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      • id669
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      • abstract_of_study<p>\n Safe and Effective Contraception is a universal right for all men and women. Many women of reproductive age are unable to  use the current contraception methods available to them and rely on their male partners to protect them from unplanned pregnancy.  A majority of men surveyed internationally reported interest and willingness to use contraceptive methods; unfortunately no safe, highly effective reversible method is available to men interested in sharing the responsibility of family planning.The primary objective  of the CCN017 male contraception study is to determine the contraception efficacy, safety and acceptablily for a couple provided by daily application of the male partner of a gel containing Nesteron 8mg and Testesterone 62mg (NES 8/T 62) for a period of 52 weeks</p>\n<p>\n <strong>Methodology</strong></p>\n<p>\n This is a prospective, phase IIb, open label, single arm, multicenter study. The study consists of a screening phase lasting 4 to 8 weeks, a suppression phase estimated to last up to 20 weeks, a 52- week maintenance/efficacy phase, and a 24-week (estimated) recovery phase.  The study population will comprise healthy men ages 18 – 50 years, involved in a stable, monogamous, relationship  with an 18 – 34 year-old female partner (at the time of enrolment) with regular cycles per patient report from her previous non-hormonal contraceptive gynecology history. Across all sites, the study will enrol 420 couples into the suppression phase. The Couples Counselling Clinic will aim to enrol 60 couples into the suppression phase.Questionnaires will be administered during the study in the Couples Counselling Clinic, with the exception of the 7-Day Validated Psychosexual Daily Questionnaire that will be completed by the participant at home.  Blood samples for laboratory analyses will be collected at visits throughout each phase of the study for processing at both the central laboratory and at Pathology Lancet Kenya.</p>\n<p>\n <strong>Informed Consent</strong></p>\n<p>\n The principles of informed consent will be implemented according to the Declaration of Helsinki in its currently acknowledged version, ICH Consolidated Good Clinical Practice, KNH/UON Ethics Review committee.   Participants male and female, that agree to voluntarily participate in the study must sign the informed consent form (ICF) prior to study-specific procedures.</p>\n
      • study_title<h1>\n <em><strong><span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Clinical Evaluation of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception.</span></span></strong></em></h1>\n<h1>\n  </h1>\n
      • laymans_summary<p>\n Forty percent (40%) of preg- nancies globally are un- planned. Many women are unable to use hormonal con- traceptives due to the side effects.  International surveys show that men are interested and willing to use male contracep- tion to support their female partners</p>\n<div>\n Current contraception options available for men are con- doms and vasectomies.</div>\n<div>\n More options are needed to support men in meeting their contraceptive needs.</div>\n<div>\n  </div>\n<div>\n OUR STUDY</div>\n<div>\n We are conducting and international, multicenter clinical trial study for male birth control. Our Mission is to develop safe and effective contraception for men.</div>\n<div>\n The primary objective of our study is to determine contracep- tive efficacy for a couple provided by daily application by the male partner of a gel containing testosterone (T) and Nestorone (NES) .</div>\n<div>\n The couples will be in the study for 2 years to test the safety and efficacy of the study gel</div>\n<div>\n Study Goal:</div>\n<div>\n To develop new forms of birth control for men that are:</div>\n<div>\n • Safe</div>\n<div>\n • Reversible</div>\n<div>\n • May be self-delivered</div>\n<div>\n • Affordable</div>\n<div>\n • Have health benefits for men</div>\n<div>\n  </div>\n<div>\n Study Gel</div>\n<div>\n General requirements for entering the study:</div>\n<div>\n Be heterosexual couple: Male, 18-50 years and fe- male, age 18-34 years.</div>\n<div>\n Sexually active, in a stable, monogamous relationship for at least 1 year and plan to be in the relationship for duration of the study duration.</div>\n<div>\n Willingness to accept a low but unknown risk of con- ceiving a pregnancy for the duration of the study.</div>\n<div>\n Live in Nairobi and its environs</div>\n<div>\n Female Partner:</div>\n<div>\n Have regular menstrual cycles of 21-35 days in duration, when not using hormonal contraception.</div>\n<div>\n Intend to remain in a monogamous relationship with male study partner during study.</div>\n<div>\n Not breastfeeding or pregnant.</div>\n<div>\n  </div>\n<div>\n Male Partner:</div>\n<div>\n Be in good health and of normal height and weight. No current disease ( eg diabetes, HIV, hepatitis).</div>\n<div>\n Able to fast for at least 8 hours during the study prior to blood draws and abstain from sex for 2-7 days prior to scheduled clinic visit.</div>\n<div>\n Able to provide semen sample by masturbation during clinic visits</div>\n<div>\n No history of depression or other serious mental health disorder, including use of an antidepressant</div>\n<div>\n No current or previous excessive alcohol use, illicit drug, including marijuana, or anabolic steroid abuse.</div>\n<div>\n A combination Gel with Nestorone® (NES) and Testos- terone (T) applied daily.</div>\n<div>\n The 5ml of the gel is applied on the upper arms and shoulders daily.</div>\n
      • short_titleCCNO17 Male contraception study.
      • protocol_noECCT/18/07/01
      • version_no3.0
      • date_of_protocol04-04-2018
      • study_drugNestorone (NES) and Testosterone (T) Combination Gel
      • disease_conditionContraception
      • 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_nameNES 8 mg/day + T 62 mg/day (NES-8/T-62) gel
      • product_type_medical_device_namemetered pump canisters
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressseshiwanin@gmail.com
      • applicant_covering_letter1
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      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
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      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Sheila Juliet Eshiwani
      • declaration_date125-06-2018
      • declaration_principal_investigatorDr John Kinuthia
      • declaration_date225-06-2018
      • placebo_presentNo
      • study_objectives<p>\n The overall goal of this study is to develop a hormonal contraceptive method for men that is effective, safe, reversible, self-delivered, user-controlled and affordable. The objective of this study is to determine whether application of a combined gel containing an androgen, Testosterone (T), and a progestin, Nestorone®, applied transdermally once per day will suppress spermatogenesis and be effective as a contraceptive method in healthy couples who wish to avoid pregnancy and are willing to use the method as their primary method of birth control.</p>\n<div>\n Primary objective</div>\n<div>\n The primary objective of the study is to determine the contraceptive efficacy for a couple provided by continued daily application by the male partner of a gel containing testosterone (T) and Nestorone (NES) for a period of 52 weeks (about 12 months).</div>\n<div>\n  </div>\n<div>\n  Secondary objectives</div>\n<div>\n The secondary objectives of the study are to assess safety and acceptability of the NES 8 mg/day + T 62 mg/day (NES-8/T-62) gel.</div>\n<div>\n  </div>\n
