Dataset Information

Home-based tuberculosis contact investigation in Uganda: a household randomised trial.

ABSTRACT: Introduction:The World Health Organization (WHO) recommends household tuberculosis (TB) contact investigation in low-income countries, but most contacts do not complete a full clinical and laboratory evaluation. Methods:We performed a randomised trial of home-based, SMS-facilitated, household TB contact investigation in Kampala, Uganda. Community health workers (CHWs) visited homes of index patients with pulmonary TB to screen household contacts for TB. Entire households were randomly allocated to clinic (standard-of-care) or home (intervention) evaluation. In the intervention arm, CHWs offered HIV testing to adults; collected sputum from symptomatic contacts and persons living with HIV (PLWHs) if ?5?years; and transported sputum for microbiologic testing. CHWs referred PLWHs, children <5 years, and anyone unable to complete sputum testing to clinic. Sputum testing results and/or follow-up instructions were returned by automated SMS texts. The primary outcome was completion of a full TB evaluation within 14?days; secondary outcomes were TB and HIV diagnoses and treatments among screened contacts. Results:There were 471 contacts of 190 index patients allocated to the intervention and 448 contacts of 182 index patients allocated to the standard-of-care. CHWs identified 190/471 (40%) intervention and 213/448 (48%) standard-of-care contacts requiring TB evaluation. In the intervention arm, CHWs obtained sputum from 35/91 (39%) of sputum-eligible contacts and SMSs were sent to 95/190 (50%). Completion of TB evaluation in the intervention and standard-of-care arms at 14?days (14% versus 15%; difference -1%, 95% CI -9% to 7%, p=0.81) and yields of confirmed TB (1.5% versus 1.1%, p=0.62) and new HIV (2.0% versus 1.8%, p=0.90) diagnoses were similar. Conclusions:Home-based, SMS-facilitated evaluation did not improve completion or yield of household TB contact investigation, likely due to challenges delivering the intervention components.

SUBMITTER: Davis JL

PROVIDER: S-EPMC6661318 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Home-based tuberculosis contact investigation in Uganda: a household randomised trial.

Davis J Lucian JL Turimumahoro Patricia P Meyer Amanda J AJ Ayakaka Irene I Ochom Emma E Ggita Joseph J Mark David D Babirye Diana D Okello Daniel Ayen DA Mugabe Frank F Fair Elizabeth E Vittinghoff Eric E Armstrong-Hough Mari M Dowdy David D Cattamanchi Adithya A Haberer Jessica E JE Katamba Achilles A

ERJ open research 20190729 3

<h4>Introduction</h4>The World Health Organization (WHO) recommends household tuberculosis (TB) contact investigation in low-income countries, but most contacts do not complete a full clinical and laboratory evaluation.<h4>Methods</h4>We performed a randomised trial of home-based, SMS-facilitated, household TB contact investigation in Kampala, Uganda. Community health workers (CHWs) visited homes of index patients with pulmonary TB to screen household contacts for TB. Entire households were rand ...[more]

PMID: 31367636

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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.

Project description:BackgroundTuberculosis(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.MethodsWe 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-over 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 and waived informed consent for the main trial implementation-effectiveness outcomes. We will submit results for publication in peer-reviewed journals and disseminate findings to local policymakers and representatives of affected communities.DiscussionThis pragmatic, quasi-experimental implementation trial will inform efforts to find and prevent undiagnosed persons with TB in high-burden settings using contact investigation. It will also help assess the suitability of human-centred design and communities of practice for tailoring implementation strategies and sustaining evidence-based interventions in low-and-middle-income countries.Trial registrationThe trial was registered(ClinicalTrials.gov Identifier NCT05640648) on 16 November 2022, after the trial launch on 7 March 2022.

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.

Dataset Information

Home-based tuberculosis contact investigation in Uganda: a household randomised trial.

Publications

Home-based tuberculosis contact investigation in Uganda: a household randomised trial.

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