title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Effect of probe filtering pre-normalisation | Filtering probes prior to normalisation, compared to filtering after normalisation, led to modest differences in number of DMPs, rankings of probes by logFC and Probe rankings, by logFC and The question of whether probe filtering should be carried out before or after normalisation is one which has received surprisingly... | PMC9901304 | ||
Effect of normalisation method | Normalisation method had a substantial influence on number and identity of DMPs, rankings of probes and There was a fair degree of consistency in rankings of probes by Distributions of Overall, there was little difference between SQN and SWAN methods when adjusting for batch in the model. There is some evidence that SQ... | PMC9901304 | ||
Effect of batch correction method | There were clear differences in all dimensions between batch correction methods. For all effects (infant sex, BMI, intervention and fake groups), supervised ComBat processing produced a larger number of DMPs compared to either unsupervised ComBat processing or adjustment for batch in the analysis model. The difference ... | PMC9901304 | ||
Effect of adjustment for estimated cell type proportion | Adjustment for cell type proportion affected results, but the impact was not consistent across the different types of effects studied. Adjustment for batch resulted in a substantially larger number of DMPs (both negative and positive) for infant sex, but reduced the number of DMPs for fake groups (for models where ther... | PMC9901304 | ||
Supplemental Information | PMC9901304 | |||
Supplementary Material | Click here for additional data file. | PMC9901304 | ||
R scripts | Click here for additional data file.We would like to acknowledge the participants in the LIMIT Randomised Controlled Trial, whose samples and data are used in this study, as well as the LIMIT research team who collected data and samples for the study. We would also like to acknowledge Shobana Navaneethabalakrishnan, th... | PMC9901304 | ||
Additional Information and Declarations | PMC9901304 | |||
Competing Interests | The authors declare there are no competing interests. | PMC9901304 | ||
Human Ethics | The following information was supplied relating to ethical approvals (i.e., approving body and any reference numbers):The study was reviewed by the ethics committee of each participating institution: the Women’s and Children’s Health Network Human Research Ethics Committee (1839 & 2051), the Central and Northern Adelai... | PMC9901304 | ||
Data Availability | The following information was supplied regarding data availability:The R scripts contain all code for data processing and analysis are available in the | PMC9901304 | ||
References | PMC9901304 | |||
Subject terms | DCD kidney transplants, death, ischemic injury | END-STAGE RENAL DISEASE, KIDNEY, COLD | Kidney transplantation is the optimal treatment for end-stage renal disease, but it is still severely limited by a lack of suitable organ donors. Kidneys from donation after circulatory death (DCD) donors have been used to increase transplant rates, but these organs are susceptible to cold ischemic injury in the storag... | PMC10287561 |
Main | ischemia, allograft dysfunction, bile duct, acute kidney injury | ISCHEMIA, KIDNEY, COLD, COMPLICATIONS | Kidney transplantation is one of the major successes of modern medicine in the 20th century, transforming and extending the lives of many thousands of patients. However, a longstanding limitation of kidney transplantation is that the supply of transplantable organs does not meet demandFor more than 50 years, the tradit... | PMC10287561 |
Results | PMC10287561 | |||
Patient population | diabetes | HYPERTENSION, COLD, DIABETES | The characteristics of the donors and recipients are detailed in Table Donor and recipient characteristics for the MITT analysis populationBMI, body mass index; HLA, human leucocyte antigen. The warm ischemic time is defined from the cession of circulation after withdrawal of life-sustaining treatment until the start o... | PMC10287561 |
CONSORT diagram. | COLD, RECRUITMENT | Two eligibility periods are presented due to the COVID-19 pandemic: 4 September 2020 is the date the trial officially closed to recruitment, and 23 March 2020 was the start of the UK national lockdown. No participants were recruited between 23 March 2020 and 4 September 2020. Two participants did not have a cold ischem... | PMC10287561 | |
Secondary outcome measures | thrombosis, DGF, necrosis | THROMBOSIS, NECROSIS | Nine participants had PNF (three in the SCS arm and six in the NMP arm) and were excluded from subsequent analyses. In the SCS arm, two patients had a vascular thrombosis, and one had cortical necrosis. In the NMP arm, one patient had a vascular thrombosis; two patients had acute rejection; and, in three cases, the rea... | PMC10287561 |
