div>\n  </div>\n <div>\n  E07. Member of a household that contains an immunocompromised individual, including, but not limited to: </div>\n <div>\n • a person who is HIV infected </div>\n <div>\n • a person who has received chemotherapy within the 12 months prior to study enrollment </div>\n <div>\n • a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents </div>\n <div>\n • a person living with a solid organ or bone marrow transplant Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator’s discretion</div>\n <div>\n  </div>\n <div>\n <strong>PRIOR/CONCOMITANT THERAPY</strong></div>\n <div>\n E08. Participant’s biological mother’s previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding. </div>\n <div>\n  </div>\n <div>\n E09. Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration: • Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration </div>\n <div>\n • Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after.</div>\n <div>\n  Concomitant receipt on the day of Dose 1 study administration is allowed.</div>\n <div>\n  </div>\n <div>\n  E10. Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.</div>\n <div>\n  </div>\n <div>\n  E11. Receipt of immune globulins, blood or blood-derived products in the past 3 months </div>\n <div>\n E12. Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment</div>\n <div>\n  </div>\n <div>\n <strong> PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE</strong></div>\n <div>\n  E13. Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure </div>\n <div>\n <strong>OTHER EXCLUSIONS</strong></div>\n <div>\n  E14. Deprived of freedom in an emergency setting, or hospitalized involuntarily </div>\n <div>\n E15. Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study</div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<p>\n <strong>Efficacy </strong></p>\n<div>\n <strong>1. Occurr</strong>ence of LRTD (during RSV Season 1) associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2 </div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
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      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • 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<p>\n <strong>Capacity and experience:</strong></p>\n<p>\n KENYA MEDICAL RESEARCH INSTITUTE Establishment of KEMRI: KEMRI was established in 1979 under the Science and Technology (Amendment) Act. It serves as the national body responsible for conducting health science research in Kenya. The KEMRI Research Care and Treatment Program (RCTP), a field project under KEMRI- Center For Microbiology Research.</p>\n<p>\n Location of KEMRI-RCTP: KEMRI-RCTP is situated at the Lumumba sub-county hospital and the Kargeno annex in Kisumu County, Kenya. This location serves as the base for their research and program activities. </p>\n<p>\n Staff Composition: KEMRI-RCTP has a dedicated team of over 200 full-time staff in Kenya with diverse expertise. This team includes epidemiologists, behavioral scientists, physicians, nurse-counselors, laboratory technologists, pharmacists, field workers, data managers, biostatisticians, and administrative staff. These professionals are trained in high standards of ethical research conduct and are involved in various health program services.</p>\n<p>\n Scope of Services: KEMRI-RCTP is involved in a wide range of activities, including HIV testing and counseling, PrEP (Pre-Exposure Prophylaxis) delivery,general health, and general reproductive health services, among others. These services are critical for public health in Kenya. </p>\n<p>\n Research Studies: The KEMRI-RCTP site has a rich history of conducting research studies. It has been involved in nearly 100 research studies, with some ongoing studies actively recruiting participants or archiving samples and data at the site.Demonstrating commitment to advancing medical and health knowledge in the region.</p>\n<p>\n Contributions of KEMRI-RCTP are vital for improving healthcare, understanding health issues, and developing effective interventions in Kenya and beyond.</p>\n<p>\n <strong>History of Research, Care, and Treatment Program (RCTP) </strong></p>\n<p>\n Research Care and Training Programme (RCTP) was established in 1994 with the aims of conducting research, capacity building and implementing programs that promote the provision of preventive care and high-quality health services. The program has its administrative office based in Nairobi within the Center for Microbiology Research which is one of the ten centers of the Kenya Medical Research Institute (KEMRI).</p>\n<p>\n The field KEMRI-RCTP research site is located in a secure area, in Kisumu city, Agoi Street within the Lumumba Health Center grounds.</p>\n<p>\n RCTP includes collaboration between the Center for Microbiology Research (KEMRI), RCTP-FACES Non-Governmental organization (NGO), University of Nairobi (UON), and several U.S. institutions including the University of California San Francisco (UCSF), the University of Washington (UW), University of Colorado, Denver (UC-D), University of Alabama, Birmingham (UAB), Cornell University (CU), Ohio State University (OSU), University of Michigan (UM), Yale University (YU), and Georgetown University (GU).  Over the years the program has since grown.</p>\n<p>\n RCTP has conducted research trials, clinical and implementation research, and focused on building capacity for research and care. Research activities undertaken by the program include but are not limited to family planning, reproductive tract infections, behavior change, STI/HIV prevention, HIV Care and treatment as well as operational research</p>\n<p>\n The <strong>Research</strong> arm has the sole mandate of conceptualizing, designing and implementing research studies.</p>\n<p>\n RCTP employs over 420 full-time staff in Kenya including Research scientists, social scientists, qualitative researchers, statisticians, data managers and analysts, behavioral scientists, physicians, nurse-counselors, laboratory technologists, field workers, data clerks and administrative staff. </p>\n<p>\n At the Kargeno and Lumumba research study sites, we have the following scientific staff: 14 nurses, 6 clinical officers (1 is a site coordinator) and 4 medical officers (1 is a Principal Investigator), 1 pharmacist, 3 pharmaceutical technologists, 1 lab manager and 7 laboratory technicians, 1 Data analyst, 1 data manager and 1 trial manager.  </p>\n<p>\n Non-scientific research staff include 17 field workers, 6 data clerks, 1 ICT officer, 3 receptionists, 3 administrators, 2 drivers, 1 finance manager and 5 administrative assistants.  </p>\n<p>\n <strong>Data management: </strong></p>\n<p>\n The sites use different electronic data capture systems from teleforms, to ODK, Redcap, and DF Explore. We have a well established QA/QC processes for both electronic and paper data and a training program in place for all relevant study staff engaged in data collection and entry. We ensure confidentiality of participant data collected at all times by ensuring safety and security of data in storage spaces where the data room doors is double locked and access to the rooms  controlled, use of password controlled computers, non linking of participant identifier-documents and PTIDs. We also have an archival space for long term storage of paper data of studies after close up. We have 8 data clerks, 1 data manager and 1 data analyst.</p>\n<p>\n <strong>Clinical facility and experience:</strong></p>\n<p>\n We have 23 clinical team members and 8 lab staff who are seasoned, experienced and well trained on data collection on both eCRFs and paper CRFs, participant eligibility assessment, follow up safety assessment, contraceptive and HIV care, and regulatory.</p>\n<p>\n We have 6 clinical rooms at Lumumba site and 4 clinical rooms at Kargeno that are well equipped for all clinical procedures.</p>\n<p>\n <strong>Regulatory and ethics</strong></p>\n<p>\n The sites are ICH/GCP compliant.</p>\n<p>\n The sites through the site PIs hold certified structured trainings on bioethics, research methodology and conduct and scientific writing skills for staff.</p>\n<p>\n All site staff go through the ethical training, GCP and Human subjects protection training certificate accessed at the Collaborative Institutional Training Initiative (CITI Program) prior to involvement in any research related procedures. This ensures that they conform with the ICH guidelines. CITI is an access free web-based certification. Laboratory staff receive GCLP training from certified training international organizations.   </p>\n<p>\n <strong>Laboratory </strong></p>\n<p>\n The lab is registered by the registered by the Kenya Medical Laboratory Technician and technologist Board, license is renewed yearly. It is monitored by Clinical Laboratory Services (South Africa) monitors and Drugs for Neglected Diseases Initiative monitors. We have 5 experienced staff who are professionally trained and qualified to carry out the desired assays. All staff are both GCLP and IATA certified. The space is sufficient to workflow and staff safety. The lab has proper equipment placement, proper ventilation, and has a designated area for sample storage, reagent storage as well as shelves and cabinets for files with access to only authorized personnel. The space is temperature and humidity controlled and closely monitored to ensure that equipment and testing is maintained within the tolerance limits set forth by the manufacturer.  Fire extinguishers ,fire blankets, spill kits and First Aid box are also placed at strategic points for use if need arise and has an Exit Emergency window as recommended by Biosafety standards in the country. Samples received, tracked, stored and results released according to the lab SOPs and manual of operations. We have a Freezerworks system that ensures samples can be easily stored, located and retrieved in their various storage areas in the different storage conditions in various freezers.</p>\n<p>\n The lab testing Capacity and machines and equipment that are routinely maintained among others; 1) COBAS 400+ Integra biochemistry machine with a broad test menu comprising over 400 plus tests; 2) Reflotron Plus Clinical Chemistry Analyzer which is a point of care analyzer for   biochemistry tests and has the capacity to do Hb estimation, it accepts whole blood as well as serum and plasma; 3) BD <em>FACSCount</em>™ system which provides absolute and percentage results of CD4 T lymphocytes to stage progression of HIV/AIDS; 4) COULTER AC•T5diff hematology analyzer that deliver a 5-part differential analysis for full blood count; 5) ELISA Micro plate readers: This is an ELISA plate reader for protocols that may require ELISA; 6) Light microscope; 7) Incubators; 8) Biosafety cabinets level II; 9) Centrifuges; 10) 2 Fridges and 6 Freezers.</p>\n<p>\n <strong>Computers:</strong> Internet: The network infrastructure and security measures in place at KEMRI-RCTP (Kenya Medical Research Institute - Research Care and Training Program). This setup prioritizes data security and reliable network access for study staff through: </p>\n<p>\n Dedicated Internet Line: KEMRI-RCTP has a dedicated Internet line with high-speed connection, to ensure stable and reliable internet access. Contract with Liquid-Telcom: KEMRI-RCTP has a service contract with Liquid-Telcom, an internet service provider, to provide network connectivity to our offices. Password-Protected Network: The network is password-protected.Only the IT officer has access to the password, thus strict access control. Departmental Networking: All departments within KEMRI-RCTP are interconnected, facilitating communication and data sharing among different teams. Backup Power Systems: The presence of backup power systems ensures network continuity during power outages, minimizing disruptions to operations. Maintenance by Contracted Companies: Study computers are serviced and maintained by contracted companies, ensuring that the equipment is in good working order and reducing downtime due to technical issues. Access to Central Server: Access to the central server where study data is transmitted and stored is restricted, ensuring robust data security measures to protect sensitive information. Overall, the set infrastructure and security measures is to provide well-organized and secure IT environment within KEMRI-RCTP, which is crucial for maintaining the integrity of research data and ensuring uninterrupted operations for study staff.</p>\n<p>\n <strong>Data Security: </strong>The site has implemented several security measures to protect its data, especially when dealing with sensitive information like medical or research data. Key security measures include: </p>\n<p>\n Electronic Data Security System (SQL Server): We have g an electronic data security system l SQL Server which is a good choice for managing and securing sensitive data. SQL Server provides various security features, such as role-based access control, encryption, and auditing, which help protect the confidentiality and integrity of the data.</p>\n<p>\n User Authentication and Data Access Control: We require staff to have login credentials is a fundamental security practice. Limiting data access based on departments ensures that employees can only access information relevant to their roles, reducing the risk of unauthorized access.</p>\n<p>\n Firewall Protection: We have an activated inbuilt firewall on Windows 8.1 and Windows 10 which is crucial for network security. Firewalls helps block unauthorized access to the network and prevents external threats from compromising data. Non-Public IP Addresses: Using public IP addresses is prohibited within the site adding an extra layer of security by making it more difficult for external entities to locate and target our study site's network. This has worked in keeping the network and data safe from internetbased attacks. Physical Document Security: We store print data (such as case report forms and consent forms) in lockable cabinets and archival containers with controlled access. This is essential for protecting physical records. This approach ensures that only authorized personnel can access and handle sensitive documents.</p>\n<p>\n Access Approval: One requires approval for access to physical records adding an additional layer of security. This means that even authorized personnel must have a legitimate reason to access the data, reducing the risk of unauthorized or inappropriate access.</p>\n<p>\n <strong>Past Studies hosted at the site</strong></p>\n<p>\n The following studies have been conducted at the sites: Partners in Prevention HSV/HIV Transmission Study, Partners PrEP Study, Partners Demonstration Project, Prospective study of 297 HIV-infected women undergoing loop electrosurgical excision procedure for cervical intraepithelial neoplasia 2/3 (CIN2/3) in  HIV-clinic, Diagnostic validation study in which 1800 HIV-positive women were screened sequentially with VIA, Visual Inspection with Lugol’s Iodine (VILI), HPV and the biomarker p16^INK4a followed by colposcopic confirmation, IPM 014A, IPM 015, IPM 100.1, ECHO Trial, MPYA Study, Living study, PrEP SCALE UP and POWER study.</p>\n<p>\n Currently we are conducting HPV vaccine study, dPEP study, PrEPmyWay study, PrEP pharmacy.</p>\n<p>\n <strong>Community engagement strategy and accountability</strong></p>\n<p>\n The sites are compliant with the Good Participatory Practice (GPP) within our community and therefore we have a site specific GPP plan document for guidance at site level in which our site objectives and various community engagement plans, participant recruitment/retention activities at given phases of study cycle are outlined as well as a systematic analysis of all stakeholders engaged in the study, strategies of engagement, outcome. We are able to assess and evaluate gaps and account for all the activities and strategies implemented based on the plans using assessment tools and approaches for given strategies.</p>\n<p>\n We also have community Engagement/involvement and communication SOPs that guides us on working within the community.</p>\n<p>\n <strong>Principal Investigator</strong><strong>-</strong> Dr. Onono is a physician and a senior principal clinical research scientist with broad experience in basic science, clinical trials, implementation, operations, dissemination and policy research. Presently she is he Country Director for the Kenya Single dose HPV Vaccine Efficacy trial and the country Ag Director for Scientific Programs, Partnerships, and Grants Management. As the co-principal investigator on this project, Dr. Onono will serve as contact PI and will assume scientific, technical, fiscal and administrative management including maintaining communication among PIs and key personnel through monthly meetings. She will provide oversight of implementation of all research components, including study and intervention design, preparation of data collection instruments, intervention implementation, data collection and management, statistical analyses, recruitment and retention strategies as well as clinical care components of the study. She will also be responsible for the IRB process in Kenya. Dr. Onono will also participate in regular conference calls and email communication with the other investigators. She will also act as a liaison between KEMRI, Ministry of Health, county, and other health leaders.