      • principal_inclusion_criteria<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" height=\"345\" width=\"568\">\n <tbody>\n <tr>\n <td style=\"width:564px;height:350px;\">\n <p style=\"margin-left:5.15pt;\">\n <strong>Male Partner – Inclusion Criteria</strong>: Men who meet all the following criteria will be eligible for enrollment in the trial:</p>\n <ol>\n <li>\n Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;</li>\n <li>\n 18 to 50 years of age, at the enrollment visit;</li>\n <li>\n BMI < 33 kg/m2;</li>\n <li>\n No history of androgen use in the six months prior to the first screening visit;</li>\n <li>\n Agreement to use an effective method of contraception with his female partner during the suppression and recovery phases and then only use the experimental method during the efficacy phase of the study;</li>\n <li>\n In the opinion of the investigator, the male participant is willing and able to comply with the protocol;</li>\n <li>\n The participant is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study’s provisions and has duly signed the informed consent form</li>\n <li>\n <p>\n Sexually active with a female partner (as specified below) with whom he has been in a stable, mutually monogamous relationship for at least 1 year prior to screening and with whom he intends to remain in a relationship for the duration of the study;</p>\n </li>\n <li value=\"9\">\n Normal reproductive state as demonstrated by:\n <ul>\n <li>\n Sperm concentration ≥15 million/mL in two semen samples and with no gross abnormalities of sperm motility and morphology on at least one semen sample assessment;</li>\n <li>\n Screening Testosterone within the study site’s local lab normal reference range for adult men;</li>\n </ul>\n </li>\n <li value=\"10\">\n Willingness to accept a low but unknown risk of conceiving a pregnancy for the duration of the trial.</li>\n </ol>\n <p style=\"margin-left:5.15pt;\">\n <strong>Female Partner – Inclusion Criteria: </strong>Women who meet all the following criteria will be eligible for enrollment in the trial:</p>\n <ol>\n <li>\n Good general health with no chronic medical conditions that result in periodic exacerbations which require significant medical care or are known to affect fertility;</li>\n <li>\n Aged between 18 and 34 years, inclusive, at the enrollment visit;</li>\n <li>\n Have regular menstrual cycles of 21-35 days in duration, per patient report, when not using hormonal contraception. If hormonal contraception has been used, the following applies:\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n If recently used intramuscular Depo-Provera must have had last injection at least 3 months prior enrollment;</li>\n <li>\n If using an IUD or an implant, she is planning to have this removed for purposes unrelated to enrollment in the study prior to entering the efficacy phase;</li>\n <li>\n Completion of her last pack of oral contraceptives or completion of effectiveness period for a monthly injection, patch or ring if any has been used prior to entering the efficacy phase;</li>\n </ol>\n </li>\n <li>\n Have intact uterus and both ovaries (waivers for women who have one ovary may be submitted so that the circumstances related to prior ovarian removal can be assessed);</li>\n <li>\n The participant is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study’s provisions and has duly signed the informed consent form (ICF);</li>\n <li>\n Consistent use of effective contraception during the preceding cycle prior to enrolling;</li>\n <li>\n No known infertility;</li>\n <li>\n Intends to remain in a monogamous relationship with male study partner (as specified above). (Note: this study will not provide her contraception for intercourse with any other male partners);</li>\n <li>\n Be at risk for pregnancy with participating male partner (heterosexual vaginal intercourse at least once per cycle and not sterilized);</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" height=\"626\" width=\"566\">\n <tbody>\n <tr>\n <td style=\"width:145px;height:877px;\">\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:564px;height:877px;\">\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p style=\"margin-left:5.15pt;\">\n <strong>Male Partner  </strong>Men who meet any of the following criteria are not eligible for enrollment in the trial:</p>\n<p style=\"margin-left:59.15pt;\">\n 1.            Men participating in another clinical trial involving an investigational drug within the last 30 days (or within five half-lives of the investigational drug, whichever is longer) prior to the first screening visit.</p>\n<p style=\"margin-left:59.15pt;\">\n 2.            Men not living in the catchment’s area of the study site or within a reasonable distance from the site.</p>\n<p style=\"margin-left:59.15pt;\">\n 3.            Clinically significant abnormal findings at screening per the Investigator’s medical judgment.</p>\n<p style=\"margin-left:59.15pt;\">\n 4.            Elevated PSA levels ≥ 4 ng/mL.</p>\n<p style=\"margin-left:59.15pt;\">\n 5.            Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction.</p>\n<p style=\"margin-left:59.15pt;\">\n 6.            Use of androgens or other anabolic steroids that may suppress gonadotropins within 6 months prior to the first screening visit.</p>\n<p style=\"margin-left:59.15pt;\">\n 7.            Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 3 measurements will be used to determine eligibility).</p>\n<p style=\"margin-left:59.15pt;\">\n 8.            History of hypertension, including hypertension controlled with treatment.</p>\n<p style=\"margin-left:59.15pt;\">\n 9.            Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.</p>\n<p style=\"margin-left:59.15pt;\">\n 10.          Known hypersensitivity to progestins or testosterone or any excipient of the investigational product.</p>\n<p style=\"margin-left:59.15pt;\">\n 11.          History of prostate, testicular or breast carcinoma.</p>\n<p style=\"margin-left:59.15pt;\">\n 12.          Significant prostatic symptoms (IPSS > 15).</p>\n<p style=\"margin-left:59.15pt;\">\n 13.          Known history of reproductive dysfunction including vasectomy or infertility.</p>\n<p style=\"margin-left:59.15pt;\">\n 14.          Known history of significant cardiac, renal, hepatic or prostatic disease.</p>\n<p style=\"margin-left:59.15pt;\">\n 15.          History of thromboembolic disease.</p>\n<p style=\"margin-left:59.15pt;\">\n 16.          A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV, or morbid obesity.</p>\n<p style=\"margin-left:59.15pt;\">\n 17.          Current active or ongoing Hepatitis infection.</p>\n<p style=\"margin-left:59.15pt;\">\n 18.          History of untreated sleep apnea.</p>\n<p style=\"margin-left:59.15pt;\">\n 19.          Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.</p>\n<p style=\"margin-left:59.15pt;\">\n 20.          Any known active or chronic dermatitis or other severe skin disorder.</p>\n<p style=\"margin-left:59.15pt;\">\n 21.          Any skin condition that might interfere with absorption of gel.</p>\n<p>\n Couples           desiring            fertility within   the       study   participation     period (approximately 104 weeks from screening to end of recovery).</p>\n<p style=\"margin-left:59.15pt;\">\n 23.          PHQ9 score ≥15 or history of severe depression or other serious mental health disorder, including ongoing use of an anti-depressant.</p>\n<p style=\"margin-left:59.15pt;\">\n 24.          Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) of a single application.</p>\n<p style=\"margin-left:59.15pt;\">\n 25.          Use of sex steroids or medications which might interfere with steroid metabolism (i.e. ketoconazole, finasteride, oral corticosteroids, dutasteride and statins).</p>\n<p style=\"margin-left:59.15pt;\">\n 26.          Use of anticoagulants.</p>\n<p style=\"margin-left:59.15pt;\">\n 27.          Use of medications that will interfere or interact with Nestorone or Testosterone (see <strong>Appendix 2</strong>).</p>\n<p style=\"margin-left:59.15pt;\">\n 28.          Use of oily cosmetic skin gels/products that would prevent absorption of steroids.</p>\n<p style=\"margin-left:59.15pt;\">\n 29.          Previous participation in this clinical trial.</p>\n<p style=\"margin-left:59.15pt;\">\n 30.          Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.</p>\n<p>\n  </p>\n<p style=\"margin-left:5.15pt;\">\n <strong>Female Partner – Exclusion Criteria:</strong></p>\n<p style=\"margin-left:59.15pt;\">\n 1.            Desire to become pregnant during the study.</p>\n<p style=\"margin-left:59.15pt;\">\n 2.            Breastfeeding.</p>\n<p style=\"margin-left:59.15pt;\">\n 3.            Known or suspected current alcoholism or drug abuse.</p>\n<p style=\"margin-left:59.15pt;\">\n 4.            Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.</p>\n<p style=\"margin-left:59.15pt;\">\n 5.            Currently pregnant.</p>\n<p style=\"margin-left:59.15pt;\">\n 6.            Known hypersensitivity to progestins or testosterone.</p>\n<p style=\"margin-left:59.15pt;\">\n 7.            History associated with impaired fertility (e.g. history of pelvic inflammatory disease, unilateral salpingectomy or endometriosis).</p>\n<p style=\"margin-left:59.15pt;\">\n 8.            Previous participation in this clinical trial.</p>\n<p>\n Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.</p>\n