Renal function in renal transplant recipients receiving donor kidneys randomized to preservation by SCS or NMP. | Serum creatinine levels (No differences were observed in tacrolimus trough blood levels between the SCS and NMP groups at 1, 3, 6 and 12 months after transplant (Supplementary Table | PMC10287561 | ||
Patient and graft survival | Patient and graft survival were similar between the arms for both the MITT and per-protocol analyses (patient survival: SCS 97.2 versus NMP 96.3 (HR (95% CI) 1.44 (0.33–6.36)); Fig. | PMC10287561 | ||
Patient and allograft survival in renal transplant recipients receiving donor kidneys randomized to preservation by SCS or NMP. | Kaplan–Meier plot for 12-month patient survival ( | PMC10287561 | ||
Exploratory assessment of kidney quality during NMP | COLD | The median renal blood flow was 180 ml/min/100 g (interquartile range (IQR) 120–230), and the median arterial pressure was 76 mmHg (IQR 74–80). The median amount of urine produced was 95 ml (IQR 50–180). The quality assessment score was applied to each of the analyzed kidneys. Forty-six percent had an assessment score ... | PMC10287561 | |
Post hoc subgroup analysis of DGF | In a sub-analysis including nine PNF cases in the MITT cohort and six in the per-protocol cohort, no significant difference was observed in rates of DGF between the study arms ( | PMC10287561 | ||
Post hoc analysis of CRR2 | In the MITT and per-protocol analysis, excluding patients who were not on dialysis before transplant, the CRR2 was significantly higher in the NMP arm ( | PMC10287561 | ||
Post hoc analysis of missing eGFR values | A sub-analysis imputing all missing eGFR values with the value 8.5 ml/min/1.73 m | PMC10287561 | ||
Post hoc analysis of the effect of a second period of cold ischemia on DGF rates after NMP | COLD | In the MITT analysis, no statistically significant difference was observed in the duration of the second cold ischemic time in NMP kidneys with initial graft function or DGF (median (range) 113.5 (1–514) minutes in NMP kidneys with initial graft function versus 134.6 (8–696) minutes in NMP kidneys with DGF; | PMC10287561 | |
Discussion | agonal, thrombosis, ischemic injury, DGF.In liver transplantation, atrributable, ischemia, inflammation, infection, hypotension | THROMBOSIS, GRAFT DYSFUNCTION, CIRCULATORY ARREST, ADVERSE EVENTS, ISCHEMIA, INFLAMMATION, CARDIAC ARREST, COMPLICATION, INFECTION, COMPLICATIONS, VENOUS THROMBOSIS, COLD, COMPLICATIONS | We compared a 1-h period of NMP with conventional SCS for kidney transplantation from DCD donors. The NMP protocol had no effect on the primary endpoint, which was the incidence of DGF, defined as the requirement for dialysis in the first 7 d after transplant. No significant statistical differences were observed in the... | PMC10287561 |
Methods | PMC10287561 | |||
Trial design | This investigator-led, randomized controlled, open-label trial was approved by the UK National Research Ethics Service and local institutional review boards (REC 15/EE/0356), with trial registration number | PMC10287561 | ||
Trial patients | multi-organ, end-stage renal failure | END-STAGE RENAL FAILURE | Eligible patients enrolled on the transplant waiting list and allocated a suitably matched kidney were enrolled at four UK transplant centers. Inclusion criteria included recipients 18 years of age or older with end-stage renal failure requiring their first or second kidney transplant who received a kidney from Maastri... | PMC10287561 |
SCS | BLOOD | Kidneys were retrieved by National Health Service Blood and Transplant (NHSBT) National Organ Retrieval Service teams, and, after flushing with cold preservation solution, they were stored on ice until transplanted. | PMC10287561 | |
NMP | NMP was performed at the transplanting center for 1 h using a customized pediatric cardiopulmonary bypass system. Kidneys were perfused with an oxygenated red-cell-based solution supplemented with a crystalloid solution and amino acids. Details are documented in the | PMC10287561 | ||
Transplantation | Kidneys were transplanted into either iliac fossa with anastomosis of the artery to the common, external or internal iliac arteries. The vein was anastomosed to either the common or the external iliac vein. The ureteric anastomosis was performed as an extravesical onlay over a double J stent. | PMC10287561 | ||