</p>\n<p>\n <strong>Co-Investigator -</strong>Imeldah Wakhungu, RCO, HND Counseling/Psy, BSc PH, MGB</p>\n<p>\n Imeldah is a trained Clinical officer with experience in trail conduct and coordination. She has coordinated and participated in several Phase II-IV drug, and vaccine trials in Kisumu site and has vast experience in trial conduct and management, IRB/regulatory requirements, study implementation to close out. She has a Masters in Global Bioethics that has enhanced her research skills further. Imeldah will play a critical role in the day-to-day implementation and running of this project as well as oversight. She will be closely leading the research staff in Kisumu site, training them and guiding them throughout the data collection and management process.  Her insight and familiarity with the day-to-day activities at the Kisumu site is essential in being able to implement this study in a timely and efficient manner</p>\n<p>\n <strong>Co-Investigator- </strong>Dr. Bernard Awuonda, MBChB, MMed, MBA, MPH</p>\n<p>\n Dr. Awuonda is a senior pediatrician with vast experience in clinical trials conduct. He has participated in several pediatric studies as a Principal and coinvestigator. In this study Dr. Awuonda will be the site contact pediatrician and will oversee care and outcome measures for participants.</p>\n<p>\n <strong>Co-Investigator /Pharmacist or record-</strong>Dr. Teresia Otieno, Bpharm</p>\n<p>\n Dr. Teresia is a trained and registered pharmacist, with experience in clinical trials and specifically vaccine/drug trials and pharmacy operations. She will be responsible for the day-to-day coordination of study activities at the site. She will participate in training of staff site, ensuring adherence to GCP and IRB/Regulatory requirements. She will also have active communication with investigators and IRB authorities.</p>\n<p>\n <strong>Co-Investigator- </strong>Dr. Caren Awinja, MBCHB</p>\n<p>\n Dr. Caren is a study doctor with experience in clinical trials conduct and coordination. She will work closely with other investigators to ensure proper implementation and oversight of the study protocol. She will participate in regular conference calls and email communication with the other investigators and IRB processes. She will also participate in the day to day running of the study, training site staff and overseeing the review, care and safety of participants.</p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The study will also be done in USA. </span></p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <tbody>\n <tr>\n <td>\n RA</td>\n <td>\n Submitted on</td>\n <td>\n Approval Pending</td>\n </tr>\n <tr>\n <td>\n Kenya</td>\n <td>\n 09 October 2023</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <tbody>\n <tr>\n <td>\n RA</td>\n <td>\n Submitted on</td>\n <td>\n Approval Pending</td>\n </tr>\n <tr>\n <td>\n South Africa</td>\n <td>\n 11 Aug 2023</td>\n <td>\n 01 December 2023</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">None</span></p>\n
      • other_details_regulatory_halted<p>\n <font color=\"#333333\" face=\"Trebuchet MS, Tahoma, Verdana, Arial, sans-serif\" font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The trial has not been haulted  anywhere  this </font><font color=\"#333333\" face=\"Trebuchet MS, Tahoma, Verdana, Arial, sans-serif\" font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">far.</font></p>\n
      • estimated_duration4years. - each participant will be followed up for 24months.
      • 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_comparatorplacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states19 Countries
      • number_of_sites7
      • multi_country_listChina India South Korea Thailand Japan Finland Germany Ghana Kenya South Africa Spain Turkey United Kingdom Brazil\nColombia Honduras Mexico Canada United States (inc. Puerto Rico)\n
      • data_monitoring_committeeYes
      • total_enrolment_per_sitecompetitive enrollment
      • total_participants_worldwide6300
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specify6 months to < 22 months of age. Pediatric Population
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Fredrick
      • investigator1_middle_name
      • investigator1_family_nameSawe
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressMedical Research Institute/Walter Reed, Hospital Road, Kericho, Kenya
      • investigator1_telephone+254703247902
      • investigator1_emailFredrick.sawe@usamru-k.org
      • organisations_transferred_Yes
      • number_participants1500
      • notification
      • approval_date10-05-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-05-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted19-03-2024
      • 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)
      • modified2025-04-14 16:46:31
      • created2023-12-08 08:28:25
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1024
        • application_id1359
        • given_nameDr. Maricianah
        • middle_name
        • family_nameOnono
        • qualificationMedical Doctor
        • professional_addressKEMRI-CMR CIS building, Lumumba Sub County hospital grounds Opposite Ondiek Estate, Agoi street, Kisumu
        • telephone0732390992
        • emailmaricianah@gmail.com
        • created2023-12-08 08:29:09
        • modified2024-05-20 12:34:52
    • SiteDetail(array)
      • 0(array)
        • id1647
        • application_id1359
        • county_id42
        • site_nameVictoria Biomedical Research Institute (VIBRI)
        • physical_addressWithin Kisumu Country Referral Hospital
        • contact_detailsP.O. Box 7180, Postal Code 40100,
        • contact_personDr. Lucas Otieno Tina,
        • site_capacity(null)
        • misc(null)
        • created2023-12-08 08:29:09
        • modified2024-05-20 12:34:52
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1649
        • application_id1359
        • county_id35
        • site_nameWalter Reed Army Institute of Research -Kericho Site
        • physical_addressKenya Medical Research Institute/Walter Project - Kericho
        • contact_detailsP.O. Box 1357 – 20200, Hospital Road, Kericho, Ken
        • contact_personDr Fredrick Sawe
        • site_capacity(null)
        • misc(null)
        • created2023-12-08 09:33:58
        • modified2024-05-20 12:34:52
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 2(array)
        • id1650
        • application_id1359
        • county_id37
        • site_nameKEMRI CCR – Butere Clinical Research Centre
        • physical_addressWithin Butere County Hospital
        • contact_detailsP.O. Box 40, 50101 Butere
        • contact_personDr. Janet Nyawira Oyieko
        • site_capacity(null)
        • misc(null)
        • created2023-12-08 09:40:52
        • modified2024-05-20 12:34:52
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
      • 3(array)
        • id1651
        • application_id1359
        • county_id41
        • site_nameSiaya County Referral Hospital (SCRH)
        • physical_addressKEMRI/CGHR, SIAYA, Within Siaya County Hospital
        • contact_detailsKEMRI/CGHR, Off Kisumu-Busia Road, P. O. Box 1578-40100, Kisumu
        • contact_personDr. Simon Kariuki
        • site_capacity(null)
        • misc(null)
        • created2023-12-08 09:40:52
        • modified2024-05-20 12:34:52
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 4(array)
        • id1652
        • application_id1359
        • county_id42
        • site_nameKenya Medical Research Institute Center for Microbiology Research (CMR)
        • physical_addressKEMRI CMR- Kargeno research and policy hub Junction of Ojijo-Karume road Opposite Upper railways Ap line dispensary, Kisumu
        • contact_detailsKEMRI-CMR CIS building,
        • contact_personDr. Maricianah Onono
        • site_capacity(null)
        • misc(null)
        • created2023-12-08 09:40:52
        • modified2024-05-20 12:34:52
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 5(array)
        • id1653
        • application_id1359
        • county_id47
        • site_nameKAVI - Institute of Clinical Research (KAVI - ICR)
        • physical_addressKAVI-Institute of Clinical Research
        • contact_detailsUniversity of Nairobi, P.O Box 19676 Nairobi-00202
        • contact_personProf. Walter Jaoko
        • site_capacity(null)
        • misc(null)
        • created2023-12-08 09:40:52
        • modified2024-05-20 12:34:52
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 6(array)
        • id1654
        • application_id1359
        • county_id42
        • site_nameKombewa Clinical Research Center, KEMRI,
        • physical_addressKombewa Clinical Research Center, KEMRI
        • contact_detailsP.O. Box 54-40100, Kisumu, Kenya
        • contact_personDr. Walter Otieno
        • site_capacity(null)
        • misc(null)
        • created2023-12-08 09:40:52
        • modified2024-05-20 12:34:52
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id713
        • application_id1359
        • sponsorSanofi Pasteur Inc.