      • primary_end_points<p>\n Twelve-month (365 days) cumulative contraceptive efficacy in couples, during the efficacy portion of the study, in which the male partner uses the product daily to suppress sperm production and the couple uses the method as their sole contraceptive method is the primary endpoint for this study. Kaplan-Meier methods will be used to estimate the twelve-month cumulative pregnancy probability (and 95% CI) in the typical use population </p>\n
      • scope_diagnosis0
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      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
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      • site_capacity(null)
      • staff_numbers<p class=\"MsoNormal\" style=\"margin-top:0cm;margin-right:.1pt;margin-bottom:9.55pt;\nmargin-left:0cm\">\n <b style=\"mso-bidi-font-weight:normal\"><span lang=\"EN-GB\">Study Site</span></b></p>\n<p class=\"MsoNormalCxSpMiddle\" style=\"margin-right:.1pt;mso-add-space:auto;\nline-height:150%\">\n <span lang=\"EN-GB\" style=\"color:black\">The</span><span lang=\"EN-GB\"> study will be located in our research clinic at Kenyatta National Hospital, located in the Couples Counselling Center. The Couple Counselling Center was founded in 2004 as a research study site by the Kenyatta National Hospital in collaboration with University of Washington. </span></p>\n<p class=\"MsoNormalCxSpMiddle\" style=\"margin-right:.1pt;mso-add-space:auto;\nline-height:150%;tab-stops:163.5pt\">\n <span lang=\"EN-GB\"><span style=\"mso-tab-count:\n1\">                                                       </span></span></p>\n<p class=\"MsoNormalCxSpLast\" style=\"margin-right:.1pt;mso-add-space:auto;\nline-height:150%\">\n <span lang=\"EN-GB\">The Couple Counselling Center has the following facilities to support conduct of research:</span></p>\n<p class=\"MsoListParagraphCxSpFirst\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">1.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Two reception areas</span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">2.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Six consultation/data collection rooms</span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">3.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Data management room</span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">4.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Pharmacy </span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">5.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Procedure room that will be used for semen collection.<span style=\"mso-spacerun:yes\">  </span></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -18pt; line-height: 150%; margin-left: 54pt;\">\n The study will employ the following staff;</p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">Site staff, names , qualifications and Experience</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">1 study coordinator</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">2 Clinical officer</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">1 nurse</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">2 Recruitment and retention Officers</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">1 data clerk</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">I Study administrator</span></span></strong></span></p>\n<p class=\"MsoNormalCxSpFirst\" style=\"margin-right:.1pt;mso-add-space:auto;\nline-height:150%\">\n <span lang=\"EN-GB\">Several studies involving couples have been conducted at the Couples Counselling Centre including <span style=\"mso-spacerun:yes\"> </span><span style=\"mso-spacerun:yes\"> </span>women’s reproductive lifecourse events and HIV transmission potential: The clinic is currently a Prevention and Care and treatment center for HIV affected couples and is also a site for the Impact of Periconceptual Vaginal Microbiota on Women’s Risk of Preterm Birth Study that is currently ongoing.  </span></p>\n<p>\n <strong>Laboratory procedures </strong></p>\n<p>\n Blood samples for laboratory analyses will be collected at visits throughout each phase of the study for processing at both the central laboratory and at Pathology Lancet Kenya. (Please see page 38-41 of the main study protocol ).</p>\n<p>\n <span lang=\"EN-GB\" style=\"color:black\">Pathologists Lancet Kenya Limited is part of the Lancet Group of Laboratories, originally founded in South Africa. <span style=\"mso-spacerun:yes\"> </span>The Main Laoratory in Nairobi is located at 5th Avenue Office Suites just opposite traffic headquarters.<span style=\"mso-spacerun:yes\">  </span><span style=\"mso-spacerun:yes\"> </span>T</span><span lang=\"EN-GB\">he laboratory is about 1.3kilometres from the Couple Counselling Center. </span></p>\n<p class=\"MsoNormalCxSpMiddle\" style=\"line-height:150%\">\n <span lang=\"EN-GB\" style=\"color:black\">The Pathologists Lancet Kenya will perform laboratory-screening tests for the determination of study eligibility of the participants. This include semen analysis, complete blood counts, clinical chemistry panel, full lipid panel and prostatic specific antigen.<span style=\"mso-spacerun:yes\">  </span></span></p>\n<p class=\"MsoNormalCxSpMiddle\" style=\"line-height:150%\">\n <span lang=\"EN-GB\" style=\"color:black\">Pathologists Lancet Kenya andrology department received SANAS accreditation in 2017. The department has two trained technologists who handle the semen samples. The laboratory runs about 100 semen lysis samples every month. 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      • other_details_explanation
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Kenyatta  National Hospital/ University of Nairobi Ethical review Comittee.  KNH/UoN ERC</p>\n<p>\n University of Washington Institutional Review Board (IRB)</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3years
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNo comparator
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaCouples counselling Center
      • single_site_physical_addressKenyatta National Hospital
      • single_site_contact_personDr John Kinuthia
      • single_site_telephone0722799052
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites
      • multi_country_list1)United States of America\nLos angeles biomedical Research Institute at Harbor- UCLA Medical\nUniversity of Washington\nUniversity of Kansas\n2)Chile, Chilean Institute of Reproductive Medicine, Santiago.\n3) Sweden Karolinsk Institute, Stockholm.\n4) United Kingdom, University of Manchester.\nUniversity of Edinburgh \n5)Italy, University of Bologna\n6) Kenya, Kenyatta National Hospital.\n
      • data_monitoring_committeeYes
      • total_enrolment_per_site40-70
      • total_participants_worldwide420
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Sheila
      • investigator1_middle_name
      • investigator1_family_nameEshiwani
      • investigator1_qualificationMBChB
      • investigator1_professional_addressPO BOX 30681 00100
      • investigator1_telephone0721236111
      • investigator1_emailseshiwanin@gmail.com
      • organisations_transferred_Yes
      • number_participants40-70
      • notification
      • approval_date19-11-2018
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-08-2020
      • 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)
      • modified2024-04-11 10:18:49
      • created2018-05-02 10:17:50
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id420
        • application_id669
        • given_nameDr John
        • middle_name
        • family_name Kinuthia
        • qualificationMBChB, MMed Obs/gyn MPH
        • professional_addressPO Box 20273-00202,Kenyatta National Hospital
        • telephone0722799052
        • emailkinuthia@uw.edu
        • created2018-05-02 10:53:03
        • modified2020-08-18 14:32:20
    • SiteDetail(array)
      • 0(array)
        • id537
        • application_id669
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-05-02 10:53:03
        • modified2020-08-18 14:32:20
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id335
        • application_id669
        • sponsorNational Institute of Health NIH (Eunice Shriver National institute of childhealth and human development NICHD
        • sponsor_typeResearch Institution
        • contact_personDr Jill Long
        • address6710B ROCKLEDGE DRIVE
        • telephone_number+13014961662
        • fax_number
        • cell_number+13014961662
        • email_addressjill.long@nih.gov
        • created2018-05-02 10:53:03
        • modified2020-08-18 14:32:20
      • 1(array)
        • id342
        • application_id669
        • sponsorPopulation Council.
