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JiVitA history

By JiVitA

  • First exploratory visit by JHU faculty to Bangladesh to establish collaboration with BIRPERHT and USAID mission in Dhaka

  • Meeting with MOHFW to discuss maternal nutrition research

  • Gaibandha and Rangpur are selected as study sites

  • USAID Mission expresses interest in the nutrition trial to MOHFW

  • National Technical Committee (NTC) is established by MOHFW

  • Study protocol and draft forms are submitted to Bangladesh Medical Research Council (BMRC) for ethical review and approval

  • Start of field work (mapping of households and 'sector' defining)

  • Implementation Agreement signed between BIRPERHT and the GOB

  • Study management established and staff recruited/trained

  • JiVitA-1 protocol submitted to JHU CHR

  • Study sectors randomized to 3 treatment codes

  • Protocol approved by BMRC

  • Protocol approved by JHU CHR

  • Study sectors profiled and surveyed

  • Enumeration of married women for inclusion in JiVitA (JiVitA weeks 28-32)

  • Five weekly, community-based pregnancy surveillance with urine-test verifications initiated (JiVitA week 33)

  • supplementation of pregnant women by treatment code begun (week 34))

  • Five weekly surveillance (PSF) begun

  • JiVitA is formally registered as a Project under the National Integrated Population and Health Program (NIPHP) under the Strategic Objective between the GOB and US Government

  • JiVitA-1 'Substudy' is launched

  • JiVitA-1 sample size increased from 54,000 to 68,000 pregnancies

  • Re-consent process for all pregnant participants

  • JiVitA-1 dataset frozen for DSMB-1 analysis (JiVitA week 130)

  • MoU with Institute of Nutrition and Food Sciences (INFS) Urinary Iodine Study

  • Barbara Seligman (USAID-Wash) visits JiVitA

  • MoU for collaboration with Bangladesh Atomic Energy Commission (BAEC)

  • Bacterial Vaginosis Substudy

  • GIS survey begins

  • First DSMB meeting

  • Birth defect verification process begins

  • JiVitA first public introduction at ASCODD conference

  • Consent for JiVitA-2 begins

  • JiVitA-2 supplementation begins

  • John Rogosh (USAID-Wash) visits JiVitA

  • JiVitA training practicum (INFS students-Batch 1)

  • Referral system initiated

  • JiVitA training practicum (Pakistan students)

  • GIS survey completed

  • JiVitA training practicum (INFS students-Batch 2)

  • JiVitA-1 dataset frozen for DSMB-2 analysis

  • IVBA training for RPs at Dhaka Shishu Hospital

  • KISHORI study begins (Baseline Adolescent Census)

  • Second DSMB meeting

  • National Technical Advisory Panel meeting

  • randomization of sectors

  • JHSPH IRB Pre-approval (pending BMRC clearance)

  • BMRC conditional approval obtained

  • JHSPH IRB approval to begin trial

  • Enumeration of reproductive age women begins

  • Pregnancy enrollment interviews begin

  • No objection certificate for Pre-mix import into country

  • Receipt of pre-mix & delivery to BEXIMCO (supplement manufacturer)

  • Receipt of tablets by JiVitA

  • Supplementation for enrolled women from the 12th week of gestation

  • Newborn dosing of infants born to enrolled women begins

  • BMRC unconditional approval obtained (to supplement in 1st trimester)

  • Dosing begins as soon as women consent

  • Sub-study recruitment begins

  • First DSMB meeting convened

  • DSMB interim meeting

  • DSMB meeting

  • Sub-study recruitment ends

  • DSMB meeting

  • end of J-3 enrollment