Dataset Information

Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial.

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 (DiscussionThis 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.

SUBMITTER: Vasiliu A

PROVIDER: S-EPMC7927252 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial.

Vasiliu Anca A Eymard-Duvernay Sabrina S Tchounga Boris B Atwine Daniel D de Carvalho Elisabete E Ouedraogo Sayouba S Kakinda Michael M Tchendjou Patrice P Turyahabwe Stavia S Kuate Albert Kuate AK Tiendrebeogo Georges G Dodd Peter J PJ Graham Stephen M SM Cohn Jennifer J Casenghi Martina M Bonnet Maryline M

Trials 20210302 1

<h4>Background</h4>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.<h4>Methods/design</h4>This multicenter parallel open-label cl ...[more]

PMID: 33653385

Similar Datasets

Project description:Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide. Considering the World Health Organization recommendation to implement child contact management (CCM) for TB, we conducted a mixed-methods systematic review to summarize CCM implementation, challenges, predictors, and recommendations. We searched the electronic databases of PubMed/MEDLINE, Scopus, and Web of Science for studies published between 1996-2017 that reported CCM data from high TB-burden countries. Protocol details for this systematic review were registered on PROSPERO: International prospective register of systematic reviews (#CRD42016038105). We formulated a search strategy to identify all available studies, published in English that specifically targeted a) population: child contacts (<15 years) exposed to TB in the household from programmatic settings in high burden countries (HBCs), b) interventions: CCM strategies implemented within the CCM cascade, c) comparisons: CCM strategies studied and compared in HBCs, and d) outcomes: monitoring and evaluation of CCM outcomes reported in the literature for each CCM cascade step. We included any quantitative, qualitative, mixed-methods study design except for randomized-controlled trials, editorials or commentaries. Thirty-seven studies were reviewed. Child contact losses varied greatly for screening, isoniazid preventive therapy initiation, and completion. CCM challenges included: infrastructure, knowledge, attitudes, stigma, access, competing priorities, and treatment. CCM recommendations included: health system strengthening, health education, and improved preventive therapy. Identified predictors included: index case and clinic characteristics, perceptions of barriers and risk, costs, and treatment characteristics. CCM lacks standardization resulting in common challenges and losses throughout the CCM cascade. Prioritization of a CCM-friendly healthcare environment with improved CCM processes and tools; health education; and active, evidence-based strategies can decrease barriers. A focused approach toward every aspect of the CCM cascade will likely diminish losses throughout the CCM cascade and ultimately decrease TB related morbidity and mortality in children.

Project description:IntroductionHIV status awareness is important for household contacts of patients with tuberculosis (TB). Home HIV testing during TB contact investigation increases HIV status awareness. Social interactions during home visits may influence perceived stigma and uptake of HIV testing. We designed an intervention to normalise and facilitate uptake of home HIV testing with five components: guided selection of first tester; prosocial invitation scripts; opt-out framing; optional sharing of decisions to test; and masking of decisions not to test.Methods and analysisWe will evaluate the intervention effect in a household-randomised controlled trial. The primary aim is to assess whether contacts offered HIV testing using the norming strategy will accept HIV testing more often than those offered testing using standard strategies. Approximately 198 households will be enrolled through three public health facilities in Kampala, Uganda. Households will be randomised to receive the norming or standard strategy and visited by a community health worker (CHW) assigned to that strategy. Eligible contacts ≥15 years will be offered optional, free, home HIV testing. The primary outcome, proportion of contacts accepting HIV testing, will be assessed by CHWs and analysed using an intention-to-treat approach. Secondary outcomes will be changes in perceived HIV stigma, changes in perceived TB stigma, effects of perceived HIV stigma on HIV test uptake, effects of perceived TB stigma on HIV test uptake and proportions of first-invited contacts who accept HIV testing. Results will inform new, scalable strategies for delivering HIV testing.Ethics and disseminationThis study was approved by the Yale Human Investigation Committee (2000024852), Makerere University School of Public Health Institutional Review Board (661) and Uganda National Council on Science and Technology (HS2567). All participants, including patients and their household contacts, will provide verbal informed consent. Results will be submitted to a peer-reviewed journal and disseminated to national stakeholders, including policy-makers and representatives of affected communities.Trial registration numberClinicalTrials.gov Identifier: NCT05124665.