        • sponsor_typeResearch Institution
        • contact_personDr Regine Sitruk-Ware
        • address1230 york avenue, New york,NY 10065 USA
        • telephone_number+13014961662
        • fax_number
        • cell_number+13014961662
        • email_addressfsitrukware@popcouncil.org
        • created2018-05-25 11:37:33
        • modified2020-08-18 14:32:20
  • 1(array)
    • Application(array)
      • id694
      • user_id408
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong>Background: </strong>According to WHO, Vitamin A is one of the essential micronutrient whose deficiency affects approximately one third of children under five years around the world. About 40,000 children die annually due to underweight and vitamin A deficiency in Kenya.  Nationally Vitamin A coverage is 40% with deficiency being ranked 7^th mortality risk factor (5^th in Busia) and an all spectrum prevalence of 61.8% in preschool children. Studies have recommended high-dose supplementation and zinc administration to deficient populations.</p>\n<p>\n  </p>\n<p>\n <strong>Objective:</strong> The main objective of this study is to determine the efficacy of a stepped up Vitamin A supplementation dose to infants (6-12 months) in Busia County in Kenya.</p>\n<p>\n  </p>\n<p>\n <strong>Materials and methods</strong>: Mixed methods design will address the efficacy of different doses of Vitamin A and challenges associated with it’s supplementation. Under quantitative, biochemical analysis sheets, check lists and mother child health records will be used to test the theory of improved immunity with a higher dose, which predicts that a stepped up Vitamin A dose (200,000 IU) as compared to standard dose (100,000 IU) will influence retinol levels and immuno-biomakers positively hence reduced morbidity episodes for 120 infants (6-12 months) at Busia Level 4 Hospital, Busia County.  Qualitative data using key informant interviews and focus group discussions will explore the challenges of Vitamin A supplementation for 72 mothers, 4 County Health Management Team (4) and 6 staff. The mixed methods design will bring together the strengths of both methods to triangulate and corroborate results. Quantitative and qualitative data will be analyzed using descriptive statistics and thematic framework respectively. The proposal will be submitted to Scientific and Ethical Review Unit at KEMRI for approval. The results will benefit the Ministry of Health with policy briefs, programme implementers with improved intervention strategies, scientists with new knowledge and mothers/infants with improved child survival outcomes. </p>\n
      • study_title<p>\n BUSIA LEVEL IV HOSPITAL</p>\n
      • laymans_summary(null)
      • short_titleRANDOMIZED CONTROLLED TRIAL OF STEPPED UP VITAMIN A SUPPLEMENTATION DOSE ON IMMUNE RESPONSES AMONG INFANTS 6-12 MONTHS AT BUSIA LEVEL 4 HOSPITAL IN BUSIA COUNTY, KENYA
      • protocol_noECCT/18/06/04
      • version_no1
      • date_of_protocol01-01-1970
      • study_drugVitamin A
      • disease_conditionVitamin A Deficiency (VAD)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameRetinol Palmitate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressbenard.wesonga@mmust.ac.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Benard Wesonga
      • declaration_date111-06-2018
      • declaration_principal_investigatornational Principal Investigator
      • declaration_date211-06-2018
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p style=\"margin-left:.5in;\">\n   Infants 6-12 months of age</p>\n<p style=\"margin-left:.5in;\">\n  Infants whose mothers give written consent</p>\n<p>\n                Those who meet protocol requirements</p>\n
      • principal_exclusion_criteria<ul>\n <li>\n Infants below 6 and above 12 months</li>\n <li>\n Children with confirmed immunological disorders.</li>\n <li>\n Children on Vitamin A/zinc treatment or supplementation</li>\n <li>\n Those whose parents refuse to give consent.</li>\n <li>\n Children with known allergic reactions to Vitamin A.</li>\n <li>\n Children on treatment with another investigational drug or other intervention</li>\n</ul>\n
      • primary_end_points<ul>\n <li>\n Frequency of occurrence of fever and diarrhea in infants in both control and treatment groups</li>\n <li>\n CD<strong>₄</strong> Counts</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Doctors (2)</p>\n<p>\n Clinical officers (4)</p>\n<p>\n Nurses  (10)</p>\n<p>\n Nutritionists (2)</p>\n<p>\n Lab technitians (3)</p>\n
      • other_details_explanation
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Scientific and Ethical Review Unit (KEMRI) 12/9/2017</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_durationSix (6) Months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorVitamin A 200,000 IU
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaBusia Level IV Hospital
      • single_site_physical_addressBusia County off Busia Kisumu Road
      • single_site_contact_personDirector of Health Services, Dr Melisa Lutomia
      • single_site_telephone0722434282
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site120
      • total_participants_worldwide120
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyinfants 6 months to 12 months
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameAnselimo
      • investigator1_middle_name
      • investigator1_family_nameMakokha
      • investigator1_qualificationPhD in nutrition
      • investigator1_professional_addressP.O. Box 62000-00200 Nairobi
      • investigator1_telephone0713817486
      • investigator1_emailanmakokha@gmail.com
      • organisations_transferred_No
      • number_participants120
      • notification
      • approval_date29-07-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-06-2018
      • 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)
      • modified2019-07-29 20:47:06
      • created2018-06-11 17:06:36
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id438
        • application_id694
        • given_nameBENARD
        • middle_nameOCHIENG
        • family_nameWESONGA
        • qualificationMBChB, MPH
        • professional_addressP.O. BOX 19967-00202
        • telephone0722584574, 0733776421
        • emailbenard.wesonga@mmust.ac.ke
        • created2018-06-11 17:20:32
        • modified2018-06-16 16:53:15
    • SiteDetail(array)
      • 0(array)
        • id554
        • application_id694
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-06-11 17:20:32
        • modified2018-06-16 16:53:15
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id347
        • application_id694
        • sponsorSelf
        • sponsor_type(null)
        • contact_person
        • addressP.O. BOX 19967-00202 Nairobi
        • telephone_number0722584572
        • fax_number
        • cell_number0722584572
        • email_addressbwesonga2@gmail.com
        • created2018-06-11 17:20:32
        • modified2018-06-16 16:53:15
  • 2(array)
    • Application(array)
      • id664
      • user_id427
      • trial_status_id5
      • abstract_of_study<div>\n <p>\n Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in low-resource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. An effective EED therapeutic would offer an opportunity to improve child growth and development in LRS. One promising intervention, enterade® (an amino acid–based oral rehydration solution [AA-ORS]), is a medical food product already sold in the United States. It consists of oral rehydration salts and a proprietary blend of amino acids designed to restore gut function, improve nutrient and electrolyte absorption, and improve barrier integrity. There is evidence that this AA-ORS reduces inflammation and promotes healing of damaged intestinal epithelium in murine models of intestinal damage (irradiated gut), and it may provide benefit to pediatric EED patients. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure. We will conduct a randomized, double-blinded, placebo-controlled pilot study in Kakamega County, Kenya, to assess the safety, feasible dosage, and acceptability/tolerability of the product in the target population (children aged 12–24 months) and their caregivers.</p>\n</div>\n<p>\n  </p>\n
      • study_title<h2 align=\"center\">\n Safety, Acceptability, and Feasibility of enterade® in children at risk for environmental enteric dysfunction in Kakamega County, Kenya</h2>\n
      • laymans_summary<div>\n <p>\n Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in low-resource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. An effective EED therapeutic would offer an opportunity to improve child growth and development in LRS. One promising intervention, enterade® (an amino acid–based oral rehydration solution [AA-ORS]), is a medical food product already sold in the United States. It consists of oral rehydration salts and a proprietary blend of amino acids designed to restore gut function, improve nutrient and electrolyte absorption, and improve barrier integrity. There is evidence that this AA-ORS reduces inflammation and promotes healing of damaged intestinal epithelium in murine models of intestinal damage (irradiated gut), and it may provide benefit to pediatric EED patients. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure. We will conduct a randomized, double-blinded, placebo-controlled pilot study in Kakamega County, Kenya, to assess the safety, feasible dosage, and acceptability/tolerability of the product in the target population (children aged 12–24 months) and their caregivers.</p>\n</div>\n<p>\n  </p>\n
      • short_titleSafety, Acceptability, and Feasibility of enterade® (SAFE)
      • protocol_noECCT/18/06/01
      • version_no1.5
      • date_of_protocol07-05-2018
      • study_drugenterade
      • disease_conditionEnvironmental enteric dysfunction
      • product_type_biologicals0
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameAmino Acid-based Oral Rehydration Solution (AA-ORS)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressMArndt@path.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_pi1
      • 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_applicantJames Mukabi
      • declaration_date106-06-2018
      • declaration_principal_investigatorMichael Arndt (co-PI)
      • declaration_date206-06-2018
      • placebo_presentYes