        • sponsor_typeIndustry
        • contact_personSomnath Mangarule _Global Clinical Development Strategic Expert vaccines
        • address1541,Avenue Marcel Mérieux 69280 Marcy l’Etoile, France
        • telephone_number+33 (0)6 76 97 20 84
        • fax_number
        • cell_number+33 (0)6 76 97 20 84
        • email_addressSomnath.mangarule@sanofi.com
        • created2023-12-08 08:29:09
        • modified2024-05-20 12:34:52
  • 1(array)
    • Application(array)
      • id853
      • user_id56
      • trial_status_id5
      • abstract_of_study<p>\n Over two million persons become newly infected with HIV each year with the majority in Africa. In Kenya, more than 1.4 million people are living with HIV[1] making it the country with the fourth largest epidemic globally. The past five years has witnessed major strides in the development of highly-effective HIV prevention interventions, particularly using pre-exposure prophylaxis (PrEP) to prevent acquisition. Kenya is a leader for PrEP delivery in Africa and efforts are ongoing to increase PrEP accessibility; however, most approaches include expanding access within health facility-based settings. Novel strategies to successfully and efficiently deliver PrEP are needed to achieve maximum prevention impact and reach HIV prevention priority populations who do not frequently attend health facilities. For example, many adolescent girls and young women (AGYW) at risk for HIV in Kenya access contraception at commercial pharmacies without interfacing with public sector health facilities and would be missed by current PrEP delivery platforms. Pharmacy-based PrEP delivery has never been explored in an African setting. Adding pharmacies to the range of locations that deliver PrEP would increase the available options for reaching individuals at risk of HIV infection, including AGYW who frequently obtain contraception at pharmacies outside of health facilities. Development of collaborative practice agreements with pharmacies for fully self-contained PrEP delivery is ongoing in Kenya, but has not yet been tested. Collecting data on acceptability, utilization, user experiences of pharmacy-based PrEP delivery among individuals at HIV risk could inform future implementation of pharmacy-based PrEP delivery in this setting. We propose that situating a PrEP-prescribing nurse within pharmacies could expedite evidence gathering for aspects of delivery (e.g., acceptability and utilization of PrEP among AGYW in this setting). We will conduct a pilot evaluation by offering PrEP to AGYW within commercial pharmacies according to current national guidelines (i.e., a nurse stationed in the pharmacy with remote physician oversight) in Kisumu, Kenya to collect information on whether or not AGYW accept and utilize PrEP when offered in pharmacies. We will also gather qualitative perspectives from in-depth interviews on user experiences</p>\n
      • study_title<p>\n Pilot evaluation of pharmacy-based pre-exposure prophylaxis (PrEP) delivery</p>\n
      • laymans_summary<p>\n PrEP is a new medication to prevent HIV. It works when you take it as prescribed by a healthcare provider. To take full advantage of the public health benefits of PrEP for HIV prevention, there is need to increase access and reduce costs for people who may be at risk of HIV, such as adolescent girls and young women. In Africa, PrEP is being added to busy public health clinics and health systems will need to finding novel strategies to improve access. Additionally, there are major barriers to PrEP which include stigma, long waiting times, costs of staffing, and healthcare providers’ unfamiliarity with PrEP. In Kenya, retail pharmacies fill an important gap in the health care system by providing first stop access to treatment and preventive care of health conditions. Adolescent girls and young women frequently obtain contraception at pharmacies without attending a health facility. Potential PrEP users may prefer obtaining PrEP at a retail pharmacy due to its convenience and privacy. The core components of PrEP – including HIV testing, counselling, assessment of side effects, and refills – can easily be delivered within pharmacies. We will offer PrEP to adolescent girls and young women at two retail pharmacies in Kisumu, Kenya to assess whether pharmacies are acceptable as a new PrEP access point.</p>\n
      • short_titlePharm PrEP for AGYW
      • protocol_noECCT/20/02/01
      • version_no1.0
      • date_of_protocol19-09-2019
      • study_drugEmtricitabine/Tenofovir
      • disease_conditionHIV
      • 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_nameTruvada
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaachoka@kemri-ucsf.org
      • 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_data0
      • 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_plan0
      • applicant_contractual_agreement0
      • declaration_applicantP.O BOX 614-40100
      • declaration_date113-02-2020
      • declaration_principal_investigatorProf. Elizabet Bukusi (Principal Investigator)
      • declaration_date213-02-2020
      • placebo_presentNo
      • study_objectives<p>\n The primary objectives of this evaluation are to:</p>\n<p>\n 1. To determine acceptability of pharmacy-based PrEP delivery among AGYW by situating a PrEP-prescribing at up to 4 commercial pharmacies in Kisumu, Kenya who will offer PrEP per national guidelines to all AGYW (age 15-24 years) seeking contraception (e.g., emergency contraception, oral contraceptive pills [OCP], injectables, condoms) over a 3-month period. a. Secondary objectives: i. To describe reasons for declining PrEP among AGYW with behavioral risk factors for HIV. ii. To compare frequency of PrEP acceptability by specific behavioral risk factors for HIV per national guidelines for PrEP screening (e.g., partner HIV status, transactional sex, intimate partner violence)</p>\n<p>\n 2. To evaluate utilization and describe user experiences among AGYW who accepted PrEP using a mixed methods approach by:</p>\n<p>\n 1) administering questionnaires at a one-time follow-up visit among all AGYW who accepted PrEP (n=200) to quantify the proportion of AGYW who initiated PrEP use since acceptance and</p>\n<p>\n 2) conducting qualitative IDIs among a subset (n=40) of AGYW who did an did not initiate PrEP use to describe user experiences.</p>\n<p>\n a. Secondary objectives:</p>\n<p>\n i. To determine utilization of HIV self-test kits for at-home male partner and/or couples testing after accepting kits in commercial pharmacies.</p>\n<p>\n ii. To compare potential barriers and facilitators of pharmacy PrEP described by AGYW who did and not initiate PrEP use.</p>\n
      • principal_inclusion_criteria<p>\n 1. AGYW (PrEP screening)</p>\n<p>\n 1) Inclusion criteria •</p>\n<p>\n Female gender •</p>\n<p>\n Seeking emergency contraception (EC),</p>\n<p>\n oral contraceptive pills (OCP),</p>\n<p>\n injectable contraception, or condoms from the commercial pharmacy study site</p>\n<p>\n • ≥15 and <24 years old •</p>\n<p>\n Willing to receive PrEP screening per NASCOP guidelines, including HIV testing •</p>\n<p>\n Able and willing to provide informed consent for participation 2)</p>\n<p>\n Exclusion criteria • Male gender • <15 or >24 years old • Not seeking EC, OCP, injectable contraception, or condoms from the commercial pharmacy study site • Unwilling to accept PrEP screening and/or HIV testing • Unable or unwilling to provide informed consent</p>\n
      • principal_exclusion_criteria<p>\n 2) Exclusion criteria •</p>\n<p>\n Male gender</p>\n<p>\n • <15 or >24 years old</p>\n<p>\n • Not seeking EC, OCP, injectable contraception, or condoms from the commercial pharmacy study site</p>\n<p>\n • Unwilling to accept PrEP screening and/or HIV testing</p>\n<p>\n • Unable or unwilling to provide informed consent</p>\n