Immunosuppression | A standard immunosuppressive protocol was used in all four trial centers. All patients received induction therapy with basiliximab 20 mg IV given on the day of transplantation and on the fourth postoperative day. All patients received methylprednisolone 500 mg IV at induction of anaesthesia. Maintenance immunosuppressi... | PMC10287561 | ||
Clinical outcomes | infection, renal graft dysfunction | COMPLICATION, INFECTION, VENOUS THROMBOSIS, RENAL DISEASE, COMPLICATIONS | The primary outcome measure was DGF, defined as the requirement for dialysis in the first week after transplantation. Secondary outcome measures included incidence of PNF; duration of DGF; functional DGF defined as less than 10% fall in serum creatinine for three consecutive days in the first week after transplantation... | PMC10287561 |
Statistical analysis | PMC10287561 | |||
Study design | RECRUITMENT | The NHSBT Clinical Trials Unit supported the design, data management and analysis of the trial. Historical data spanning a 5-year period for three participating centers showed that the overall rate of DGF in DCD kidney transplants was 50%. This was used as the baseline rate. In a pilot series of kidney transplants from... | PMC10287561 | |
Interim analysis | A group sequential design, with O’Brien–Fleming stopping rules (which preserved the 5% significance level in the final analysis), was used to allow the DMC to review the primary outcome for evidence of harm, benefit or futility. Two unadjusted interim analyses were performed—the first after 124 patients were randomized... | PMC10287561 | ||
Study population | SECONDARY, COLD | The population used for efficacy analyses was a MITT population including all randomized patients who received a transplant. This was a change from the original protocol because it was deemed illogical to include those participants who did not receive a transplant, as no outcome data were available. Primary and seconda... | PMC10287561 | |
Primary and secondary outcome measures | REGRESSION, SECONDARY | The primary outcome was analyzed using an adjusted logistic regression model and excluded participants who experienced PNF. The data for this outcome were complete, and, therefore, it was not necessary to undertake any of the methods proposed in the statistical analysis plan for assessing the impact of these missing da... | PMC10287561 | |
NMP assessment score | mean renal blood flow | After NMP, kidneys were allocated a score of 1–5 based on the macroscopic appearance, mean renal blood flow and urine production. A lower value indicated a better score (details in the | PMC10287561 | |
Post hoc subgroup analyses | hyperkalemia | COLD, FLUID OVERLOAD |
PNF was included in the DGF groups to determine the impact of the pre-transplant preservation interventions on rates of non-function.To determine the effect of pre-transplant recipient dialysis status (receiving dialysis versus pre-dialysis) on DGF in the MITT analysis, we used the same model as that used for the prim... | PMC10287561 |
Reporting Summary | Further information on research design is available in the | PMC10287561 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02376-7. | PMC10287561 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-023-02376-7. | PMC10287561 | ||
Acknowledgements | KIDNEY | The authors give sincere thanks to the donor families. Without their generous gifts, this study would not have been possible. We would like to thank all the patients and the multidisciplinary teams involved in their care. We would like to acknowledge all the participating investigators from the Kidney Research UK Normo... | PMC10287561 | |
Author contributions | S.A.H. | S.A.H. and M.L.N. designed the study, acquired funding, carried out the perfusion techniques and project administration, collected the data and wrote and reviewed the manuscript. L.S. assisted in the design of the study, provided the statistical plan, analyzed and validated the data and co-wrote, reviewed and edited th... | PMC10287561 | |
Peer review | PMC10287561 | |||
Data availability | Data from the trial are stored in an online secure database hosted by the NHSBT Clinical Trials Unit. The protocol, consent form, statistical analysis plan, definition and derivation of clinical characteristics and outcomes, training materials, regulatory documents and other relevant study materials are available onlin... | PMC10287561 | ||
Competing interests | The authors declare no competing interests. | PMC10287561 | ||
References | PMC10287561 | |||
Subject terms | HER2-negative, adenocarcinoma | ADENOCARCINOMA, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA | There is an urgent need for first-line treatment options for patients with human epidermal growth factor receptor 2 (HER2)-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. Claudin-18 isoform 2 (CLDN18.2) is expressed in normal gastric cells and maintain... | PMC10427418 |
