eprintid: 10205915 rev_number: 8 eprint_status: archive userid: 699 dir: disk0/10/20/59/15 datestamp: 2025-03-11 10:48:17 lastmod: 2025-03-11 10:50:11 status_changed: 2025-03-11 10:48:17 type: article metadata_visibility: show sword_depositor: 699 creators_name: Abou Jaoude, Gerard Joseph creators_name: Namakoola, Ivan creators_name: Aikaeli, Faith creators_name: Kimaro, Godfather creators_name: Moyo, Faith creators_name: Kasujja, Francis Xavier creators_name: Van Widenfelt, Erik creators_name: Kivuyo, Sokoine creators_name: Birungi, Josephine creators_name: Mutungi, Gerald creators_name: Ubuguyu, Omary Said creators_name: Watiti, Stephen creators_name: Ramaiya, Kaushik creators_name: Mfinanga, Sayoki creators_name: Nyirenda, Moffat creators_name: Garrib, Anupam creators_name: Jaffar, Shabbar creators_name: Skordis, Jolene creators_name: Batura, Neha title: Protocol for the economic evaluation of integrated community-based care compared with integrated facility-based care for HIV, hypertension and diabetes in Tanzania and Uganda (INTE-COMM trial) [version 2; peer review: 3 approved] ispublished: pub divisions: UCL divisions: B02 divisions: D01 keywords: Economic evaluation, HIV, diabetes, hypertension, non-communicable diseases, integrated care, community care, sub-Saharan Africa note: Copyright © 2025 Abou Jaoude GJ et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, https://creativecommons.org/licenses/by/4.0/, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. abstract: Background: The number of people living with multiple chronic conditions in sub-Saharan Africa is increasing, but health facilities are unable to meet demand. To improve health system capacity and access to care, community models of HIV care have been trialled in countries such as Tanzania and Uganda. However, no evidence exists to inform policymakers on the effectiveness and cost-effectiveness of integrated community-based models of care for HIV and chronic non-communicable conditions. This protocol outlines a within-trial economic evaluation to address this gap. // Methods & analysis: We will estimate the costs and cost-effectiveness of integrated community-based care for HIV, hypertension and diabetes compared with facility-based care within the INTE-COMM pragmatic cluster-randomised trial in Tanzania and Uganda. Analyses will adopt a 52-week time horizon, the duration of trial follow-up. The full enrolled trial sample will be analysed from a societal perspective, comprising provider and patient perspectives. Economic costs will be estimated, which includes valuing inputs such as donated goods or time foregone by participants because of receiving care. For provider costs, participant case report forms will inform resource use along with data from facilities and community sites. Resources will be valued using project accounts, facility spending, and locally available cost data. Patient costs will be estimated based on a care-seeking and cost questionnaire administered to participants. Estimated costs will be analysed with co-primary trial outcomes on plasma viral load suppression, glycaemia and blood pressure control to calculate incremental cost-effectiveness ratios (ICER). We will also calculate ICERs for secondary trial outcomes related to health-related quality of life and wellbeing. Cost drivers and outcomes will be varied within confidence bounds in a two-way sensitivity analysis. We will investigate equity impact by estimating the mean difference in outcomes between integrated community-based and facility-based care across household socio-economic quintiles and by measuring whether participants incurred catastrophic health expenditures. // Trial registration number: The ISRCTN Registry: ISRCTN15319595. Registered on 07 June 2022: https://doi.org/10.1186/ISRCTN15319595 date: 2025 date_type: published publisher: National Institute for Health and Care Research official_url: https://doi.org/10.3310/nihropenres.13794.2 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 2359992 doi: 10.3310/nihropenres.13794.2 medium: Electronic-eCollection lyricists_name: Batura, Neha lyricists_name: Abou Jaoude, Gerard lyricists_name: Jaffar, Shabbar lyricists_name: Skordis, Jolene lyricists_name: Garrib, Anupam lyricists_id: NBATU68 lyricists_id: GJABO93 lyricists_id: SJAFF75 lyricists_id: JSKOR31 lyricists_id: AGARR22 actors_name: Abou Jaoude, Gerard actors_id: GJABO93 actors_role: owner full_text_status: public publication: NIHR Open Research volume: 4 article_number: 80 event_location: England issn: 2633-4402 citation: Abou Jaoude, Gerard Joseph; Namakoola, Ivan; Aikaeli, Faith; Kimaro, Godfather; Moyo, Faith; Kasujja, Francis Xavier; Van Widenfelt, Erik; ... Batura, Neha; + view all <#> Abou Jaoude, Gerard Joseph; Namakoola, Ivan; Aikaeli, Faith; Kimaro, Godfather; Moyo, Faith; Kasujja, Francis Xavier; Van Widenfelt, Erik; Kivuyo, Sokoine; Birungi, Josephine; Mutungi, Gerald; Ubuguyu, Omary Said; Watiti, Stephen; Ramaiya, Kaushik; Mfinanga, Sayoki; Nyirenda, Moffat; Garrib, Anupam; Jaffar, Shabbar; Skordis, Jolene; Batura, Neha; - view fewer <#> (2025) Protocol for the economic evaluation of integrated community-based care compared with integrated facility-based care for HIV, hypertension and diabetes in Tanzania and Uganda (INTE-COMM trial) [version 2; peer review: 3 approved]. NIHR Open Research , 4 , Article 80. 10.3310/nihropenres.13794.2 <https://doi.org/10.3310/nihropenres.13794.2>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10205915/1/fe37cf09-c1b1-46ed-9d05-045c63531b67_13794_-_gerard_joseph_abou_jaoude_v2.pdf