      • primary_end_points<p>\n Analysis of Primary Outcomes: Analyses to address proposed research objectives regarding the acceptability and utilization of PrEP within commercial pharmacies and exploration of user experiences described below by study objectives:</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
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyImplementation Sciense
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Study PI: Prof. Elizabet Bukusi</p>\n<p>\n Study Cordinator: Josephine Odoyo</p>\n<p>\n Study Cordinator: Kevin Kamolloh</p>\n<p>\n Study Pharmacist: Dr. Peter Mugo</p>\n<p>\n Data: 2</p>\n<p>\n Research Assistants-3</p>\n<p>\n Administrator -1</p>\n<p>\n Study nurse-1</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n This study will be conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n University of Washington IRB. Only one site in Kenya</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration4 months
      • 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/CMR/RCTP Kisumu-Lumumba Sub-County Hospital
      • single_site_physical_addressP.O BOX 614-40100
      • single_site_contact_personProfessor Elizabet Ann Bukusi
      • single_site_telephone0733 617 503
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site200
      • total_participants_worldwide200
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • 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_nameDr.Elizabeth Bukusi
      • investigator1_middle_nameAnn
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
      • investigator1_professional_addressP.O Box 614-40100
      • investigator1_telephone0733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_No
      • number_participants200
      • notification
      • approval_date23-03-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-05-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonEdwardabwao
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2022-11-23 10:08:22
      • created2020-02-13 15:34:43
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id524
        • application_id853
        • given_nameProf. Elizabeth Ann
        • middle_name
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
        • professional_addressP.O Box 614-40100
        • telephone0733617503
        • emailebukusi@rctp.or.ke
        • created2020-02-13 15:48:42
        • modified2021-05-03 08:30:43
    • SiteDetail(array)
      • 0(array)
        • id695
        • application_id853
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-02-13 15:48:42
        • modified2021-05-03 08:30:43
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id411
        • application_id853
        • sponsorBill and Melinda Gates Foundation
        • sponsor_typeOthers
        • contact_person
        • addressPO Box 23350 Seattle, WA 98102
        • telephone_number(206) 709-3100
        • fax_number
        • cell_number(206) 709-3100
        • email_addressmedia@gatesfoundation.org
        • created2020-02-13 15:48:42
        • modified2021-05-03 08:30:43
  • 2(array)
    • Application(array)
      • id1067
      • user_id667
      • trial_status_id8
      • abstract_of_study<p>\n Adolescent girls and young women (AGYW) in Kenya face parallel epidemics for unintended pregnancy and HIV. Existing reproductive health and family planning programs are acceptable and effective entry points to reach AGYW with comprehensive services to prevent these events. AGYW seeking care for an early pregnancy loss- whether from a spontaneous miscarriage or induced abortion- face these epidemics and integrating HIV prevention services, particularly daily oral PrEP, into PAC services is an opportune method to reach them. PrEP is widely available in Kenya for people with substantial risk for HIV. Prior formative work by the protocol investigators found that young women accessing PAC had characteristics (existing STI infection and sexual behavior) that render them susceptible to HIV acquisition. More than half of the women indicated willingness to use PrEP. An additional important finding from the study was that PrEP screening and initiation could be integrated into services provided through the PAC clinic and follow-up for PrEP refills conducted outside of these clinics (e.g. family planning-FP- clinics).</p>\n<p>\n Through the proposed work, we plan to pilot PrEP integration into PAC services among 14 health facilities (public and private) providing PAC to AGYW in Thika, Nairobi, and Kisumu. The project will enroll 2000 AGYW accessing PAC services and engage a subset of 400 for research procedures to evaluate: 1) uptake, adherence, and continuation of PrEP and FP 2) linkage and follow-up on PrEP and FP services 3) impact of enhanced adherence support on PrEP continuation and adherence 4) experiences of young women and providers with an integrated PrEP program, and 5) factors associated with adherence to PrEP and FP. Specifically, we hope that the work will result in robust recommendations for how to optimize and advance long-standing delivery of HIV prevention as part of PAC services in Kenya and similar settings.</p>\n
      • study_title<p>\n PILOTING HIV PRE-EXPOSURE PROPHYLAXIS (PREP) INTEGRATION INTO SERVICES FOR EARLY PREGNANCY LOSS</p>\n
      • laymans_summary<p style=\"margin:0cm;margin-bottom:.0001pt;text-align:justify\">\n <span style=\"font-size:11.0pt;font-family:"Arial",sans-serif;color:#0E101A\">Adolescent girls and young women (AGYW) receiving care following a pregnancy loss – whether from a spontaneous miscarriage or induced abortion - are extremely vulnerable to ongoing sexual and HIV risk because of infrequent condom use, recent sexual debut, and experiences with psychosocial distress, stigma, and violence that often characterize their recent past. . Results from prior formative work showed that AGYW accessing services from PAC clinics were at a high risk for HIV infection and willing to initiate PrEP alongside PAC services but would only access refills from outside of these clinics (e.g. at family planning clinics). Accessing these women through post-abortal care (PAC) clinics provides an entry point to engage women in HIV prevention, specifically oral PrEP, because of the HIV risk they face. Through the proposed study, we will assess the feasibility and impact of using PAC services in both private and public facilities as an entry point to link AGYW to PrEP, as well as integrated PrEP and contraceptive services in Thika, Nairobi, and Kisumu. This project will result in recommendations for how to optimize and advance the delivery of HIV prevention services as part of PAC care in Kenya and similar settings.</span></p>\n
      • short_titleThe PrEDIRA Study
      • protocol_noECCT/21/09/06
      • version_no1.0
      • date_of_protocol15-07-2021
      • study_drugEmtricitabine and Tenofovir Disoproxil Fumarate Tablets
      • disease_conditionHIV
      • 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_nameEmtricitabine and Tenofovir Disoproxil Fumarate Tablets 200mg/300mg
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressrgreshon@kemri-ucsf.org
      • 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_data0
      • 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_agreement0
      • declaration_applicantDr. Greshon Rota
      • declaration_date122-09-2021
      • declaration_principal_investigatorProf Elizabeth Bukusi
      • declaration_date222-09-2021
      • placebo_presentNo
