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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id466
      • user_id306
      • trial_status_id7
      • abstract_of_study<p>\n Important life decisions are often taken under stress. More generally, it has been shown that living in the context of poverty may lead to stress (see Haushofer, Johannes and Ernst Fehr, “On the Psychology of Poverty.”  <em>Science </em>344 (2014), 862–867.) Therefore, it is highly important to understand the impact of stress on economic decision-making, because if stress biases decision making (or influences individuals in other negative ways), it may actually worsen poverty, creating a negative feedback loop.</p>\n<p>\n Because the study is motivated by understanding the impact of poverty, we have chosen the context of informal settlement in Nairobi, where research has shown stress levels are high. By allowing us to understand the link between poverty, stress, and economic decision-making, we hope that in the long run this study will inform the design of poverty interventions in Kenya and beyond. For example, if the study finds that stress levels affect social cooperation, this will give us reason to believe that interventions that reduce stress would have an impact on conflict.     </p>\n<p>\n The objective of this study is to explore the effect of hormones on economic behavior. More specifically, it will explore how stress affects in-group/out-group behavior. This study will answer questions on whether stress increases in-group biases and tendency to protect the in-group, or whether stress increases the need for cooperation, increasing positive interaction with the out-group.</p>\n<p>\n         The proposed study will administer hydrocortisone to healthy male participants, and then tests its effects on in-group/out-group behavior. A wide variety of economic games (including dictator, trust, and public goods) will be played. Participants will also play multiple other games requiring social interaction between in-group and out-group participants. The main hypothesis is that higher levels of cortisol will increase prosocial behavior towards the in-group and antisocial behavior towards the out-group.</p>\n
      • study_title<p>\n Hormones and Economic Choice: Evaluating the Effects of Hydrocortisone Administration on Economic Decision Making, Psychology and Social Behavior among Adult Males in Nairobi, Kenya</p>\n
      • laymans_summary(null)
      • short_titleHormones and Economic Choice
      • protocol_noECCT/15/12/04
      • version_no1
      • date_of_protocol20-11-2015
      • study_drugHyrdocortisone
      • disease_conditionNone. This study is on healthy adults
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameHydrocortisone
      • product_type_medical_device_nameCapsule
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskelvin.kinyua@busaracenter.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
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      • declaration_applicantColin West
      • declaration_date120-11-2015
      • declaration_principal_investigatorJohannes Haushofer
      • declaration_date220-11-2015
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p class=\"p1\">\n Healthy adult volunteers between the ages 18-40</p>\n
      • principal_exclusion_criteria<p class=\"p1\">\n Weighs more than 190 lbs (86.2 kg); substantial consumption of alcohol, tobacco, or other drugs; candidate has any of the following infections or medical conditions (liver disease, kidney disease, thyroid disease or hypothyroidism, diabetes, current malaria, TB, osteoporosis, muscle disorder, glaucoma, eye infection, stomach ulcer, ulcerative colitis, diverticulitis, recent abdominal surgery, any heart problem, high or low blood pressure, strongyloides infection, herpes or any genital ulcer disease, immunodeficiency, any other infection or condition); uses or recently used any of the following medications (drugs that induce hepatic enzymes, troleandomycin, chronic high dose aspirin, oral anticoagulants, heart or BP medication, recent vaccination); or has a mental health concern (severe stress, history of depression, anxiety or other psychiatric disorder, is under psychiatric treatment).</p>\n<p class=\"p1\">\n For full details see submitted Checklist for Subject Inclusion</p>\n
      • primary_end_points<p class=\"p1\">\n The primary endpoints of this study  are: salivary cortisol concentration (nanomol/l), a self-report measure of participant's subjective emotional state (PANAS: positive and negative affect schedule), and a series of economic games and behavioral tasks (all of which are standard paradigms in economic and psychological research). </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyExploring the effect of low-doses of hormones on economic and social behaviors
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyBehavioral economics research trial on hormones and economic decision making.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p class=\"p1\">\n The Busara Center for Behavioral Economics lab team has extensive training in conducting scientifically controlled lab experiments, and years of experience in designing, leading, and managing experimental protocols. The lab is under the direction of Busara's senior leadership team: Johannes Haushofer (Prof. at Princeton University), Jeremy Shapiro (PhD in Economics at MIT), Chaning Jang (PhD in Economics, University of Hawaii), and James Vancel (Managing Director of Busara). For more detailed qualifications, see CVs included in this package. </p>\n<p class=\"p1\">\n Study Coordinators: the on-site research staff at Busara will coordinate the study. Busara's staff are managed by Joseph Muiruri (Mr. Mururi is a graduate of the University of Nairobi, and has extensive experience supporting scientific experiments and managing lab project). </p>\n<p class=\"p1\">\n Site facilities: Busara is located in a compound with 24-hr security. The lab facility includes a networked computer cluster (touchscreen computers that can be used by illiterate participants), a waiting room; lab space for saliva sampling, a -20 deg C freezer for specimen storage, continuous and uninterrupted power through a backup system. </p>\n<p class=\"p1\">\n Emergency facilities: Busara has a fully equipped first aid kit, and a licensed nurse will be on-site at all times during this study. </p>\n
      • other_details_explanation<p class=\"p1\">\n The study is designed to understand the impact of poverty. Research has shown that stress levels are high in informal settlements in Nairobi. We hope that our study will inform poverty interventions in Kenya and beyond. </p>\n
      • other_details_regulatory_notapproved<p class=\"p1\">\n None. This study has already been approved by all other applicable regulatory authorities.</p>\n
      • other_details_regulatory_approved<p class=\"p1\">\n 1) Princeton University Institutional Review Board for Human Subjects: approved June 15, 2015 for single site in Kenya;</p>\n<p class=\"p1\">\n 2) Kenya Medical Research Institute (KEMRI): approved October 5, 2015 for single site in Kenya </p>\n
      • other_details_regulatory_rejected<p>\n None. </p>\n
      • other_details_regulatory_halted<p>\n None.</p>\n
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo controlled
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaBusara Center for Behavioral Economics
      • single_site_physical_addressJonathan Court, Ngong Road, Nairobi 0200
      • single_site_contact_personJames Vancel
      • single_site_telephone+(254) 725 066 428
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site11,500 (Single-site in Kenya)
      • total_participants_worldwide11,500
      • 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_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJohannes
      • investigator1_middle_name
