Conditional cash transfers to retain rural Kenyan women in the continuum of care during pregnancy, birth and the postnatal period: protocol for a cluster randomized controlled trial.

BACKGROUND: Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven to reduce maternal and child mortality and morbidity in high-burden settings. However, few pregnant rural women use these services sufficiently. This study aims to assess the impact, cost-effectiveness and scalability of conditional cash transfers to promote increased contact between pregnant women or women who have recently given birth and the formal healthcare system in Kenya. METHODS: The intervention tested is a conditional cash transfer to women for ANC health visits, a facility birth and PNC visits until their newborn baby reaches 1 year of age. The study is a cluster randomized controlled trial in Siaya County, Kenya. The trial clusters are 48 randomly selected public primary health facilities, 24 of which are in the intervention arm of the study and 24 in the control arm. The unit of randomization is the health facility. A target sample of 7200 study participants comprises pregnant women identified and recruited at their first ANC visit over a 12-month recruitment period and their subsequent newborns. All pregnant women attending one of the selected trial facilities for their first ANC visit during the recruitment period are eligible for the trial and invited to participate. Enrolled mothers are followed up at all health visits during their pregnancy, at facility delivery and for a number of visits after delivery. They are also contacted at three additional time points after enrolling in the study: 5-10days after enrolment, 6 months after the expected delivery date and 12 27 months after birth. If they have not delivered in a facility, there is an additional follow-up 2 wees after the expected due date. The impact of the conditional cash transfers on maternal healthcare services and utilization will be measured by the trial's primary outcomes: the proportion of all eligible ANC visits made during pregnancy, delivery at a health facility, the proportion of all eligible PNC visits attended, the proportion of referrals attended during the pregnancy and the postnatal period, and the proportion of eligible child immunization appointments attended. Secondary outcomes include; health screening and infection control, live birth, maternal and child survival 48 h after delivery, exclusive breastfeeding, post-partum contraceptive use and maternal and newborn morbidity. Data sources for the measurement of outcomes include routine health records, an electronic card-reader system and telephone surveys and focus group discussions. A full economic evaluation will be conducted to assess the cost of delivery and cost effectiveness of the intervention and the benefit incidence and equity impact of trial activities and outcomes. DISCUSSION: This trial will contribute to evidence on the effectiveness and cost-effectiveness of conditional cash transfers in facilitating health visits and promoting maternal and child health in rural Kenya and in other comparable contexts. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03021070 . Registered on 13 January 2017

EBV AND MYC IN BURKITT LYMPHOMA: WHICH IS THE MAIN ACTOR?