      • study_objectives<ol>\n <li>\n <strong>Among women accessing post-abortal care (PAC) services in Kenya, we will use methods from implementation science to evaluate feasibility of integrating PrEP into PAC services by estimating: </strong><strong>a) uptake of PrEP and FP at the PAC site</strong>\n <p style=\"margin-left: 36pt;\">\n <strong>b) linkage of women from PAC to follow-on PrEP and FP services</strong></p>\n <p style=\"margin-left: 36pt;\">\n <strong>c) retention in PrEP and FP programs</strong></p>\n <p style=\"margin-left: 36pt;\">\n <strong>d) continuation of PrEP and FP during a 6 month period</strong></p>\n </li>\n <li>\n <strong>To determine the effect of enhanced adherence activities on PrEP continuation and adherence</strong></li>\n <li>\n <strong>To qualitatively evaluate the feasibility of integrating PrEP into PAC services and experiences of young women and providers with an integrated PrEP program</strong></li>\n <li>\n <strong>To determine factors associated with adherence to PrEP and FP</strong></li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Aged 15-30 years</li>\n <li>\n HIV-negative, according to national HIV testing algorithm</li>\n <li>\n Accessing services for early pregnancy loss at one of the participating facilities and other facilities within the program area</li>\n <li>\n Not currently using PrEP</li>\n <li>\n Eligible for PrEP, according to Kenya national guidelines </li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Living with HIV, according to national HIV testing algorithm</li>\n <li>\n Has any condition (social or medical) which in the opinion of the investigator would make program participation unsafe</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n  Analytic approach: Through data abstracted from facility records, we will describe the number of women accessing PAC services/month, the proportion of these women who have substantial HIV risk, and the proportion of these women who initiate PrEP/FP. Through data abstraction at partner programs providing long term PrEP and FP services, we identify women being referred through the PAC PrEP program and estimate the proportion of women referred who actually link to these services, are retained each month in the program, and continue to receive PrEP medication. We will use these data to populate a “PrEP cascade” showing the continuum of women’s engagement with PrEP and family planning</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
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specifyImplementation Science
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n Study PI: Prof. Elizabet Bukusi, Dr. Nelly Mugo, Renee Heffron PHD</div>\n<div>\n Co-Investigator: Dr. Victor Omollo</div>\n<div>\n Co-Investigator: Josephine Odoyo</div>\n<div>\n Study Cordinator: Dr. Felix Mogaka</div>\n<div>\n Study Cordinator: Kevin Kamolloh</div>\n<div>\n Study Pharmacist: Dr. Greshon Rota</div>\n<div>\n Data: 2</div>\n<div>\n Research Assistants-3</div>\n<div>\n Administrator -1</div>\n<div>\n Study nurse-1</div>\n
      • other_details_explanation<p>\n This study will be conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration24 months
      • 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_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites14
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site400
      • total_participants_worldwide400
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • 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_nameProf. Elizabeth
      • investigator1_middle_name
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
      • investigator1_professional_addressBox 19464, post code 00202, Nairobi
      • investigator1_telephone+254 733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_No
      • number_participants400
      • notification
      • approval_date10-11-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-09-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-10-16 13:53:34
      • created2021-09-14 07:01:58
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id728
        • application_id1067
        • given_nameProf. Elizabeth
        • middle_name
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
        • professional_addressBox 19464, post code 00202, Nairobi
        • telephone+254 733617503
        • emailebukusi@rctp.or.ke
        • created2021-09-14 07:07:35
        • modified2021-09-22 12:43:56
      • 1(array)
        • id729
        • application_id1067
        • given_nameDr. Nelly
        • middle_name
        • family_nameMugo
        • qualificationMBChB, Mmed, MPH
        • professional_addressPartners in Health, Research and Development - Thika
        • telephone067 2222561
        • emailrwamba@uw.edu
        • created2021-09-14 07:14:32
        • modified2021-09-22 12:43:56
      • 2(array)
        • id730
        • application_id1067
        • given_nameRenee
        • middle_name
        • family_nameHeffron
        • qualificationMPH, PhD
        • professional_address4333 Brooklyn Ave.NE, Box 359470 Seatle, WA 98195-9470
        • telephone+1206-520-3800
        • emailrheffron@uw.edu
        • created2021-09-14 07:14:32
        • modified2021-09-22 12:43:56
    • SiteDetail(array)
      • 0(array)
        • id1133
        • application_id1067
        • county_id42
        • site_nameKEMRI RCTP
        • physical_addressLUMUMBA SUBCOUNTY HOSPITAL - KISUMU
        • contact_details+254 720 018880, P.O BOX 614-40100
        • contact_personJOSEPHINE ODOYO
        • site_capacity(null)
        • misc(null)
        • created2021-09-14 07:07:35
        • modified2021-09-22 12:43:56
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1134
        • application_id1067
        • county_id22
        • site_namePARTNERS IN HEALTH RESEARCH AND DEVELOPMENT - THIKA
        • physical_addressTHIKA TOWN
        • contact_detailsP.O BOX 112
        • contact_personPETER MOGERE
        • site_capacity(null)
        • misc(null)
        • created2021-09-14 07:37:56
        • modified2021-09-22 12:43:56
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
    • Sponsor(array)
      • 0(array)
        • id541
        • application_id1067
        • sponsorChildren’s Investment Fund Foundation
        • sponsor_typeOthers
        • contact_person
        • address7 Clifford Street London, W1S 2FT United Kingdom
        • telephone_number+44 (0) 20 3740 6100
        • fax_number
        • cell_number+44 (0) 20 3740 6100
        • email_addressinfo@ciff.org
        • created2021-09-14 07:07:35
        • modified2021-09-22 12:43:56
  • 3(array)
    • Application(array)
      • id393
      • user_id89
      • trial_status_id(null)
      • abstract_of_study<p>\n Dafra Pharma and CCR-KEMRI have initiated the first in man clinical Phase 1 study<br />\n using single oral doses of 50 mg, 100 mg and 150 mg of oleylphosphocholine in healthy<br />\n adult males (protocol DRD140-L2.2012, SSC #2512). The study made use of a capsule<br />\n formulation of oleylphophocholine containing 50 mg of active ingredient. The subjects of<br />\n the first three cohorts were receiving one, two or three of those capsules as a single dose.<br />\n Based on the positive results obtained so far, two additional cohorts of 10 volunteers are<br />\n now planned to be dosed with single dose of 200 mg and 250 mg, upon approval by<br />\n KEMRI IRB. The capsule formulation of oleylphosphocholine was of limited shelf life and was only<br />\n meant to be used for early clinical studies. Since the initiation of the Phase 1 trial, the<br />\n pharmaceutical research around the formulation of oleylphosphocholine has progressed<br />\n and the final formulation of the active ingredient intended to be marketed has become<br />\n available. This formulation is in the form of 50 mg oral solid tablets. Our intention is to<br />\n continue the Phase 1 protocol DRD140-L2.2012, SSC #2512 with this new formulation,<br />\n but before, we wish to confirm that both the capsule and tablet formulations of the active<br />\n ingredient are comparable in terms of safety/tolerance, and pharmacokinetics.The primary objective is to evaluate safety and tolerability of single dose 100 mg<br />\n oleylphosphocholine oral solid tablets in healthy male volunteers.The secondary objective is to obtain data on pharmacokinetics following oral<br />\n administration of single dose 100 mg tablets oleylphosphocholine in human, and to<br />\n calculate bioequivalence with the capsule formulation</p>\n<p>\n  </p>\n