      • study_objectives<div>\n <p>\n Primary Objective: To determine the safety of AA-ORS among children with mild to moderate stunting, administered as a daily dose over 2 weeks, ad libitum up to 237 ml in 3 hours.</p>\n <p>\n <em>Safety assessment in children will compare adverse event (AE) and serious adverse event (SAE) rates and changes to dietary and digestive habits between children receiving AA-ORS versus an inactive placebo solution containing no amino acids.</em></p>\n <p>\n Primary Objective: To determine the feasibility and well-tolerated dose of AA-ORS among children with mild to moderate growth stunting administered as a daily dose over 2 weeks, ad libitum up to 237 ml in 3 hours.</p>\n <p>\n <em>User preferences among children include average daily volume consumed over days, trends in volume consumed, and factors that influence children’s willingness and ability to ingest the product as intended.</em></p>\n <p>\n Secondary Objective: To determine the perceptions among caregivers on the use and acceptability of this product as a potential intervention for EED.</p>\n <p>\n <em>Acceptability by caregivers includes factors that influence their willingness to have the product used by their children and their perception of their child’s response to its consumption.</em></p>\n <p>\n Exploratory Objective: To determine the impact of AA-ORS on gut dysfunction, metabolism, gut and systemic inflammation, and micronutrient status.</p>\n <p>\n <em>Impact of AA-ORS on gut dysfunction, systemic inflammation, and micronutrient status</em><em> will be assessed by comparing non-invasive biomarker levels in blood samples collected following the intervention. These biomarkers will be assessed in both groups at baseline in order to have setting-specific descriptive data with which to power a future EED efficacy trial.</em></p>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <u>Pediatric and caregiver pairs (must meet inclusion criteria for both categories):</u></p>\n<p>\n Child:</p>\n<ol>\n <li>\n Is between 12 and 24 months of age.</li>\n <li>\n LAZ between –1 and –3 SD.</li>\n <li>\n At least one week post routine immunization or vitamin A supplementation visit at the study site.</li>\n <li>\n Has a parent or legally acceptable representative willing and able to provide informed consent.</li>\n <li>\n No plans for travel outside of the community for the duration of the study.</li>\n</ol>\n<p>\n Caregiver of child:</p>\n<ol>\n <li>\n Is a parent or legally accepted representative of a child eligible for this study.</li>\n <li>\n Is 18 years of age or older.</li>\n <li>\n Has a working mobile phone.</li>\n <li>\n Is willing and able to provide informed consent.</li>\n <li>\n If illiterate—there is at least one literate adult living in the child’s household.</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n <u>Pediatric and caregiver pairs (must meet none of the exclusion criteria for either category):</u></p>\n<p>\n Child:</p>\n<p style=\"margin-left:.25in;\">\n 1.       Has any sign of acute illness, including but not limited to fever, cough, and diarrhea.</p>\n<p style=\"margin-left:.25in;\">\n 2.       Is wasted (weight for length z-score < –2 or mid-upper arm circumference [MUAC] < 12.4 cm) or has pitting edema.</p>\n<p style=\"margin-left:.25in;\">\n 3.       Is exclusively breastfed.</p>\n<p style=\"margin-left:.25in;\">\n 4.       Is seeking medical attention at the health facility other than for routine, preventative care (e.g., immunization visit, vitamin supplementation).</p>\n<p style=\"margin-left:.25in;\">\n 5.       Has suffered within the prior week from illnesses that might impact nutritional status (e.g., severe diarrhea or pneumonia; vomiting; persistent diarrhea; cleft lip or palate; blindness; tuberculosis; jaundice; renal or cardiac disease; cerebral palsy; known metabolic disorders; and chromosomal disorders, including trisomy 21).</p>\n<p style=\"margin-left:.25in;\">\n 6.       Medical history of chronic health condition (i.e., HIV, hepatitis B or C, end stage renal disease, severe liver disease—absence of a diagnosis is sufficient).</p>\n<p style=\"margin-left:.25in;\">\n 7.       Participating in any other clinical trials.</p>\n<p style=\"margin-left:.25in;\">\n 8.       Recent (prior 2 weeks) use of antibiotics or any other medical treatments (including ORT, but not including vaccines or vitamin/mineral supplementation).</p>\n<p style=\"margin-left:.25in;\">\n 9.       Cannot give the necessary biological (blood) sample.</p>\n<p>\n Caregiver:</p>\n<p>\n Reports diarrhea in the household in the prior 7 days.</p>\n
      • primary_end_points<p>\n <strong>Primary:</strong> Adverse events and serious adverse events through 28 days of follow-up, and changes to dietary and digestive habits through day 21 of follow-up.</p>\n<p>\n <strong>Primary:</strong> Average product volume consumed daily through 21 days of follow-up, time trends in average daily volume consumed, and factors that influence children’s willingness and ability to ingest the product as intended.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • 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_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyThis study will provide critical information about the safety of commercially available AA-ORS in this at-risk pediatric population and qualitative and quantitative information on the user-preferred product volume for this age group, palatability, and ease of administration.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <p>\n Kakamega CGH is a Level 5 Hospital that offers maternal services, comprehensive care center (CCC) services, maternal and child health unit, comprehensive emergency obstetric care, curative in-patient services, curative outpatient services, family planning, growth monitoring and promotion, HIV counselling and testing, rural health training centre / rural health demonstration centre, Tuberculosis services, laboratory services.</p>\n <table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"547\">\n <tbody>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Consultants </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p>\n 19, two (2) of which are Pediatricians and two (2) are obstetrician/Gynecologists.</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n General Doctors/Registrars</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 43</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Pharmacists</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 7</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Pharmaceutical Technologists </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 6</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Medical Laboratory Technologists</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 25</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Dental Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 4</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Clinical Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 29</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Nutritionists </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 3</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Nursing Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 261</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Public Health officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Health Promotion Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Plaster Technologists </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 8</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Medical Social Worker </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Health Administrator </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:5px;\">\n <p>\n Orthopedic Technologists </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:5px;\">\n <p align=\"right\">\n 7</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Physiotherapists</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n                11</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Occupational Therapists</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 6</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Dental Technologists/COHO </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 3</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Records Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 11</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Radiographers                </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 11</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Medical Engineers           </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 9</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Secretaries                       </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 2</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Clerical Officers               </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 4</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Drivers                              </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 5</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Telephone Operators    </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 2</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Artisans                             </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Mortuary Attendants     </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 6</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Cooks                                </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 2</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n ICT                                     </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 2</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Support Staff                  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 13</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Casuals                            </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 99</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n TOTAL  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 586</p>\n </td>\n </tr>\n </tbody>\n </table>\n <p>\n  </p>\n <p>\n <strong>Number of Beds:</strong> 449</p>\n <p>\n  </p>\n <p>\n <strong>Number of Cots:</strong> 79</p>\n <p>\n  </p>\n <p>\n Research study staff:</p>\n <p style=\"margin-left:30.5pt;\">\n <strong>Dr. James Mukabi, MD<em>. </em></strong>Principal Investigator.</p>\n <p style=\"margin-left:30.5pt;\">\n <strong>Alfred Ochola, MPH.</strong> Project coordinator.</p>\n <p style=\"margin-left:30.3pt;\">\n <strong>Dorothy Brown, Kenya Registered Nurse. </strong>Study nurse.</p>\n <p style=\"margin-left:30.3pt;\">\n <strong>Dr. Nick </strong><strong>Aduro</strong><strong> Kidaha, MBChB, MMed (Paeds). </strong>Study pediatrician.</p>\n <p style=\"margin-left:30.3pt;\">\n <strong>Research assistant(s), to be determined. </strong></p>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The study will be conducted in Kakamega County in Western Kenya. Kakamega county was selected as containing both rural and urban settings and is suitable for this research due to the high prevalence of malnutrition, and PATH Kenya’s established relationships with health facilities in the area. In former Nyanza province, the stunting (LAZ<-2) prevalence in children under 5 years ranges from 2.5% in Migori County to 5.14% in Kisumu County. In neighboring Western province, where Kakamega is located, the prevalence is thought to be much higher. PATH has been involved in the establishment of the APHIA<em>plus </em>program in western Kenya. APHIA<em>plus</em> promotes HIV testing and improved access to ORS for children experiencing diarrhea through ORS corners in several hundred health facilities in the region. Participants will be recruited from Kakamega County General Hospital (CGH). This facility draws from a peri-urban catchment area, has been participating in APHIA<em>plus</em> programming, and has set up an ORS corner for treatment of pediatric diarrhea. Therefore, health care providers in the facility are quite familiar with the use of ORS.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p align=\"left\">\n None.</p>\n