Main | Gastric adenocarcinoma, cancer, HER2-negative, adenocarcinoma, gastroesophageal junction adenocarcinomas | GASTRIC ADENOCARCINOMA, CANCER, ADENOCARCINOMA, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA, CYTOTOXICITY | Gastric adenocarcinoma is the fifth most commonly diagnosed cancer worldwide, and incidence of gastroesophageal junction adenocarcinomas has markedly increased in the last few decadesThe combination of targeted therapies or immunotherapies with chemotherapy can improve overall survival (OS) in some patients with metast... | PMC10427418 |
Results | PMC10427418 | |||
Patients and treatment | HER2-negative, tumor, tumors, adenocarcinoma | TUMOR, TUMORS, ADENOCARCINOMA | Between 28 November 2018 and 18 February 2022, a total of 2,333 patients with previously untreated, locally advanced unresectable or mG/GEJ adenocarcinoma were screened at 166 sites in 18 countries. CLDN18.2 tumor status was assessed in 2,104 patients, of whom 808 (38.4%) had tumors that met the cutoff for CLDN18.2 pos... | PMC10427418 |
PFS | PFS as the primary endpoint was statistically significantly prolonged in patients randomized to receive zolbetuximab versus placebo (median, 8.21 months versus 6.80 months, respectively; hazard ratio (HR) = 0.687; 95% confidence interval (CI), 0.544–0.866; | PMC10427418 | ||
OS | SECONDARY | At the interim analysis, 318 out of 507 (62.7%) patients had died: 144 of the 254 (56.7%) patients randomized to receive zolbetuximab, and 174 of the 253 (68.8%) patients randomized to receive placebo. OS as a key secondary endpoint was statistically significantly prolonged in patients in the zolbetuximab arm versus th... | PMC10427418 | |
Discussion | HER2-negative, nausea and vomiting, tumors | EVENTS, DISEASE, TUMORS, ADENOCARCINOMA | In GLOW, the addition of first-line zolbetuximab to CAPOX significantly improved PFS and OS in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or mG/GEJ adenocarcinoma. GLOW confirmed the increased survival benefit of adding zolbetuximab to chemotherapy observed in previous phase 2 and 3 s... | PMC10427418 |
Methods | PMC10427418 | |||
Trial oversight | Astellas (the study sponsor) collaborated with the academic authors on the design of the study and on the collection and interpretation of the data after analysis. The protocol and all amendments were approved by the appropriate independent ethics committee (IEC) or institutional review board (IRB) at each participatin... | PMC10427418 | ||
Patients | HER2-negative, tumor, tumors | DISEASE, TUMOR, TUMORS | Eligible patients were adults according to local regulations and had CLDN18.2-positive (defined as ≥75% of tumor cells with moderate-to-strong membranous CLDN18 staining as determined by central immunohistochemistry using the investigational VENTANA CLDN18 (43-14A) RxDx Assay), HER2-negative (per local or central testi... | PMC10427418 |
Inclusion criteria | WOCBP, tumor, ≤28 | TUMOR, LIVER METASTASES, DISEASE, METASTATIC DISEASE, ADENOCARCINOMA, APPENDIX | General criteria:IRB/IEC-approved written informed consent and privacy language as per national regulations (for example, Health Insurance Portability and Accountability Act (HIPAA) authorization for US sites) must be obtained from the patient or legally authorized representative (if applicable) before any study-relate... | PMC10427418 |
Exclusion criteria | Torsades de Pointes)QTc interval, malignancy, ≤28, autoimmune disease, coronary stenting, allergic reaction, toxicity, ventricular arrhythmias, cancer, infections, gastric outlet syndrome, persistent/recurrent vomiting, infection, adenocarcinoma, long QT syndromeCardiac arrhythmias, peripheral sensory neuropathy grade,... | DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY, CARCINOMATOUS MENINGITIS, CARDIOVASCULAR DISEASE, UNSTABLE ANGINA, HEART, AUTOIMMUNE DISEASE, ALLERGIC REACTION, GASTRIC BLEEDING, VENTRICULAR ARRHYTHMIA, CANCER, INFECTIONS, HEPATITIS C INFECTION, HEPATITIS B, GASTRIC ULCERS, INFECTION, HEPATITIS C, ADENOCARCINOMA, METASTASE... | Prohibited treatment or therapies:Patient has received prior systemic chemotherapy for locally advanced unresectable or mG/GEJ adenocarcinoma. However, patient may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anti-cancer therapies as long as it was completed at least 6 mont... | PMC10427418 |
Study design and treatment | non-Asia | METASTASES | GLOW is a global, randomized, double-blind, phase 3 trial. Patients were randomly assigned 1:1 to receive intravenous infusion of zolbetuximab 800 mg/mRandomization was performed by blinded site staff using interactive response technology by block randomization with block sizes of two and was stratified according to re... | PMC10427418 |