      • study_title<p>\n Plasma concentration profiles after oral<br />\n administration of oleylphosphocholine tablet<br />\n formulation: safety, tolerability and pharmacokinetics<br />\n of 100 mg single dose in healthy male volunteers.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/04/02
      • version_no2.1
      • date_of_protocol03-02-2015
      • study_drugOleylphosphocholine (OlPC)
      • disease_conditionleishmaniasis
      • 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_nameOleylphosphocholine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssnjoroge@kemri.org
      • 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_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Rashid J R
      • declaration_date129-04-2015
      • declaration_principal_investigatorDr Njenga S Njoroge CO_PI
      • declaration_date229-04-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Healthy males, adults, aged 18-45 years inclusively at the time of screening.<br />\n · Weight between 45 kg and 80 kg inclusively.<br />\n · Written informed consent obtained from the participant before study start.</p>\n
      • principal_exclusion_criteria<p>\n HIV positive or other immunosuppressive statusSymptomatic infection<br />\n · Concomitant exposure to other investigational medicinal products<br />\n · History of alcohol or drug abuse<br />\n · Known hypersensitivity to miltefosine<br />\n · Known skin condition which could confound assessments of rash as an adverse event.<br />\n · Lipid disorders, including abnormal blood levels of total cholesterol, HDL, LDL, and<br />\n triglycerides.<br />\n · Laboratory result abnormalities, including clinically significant abnormal ECG, liver function<br />\n tests more than x3 upper limit of normal, creatinine outside normal range.<br />\n · Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition. Or any<br />\n other findings that in the opinion of the PI may increase the risk to the participant from<br />\n participating in the study.<br />\n · Other condition that in the opinion of the investigator would jeopardize the safety or rights of<br />\n a participant in the trial or would render the participant unable to comply with the protocol.</p>\n
      • primary_end_points<p>\n Documentation of solicited and spontaneously reported adverse events after administration<br />\n during a 29-day follow-up period, i.e. from day 0 (day of administration) to day 28 postadministration.<br />\n · Documentation of the occurrence of serious adverse events (SAE) throughout the study<br />\n period.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The Centre for Clinical Research (CCR) at KEMRI was established in 1983 and has since grown to<br />\n an international centre for clinical research. The facilities consist of 30 clinical beds, 10 of which are<br />\n dedicated to Phase 1 clinical trials.<br />\n CCR has clinical laboratories for haematology, clinical biochemistry and parasitology. The centre<br />\n also has a full-fledged radiology Unit as well as a facility for upper-GI and lower-GI endoscopy. The<br />\n laboratory equipments are regularly maintained and serviced. All laboratories have SOPs for<br />\n maintenance and for running the different tests.<br />\n In terms of personnel the centre has 6 highly qualified doctors and a clinical officer. The laboratory<br />\n has 10 highly qualified technical employees. There is also 1 radiologist, 3 radiographers and 17<br />\n research nurses. A pharmacy and a qualified pharmacist are also present on site.<br />\n This study team is highly experienced in conducting complex studies and complying with ICH/GCP<br />\n requirements. All CCR scientific, nursing and laboratory staffs are GCP/GcLP trained, and biannually undergo GCP/GcLP refresher courses.<br />\n The team of CCR has conducted several clinical trials including Phase 1 studies.</p>\n
      • other_details_explanation<p>\n Dafra Pharma distributes its products exclusively on the African market and has always<br />\n focused on making drugs available for the African population, where the need is high and<br />\n drugs need to be affordable. Therefore it is ethically fair that the African population and<br />\n scientific community, who are likely to use the medicine in clinical practice, participate in<br />\n the clinical development. This will allow reliable and accurate data about tolerance and<br />\n pharmacokinetics to be compiled in the target population.<br />\n Dafra Pharma is developing the investigational drug oleylphosphocholine (OlPC) as a<br />\n new therapeutic treatment option for visceral leishmaniasis. This neglected parasitic<br />\n disease does not occur in the country of the sponsor (Belgium), whereas it is endemic to<br />\n Kenya. The goal of the current Phase I study is to assess the safety and pharmacokinetic<br />\n profile of OlPC in healthy Kenyan volunteers.<br />\n  </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 NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_durationEnrolment and clinical part: up to 3 months Data analysis and preliminary report: 2 months Final report: 1 month
      • 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
      • single_site_physical_addressoff mbagathi way
      • single_site_contact_personDr J R Rashid
      • single_site_telephone254 20 2726781
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site10
      • total_participants_worldwide10
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • 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_nameRashid Juma
      • investigator1_middle_name
      • investigator1_family_nameRavasco
      • investigator1_qualificationMedical Doctor MBChB, MMed(medicine)
      • investigator1_professional_addressCenter for Clinical Research Kenya Medical Research Institute (KEMRI) Box 20778-00202 Nairobi, Kenya
      • investigator1_telephone254 20 2726781
      • investigator1_emailjrashid@kemri.org
      • organisations_transferred_No
      • number_participants10
      • notification
      • approval_date15-06-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted29-04-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2015-06-15 19:23:44
      • created2015-04-29 08:57:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id266
        • application_id393
        • given_nameRavasco
        • middle_nameRashid
        • family_nameJuma
        • qualificationMBChB Mmed(Internal Medicine)
        • professional_address KEMRI 54840-00200 Nairobi
        • telephone0723726526
        • emailjrashid@kemri.org
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
    • SiteDetail(array)
      • 0(array)
        • id322
        • application_id393
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id205
        • application_id393
        • sponsorDafra Pharma International NV
        • sponsor_type(null)
        • contact_personBruno Jansen
        • addressSlachthuisstraat 30/7, 2300 Turnhout, Belgium
        • telephone_number+32 14 61 78 20
        • fax_number+32 14 47 29 90
        • cell_number+32 475 912 920
        • email_addressbruno.jansen@dafra.be
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
  • 4(array)
