Anca Vasiliu1, Sabrina Eymard-Duvernay1, Boris Tchounga2, Daniel Atwine3, Elisabete de Carvalho1, Sayouba Ouedraogo1, Michael Kakinda4, Patrice Tchendjou2, Stavia Turyahabwe5, Albert Kuate Kuate6, Georges Tiendrebeogo1, Peter J Dodd7, Stephen M Graham8,9, Jennifer Cohn10, Martina Casenghi10, Maryline Bonnet11. 1. French National Research Institute for Sustainable Development (IRD UMI 233 TransVIHMI- UM-INSERM U1175), Montpellier, France. 2. Elizabeth Glaser Pediatric AIDS Foundation, Yaoundé, Cameroon. 3. Epicentre Research Center, Mbarara, Uganda. 4. Elizabeth Glaser Pediatric AIDS Foundation, Mbarara, Uganda. 5. National Tuberculosis and Leprosy Program, Kampala, Uganda. 6. National Tuberculosis Program, Yaoundé, Cameroon. 7. School of Health and Related Research, University of Sheffield, Sheffield, UK. 8. Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Australia. 9. International Union Against Tuberculosis and Lung Disease (The Union), Paris, France. 10. Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland. 11. French National Research Institute for Sustainable Development (IRD UMI 233 TransVIHMI- UM-INSERM U1175), Montpellier, France. maryline.bonnet@ird.fr.
Abstract
BACKGROUND: There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings. METHODS/ DESIGN: This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5-14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm. DISCUSSION: This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03832023 . Registered on 6 February 2019.
RCT Entities:
BACKGROUND: There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings. METHODS/ DESIGN: This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5-14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm. DISCUSSION: This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03832023 . Registered on 6 February 2019.
Authors: Paul A Harris; Robert Taylor; Brenda L Minor; Veida Elliott; Michelle Fernandez; Lindsay O'Neal; Laura McLeod; Giovanni Delacqua; Francesco Delacqua; Jacqueline Kirby; Stephany N Duda Journal: J Biomed Inform Date: 2019-05-09 Impact factor: 6.317
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Authors: Anca Vasiliu; Georges Tiendrebeogo; Muhamed Mbunka Awolu; Cecilia Akatukwasa; Boris Youngui Tchakounte; Bob Ssekyanzi; Boris Kevin Tchounga; Daniel Atwine; Martina Casenghi; Maryline Bonnet Journal: Pilot Feasibility Stud Date: 2022-02-11