ABSTRACT Burkitt Lymphoma remains an enigmatic gem in cancer research. It was the first human tumour to be discovered to be having a link to a virus (Epstein-Barr virus). The tumour was discovered to be having a genetic alteration involving an oncogene MYC and leading to its over-expression, it was also discovered to successively responding to chemotherapeutic treatment alone successfully. A lot of scientific work have focused on finding the molecular biology of the disease, some have been successful others are still on course to dissect further discoveries. This study focuses on investigating the roles played by EBV and MYC in Burkitt lymphoma development and or with a view of possibly understanding the best practice on the disease diagnostic platform. After the discovery of EBV virus by Epstein and Barr, the pathogen has been under intense studies to discover its role in Burkitt lymphoma development. The possible contributory role of EBV to BL pathogenesis is largely unknown. It has been suggested that EBV may be associated with all of the cases, including those diagnosed as EBV negative by a mechanism of hit-and-run. Early during oncogenesis, viral genes are essential for initiating disease. Progressively, viral genome is lost to escape the immune system and host mutations accumulate in proto-oncogenic cell. The main problem with the hit-and-run hypothesis is the lack of evidence in primary tumors. (Paper 1) Aimed at identification of a suitable method of detect EBV infection in pathologic samples, by an application of conventional and non-conventional methods (i.e., EBV-microRNAs detection and EBV viral load measurement). Diagnosis of Burkitt lymphoma has had some challenges by the fact that it has borderline or gray zone disease that makes morphology alone difficult. Immunohistochemistry as a method of BL diagnosis has been proposed as an alternative confirmatory after the initial cytology results. Despite its adoption by several clinical laboratories, the performance of the assay in routine practice remains undefined. Immunohistochemistry IHC studies can be hampered by technical difficulties that are related to fixation, methods, antibody choice and scoring of staining. The cut-off values for considering case “positive” lack uniformity. (Paper 2) Aimed to standardize MYC IHC by defining the intensity of staining and the percentage of positive cells, correlate MYC gene alterations with MYC protein expression and compare the Double Hit and Double Expresses status in terms of Overall Survival and Progression Free Survival. MYC family members largely share their target genes; they can compensate and substitute for each other in both physiological and pathological conditions. Previous studies demonstrated a cross regulating expression of MYC family members; in particular, it was shown that MYC and MYCN reciprocally control their expression via auto-regulatory loops and via repressing each other at defined promoter sites. MYCN expression has not been systematically studied so far. Recently, while assessing the degree of correlation between MYC gene rearrangement by fluorescent in situ hybridization (FISH) and MYC protein expression by immunohistochemistry (IHC) in aggressive B-cell lymphomas, we observed few BL cases lacking MYC protein expression despite carrying the typical t(8;14) translocation (EAHP 2017, personal communication) (Paper 3) Aimed to better characterize such BL cases lacking MYC protein expression, evaluate whether the cross-talk between the MYC gene family members does also exist in BL, and explore the genetic landscape of these rare BL cases

Conditional cash transfers to retain rural Kenyan women in the continuum of care during pregnancy, birth and the postnatal period: protocol for a cluster randomized controlled trial

Abstract Background Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven to reduce maternal and child mortality and morbidity in high-burden settings. However, few pregnant rural women use these services sufficiently. This study aims to assess the impact, cost-effectiveness and scalability of conditional cash transfers to promote increased contact between pregnant women or women who have recently given birth and the formal healthcare system in Kenya. Methods The intervention tested is a conditional cash transfer to women for ANC health visits, a facility birth and PNC visits until their newborn baby reaches 1 year of age. The study is a cluster randomized controlled trial in Siaya County, Kenya. The trial clusters are 48 randomly selected public primary health facilities, 24 of which are in the intervention arm of the study and 24 in the control arm. The unit of randomization is the health facility. A target sample of 7200 study participants comprises pregnant women identified and recruited at their first ANC visit over a 12-month recruitment period and their subsequent newborns. All pregnant women attending one of the selected trial facilities for their first ANC visit during the recruitment period are eligible for the trial and invited to participate. Enrolled mothers are followed up at all health visits during their pregnancy, at facility delivery and for a number of visits after delivery. They are also contacted at three additional time points after enrolling in the study: 5–10days after enrolment, 6 months after the expected delivery date and 12 27 months after birth. If they have not delivered in a facility, there is an additional follow-up 2 wees after the expected due date. The impact of the conditional cash transfers on maternal healthcare services and utilization will be measured by the trial’s primary outcomes: the proportion of all eligible ANC visits made during pregnancy, delivery at a health facility, the proportion of all eligible PNC visits attended, the proportion of referrals attended during the pregnancy and the postnatal period, and the proportion of eligible child immunization appointments attended. Secondary outcomes include; health screening and infection control, live birth, maternal and child survival 48 h after delivery, exclusive breastfeeding, post-partum contraceptive use and maternal and newborn morbidity. Data sources for the measurement of outcomes include routine health records, an electronic card-reader system and telephone surveys and focus group discussions. A full economic evaluation will be conducted to assess the cost of delivery and cost effectiveness of the intervention and the benefit incidence and equity impact of trial activities and outcomes. Discussion This trial will contribute to evidence on the effectiveness and cost-effectiveness of conditional cash transfers in facilitating health visits and promoting maternal and child health in rural Kenya and in other comparable contexts. Trial registration ClinicalTrials.gov, NCT03021070. Registered on 13 January 2017