      • investigator1_family_nameHaushofer
      • investigator1_qualificationProfessor, Princeton University
      • investigator1_professional_address427 Peretsman Scully Hall, Princeton, NJ 08540
      • investigator1_telephone001-609-258-7167
      • investigator1_emailhaushofer@princeton.edu
      • organisations_transferred_No
      • number_participants11,500
      • notification<p>\n Note: hard copies of this application were submitted to the PPB offices on November 20, 2015</p>\n
      • approval_date11-03-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-12-2015
      • 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)
      • modified2019-09-30 09:42:57
      • created2015-12-17 16:18:45
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id304
        • application_id466
        • given_nameJohannes
        • middle_name
        • family_nameHaushofer
        • qualificationProfessor, Princeton University
        • professional_address427 Peretsman Scully Hall, Princeton, NJ 08540
        • telephone001-609-258-7167
        • emailhaushofer@princeton.edu
        • created2015-12-17 16:25:59
        • modified2015-12-17 18:11:06
    • SiteDetail(array)
      • 0(array)
        • id363
        • application_id466
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-12-17 16:25:59
        • modified2015-12-17 18:11:06
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id237
        • application_id466
        • sponsorPrinceton University, Department of Psychology
        • sponsor_type(null)
        • contact_person
        • addressPeretsman Scully Hall, Princeton, NJ 08540
        • telephone_number001-609-258-4793
        • fax_number
        • cell_number001-609-258-4793
        • email_addresslscalice@princeton.edu
        • created2015-12-17 16:25:59
        • modified2015-12-17 18:11:06
  • 1(array)
    • Application(array)
      • id658
      • user_id73
      • trial_status_id7
      • abstract_of_study<div>\n A challenge to development of HIV-1 vaccines is to better understand the natural immune mechanisms for protection from HIV-1 infection. To this end, immunologists have increasingly appreciated the importance of regulatory T cells in peripheral blood that modulate the magnitude and characteristics of the host</div>\n<div>\n inflammatory response including against infectious diseases. We have also recently identified specific host genetic variants in the genes CD101 and UBE2V1 that appear to strongly predispose to HIV-1 infection risk and may act through regulatory T cells and other immunologic pathways. Most studies of individuals who are repeatedly HIV-1 exposed but remain seronegative (HESN) have focused on immunological correlates in peripheral blood rather than mucosal immune responses. However, with genital mucosal tissues being the portal of entry for heterosexually transmitted HIV-1 infection, it is critical that we understand the role of immunological responses to HIV-1 that occur in the genital mucosa. A valuable model to carry out such studies is offered by HESN, particularly in the context of heterosexual sex with a stable HIV-1 infected partner e.g., HIV-1 serodiscordant couples (SDC). In order to understand how exposure to HIV-1 may modulate these immune pathways, HIV-1 serodiscordant couples should be compared to heterosexual partners in concordant HIV-1 negative couples (CNC) where neither partner has HIV-1. Here we propose to address this important knowledge gap by enrolling high-risk HESN with defined heterosexual HIV-1 exposures in the context of serodiscordant partnerships compared to unexposed concordant seronegative controls. We will prospectively obtain mucosal and peripheral blood samples for a detailed analysis of longitudinal immune responses, while also collecting samples for genetic characterization to understand how variants in CD101 and UBE2V1 may modulate host mucosal responses and HIV-1 infection risk.</div>\n<div>\n  </div>\n<div>\n <strong>Design:</strong> Single study site, prospective, observational cohort.</div>\n<div>\n  </div>\n<div>\n <strong>Population</strong>: African heterosexual HIV-serodiscordant (SDC) and HIV-1 concordant negative couples (CNC) will be recruited for this study. The exclusion criteria will be current use of ART by HIV-1 infected partners, or PrEP by HIV-1 uninfected partners at the time of screening or prior to enrollment. Inclusion criteria applied to all partners includes age≥18 years, willingness to engage in voluntary couples HIV-1 counseling and testing, to disclose these testing results to their enrolled partner, and to provide samples requested. Among SDC the HIV-1 uninfected partners may be either male or female.</div>\n<div>\n  </div>\n<div>\n <strong>Study Size: </strong>The study will enroll both partners in 500 heterosexual Kenyan couples:</div>\n<div>\n  </div>\n<div>\n • <strong>300 </strong>HIV-1 serodiscordant couples (200 with male, and 100 with female HIV-1 infected partners) and</div>\n<div>\n • <strong>200</strong> HIV-1 concordant seronegative couples (400 HIV-1 negative partners).</div>\n<div>\n  </div>\n<div>\n  </div>\n
      • study_title<p>\n Immunogenetic Modulators of Mucosal Protection from HIV-1: The Kinga Study</p>\n
      • laymans_summary<div>\n A challenge to development of HIV-1 vaccines is to better understand the natural immune mechanisms for protection from HIV-1 infection. To this end, immunologists have increasingly appreciated the importance of regulatory T cells in peripheral blood that modulate the magnitude and characteristics of the host</div>\n<div>\n inflammatory response including against infectious diseases. We have also recently identified specific host genetic variants in the genes CD101 and UBE2V1 that appear to strongly predispose to HIV-1 infection risk and may act through regulatory T cells and other immunologic pathways.</div>\n
      • short_titleKINGA Study
      • protocol_noECCT/18/05/02
      • version_no2.3
      • date_of_protocol28-02-2018
      • study_drugTruvada - Immunogenetic Modulators (KINGA Study)
      • disease_conditionHuman Immunodeficiency Virus
      • 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_nameTenofovir Disoproxil Fumarate 300mg / Emtricitabine 200mg (TDF/FTC)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
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      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
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      • applicant_registration_ctr(null)
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      • applicant_hard_copies(null)
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      • applicant_contractual_agreement(null)
      • declaration_applicantPeter Mogere
      • declaration_date103-05-2018
      • declaration_principal_investigatorDr. Nelly Mugo
      • declaration_date203-05-2018
      • placebo_presentNo