Endpoints | abdominal pain, Cancer | SECONDARY, CANCER | The primary endpoint was PFS per RECIST version 1.1 as determined by an IRC. Key secondary endpoints were OS and time to confirmed deterioration in scores for European Organization for Research and Treatment of Cancer global health status and quality of life, physical functioning and abdominal pain and discomfort asses... | PMC10427418 |
Assessments | Tumor, Pain, Cancer | DISEASE PROGRESSION, ADVERSE EVENT, TUMOR, ADVERSE EVENT, CANCER | Tumor response was assessed by imaging at screening, every 9 weeks for the first 54 weeks of treatment and every 12 weeks thereafter until disease progression or start of another anti-cancer treatment. Survival was assessed at least every 12 weeks during follow-up. Patients completed health-related quality of life asse... | PMC10427418 |
Statistical analysis | deaths, death | DISEASE PROGRESSION | The Kaplan–Meier method was used to estimate the median and distribution of PFS, OS and DOR; stratified log-rank tests were used to assess between-group differences, and the stratified Cox proportional hazard model was used to calculate HRs and associated 95% CIs. The Cochran–Mantel–Haenszel test was used to assess bet... | PMC10427418 |
Reporting summary | Further information on research design is available in the | PMC10427418 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02465-7. | PMC10427418 | ||
Supplementary information |
Supplementary Tables 1–6, Study Protocol, Statistical Analyis Plan (SAP) and SAP amendmentsReporting Summary | PMC10427418 | ||
Extended data | PMC10427418 | |||
PFS in the ITT population by investigator. | Kaplan-Meier curve of PFS in all patients. CAPOX, capecitabine plus oxaliplatin regimen; CI, confidence interval; HR, hazard ratio; ITT, intent-to-treat; mo., months; No., number; PFS, progression-free survival.
| PMC10427418 | ||
First occurrence of nausea and vomiting in the safety analysis set. | EVENTS | Events were counted if they did not occur in any previous onset interval. Individual data points are reported in Supplementary Tables
| PMC10427418 | |
Extended data | is available for this paper at 10.1038/s41591-023-02465-7. | PMC10427418 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-023-02465-7. | PMC10427418 | ||
Acknowledgements | J. Donnelly | The study was funded by Astellas Pharma Inc. The authors thank the patients, caregivers, investigators and site staff who participated in this study. We thank J. Raizer; study managers J. Donnelly, S. Koshy Hunt, A. Shrivastava and C. Muench; and steering committee members S. Kim and S. Klempner. We thank S. Moran, C. ... | PMC10427418 | |
Author contributions | M.A.S., J.A., Y.-J.B., P.E., D.I., F.L., K.S., E.V.C., M.O., J.W.P., D.M., P.B., A.A. and R.-H.X. made substantial contributions to the study design. M.A.S., J.A., Y.-J.B., P.E., D.I., F.L., K.S., E.V.C., J.G.P., J.H., L.S., S.C.O., P.S., H.F.S.H., H.M.T. and R.-H.X. acquired the study data. M.O., J.W.P., D.M., P.B. an... | PMC10427418 | ||
Peer review | PMC10427418 | |||
Data availability | Upon request, and subject to certain criteria, conditions and exceptions, Astellas will provide access to anonymized patient-level data from completed Astellas-sponsored phase 1 to phase 4 interventional clinical studies conducted for products and indications that have been approved in any country and also for studies ... | PMC10427418 | ||
Competing interests | SE, Pierre | ONCOLOGY | M.A.S. reports receiving research funding from Astellas Pharma Inc., Merck, Bristol Myers Squibb and Oncolys BioPharma and serving a leadership or judiciary role in board, society, committee or advocacy groups for the American Society of Clinical Oncology Leadership Council. K.S. reports receiving research funding from... | PMC10427418 |
References | PMC10427418 | |||
Background | HIV infection, HIV in Kilimanjaro and Arusha Region, Tanzania., ®, HIV and retention | HIV INFECTION | Adherence to antiretroviral (ARV) treatment for HIV infection is challenging because of many factors. The World Health Organization (WHO) has recommended using digital adherence technologies (DATs). However, there is limited evidence on how DATs improve adherence. Wisepill® is an internet-enabled medication dispenser f... | PMC10120095 |
Methods | We will conduct a formative mixed-methods study and three sub-trials in Kilimanjaro and Arusha Regions among (1) children aged 0–14 years and their caregivers, (2) adolescents aged 15–19 years and (3) breastfeeding women and their HIV-negative infants. In the formative study, we will collect and analyse data on needs a... | PMC10120095 | ||