      • other_details_regulatory_approved<p>\n None.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_duration4 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo solution
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKakamega County General Hospital (CGH)
      • single_site_physical_addressP.O. Box 15-G.P.O.-50100 Kakamega, Kenya
      • single_site_contact_personVictor Zimbulu, Medical Superintendent
      • single_site_telephone0702930346
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site66
      • total_participants_worldwide66
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren between the ages of 12 and 24 months
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJames
      • investigator1_middle_name
      • investigator1_family_nameMukabi
      • investigator1_qualificationMBChB, MPH
      • investigator1_professional_addressPATH Kakamega- Kenafya Building, Okwemba Road next to Kenya Medical Training College Kakamega 50100
      • investigator1_telephone+254722565432
      • investigator1_emailjmukabi@path.org
      • organisations_transferred_Yes
      • number_participants66
      • notification<p>\n Dear PPB --</p>\n<p>\n Attached please find PATH’s request for closure of the Safety, Acceptability, and Feasibility of Enterade® (SAFE) study in Children at Risk for Environmental Enteric Dysfunction in Kakamega County, Kenya.</p>\n<p>\n The request includes the following documents:</p>\n<ul>\n <li>\n Cover letter</li>\n <li>\n SAFE Executive Summary Final Report</li>\n <li>\n DSMB Final Meeting Minutes</li>\n</ul>\n<p>\n  </p>\n<p>\n We will be submitting the Clinical Study Report to PPB no later than the July 31, 2020 (180 days following study closure).</p>\n<p>\n  </p>\n<p>\n Kindly let us know if you need additional information.</p>\n<p>\n  </p>\n<p>\n Thank you for the support during the study.</p>\n<div>\n  </div>\n
      • approval_date02-10-2018
      • submitted1
      • deleted0
      • deleted_date2018-04-09 14:53:11
      • deactivated0
      • date_submitted28-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in lowresource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure.</p>\n<p>\n We conducted a randomized, double-blinded, placebo-controlled pilot study in Kakamega County, Kenya, to assess the safety, feasible dosage, and caregiver acceptability of enterade®, an amino acid-based oral rehydration solution (AA-ORS), in the target population of children at risk for EED. Children were randomized to to receive AA-ORS or placebo solution (given ad libitum for 3 hours, up to 237 ml) for 14 days, and compare the rate of adverse events (AEs) in the two groups through 21 days of follow up.</p>\n<p>\n enterade® (an amino acid–based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts and a blend of amino acids that drive the uptake of water and electrolytes. The blend of amino acids appears to reduce intestinal damage and promote healing of the intestinal epithelium in irradiated mouse models commonly used to simulate gut damage encountered in inflammatory bowel diseases. This AA-ORS contains water, a proprietary blend of amino acids (L-Valine, L-Aspartic Acid, L-Serine, L-Threonine, and L-Tyrosine), sodium chloride, sodium citrate, potassium chloride, gum acacia, magnesium chloride, calcium chloride, and stevia leaf extract (sweetener).</p>\n<p>\n A total of 12 participants aged 12-24 months with length for age z-score between -1 and -3, from outpatient department at Kakamega County General Hospital in Kakamega, Kenya were enrolled before the study terminated on May 2, 2019. Several rounds of microbial testing on bottles stored at the study site in Kenya and from the manufacturer’s warehouse confirmed that some of the study product bottles were contaminated with potentially pathogenic microorganisms: <em>Burkholderia cepacia, Cryptococcus uniguttulatus,</em> <em>Exophiala dermatitidis, Exophiala heteromorpha</em>, <em>Capronia munkii, Penicillium roqueforti</em>, and <em>Eurotium herbariorum</em> (a.k.a. <em>Aspergillus glaucus</em> OR <em>Eurotium rubrum</em> (a.k.a. <em>A. rubrum</em>).</p>\n<p>\n Following study termination, an additional weekly safety follow-up of all participants that were enrolled in the study for an additional 6 weeks received ethical approvals as a change to research procedures, but not as an amendment to the protocol. In order to inform SAFE study participants about the study product microbial testing findings and proposed safety follow-up, a letter was sent to each enrolled child-caregiver pair. This letter summarized the current study status; known risks of potential exposure to microbial contaminants; what to do in case of any observed adverse event(s), question, or concern; and details of the purposed 6-week safety follow-up. Subsequently, a consent form addendum was signed by caregivers to authorize the additional safety follow-up procedures.</p>\n<p>\n All 12 participants that were enrolled in the study between February 26, 2019 and March 20, 2019 (the date of study suspension) were contacted and consented to the 6-week safety follow-up. The informed consent form allowed for travel reimbursement on an as-needed basis. The additional weekly safety follow-up for all 12 participants that were enrolled in the SAFE study were conducted between November 20, 2019 and January 16, 2020. All research participants completed the procedures done as part of the additional safety follow-up and/or monitoring.</p>\n<p>\n Any adverse events (AEs) that were noticed by participants, however minor, from the time the study was terminated to date were recorded (see Table 1 below). Five out of the 12 participants reported at least one AE following the study. All safety reports of acute illness were reported recovering/resolving or recovered/resolved. Only PT021 experienced two AEs that were ongoing at the end of the study and thus has no end date recorded.</p>\n<p>\n  </p>\n<p>\n Table 1. Details on adverse events reported by participant during additional safety assessment.</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:111px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:69px;\">\n <p>\n <strong>Severity</strong></p>\n </td>\n <td style=\"width:66px;\">\n <p>\n <strong>Start date</strong></p>\n </td>\n <td style=\"width:67px;\">\n <p>\n <strong>End date</strong></p>\n </td>\n <td style=\"width:186px;\">\n <p>\n <strong>Medical action</strong></p>\n </td>\n <td style=\"width:79px;\">\n <p>\n <strong>Resolving/ resolved</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT005</strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n      Diarrhea</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/17/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/22/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n ORS and amoxicillin</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n      Fever</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/17/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/19/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Artemether lumefantrine and paracetamol</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT006</strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Cough</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/21/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/24/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Amoxicillin, panadol, piriton</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Runny nose</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/21/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/25/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n None</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT016</strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Cough</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/24/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/27/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Septrin, piriton and panadol</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT021    </strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Cough</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/16/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n Ongoing</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Baby on co-trimoxazole; mother on care</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Night sweats</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/16/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n Ongoing</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n None</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT049</strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Diarrhea</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Moderate</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 12/11/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 12/14/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n ORS, piriton, and amoxicillin</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Fever</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Moderate</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 12/11/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 12/12/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Paracetamol</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Vomiting</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 12/11/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 12/12/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n None</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n The study closeout visit was conducted once the last participant completed study participation in the additional safety follow-up. The three-day closeout visit was conducted between January 28-30, 2020 by the Independent Study Monitor (ISM). The final DSMB meeting to review additional safety assessment findings and study closeout was held on February 11, 2020.</p>\n<p>\n All study product that were shipped from the study site to the manufacturer and Nelson Laboratories for microbial testing have been discarded. The remaining study product at the study site is accounted for and awaiting destruction in the presence of the Kenyan Pharmacy and Poisons Board (PPB) regulatory representative on February 25-26, 2020.</p>\n<p>\n The completion of biomarker testing of blood samples by staff at the Kenya Medical Research Institute (KEMRI) laboratory in Kilifi is underway to measure enteric dysfunction, systemic inflammation, and micronutrient deficiency in this small pediatric sample. These exploratory analyses are on a small sample size that lacks adequate power for statistical comparisons of the EED outcomes (non-invasive biomarkers); however, the expected results from the exploratory biomarker testing could be useful for understanding EED in this locality and special population and informing study design considerations for future research on AA-ORS and similar EED interventions in LRS. The Environmental Enteric Dysfunction Assessment Tool (MEEDAT) kits to complete the exploratory laboratory assays will measure the average plasma/serum concentrations of gut dysfunction, systemic inflammation, and micronutrient biomarkers will be tested on blood samples that were collected at baseline and day 22 of follow-up. All blood samples following completion of the exploratory laboratory assays by KEMRI will be destroyed.</p>\n