      • study_objectives<p>\n  <strong>Primary Objective:</strong></p>\n<ul>\n <li>\n To identify mucosal immunoregulatory mechanisms in host response to natural heterosexual exposure to HIV-1.</li>\n <li>\n To determine how high priority variants in <em>CD101 </em>and <em>UBE2V1</em> modify host mucosal responses to HIV-1 exposure and infection.</li>\n</ul>\n<p>\n <strong>Secondary Objective:</strong></p>\n<p>\n 1) <u>Identify factors influencing immunoregulatory mechanisms in host response to HIV-1</u></p>\n<ul>\n <li>\n To evaluate the impact on host immunoregulatory responses from variation in cofactors including but not limited to</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n sexually transmitted infections and the host microbiome,</li>\n <li>\n HIV-1 exposure as defined by the frequency of sexual activity and the HIV-1 viral load in the HIV-1 infected partner, and</li>\n <li>\n HIV-1 prevention measures including antiretroviral PrEP provided to the HESN partner, or ART provided to the HIV-1 infected partner.</li>\n <li>\n Characteristics of sexual exposures (frequency, type and duration of sex acts)</li>\n</ul>\n<ul>\n <li>\n To assess the effect of biological factors such as host genetic factors, microbiome and virome constituents and viral genetic factors on these immunoregulatory responses.</li>\n <li>\n To determine how these immunogenetic responses may alter HIV-1 disease progression</li>\n</ul>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p style=\"margin-left:13.5pt;\">\n 2) <u>To evaluate how these immunogenetic regulatory mechanisms influence other infectious and immunological outcomes:</u></p>\n<ul>\n <li>\n To assess the role immunoregulatory mechanisms on host response to other infections (e.g., sexually transmitted infections and bacterial vaginosis),</li>\n <li>\n To define the role of these immunogenetic regulatory mechanisms in other acute and chronic manifestations of inflammation.</li>\n</ul>\n<p>\n  </p>\n<p>\n 3) <u>Evaluate the effect of PrEP on early HIV-1 disease</u></p>\n<ul>\n <li>\n Among initially HIV-1 uninfected individuals in the study who seroconvert to HIV-1, to assess the level of genital tract inflammation present prior to HIV-1 infection.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Tertiary Objectives</strong></p>\n<ul>\n <li>\n To utilize archived samples from this study for evaluation of immunogenetic and virologic determinants on inflammatory disorders, and HIV-1 and sexually transmitted infection (STI) acquisition, transmission and disease progression including viral phenotype and genotype, HIV-1 co-receptor usage, innate and adaptive immune polymorphisms, human genomic, microbiome and virome constituents and other biological factors.  </li>\n</ul>\n
      • principal_inclusion_criteria<div>\n The partner (HIV-1 uninfected) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study:</div>\n<ul>\n <li>\n Age ≥18 and ≤65 and able to provide independent informed consent for research per local regulations and guidelines</li>\n <li>\n Able and willing to provide written informed consent to be screened for and to take part in the study</li>\n <li>\n Part of a heterosexual couple in which either one or both partners meet the study eligibility criteria for partner (HIV-1 uninfected) participants.</li>\n</ul>\n<div>\n Potential index (HIV-1 infected) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study:</div>\n<div>\n  </div>\n<ul>\n <li>\n Of legal age to provide independent informed consent for research per local regulations and guidelines.</li>\n <li>\n Able and willing to provide written informed consent to be screened for and to take part in the study.</li>\n <li>\n Part of a heterosexual couple in which one partner meets the study eligibility criteria for index (HIV-1 infected) participants and the other partner meets the study eligibility criteria for partner (HIV-1 uninfected) participants, including the following criteria for the couple:</li>\n <li>\n Partners who are sexually active (defined as having had vaginal intercourse with the enrolled HIV-1 uninfected partner participant at least 6 times in the last three months)</li>\n <li>\n Partners plan to remain in the relationship for at least 6 months</li>\n <li>\n Current or previous use of antiretroviral therapy with unsuppressed HIV-1 viral load</li>\n <li>\n HIV-1 infected based on positive EIA and, when available, detectable viral load.</li>\n <li>\n No history of any clinical AIDS-defining diagnoses.</li>\n <li>\n Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures.</li>\n</ul>\n<div>\n  </div>\n
      • principal_exclusion_criteria<div>\n Potential partner (HIV-1 uninfected) participants who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:</div>\n<div>\n  </div>\n<ul>\n <li>\n Abnormal serum creatinine (based on sub-Saharan African normal values)</li>\n <li>\n Active and serious infections, including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy; active clinically significant medical problems including cardiac disease (e.g., symptoms of ischemia, congestive heart failure or arrhythmia), pulmonary disease (steroid dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication; and previously diagnosed malignancy expected to require further treatment.</li>\n</ul>\n<div>\n <ul>\n <li>\n Receiving ongoing therapy with any of the following at the time of enrollment: interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, metformin, aminoglycoside antibiotics, amphotericin B, cidofovir, systemic chemotherapeutic agents, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents</li>\n <li>\n At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data)</li>\n <li>\n Pregnant at the time of screening.</li>\n </ul>\n <div>\n Potential index (HIV-1 infected) participants who meet any of the following criteria (by selfreport, unless otherwise indicated) will be excluded from the study:</div>\n <div>\n  </div>\n <ul>\n <li>\n Current or previous use of antiretroviral therapy with suppressed HIV-1 viral load</li>\n <li>\n Currently enrolled in another HIV-1 treatment trial</li>\n <li>\n At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives.</li>\n <li>\n Pregnant at the time of screening</li>\n </ul>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<p>\n This is a prospective observational study that intends to understand the role of immunological responses to HIV-1 that occur in the genital mucosa. This is important since genital mucosal tissues presents the portal of entry for heterosexually transmitted HIV-1 infection. There being HIV serodiscordant couples participating in the study, HIV seroconversion will be an endpoint.</p>\n
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      • scope_prophylaxis1
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      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
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      • trial_administration_humans0
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      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Partners in Health & Research Development (Formerly Partners in Prevention), has 38 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff ).</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Principal Investigator: Dr. Nelly R. Mugo  MBCHB,MMED,MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Co-Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term HIV-1 serodiscordant partnerships, i.e. where one partner is HIV-1 infected and the other uninfected. </span>A challenge to development of HIV-1 vaccines is to better understand the natural immune mechanisms for protection from HIV-1 infection. To this end, immunologists have increasingly appreciated the importance of regulatory T cells in peripheral blood that modulate the magnitude and characteristics of the host inflammatory response including against infectious diseases. We have also recently identified specific host genetic variants in the genes <em>CD101 </em>and <em>UBE2V1 </em>that appear to strongly predispose to HIV-1 infection risk and may act through regulatory T cells and other immunologic pathways. Most of the sample analyses leading to the conception of this concept was conducted on speciemen samples collected in previous studies conducted in Kenya. As it is with other East African countries, Kenya has the highest number of individuals in HIV serodiscordant relationships. Kinga study seeks to explore the immunogetic responses that will in the end might offer an understanding of how to come up with an effective vaccine against HIV.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU - 13th March 2018</p>\n<p>\n UW IRB          -  18th May 2017</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 years
      • 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-CCR - Partners in Health Research & Development (PHRD) Thika Site.