Discussion | If the intervention improves adherence to ART and the devices are acceptable, accurate and sustainable, the intervention can be scaled up within the National Aids Control Programmes. | PMC10120095 | ||
Trial registration | PACTR202301844164954, date 27 January 2023. | PMC10120095 | ||
Keywords | PMC10120095 | |||
Introduction | HIV in SSA [ | DISEASE | Children and adolescents form a significant part of the world population of people living with human immunodeficiency virus (HIV), with the World Health Organization (WHO) reporting 1.8 million children (age < 15) and 1.8 million adolescents (ages 10–19) in Sub-Saharan Africa in 2019 [Despite high access for pregnant w... | PMC10120095 |
Methods/design | PMC10120095 | |||
Study area | We will conduct our project in care and treatment clinics (CTC) and postnatal clinics serving clients on antiretroviral treatment in the Kilimanjaro region in Tanzania, which has an area of 13,250 km | PMC10120095 | ||
Design | This project will evaluate a DAT consisting of real-time medication monitoring with the Wisepill® device and SMS messages and tailored feedback to participants on their adherence data. The project will consist of two stages (see Fig. Schematic display of the study | PMC10120095 | ||
Overall aim and objectives | HIV in Kilimanjaro, TanzaniaTo | SECONDARY | We aim to investigate whether our customized digital adherence tool will improve retention in care among breastfeeding women and adherence to treatment among children and adolescents.The specific objectives for the first stage are as follows:
To identify the enablers and barriers to using DAT among children and their c... | PMC10120095 |
Formative stage | The objective of this stage is to evoke feedback from the key intervention stakeholders to guide on designing and developing the newly proposed DAT. We will first survey 142 participants from each group to investigate enablers and barriers to using DAT. This figure is based on selecting an arbitrary percentage of 50% e... | PMC10120095 | ||
Clinical trials | We will conduct three clinical trials in each target groups to investigate whether the developed DATs improve adherence to treatment and virological outcomes. The study procedures can be found in the | PMC10120095 | ||
Ethical approval | The formative study and the trial have been separately approved by the College Research and Ethical Review Committee (CRERC) of Kilimanjaro Christian Medical University College (KCMUCo) and the National Health Research Ethics Sub-Committee (NatHREC) of the National Medical Research Institute (NIMR) of Tanzania. Further... | PMC10120095 | ||
Participants | HIV 0–14 | We will have three different study populations, which are the following:
Breastfeeding mothers living with HIV with their uninfected infants (for the survey of the formative phase, we will also include pregnant women to understand their views)Children aged 0–14 and their caregivers/parentsAdolescents aged 15–19The incl... | PMC10120095 | |
Intervention | The basis for the intervention is the Wisepill® device and our previously developed SMS scheme [ | PMC10120095 | ||
Attending the nurse; feedback on adherence data | Velicer | Nurse counsellors will recruit participants at their respective care and treatment clinics, follow standard care according to their normal schedule of care. After signing the informed consent, we will provide parents/caregivers of children and adolescents with a Wisepill® box which they will use for 12 months, while mo... | PMC10120095 | |
Blinding | BLIND | Due to the nature of the intervention, which is behavioural based, and the fact that assessing the outcome, which is adherence, is part of the behavioural intervention, it is impossible to blind any person in the study. During the handling of missing data, the transformation of variables, doing subgroup analyses and co... | PMC10120095 | |
Sample size calculation and randomization | We calculated the sample size for each group separately as the outcomes differed. In a previous study, the proportion of breastfeeding women that stayed in care was 41% in Kilimanjaro [The proportion of children reaching 95% adherence was 72% in a study among orphans in Dar es Salaam [The proportion of adolescents reac... | PMC10120095 | ||
Study outcomes | ADVERSE EVENT, EVENTS, ADVERSE EVENT | The primary study outcome for breastfeeding women is the percentage retained in care at 18-month post-partum. For children and adolescents, the primary outcome is mean adherence to ARV treatment.Adverse events will be monitored through an adverse event form as part of the case report form. Adverse events will be record... | PMC10120095 |
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