      • implication_results(null)
      • quantity_imported1702
      • quantity_dispensed149
      • quantity_destroyed950
      • quantity_exported471
      • balance_site0
      • final_date0000-00-00
      • modified2020-03-28 00:27:53
      • created2018-03-29 00:53:21
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id418
        • application_id664
        • given_nameMichael
        • middle_nameBenjamin
        • family_nameArndt
        • qualificationPhD
        • professional_address2201 Westlake Ave. Suite 200 Seattle, WA 98121 United States
        • telephone206-285-3500
        • emailmarndt@path.org
        • created2018-03-29 00:56:16
        • modified2020-03-28 00:19:43
      • 1(array)
        • id419
        • application_id664
        • given_nameJames
        • middle_name
        • family_nameMukabi
        • qualificationMBChB, MPH
        • professional_addressPATH Kakamega- Kenafya Building, Okwemba Road next to Kenya Medical Training College Kakamega 50100
        • telephone+254722565432
        • emailjmukabi@path.org
        • created2018-04-03 04:43:20
        • modified2020-03-28 00:19:43
    • SiteDetail(array)
      • 0(array)
        • id536
        • application_id664
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-03-29 00:56:16
        • modified2020-03-28 00:19:43
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id334
        • application_id664
        • sponsorPATH
        • sponsor_typeOthers
        • contact_personMichael Arndt
        • address2201 Westlake Ave. Suite 200
        • telephone_number2062853500
        • fax_number
        • cell_number+19254874527
        • email_addressmarndt@path.org
        • created2018-03-29 00:56:16
        • modified2020-03-28 00:19:43
  • 3(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
      • 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_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
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_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)
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        • 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
  • 4(array)
    • Application(array)
      • id655
      • user_id72
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background:</strong></p>\n<p>\n EIMC is technically simpler, safer, and less expensive compared to VMMC performed in older children or adults. However, scarcity of trained providers and resources in sub-Saharan Africa are a barrier to EIMC services. Device-assisted VMMC could simplify the procedure, enable safe task-shifting, thus increasing the availability of this service.</p>\n<p>\n  </p>\n<p>\n <strong>Objective:</strong></p>\n<p>\n To evaluate the safety, effectiveness and acceptability of the ShangRing device for EIMC.</p>\n<p>\n  </p>\n<p>\n <strong>Study design:</strong></p>\n<p>\n The study will be in two phases. In the pilot phase, 460 eligible infants will be randomised 1:1 to receive either ShangRing or Mogen clamp circumcision. Follow up will occur every seven days afterward until 42 post circumcision or until the circumcision wound is completely healed. We will assess the circumcision time, pain, adverse event (AEs), healing course, and parent and provider preferences. In the second field phase, 600 eligible infants will undergo ShangRing EIMC performed by non-physicians in routine settings. Outcomes will be similar to the first phase.</p>\n<p>\n  </p>\n<p>\n <strong>Expected results</strong>:</p>\n<p>\n Comparative safety of the two devices would be determined by the differences in the AE rates, pain experienced, parent/provider preferences. Safety and effectiveness of the ShangRing in routine clinical settings by non-physicians will be evaluated by the AE rates and provider preferences.</p>\n<p>\n  </p>\n<p>\n <strong>Significance of the results:</strong></p>\n<p>\n This trial will determine whether the ShangRing is a safe and effective alternative for EIMC. Positive outcomes from this project could further facilitate scale-up of VMMC services in Sub-Saharan Africa. If the ShangRing is shown to be safe, effective and acceptable for EIMC, it will be the only VMMC device that can be used in males of all ages, from neonates to adults. A single device usable for all ages has substantial potential for simplification of service delivery, supply chain management, training and supervision, and educational materials. When complemented with strategies to ensure effective antiretroviral therapy for those with HIV infection, VMMC has been shown to be a cost-effective approach to move toward an AIDS-free generation. Use of the ShangRing in these efforts could help to achieve this goal.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision in sub-Saharan Africa</strong></p>\n<p>\n  </p>\n
      • laymans_summary<div>\n This main aim of this trial is to compare the safety and acceptability of the ShangRing, a new device used to carry out male circumcision, vs. the Mogen clamp, another device that is approved and widely used to conduct male circumcision in children 0-60 days of age. </div>\n<div>\n This study shall be carried out in Kenya, Uganda and Tanzania. </div>\n<div>\n We will assess and compare adverse events, pain, wound healing and parent satisfaction. We will furthermore compare the length of time needed to carry out a circumcision using either device and the preferences of the clinicians who will use these devices. </div>\n<div>\n We would also like to know how feasible leaving the ShangRing device to fall off on its own is instead of needing the children to come back again to the clinic to have the device removed.</div>\n<div>\n Finally, given the concern around the bacteria that live on the surface of the penis, and how these may lead to Tetanus infection, we will also investigate this aspect on the children undergoing circumcision. This specific aim will be designed to comply with the comparative trial component of the WHO framework for such research on medical devices.</div>\n
      • short_titleShangRing vs. Mogen Clamp for EIMC
      • protocol_noECCT/18/04/03
      • version_no5
      • date_of_protocol20-01-2018
      • study_drugN/A
      • disease_conditionN/A
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameShangRing
      • comparatorYes
      • comparator_nameMogen clamp
      • comparator_registeredyes
      • comparator_countriesKenya, Uganda, Tanzania
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressqawori@engenderhealth.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_countries1
      • applicant_addendum1
      • 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_applicantQuentin Awori qawori@popcouncil.org
      • declaration_date101-06-2018
      • declaration_principal_investigatorNational Principal Investigator
      • declaration_date201-06-2018
      • placebo_presentNo
      • study_objectives<div>\n <u><strong>Phase 1</strong></u></div>\n<div>\n  </div>\n<div>\n Primary Objective</div>\n<div>\n Evaluate the safety and acceptability of the no-flip ShangRing technique vs. Mogen</div>\n<div>\n clamp for EIMC in infants up to 60 days old</div>\n<div>\n  </div>\n<div>\n <div>\n Secondary Objectives</div>\n <div>\n ï‚· Assess ease of use of the ShangRing for EIMC</div>\n <div>\n ï‚· Evaluate satisfaction of ShangRing EIMC among parents of study participants</div>\n <div>\n ï‚· Evaluate satisfaction of using the ShangRing for EIMC among VMMC providers</div>\n <div>\n ï‚· Determine the occurrence and safety of spontaneous detachment</div>\n <div>\n ï‚· Determine the penile microbiome during the healing course in infants</div>\n <div>\n  </div>\n <div>\n <u><strong>Phase 2</strong></u></div>\n <div>\n  </div>\n <div>\n <div>\n Primary Objective</div>\n <div>\n Evaluate the use of ShangRing EIMC in a non-comparative field study in settings of</div>\n <div>\n intended use, if results from Phase I demonstrate reasonable safety and effectiveness of</div>\n <div>\n the ShangRing.</div>\n <div>\n  </div>\n <div>\n <div>\n Secondary Objectives</div>\n <div>\n ï‚· Assess ease of use of the ShangRing for EIMC</div>\n <div>\n ï‚· Evaluate satisfaction of ShangRing EIMC among parents of study participants</div>\n <div>\n ï‚· Evaluate satisfaction of using the ShangRing for EIMC among VMMC providers</div>\n <div>\n ï‚· Determine the occurrence and safety of spontaneous detachment</div>\n <div>\n ï‚· Assess the cost impact of EIMC using ShangRing vs. Mogen Clamp</div>\n <div>\n ï‚· Assess whether device-driven EIMC can be safely and effectively integrated into</div>\n <div>\n maternal and child health (MCH) services as a method to promote demand creation.</div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n All participants enrolled in this research study must meet the following inclusion criteria: </div>\n<div>\n ï‚·  male, age 1 to 60 days old,</div>\n<div>\n ï‚·  normal birth weight more than or equal to 2.5 Kg,</div>\n<div>\n ï‚·  gestational age more than or equal to 37 weeks,</div>\n<div>\n ï‚·  no illness requiring medical treatment,</div>\n<div>\n ï‚·  no penile abnormality requiring surgical repair (e.g. hypospadias),</div>\n<div>\n ï‚·  no family history of bleeding disorders.</div>\n<div>\n <div>\n ï‚·  parent or legally acceptable representative is 18 years of age or older</div>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n A client will be excluded from participation in this research study if he has any of the </div>\n<div>\n following exclusion criteria: </div>\n<div>\n ï‚·  Congenital abnormality of the genitalia</div>\n<div>\n ï‚·  Any known haematological disorders, jaundice, yellow sclera or purpuric skin lesions</div>\n<div>\n ï‚·  Lack of parental consent</div>\n<div>\n ï‚·  Is currently participating in another biomedical research study</div>\n
      • primary_end_points<p>\n The study has two phases with different primary end points:</p>\n<p>\n Phase 1:</p>\n<p>\n The primary end point is the rate of adverse events between the two treatment groups i.e. ShangRing vs Mogen Clamp</p>\n<p>\n  </p>\n<p>\n Phase 2:</p>\n<div>\n The primary endpoint is the rate of adverse events when using the ShangRing in routine </div>\n<div>\n clinical settings by non-physician clinicians</div>\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_other1
      • trial_other_specifyUse of circumcision device in boys 0-60 days of age. Each of the device has been used in humans i.e. ShangRing in men and boys 10 years old and above, and Mogen clamp boy 0-60 days of age.