      • single_site_physical_addressPartners in Prevention House, Thika Section 9, OAU Road
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone067 2222561/0725641110
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site500 heterosexual Kenyan couples
      • total_participants_worldwide500 heterosexual Kenyan couples
      • 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_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJairam
      • investigator1_middle_nameRao
      • investigator1_family_nameLingappa
      • investigator1_qualificationMD, PHD
      • investigator1_professional_addressInternational Clinical Research Center Department of Global Health, University of Washington Ninth and Jefferson Building 908 Jefferson, 12th floor, Room 1231 Seattle, WA 98104
      • investigator1_telephone+1-206-520-3822
      • investigator1_emaillingappa@uw.edu
      • organisations_transferred_Yes
      • number_participants500 heterosexual Kenyan couples
      • notification
      • approval_date26-07-2018
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-03-2020
      • 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)
      • modified2021-07-06 12:56:35
      • created2018-03-22 13:35:47
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id416
        • application_id658
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MMeD, MPH
        • professional_address19865 - 00202
        • telephone067 2222561/0723914057
        • emailrwamba@csrtkenya.org
        • created2018-03-22 13:37:48
        • modified2020-03-31 18:06:00
    • SiteDetail(array)
      • 0(array)
        • id534
        • application_id658
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-03-22 13:37:48
        • modified2020-03-31 18:06:00
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id332
        • application_id658
        • sponsorFred Hutchinson Cancer Research Center, University of Washington
        • sponsor_typeOthers
        • contact_personDr. Nelly R. Mugo
        • address19865 - 00202
        • telephone_number067 2222561
        • fax_number
        • cell_number0723914057
        • email_addressrwamba@csrtkenya.org
        • created2018-03-22 13:37:48
        • modified2020-03-31 18:06:00
  • 2(array)
    • Application(array)
      • id155
      • user_id73
      • trial_status_id7
      • abstract_of_study<p>\n <strong>Design </strong>: Longitudinal Cohort Study</p>\n<p>\n <strong>Population</strong>: HIV-1 infected boys and girls age 9-14 years without clinical AIDS</p>\n<p>\n <strong>Study Size</strong>: 100 girls and 80 boys</p>\n<p>\n <strong>Treatment Plan</strong>: Three doses of intramuscular quadrivalent HPV vaccine 'Gardasil' administered at enrolment, month 2 and month 6.</p>\n<p>\n <strong>Study Duration</strong>: Each participant will be in the study for a total of 12 months.</p>\n<p>\n <strong>Outcome Variable</strong>: Antibody response to HPV vaccine will be tested at enrolment, month 7 and month 12. Second variable will be an assessment of safety and tolerability to the vaccine.</p>\n<p>\n <strong>Primary Objective</strong>: To determine the immunogenicity of quadrivalent HPV vaccine among HIV infected girls and boys age 9-14 years in Kenya.</p>\n<p>\n <strong>Secondary Objective: </strong></p>\n<ol>\n <li>\n To correlate the immune response, as measured by antibody titers, with the degree of immunosuppression</li>\n <li>\n To assess safety and tolerability to the HPV vaccine among HIV infected girls and boys age 9-14 years.</li>\n</ol>\n<p>\n <strong>Study Location</strong>: Partners in Prevention, Thika site, OAU Road, Off Kenyatta Avenue Section 9</p>\n
      • study_title<p>\n Immunogenicity and Safety of quadrivalent human Papillomavirus Vaccine in HIV-Infected pre-adolescent girls and boys in Kenya.</p>\n
      • laymans_summary<p>\n HPV is a common sexually transmitted infection that affects 80% of women and 65-70% of men.  The majority of HPV infections occur soon after a person becomes sexually active, typically between the ages of 14-24 years.  A vaccine called GARDASIL® can protect against some types of HPV (6, 11, 16 & 18). Cervical cancer affects the mouth of the uterus (cervix), and is the second commonest cancer among women. Half a million women get this cancer each year and of those who get cervical cancer, about half die. The majority of women who get cervical cancer live in sub Saharan African countries like Kenya. This disease can be prevented if detected before it becomes cancerous using a Pap smear. Most of the time, certain types of HPV (called Type 6, Type 11, Type 16, and Type 18) are responsible for cervical cancer, cancers of the vulva or vagina, precancerous cervical, vaginal and vulva lesions, and genital warts. Studies on vaccines have already been done in children who do not have HIV, and the vaccine is already being used to protect against the above diseases. The aim of this study is to confirm the safety, usefulness and long term effectiveness of this vaccine in HIV positive children so that they can get the benefits from this vaccine and assist investigators to determine the need for booster dosing.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • short_titleHIV/HPV-Adolescent Study
      • protocol_noECCT/12/02/02
      • version_no1.0
      • date_of_protocol27-06-2011
      • study_drugGardasil
      • disease_conditionHumanpapillomavirus infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Kenneth Ngure
      • declaration_date101-07-2011
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo, Principal Investigator
      • declaration_date201-07-2010
      • placebo_presentNo
      • study_objectives<p>\n <strong>Aim 1:</strong> To assess sustained efficacy for up to 48 months of the quadrivalent human papillomavirus vaccine (Gardasil®) vaccine in HIV infected girls and boys ages 9-14 in Kenya.</p>\n<p>\n <strong>Aim 2</strong>:  To determine factors associated with sustained IgG LIA antibody after 3 doses of quadrivalent HPV vaccination such as sex, age, immune reconstitution with highly active antiretroviral therapy as determined by CD4 cell %, plasma HIV RNA and WHO disease stage classification</p>\n<p>\n <strong>Aim 3: </strong>To assess incidence of genital oncogenic HPV and HPV- type 6, 11 infections among sexually active  HIV infected adolescent vaccinated with 3 doses of quadrivalent HPV vaccination</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n 1.Laboratory confirmed HIV infection</p>\n<p>\n 2.Age range 9-14 years</p>\n<p>\n 3.Parental or guardian consent and participant assent</p>\n
      • principal_exclusion_criteria<p>\n 1. Severly ill as defined by Karnofsky score (<span style=\"color: rgb(0, 0, 0);\">< 70</span>)</p>\n<p>\n 2.A diagnosis of malignancy</p>\n<p>\n 3.On-going febrile illness (temperature ≥ 37.8 degrees celsius) including active treatment of an opportunistic infection.</p>\n<p>\n 4.Have received systemic corticosteroids within prior one year.</p>\n<p>\n 5.Have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks.</p>\n<p>\n 6.History of allergy to any products included in the HPV vaccine.</p>\n<p>\n 7.Have received any of blood derivatives within prior 6 months</p>\n<p>\n 8.Are Pregnant</p>\n<p>\n 9.Lack of parental consent and/or child declines to provide assent.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • primary_end_points<p>\n To determine the immunogenicity of quadrivalent HPV vaccine among HIV infected girls and boys ages 9-14 in Kenya.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • 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_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p>\n Principal Investigator: Dr. Nelly R. Mugo  MBCHB,MMED,MPH</p>\n<p>\n Study coordinator/Co-invetigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p>\n Lead Physician: Dr. Njambi Njuguna  MBCHB, MPH</p>\n
      • other_details_explanation<p>\n The Principal Investigator is Kenyan and has proposed to conduct this single site study to provide data on immunogenicity of Gardasil Vaccine among HIV infected boys and girls. Notably, Gardasil Vaccine is already registered for use in Kenya for the general population.</p>\n
      • other_details_regulatory_notapproved<p>\n None pending</p>\n
      • other_details_regulatory_approved<p>\n 1.KNH/UON-ERC Approved 1 site in Kenya (Thika) on February 2, 2012</p>\n<p>\n 2.University of Washington IRB, approved 1 site in Kenya (Thika) on January 6, 2012</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration48 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_areaThika