Project description:BackgroundChild tuberculosis (TB) contact management is recommended for preventing TB in children but its implementation is suboptimal in high TB/HIV-burden settings. The PREVENT Study was a mixed-methods, clustered-randomized implementation study that evaluated the effectiveness and acceptability of a community-based intervention (CBI) to improve child TB contact management in Lesotho, a high TB burden country.MethodsTen health facilities were randomized to CBI or standard of care (SOC). CBI holistically addressed the complex provider-, patient-, and caregiver-related barriers to prevention of childhood TB. Routine TB program data were abstracted from TB registers and cards for all adult TB patients aged >18 years registered during the study period, and their child contacts. Primary outcome was yield (number) of child contacts identified and screened per adult TB patient. Generalized linear mixed models tested for differences between study arms. CBI acceptability was assessed via semi-structured in-depth interviews with a purposively selected sample of 20 healthcare providers and 28 caregivers. Qualitative data were used to explain and confirm quantitative results. We used thematic analysis to analyze the data.ResultsFrom 01/2017-06/2018, 973 adult TB patients were recorded, 490 at CBI and 483 at SOC health facilities; 64% male, 68% HIV-positive. At CBI and SOC health facilities, 216 and 164 child contacts were identified, respectively (p = 0.16). Screening proportions (94% vs. 62%, p = 0.13) were similar; contact yield per TB case (0.40 vs. 0.20, p = 0.08) was higher at CBI than SOC health facilities, respectively. CBI was acceptable to caregivers and healthcare providers.ConclusionIdentification and screening for TB child contacts were similar across study arms but yield was marginally higher at CBI compared with SOC health facilities. CBI scale-up may enhance the ability to reach and engage child TB contacts, contributing to efforts to improve TB prevention among children.

Project description:Background Tuberculosis (TB) is among the leading causes of infectious death worldwide. Contact investigation is an evidence-based, World Health Organisation-endorsed intervention for timely TB diagnosis, treatment, and prevention but has not been widely and effectively implemented. Methods We are conducting a stepped-wedge, cluster-randomised, hybrid Type III implementation-effectiveness trial comparing a user-centred to a standard strategy for implementing TB contact investigation in 12 healthcare facilities in Uganda. The user-centred strategy consists of several client-focused components including 1) a TB-education booklet, 2) a contact-identification algorithm, 3) an instructional sputum-collection video, and 4) a community-health-rider service to transport clients, CHWs, and sputum samples, along with several healthcare-worker-focused components, including 1) collaborative improvement meetings, 2) regular audit-and-feedback reports, and 3) a digital group-chat application designed to develop a community of practice. Sites will cross from the standard to the user-centred strategy in six, eight-week transition steps following a randomly determined site-pairing scheme and timeline. The primary implementation outcome is the proportion of symptomatic close contacts completing TB evaluation within 60 days of TB treatment initiation by the index person with TB. The primary clinical effectiveness outcomes are the proportion of contacts diagnosed with and initiating active TB disease treatment and the proportion initiating TB preventative therapy within 60 days. We will assess outcomes from routine source documents using intention-to-treat analyses. We will also conduct nested mixed-methods studies of implementation fidelity and context and perform cost-effectiveness and impact modelling. The Makerere School of Public Health IRB (#554), the Uganda National Council for Science and Technology (#HS1720ES), and the Yale Institutional Review Board (#2000023199) approved the study with a waiver of informed consent for the main trial implementation-effectiveness outcomes. We will submit trial results for publication in a peer-reviewed journal and disseminate findings to local shareholders, including policymakers and representatives of affected communities. Discussion This pragmatic, quasi-experimental implementation trial will inform efforts to find and prevent undiagnosed persons with TB in high-burden setting using contact investigation. It will help assess the suitability of human-centred design and communities of practice for tailoring implementation strategies and sustain evidence-based interventions in low-and-middle-income countries. Trial registration number ClinicalTrials.gov Identifier: NCT05640648.

Dataset Information

Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial.

Background

Methods/design

Trial registration

Publications

Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial.

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