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong>Homa Bay - Homa Bay TRH</strong></u></p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Staff at site who will conduct the research</strong></p>\n<ul font-size:=\"\" line-height:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Local PI : Jairus Oketch</li>\n <li style=\"line-height: 20px;\">\n 2 nurses - KRCHN\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li style=\"line-height: 20px;\">\n Patrick Otiende</li>\n <li style=\"line-height: 20px;\">\n Nixon Nyangweso</li>\n </ul>\n </li>\n <li style=\"line-height: 20px;\">\n 1 Research Assistant\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li style=\"line-height: 20px;\">\n Dan Ouma </li>\n </ul>\n </li>\n <li style=\"line-height: 20px;\">\n 1 Lead social mobiliser\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li style=\"line-height: 20px;\">\n Nereah Obura</li>\n </ul>\n </li>\n <li style=\"line-height: 20px;\">\n Support staff (1)</li>\n</ul>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Site & Facility building</strong></p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Homa bay distirct hospital - VMMC Theatre</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <b><u>Kismu - Jaramogo Oginga Odinga TRH</u></b></p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Staff at site who will conduct the research</strong></p>\n<ul font-size:=\"\" line-height:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Local Site PI\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li style=\"line-height: 20px;\">\n Godfrey Owino - BSc Health Ecomics, DCM</li>\n </ul>\n </li>\n <li style=\"line-height: 20px;\">\n 2 nurses - KRCHN\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li style=\"line-height: 20px;\">\n Maureen Ongoro - KRCHN</li>\n <li style=\"line-height: 20px;\">\n Rachel Anyango - DCM</li>\n </ul>\n </li>\n <li style=\"line-height: 20px;\">\n 1 Research Assistant\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li style=\"line-height: 20px;\">\n To be named</li>\n </ul>\n </li>\n <li style=\"line-height: 20px;\">\n 1 Lead social mobiliser\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li style=\"line-height: 20px;\">\n Dolrosa Anyango</li>\n </ul>\n </li>\n <li style=\"line-height: 20px;\">\n Support staff (1)\n <ul>\n <li style=\"line-height: 20px;\">\n Francis Kizito</li>\n </ul>\n </li>\n</ul>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Site & Facility building</strong></p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  - EIMC theatre (Maternity wing)</p>\n
      • other_details_explanation<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Kenya was the first country where research on the ShangRing as a device for VMMC was conducted (2009). Since then a lot of advancement into the use of the device has be gained plus inroads with the ministry of health (VMMC) and various stake holders.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n As this study is aimed at further improving the use of the device, Kenya is most suited to provide this environment of advanced research of this kind. Additionally, it is well placed to conduct the research and the comparator device, i.e. the Mogen clamp is in use in public health system.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n We suffice to say that Kenya is one of the three contries in the region, (includng Uganda and Tanzania) in which the study is being hosted.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Weill Cornel Medical College</p>\n<p>\n Kenya Medical and Research institute</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorMogen Clamp device
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites2
      • multi_country_listKenya, Uganda, Tanzania
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrollment; two principal sites\nminimum per site : 0\nmaximum per site : 1060
      • total_participants_worldwide3180
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyInfants 0-42 days of age
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameQuentin
      • investigator1_middle_name
      • investigator1_family_nameAwori
      • investigator1_qualificationMBChB
      • investigator1_professional_addressAvenue Five, Rose Avenue, Hurlingham, Nairobi
      • investigator1_telephone+254722913616
      • investigator1_emailqawori@popcouncil.org
      • organisations_transferred_Yes
      • number_participants1060
      • notification
      • approval_date10-12-2018
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-02-2020
      • 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)
      • modified2021-04-30 18:05:02
      • created2018-03-07 15:35:45
      • total_sites(null)
      • ecitizen_invoice(null)
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        • id414
        • application_id655
        • given_nameRichard
        • middle_name
        • family_nameLee
        • qualificationMD, MBA (University of Pennsylvania), Fellow (Weill Cornell Medical College)
        • professional_address 425 E. 61st St., 12th Fl, NY, NY 10065.
        • telephone+1 646-962-4811
        • emailril9010@med.cornell.edu
        • created2018-03-07 16:27:37
        • modified2020-02-03 10:55:38
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        • application_id655
        • given_nameMark
        • middle_name
        • family_nameBarone
        • qualificationDVM(University of Colorado)
        • professional_addressPopulation Council 1230 York Avenue New York, NY 10065 USA
        • telephone+1 212-561-8084
        • emailmbarone@popcouncil.org
        • created2018-03-08 11:56:37
        • modified2020-02-03 10:55:38
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        • id532
        • application_id655
        • county_id43
        • site_nameHoma Bay Teaching and Referral Hospital
        • physical_addressHoma Bay town
        • contact_details0724579750
        • contact_personJairus Oketch
        • site_capacity(null)
        • misc(null)
        • created2018-03-07 16:27:37
        • modified2020-02-03 10:55:38
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          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
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        • application_id655
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressKisumu town
        • contact_details0724817266
        • contact_personGodfrey Owino
        • site_capacity(null)
        • misc(null)
        • created2018-03-08 12:14:17
        • modified2020-02-03 10:55:38
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id331
        • application_id655
        • sponsorWeill Cornell Medical College
        • sponsor_type
        • contact_personRichard Lee
        • address425 E. 61st St., 12th Fl, NY, NY 10065
        • telephone_number+1646-962-4811
        • fax_number
        • cell_number+1646-962-4811
        • email_addressril9010@med.cornell.edu
        • created2018-03-07 16:27:37
        • modified2020-02-03 10:55:38
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  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
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App Constants

CakePHP Constants

PHP Environment

Included Files

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• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

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