      • single_site_physical_addressPartners in Prevention, Thika site, OAU Road, Off Kenyatta Avenue Section 9
      • single_site_contact_personDr. Nelly R. Mugo
      • single_site_telephone06722561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide180
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • 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_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyHIV POSITIVE BOYS AND GIRLS AGE 9-14
      • investigator1_given_nameDr. Nelly
      • investigator1_middle_nameRwamba
      • investigator1_family_nameMugo
      • investigator1_qualificationMBCHB, MMED, MPH
      • investigator1_professional_address19865-00202
      • investigator1_telephone067-22561, 0723914057
      • investigator1_emailRwamba@csrtkenya.org
      • organisations_transferred_Yes
      • number_participants180
      • notification<p>\n This study has already been approved.</p>\n
      • approval_date22-05-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-06-2021
      • 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)
      • modified2025-03-05 13:43:11
      • created2013-06-24 14:12:57
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id99
        • application_id155
        • given_nameDr. Nelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBCHB,MMED, MPH
        • professional_address19865-00202
        • telephone067-22561, 0723914057
        • emailRwamba@csrtkenya.org
        • created2013-06-25 11:03:30
        • modified2021-06-18 15:57:30
    • SiteDetail(array)
      • 0(array)
        • id126
        • application_id155
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        • site_name
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        • contact_details
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        • misc(null)
        • created2013-06-25 11:03:30
        • modified2021-06-18 15:57:30
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id80
        • application_id155
        • sponsorMerck Investigators Study Program (MISP)
        • sponsor_typeIndustry
        • contact_personDr. Nelly R. Mugo
        • address19865-00202
        • telephone_number067-22561
        • fax_number
        • cell_number0723914057
        • email_addressRwamba@csrtkenya.org
        • created2013-06-25 11:03:30
        • modified2021-06-18 15:57:30
  • 3(array)
    • Application(array)
      • id610
      • user_id81
      • trial_status_id5
      • abstract_of_study<div>\n Our study will assess the impact of an intervention consisting of a consensus acute HIV infection risk score algorithm for acute and prevalent (i.e., seropositive) HIV testing among 1,500 adult patients aged 18-39 years who seek urgent care for symptoms at primary care facilities. We will link all newly diagnosed HIV-infected patients to care, offer immediate treatment, and offer assisted partner notification, evaluation for prevalent or acute HIV infection, and either antiretroviral therapy (if HIV-infected) or pre-exposure prophylaxis (if uninfected with a serodiscordant, HIV-positive partner). We will also model the potential impact of the AHI testing and assisted partner notification interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life-year (DALY) averted using data on outcomes from our innovative program.</div>\n<div>\n  </div>\n<div>\n We will use a modified stepped wedge design to evaluate the yield of the AHI testing intervention at 2-4 public and 2-4 private health facilities in Kenya, before (1,375 patients) and after (1,500 patients) intervention delivery. We expect to diagnose over two-fold more HIV infections through this intervention than are currently diagnosed through provider-initiated testing and counselling. Assisted partner notification should identify at least two-fold more previously undiagnosed individuals for each index case identified than passive referral strategies (the current standard of care), augmenting intervention impact. Through modelling, we will estimate the impact of this combined intervention on HIV transmission and evaluate the potential cost-effectiveness of such an approach under a wide range of estimations. We expect this work to provide invaluable data that will help improve HIV testing and treatment as prevention in sSA.</div>\n
      • study_title<p>\n Impact of a novel HIV-1 RNA testing intervention to detect acute and prevalent HIV infection and reduce HIV transmission – Tambua Mapema Plus</p>\n
      • laymans_summary<div>\n <strong>What is the problem/background?</strong></div>\n<div>\n Patients who seek health care for symptoms are occasionally tested for prevalent HIV (i.e. positive on rapid antibody tests). A small proportion (~1%) of patients who test negative for prevalent HIV may actually have ‘acute HIV’ (i.e. positive on a special test, qualitative X-pert RNA test) as the cause of their symptoms. Patients with acute HIV infection (AHI) are very infectious and would benefit from early diagnosis and early treatment, and their partners would benefit from prompt notification and evaluation.</div>\n<div>\n  </div>\n<div>\n <strong>What questions are we trying to answer?</strong></div>\n<div>\n We will test whether a new AHI testing intervention will identify more HIV infections (both prevalent and acute HIV) compared to standard testing (provider-initiated testing and counselling, PITC for prevalent HIV) among patents aged 18-39 years seeking care for symptoms, and determine whether assisted partner notification and care navigation offered by HIV-1 RNA testing intervention staff will lead to more infections diagnosed among partners, more HIV-infected persons starting treatment, and more viral suppression among treated patients.</div>\n<div>\n  </div>\n<div>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></div>\n<div>\n The study will take place at six health facilities (2-4 government and 2-4 private) in Kilifi and Mombasa County. A total of 2875 patients seeking care and up to 300 partners of HIV-infected patients will be enrolled. Patients eligible for participation will be invited to participate upon urgent care seeking.</div>\n<div>\n  </div>\n<div>\n <strong>What does the study involve for those who are in it?</strong></div>\n<div>\n Participants will either be observed (PITC, comparison group) or undergo AHI testing intervention (both prevalent and AHI testing, intervention group). All participants will undergo a brief questionnaire about symptoms and sexual risk behavior. Participants who are diagnosed with acute or prevalent HIV infection will be asked about partners, who will be a contacted by research staff for HIV evaluation. All participants and partners diagnosed with HIV infection will be offered immediate treatment, and HIV-negative partners whose partner is HIV-infected will be offered pre-exposure prophylaxis (PrEP) for the duration of 6 months, or until viral suppression is achieved by the HIV-infected partner.</div>\n<div>\n  </div>\n<div>\n <strong>What are the benefits and risks/costs of the study for those involved?</strong></div>\n<div>\n Benefits include learning about research, obtaining accurate HIV status, immediate treatment when infected, and protecting one’s partner. There is some risk of loss of privacy or confidentiality.</div>\n<div>\n  </div>\n<div>\n <strong>How will the study benefit society?</strong></div>\n<div>\n Results of this study will be directly applicable to implementation of HIV-1 RNA testing intervention for acute and prevalent HIV infection among young adults in resource-limited settings. In addition, the diagnosis and immediate treatment of persons with acute and previously undiagnosed prevalent HIV infection will reduce HIV transmission risk.</div>\n<div>\n  </div>\n<div>\n <strong>When does the study start and finish?</strong></div>\n<div>\n The study will start in November 2017 and will continue for 4 years.</div>\n
      • short_titleTambua Mapema Plus
      • protocol_noECCT/17/08/07
      • version_no1.3
      • date_of_protocol06-03-2017
      • study_drugTenofovir disoproxil fumarate 300mg/ emtricitabine 200mg 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_nameTenofovir disoproxil fumarate 300mg/ emtricitabine 200mg tablets
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspmugo@kemri-wellcome.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantEduard Sanders, Co-PI