    • Application(array)
      • id286
      • user_id172
      • trial_status_id6
      • abstract_of_study<h1>\n Summary</h1>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Design:                       </strong>Randomized clinical trial involving hospitalized HIV-1 infected children.  Children will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy (7-14 days).  This trial will be unblinded.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Population:                </strong>Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve ≤ 12 years of age.</p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Sample size:              </strong>360 children will be randomized (180 per arm). </p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Treatment:                 </strong>All children will be treated with ART according to World Health Organization (WHO) and Kenyan national guidelines.   </p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Study duration:         </strong>Enrollment into the study will occur over the course of 36-48 months and each child will be routinely followed for a maximum of 6 months.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Study sites:</strong>               Kenyatta National Hospital, Kisumu District Hospital, Nyanza Provincial Hospital)</p>\n
      • study_title<p>\n POST STABILIZATION VERSUS URGENT START OF HAART IN HIV-1 INFECTED CHILDREN WITH SEVERE COINFECTION</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/07/01
      • version_noVERSION 3.0
      • date_of_protocol01-08-2012
      • study_drugANTIRETROVIRALS
      • disease_conditionHIV
      • 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_nameANTIRETROVIRALS
      • product_type_medical_device_nameN/A
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmoraahelen@yahoo.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_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Dalton Wamalwa
      • declaration_date126-06-2014
      • declaration_principal_investigatorDr Dalton Wamalwa
      • declaration_date226-06-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Inclusion Criteria</p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Aged ≤ 12 years old (reported)</li>\n <li>\n HIV-1 positive (for example, two rapid HIV-1 antibody tests for children >18 months and not breastfeeding, or one HIV-1 DNA/RNA test for children ≤18 months or who are breastfeeding)</li>\n <li>\n No prior ART (history of pMTCT antiretroviral treatment does not affect eligibility)</li>\n <li>\n Eligible to receive ART, according to current WHO guidelines</li>\n <li>\n Caregiver plans to reside in study catchment area for at least 6 months (reported)</li>\n <li>\n Caregiver provides sufficient locator information</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Exclusion Criteria:Â Suspected central nervous system infection (meningitis, encephalitis or other)</p>\n
      • primary_end_points<p>\n IRIS</p>\n<p>\n All cause mortality</p>\n<p>\n Drug toxicity</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • 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<p>\n Grace John-Stewart, BS, MD, MPH, PhD - Principal Investigator<br />\n Dalton Wamalwa, MBChB, MMed (Paeds), MPH - Site Principal Investigator<br />\n Lisa Ann Mills MD , MS - Co-Investigator<br />\n Jennifer Ann Slyker - Co-Investigator<br />\n Irene Njuguna, MBChB, MSc - Study Physician<br />\n Lisa M Cranmer, BS, MD, MPH - Study Physician<br />\n Vincent Otieno, MBChB - Study Physician<br />\n Daisy Jelagat Chebet, Dip. Clinical Medicine and Surgery - Clinical Officer<br />\n Judith Adhiambo, Dip. Clinical Medicine and Surgery, BA Soc and Psych - Clinical Officer<br />\n Benard Agony Dip. Clinical Medicine and Surgery - Clinical Officer<br />\n Helen Moraa, BSN - Study Coordinator<br />\n Clement Eweh Zeh - Laboratory Director<br />\n Esther Isarwa, KRN, - Study Nurse<br />\n Petronilla Wambulwa, KECN - Study Nurse<br />\n Sarah Njoki Mwangi - Recruitment Nurse<br />\n Beatrice Walimbwa, Cert in Med Lab - Technician Clinic Assistant/Phlebotomy<br />\n Simon Wahome, BPharm - Pharmacist<br />\n Nypha Mmayi , Pharm - Back up Pharmacist<br />\n Brian Muhanji - Lab Technologist<br />\n John Gatimu - Lab Technologist<br />\n Jackline Ouma - Pharmaceutical Technologist<br />\n Suzan Atinga - Nurse Counselor<br />\n Millicent Okongo - Nurse Counselor</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 KNH/UoN Ethics and Research Committee - date of approval, 16th February 2013</p>\n<p>\n UNIVERSITY OF WASHINGTON IRB -Â 17th May 2012</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3.5 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorURGENT ART (48 HOURS), EA
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site120 - Kenyatta National Hospital\n120 - Kisumu District Hospital\n120 - Jaramogi Oginga Odinga Teaching and Referral Hospital
      • total_participants_worldwide360
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • 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
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDalton
      • investigator1_middle_name
      • investigator1_family_nameWamalwa
      • investigator1_qualificationMmed, MPH Epidemiology
      • investigator1_professional_address19676 -00202
      • investigator1_telephone020- 273-1498
      • investigator1_emaildalton@africaonline.co.ke
      • organisations_transferred_Yes
      • number_participants360
      • notification
      • approval_date21-10-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-07-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2015-09-04 11:01:23
      • created2014-03-24 10:33:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id199
        • application_id286
        • given_nameGrace
        • middle_name
        • family_nameJohn-Stewart
        • qualificationPhD
        • professional_address325-Ninth Ave, Box 359909, Seattle WA, 98104 USA
        • telephone+1- 206-543-4278
        • emailgjohn@uw.edu
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
    • SiteDetail(array)
      • 0(array)
        • id245
        • application_id286
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressKenyatta National Hospital Grounds
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id246
        • application_id286
        • county_id42
        • site_nameJaramogi Odinga Teaching and Referral Hospital
        • physical_addressKisumu Kakamega Road
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 11:53:29
        • modified2014-07-31 15:36:36
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id247
        • application_id286
        • county_id42
        • site_nameKisumu East District Hospital
        • physical_addressKisumu
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 11:53:29
        • modified2014-07-31 15:36:36
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id158
        • application_id286
        • sponsorNational Institute of Health
        • sponsor_type(null)
        • contact_personLynne M. Mofenson MD Chief, Maternal and Pediatric Infectious Disease Branch
        • addressNational Institutes of Health 6100 Executive Boulevard, Room 4B11 Rockville, MD 20852
        • telephone_numberTelephone: 301-435-6870
        • fax_number
        • cell_numberN/A
        • email_addressLM65D@nih.gov
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
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  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
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  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 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

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      • 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