      • declaration_date123-06-2017
      • declaration_principal_investigatorSusan Graham, Co-PI
      • declaration_date223-06-2017
      • placebo_presentNo
      • study_objectives<div>\n <strong>General Objective</strong>: To conduct a proof-of-concept study to test the efficacy of a health facility-based HIV-1 RNA testing intervention to identify acute (i.e., RNA-positive, seronegative or discordant rapid results) and prevalent (i.e., RNA-positive, seropositive) HIV infection.</div>\n<div>\n  </div>\n<div>\n <strong>Specific Objectives:</strong></div>\n<div>\n 1. To identify and test 1,500 adults identified by our HIV-1 RNA testing intervention for acute and prevalent (i.e., seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment.</div>\n<div>\n 2. To offer assisted partner notification services (aPS) to all cases detected in objective 1, testing partners for acute and prevalent HIV infection and identifying local sexual networks.</div>\n<div>\n 3. To model the potential impact of the HIV-1 RNA testing and aPS interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life-year (DALY) averted using data on outcomes from our innovative program.</div>\n<div>\n 4. To conduct qualitative in-depth interviews with up to 60 newly diagnosed prevalent and AHI patients and seronegative partners in discordant relationships to gain insights into intervention uptake, including barriers and facilitators to ART or PrEP uptake and adherence in these groups.</div>\n<div>\n 5. To conduct interviews or focus groups with up to 60 individuals who work in the 6 health facilities where the trial will take place (up to 10 participants per facility), to obtain their views on the detection of acute HIV infection and the research carried out at the facility, including challenges to intervention scale-up.</div>\n
      • principal_inclusion_criteria<p>\n Volunteers will be included in the PrEP component of the study if they meet the following criteria:</p>\n<p>\n 1. Sexual partner to a newly diagnosed index case (prevalent or acute HIV)</p>\n<p>\n 2. Age over 18 years</p>\n<p>\n 3. HIV negative</p>\n
      • principal_exclusion_criteria<p>\n None</p>\n
      • primary_end_points<p>\n Proportion of participants with the following outcomes in the observation and intervention periods:</p>\n<ul>\n <li>\n tested for HIV infection;</li>\n <li>\n newly diagnosed with prevalent HIV; and</li>\n <li>\n newly diagnosed with AHI</li>\n</ul>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyCost-effectiveness
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyProof of concept of the HIV-1 RNA testing intervention
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <u>STAFF QUALIFICATIONS (see attached CVs for experience of core staff)</u></p>\n<p>\n <strong>PRINCIPAL INVESTIGATORS</strong></p>\n<p>\n Eduard Sanders, MD MPH PhD (Medical Epidemiologist)</p>\n<p>\n Susan Graham, MD MPH PhD (Consultant Infectious Diseases)</p>\n<p>\n  </p>\n<p>\n <strong>SOCIAL SCIENCE</strong></p>\n<p>\n Elise Van der Elst, MA, PhD (Social Scientist)</p>\n<p>\n Bernadette Kombo, BA, MPH (Social Scientist)</p>\n<p>\n  </p>\n<p>\n <strong>CLINICAL</strong></p>\n<p>\n Clara Agutu, MBChB, MPH (Lead physician & Project Manager)</p>\n<p>\n Peter Mugo, BPharm MSc (Pharmacist)</p>\n<p>\n Salome Chira, DCM (Clinician & Study coordinator)</p>\n<p>\n Fred Ogada, DCM (Clinician)</p>\n<p>\n Joseph Nzioka, Dip (Counselor coordinator)</p>\n<p>\n Elizabeth Njogu, Dip (Counselor)</p>\n<p>\n Aisha Galole, Dip (Counselor)</p>\n<p>\n Nana Mukuria, Dip (Counselor)</p>\n<p>\n  </p>\n<p>\n <strong>LABORATORY</strong></p>\n<p>\n Caroline Ngetsa, Dip (Laboratory Manager)</p>\n<p>\n John Mwambi, Dip (Snr. Lab Technologist)</p>\n<p>\n Clara Karani, Dip (Lab Technologist)</p>\n<p>\n  </p>\n<p>\n <strong>REGULATORY & QUALITY ASSURANCE</strong></p>\n<p>\n Jennifer Kanungi, Dip Nursing (Study Co-ordinator)</p>\n<p>\n Esther Ndiang’ui, Dip IT (Quality Officer)</p>\n<p>\n  </p>\n<p>\n <strong>DATA AND ICT</strong></p>\n<p>\n Elizabeth Wahome, BSc, MSc (Data Manager & Epidemiologist)</p>\n<p>\n Cliff Oduor, BSc (data Manager)</p>\n<p>\n  </p>\n<p>\n <strong>COMMUNITY ENGAGEMENT & RETENTION</strong></p>\n<p>\n Evanson Gichuru, BSc Psych (Community Liaison Officer)</p>\n<p>\n Brenda Nekesa, Dip (community facilitator)</p>\n<p>\n Maureen Sikubali, Dip (Tracer)</p>\n<p>\n Masuu Paiki, Dip (Receptionist)</p>\n<p>\n  </p>\n<p>\n <strong>FINANCE & HUMAN RESOURCE</strong></p>\n<p>\n Lucie Ikumi, Dip (Project Administrator)</p>\n<p>\n Alice Khonde, Dip (Admin Assistant)</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The intervention is targeted at Kenya healthcare settings, hence the trial will be conducted in Kenya to enhance generalizability</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration4 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_otherYes
      • design_controlled_specifystepped wedge
      • design_controlled_comparatorstandard practice
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Mtwapa Research Clinic
      • single_site_physical_addressMtwapa, Kilif County, Kenya
      • single_site_contact_personDr. Clara Agutu
      • single_site_telephone+254 720735000
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site75
      • total_participants_worldwide75
      • 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_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameEduard
      • investigator1_middle_nameJ
      • investigator1_family_nameSanders
      • investigator1_qualificationMD MPH PhD
      • investigator1_professional_addressKEMRI-Wellcome Trust Research Programme, P.O. Box 230, Kilifi, 80108
      • investigator1_telephone+254 723 593762
      • investigator1_emailESanders@kemri-wellcome.org
      • organisations_transferred_Yes
      • number_participants75
      • notification
      • approval_date25-08-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-10-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n In sub-Saharan Africa, adult outpatients with symptoms of acute infectious illness are not routinely tested for prevalent or acute HIV infection (AHI) when seeking healthcare.</p>\n<p>\n  </p>\n<p>\n Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus</p>\n<p>\n AHI risk score. Patients with a risk score ≥2 and no previous HIV diagnosis were enrolled in</p>\n<p>\n a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing</p>\n<p>\n (NAAT), compared to standard provider-initiated HIV testing using rapid tests in the</p>\n<p>\n observation period. The primary outcome was the number of new diagnoses in each study</p>\n<p>\n period. Generalized estimating equations with a log-binomial link and robust variance</p>\n<p>\n estimates were used to account for clustering by health facility. The trial is registered with</p>\n<p>\n ClinicalTrials.gov NCT03508908.</p>\n<p>\n  </p>\n<p>\n Between 2017-2020, 13 (0.9%) of 1374 participants in the observation period and</p>\n<p>\n 37 (2.5%) of 1500 participants in the intervention period were diagnosed with HIV infection.</p>\n<p>\n Of the 37 newly diagnosed cases in the intervention period, 2 (5.4%) had AHI. Participants in</p>\n<p>\n the opt-out intervention had a 2-fold greater odds of being diagnosed with HIV (odds ratio:</p>\n<p>\n 2.2, 95% confidence interval: 1.39–3.51) after adjustment for factors imbalanced across</p>\n<p>\n study periods.</p>\n<p>\n  </p>\n<p>\n Among symptomatic adults aged 18-39 years targeted by our POC NAAT intervention, we identified one chronic HIV infection for every forty patients and one AHI patient for every 750 patients tested. While AHI yield was low in this population, routinely offered opt-out testing could diagnose twice as many patients as an approach relying on provider discretion.</p>\n
      • implication_results<p>\n Detection of acute and prevalent HIV infection using point-of-care nucleic acid amplification testing (POC-NAAT) among outpatients with symptoms compatible with acute HIV is critical to HIV prevention but it is not clear if it is cost-effective compared to existing HIV testing strategies. </p>\n<p>\n  </p>\n<p>\n We developed and parametrized a decision tree to compare the cost-effectiveness of: (1) provider-initiated testing and counseling (PITC) using rapid tests, the standard of care; (2) expanded PITC (E-PITC) in which all patients were tested with rapid tests unless they opted out; and (3) opt-out testing and counseling using POC-NAAT, which detects both acute and prevalent infection. We obtained data from the Tambua Mapema Plus randomized controlled trial of a POC-NAAT intervention in Kenya, supplemented with results from a stochastic, agent-based network model of HIV-1 transmission to evaluate population-level and HIV prevention impact. The analysis was conducted from the perspective of the Kenyan government using a primary outcome of cost per DALY averted over a 10-year time horizon.</p>\n<p>\n  </p>\n<p>\n The average per patient cost of POC-NAAT was $214.9 compared with $173.6 for E-PITC and $47.3 for PITC. The mean DALYs accumulated per patient for POC-NAAT were 0.160 compared with 0.176 for E-PITC and 0.214 for PITC. In the incremental analysis, E-PITC was eliminated due to extended dominance and the ICER comparing POC-NAAT to PITC was $3,098 per DALY averted. The ICER was sensitive to disability weights for HIV/AIDs and the costs of antiretroviral therapy.</p>\n<p>\n  </p>\n<p>\n Expanded POC-NAAT offered to adult outpatients in Kenya who present for care with symptoms compatible with AHI is cost-effective and should be considered for inclusion as the standard of HIV testing in this population.</p>\n<p>\n  </p>\n
      • quantity_imported300
      • quantity_dispensed31
      • quantity_destroyed269
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2023-03-09 10:58:01
      • created2017-06-15 12:29:03
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id388
        • application_id610
        • given_nameEduard
        • middle_nameJ
        • family_nameSanders
        • qualificationMD MPH PhD
        • professional_addressKEMRI-Wellcome Trust Research Programme, P.O. Box 230, Kilifi, 80108
        • telephone+254 723 593762
        • emailESanders@kemri-wellcome.org
        • created2017-06-15 12:51:45
        • modified2020-10-07 11:20:46
      • 1(array)
        • id390
        • application_id610
        • given_nameSusan
        • middle_nameM
        • family_nameGraham
        • qualificationMD MPH PhD
        • professional_addressUniversity of Washington School of Medicine, Box 359909, 325 9th Avenue, Seattle, WA 98104-2499
        • telephone(206) 543 4278
        • emailgrahamsm@u.washington.edu
        • created2017-06-20 12:02:57
        • modified2020-10-07 11:20:46
    • SiteDetail(array)
      • 0(array)
        • id492
        • application_id610
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2017-06-15 12:51:45
        • modified2020-10-07 11:20:46
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id312
        • application_id610
        • sponsorDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), United States (US)
        • sponsor_typeOthers
        • contact_personUsha Sharma
        • addressClinical Prevention Research Branch, PSP, DAIDS, NIAID, NIH, DHHS, 5601 Fishers Lane, Rm 8C29, Bethesda, MD 20892
        • telephone_number+1 240-292-4809
        • fax_number
        • cell_number+1 240-292-4809
        • email_addressusharma@niaid.nih.gov
        • created2017-06-15 12:51:45
        • modified2020-10-07 11:20:46
  • 4(array)
    • Application(array)
      • id654
      • user_id32
      • trial_status_id5
      • abstract_of_study<div style=\"text-align: justify;\">\n In 2012, the WHO Strategic Advisory Group of Experts (SAGE) on immunizations made a recommendation for influenza vaccination of pregnant women. This was based upon compelling evidence of substantial risk of severe disease in this group and the safety and effectiveness of seasonal influenza vaccine in preventing disease in pregnant women as well as their young infants, in whom disease burden is also high. Sub-Saharan Africa has a high prevalence of HIV and malaria, the presence of which among expectant mothers can reduce response to influenza vaccination, and therefore affect transfer of vaccine-induced antibodies to their newborn babies. There is no documention on the effect of malaria parasitemia on influenza vaccination in pregnant women and their newborns. Few studies have shown reduced immunogenicity of influenza vaccine and associated antibody transfer among pregnant women with HIV, however the studies were done late in the course of pregnancy. We propose to conduct an influenza vaccine demonstration project, using an Inactivated Influenza Vaccine (IIV) already licensed in Kenya to vaccinate pregnant women in a high HIV prevalence and malaria-endemic setting in western Kenya. Documentation of vaccine-induced antibody transfer from vaccinated mothers to their babies is essential and key to informing the Kenya Ministry of Health on maternal immunization policy and strategy for these high-risk groups. Western Kenya is a resource-limited setting with high burden of influenza disease among infants. Vaccinating pregnant women for better outcomes in both mother and infant would therefore be a cost effective strategy in preventing influenza disease in two high-risk groups. Data from this study will also help inform influenza vaccine deployment in other countries with similar HIV and malaria profiles. If adopted by the government, maternal influenza immunization could be an important public health strategy in resource constrained settings to protect infants <6 months, not eligible for influenza vaccination themselves, and their mothers from influenza disease and associated complications.</div>\n<div>\n  </div>\n
      • study_title<p>\n Impact of HIV Infection and Malaria Parasitemia on Immunogenicity of Inactivated Influenza Vaccine in Pregnant Women and on Mother-to-Child Vaccine-induced Antibody Transfer</p>\n
      • laymans_summary<p>\n Studies have shown that influenza can be severe among pregnant women and newborn babies. Influenza vaccination during pregnancy can protect pregnant women. Also, women vaccinated against influenza during pregnancy can pass on protective antibodies to their babies who are too young (<6 months of age) to be directly vaccinated. Influenza vaccination has been offered to pregnant women around the world for many years and data show the vaccine to be safe, for the mother and their unborn babies. Based on evidence from such studies, the advisory group of experts on immunization from the WHO recommended influenza vaccination to pregnant women. Sub-Saharan Africa has a high percentage of the population suffering from HIV and malaria; these diseases may affect how pregnant women respond to influenza vaccine and therefore affect the amount of protection transfered to their newborn babies. We propose to carry out a demonstration project using an influenza vaccine licensed in Kenya to vaccinate pregnant women in a setting of western Kenya with high rates of HIV among the population and malaria presence throughout the year. Results from this study will inform the Ministry of Health on policy and startegies for vaccinating mothers to protect these two high-risk groups. These results will also be applicable to other countries with similar HIV and malaria burden and may inform their policies on vaccination of pregnant women.</p>\n
      • short_titleMaternal Influenza Vaccine Study
      • protocol_noECCT/18/04/02
      • version_no1.1
      • date_of_protocol03-11-2017
      • study_drugInactivated Influenza Vaccine
      • disease_conditionInfluenza
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstonysangke@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Tony Sang
      • declaration_date103-05-2018
      • declaration_principal_investigatorNancy Otieno
      • declaration_date203-05-2018
      • placebo_presentNo
      • study_objectives<div>\n Primary Objectives</div>\n<ol>\n <li>\n To evaluate the immunogenicity of IIV in HIV-infected pregnant women and women with peripheral malaria parasitemia at the time of vaccination.</li>\n <li>\n To evaluate the level of vaccine-induced influenza antibody transfer to infants of HIV-infected and uninfected pregnant women who receive IIV early in pregnancy.</li>\n <li>\n To evaluate the level of vaccine-induced influenza antibody transfer to infants of mothers who had peripheral malaria parasitemia by Rapid Diagnostic Test for malaria at the time of influenza vaccination during pregnancy.</li>\n</ol>\n<div>\n  </div>\n<div>\n Secondary Objectives</div>\n<ol>\n <li>\n To evaluate the impact of HIV infection and peripheral malaria parasitemia on the duration of influenza vaccine-induced antibodies transferred to infant.</li>\n</ol>\n
      • principal_inclusion_criteria<ol>\n <li>\n Pregnancy confirmed by rapid urine pregnancy test for hCG or ultrasound</li>\n <li>\n Should have a singleton current pregnancy</li>\n <li>\n ≤20 weeks’ gestation by ultrasound, fundal height, or within 4 weeks of quickening</li>\n <li>\n Consents to HIV testing and counseling as required</li>\n <li>\n Does not plan to relocate out of the study area or population-based surveillance site in the next 15 months and agrees to all follow-up visits and study procedures.</li>\n <li>\n Provides informed consent by signature or thumb print</li>\n <li>\n Not currently enrolled in another intervention study</li>\n <li>\n Must be willing to deliver in the labor ward of the study hospital</li>\n <li>\n No history of chronic illness requiring multiple hospitalizations or prolonged medical therapy (except HIV on HAART)</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n History of allergic reaction to any component of the study vaccine (e.g allergy to eggs or chicken products)</li>\n <li>\n Planning to relocate out in the 15 months following enrollment</li>\n <li>\n Received immunoglobulin or blood products within 45 days of study entry</li>\n <li>\n Used immunosuppressive medication within 45 days of study entry (inhaled and topical corticosteroids permitted)</li>\n <li>\n Multiple pregnancy (twins, triplets, etc.)</li>\n <li>\n Current enrollment in another interventional study</li>\n <li>\n Gestational age >20 weeks by last menstrual period or fundal height</li>\n <li>\n Hemoglobin <7.0 g/dL</li>\n <li>\n Influenza vaccination in previous 12 months</li>\n <li>\n Unable to give informed consent (for example due to mental disability).</li>\n <li>\n Acutely ill with temperature ≥37.5°C Axillary/38°C Oral on the day of vaccination (will be deferred and can be enrolled after treatment and fever is resolved).</li>\n</ol>\n
      • primary_end_points<ol>\n <li>\n To evaluate the immunogenicity of IIV in HIV-infected pregnant women and women with peripheral malaria parasitemia at the time of vaccination.</li>\n <li>\n To evaluate the level of vaccine-induced influenza antibody transfer to infants of HIV-infected and uninfected pregnant women who receive IIV early in pregnancy.</li>\n <li>\n To evaluate the level of vaccine-induced influenza antibody transfer to infants of mothers who had peripheral malaria parasitemia by Rapid Diagnostic Test for malaria at the time of influenza vaccination during pregnancy.</li>\n</ol>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • 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_controlledNo
      • site_capacity(null)
      • staff_numbers<div style=\"text-align: justify;\">\n <div>\n The study is to be conducted in Siaya County at two study sites namely Siaya County Referral Hospital (SCRH)and Bondo Sub-county Referral Hospital (BSRH). These are among the largest hospitals in the county with adequate equipment and structures. Siaya County Referral hospital has a Clinical Research Centre(CRC) and this is where the study will be conducted. The study personnel that will handle the study participants are well trained professionally and all of them have undergone intensive Good Clinical Practice(GCP) training. Most of the study staffs have participated in other previous clinical trials and therefore have the expertise and experience of the same.</div>\n <div>\n  </div>\n <div>\n The study is be headed by Dr. Sandra Shaves who is a medical doctor and Nancy Otieno both of which have vast experience in research in human subjects, they are the Principal Investigators, among the Coinvestigator there is Michael Otieno who is also the study coordinator, Michael is a clinical officer with a lot experience of about 8 years in clinical trials, he has worked in Rotateq Vaccine clinical trial and Malaria vaccine clinical trials, the study doctor is Dr. Allan Dungani who is also participating in Malaria vaccine clinical trial as study doctor. Dr. Tony Sang is the study pharmacist. Dr. Sang is well experienced in handling the clinical trials with more than 10 years on the same. He has participated in more than 3 vaccine clinical trials and many drug trials. The study has 10 nurses, 3 clinicians, 6 lab technologists, 3 quality assurance officers, data manager and analysts, and 10 field technicians.</div>\n <div>\n  </div>\n <div>\n The laboratory department where the samples will be handled and processed before shipment for further analysis and even stored has undergone the ISO certification. The lab staffs have all undergone the good clinical and laboratory practice training (GCLP), the lab staffs have as well participated in previous clinical trials</div>\n <div>\n  </div>\n <div>\n The clinical staffs that will be directly involved in handling the study participants have adequate skills to manage and handle any eventuality that may arise in the course of the duration of the study. Adequate preparation has been made in terms of equipment and other supplies required for the study All the staffs have undergone the protocol training and are well conversant with the study design and procedures.</div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The trial is to be conducted in Kenya due to the high prevalence of HIV and malaria.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<ol>\n <li>\n KEMRI Scientific & Ethics Review Unit approved this protocol as per letter dated XXXXXXX</li>\n</ol>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration2.5 years
      • 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_sites2
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteSiaya - 156\nBondo - 156
      • total_participants_worldwide312
      • 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_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNancy
      • investigator1_middle_name
      • investigator1_family_nameOtieno
      • investigator1_qualificationMA, PhDc
      • investigator1_professional_addressKEMRI-CGHR, Kisumu, Kenya
      • investigator1_telephone+254 720 661 245
      • investigator1_emailnotieno@gmail.com
      • organisations_transferred_No
      • number_participants312
      • notification
      • approval_date04-06-2018
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-05-2020
      • 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)
      • modified2024-01-31 09:04:07
      • created2018-02-22 10:14:08
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id413
        • application_id654
        • given_nameSandra
        • middle_nameS
        • family_nameChaves
        • qualificationMD, MSc
        • professional_addressUS Centers for Disease Control and Prevention (CDC), Nairobi, Kenya
        • telephone+254 20 2867 000
        • emailSChaves@cdc.gov
        • created2018-02-22 10:16:45
        • modified2020-05-08 11:23:15
    • SiteDetail(array)
      • 0(array)
        • id530
        • application_id654
        • county_id41
        • site_nameSiaya County Referral Hospital
        • physical_addressSiaya Town
        • contact_detailsP.O. Box 144-60400
        • contact_personNancy Otieno
        • site_capacity(null)
        • misc(null)
        • created2018-02-22 10:16:45
        • modified2020-05-08 11:23:15
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 1(array)
        • id531
        • application_id654
        • county_id41
        • site_nameBondo Sub-County Hospital
        • physical_addressBondo Town
        • contact_detailsP.O Box 595-40601
        • contact_personNancy Otieno
        • site_capacity(null)
        • misc(null)
        • created2018-02-22 11:59:52
        • modified2020-05-08 11:23:15
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id330
        • application_id654
        • sponsorUS Centers for Disease Control and Prevention, Influenza Division
        • sponsor_typeResearch Institution
        • contact_personSandra S Chaves
        • addressUS Centers for Disease Control and Prevention (CDC), Nairobi, Kenya
        • telephone_number+254 710 602 748
        • fax_number
        • cell_number+254 20 2867 000
        • email_addressschaves@cdc.gov
        • created2018-02-22 10:16:45
        • modified2020-05-08 11:23:15
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 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

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