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Kivuyo, Sokoine, Birungi, Josephine, Okebe, Joseph, Wang, Duolao, Ramaiya, Kaushik, Ainan, Samafilan, Tumuhairwe, Faith, Ouma, Simple, Namakoola, Ivan, Garrib, Anupam, van Widenfelt, Erik, Mutungi, Gerald, Jaoude, Gerard Abou, Batura, Neha, Musinguzi, Joshua, Nakawuka Ssali, Mina, Etukoit, Bernard Michael, Mugisha, Kenneth, Shimwela, Meshack, Said Ubuguyu, Omary, Makubi, Abel, Jeffery, Caroline, Watiti, Stephen, Skordis, Jolene, Cuevas, Luis, Sewankambo, Nelson K., Gill, Geoff, Katahoire, Anne, Smith, Peter G., Bachmann, Max 
ORCID: https://orcid.org/0000-0003-1770-3506, Lazarus, Jeffrey V., Mfinanga, Sayoki, Nyirenda, Moffat J. and Nyirenda, Moffat J.
and
RESPOND-AFRICA Group
(2023)
Integrated management of HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-AFRICA): a pragmatic cluster-randomised, controlled trial.
The Lancet, 402 (10409).
pp. 1241-1250.
ISSN 0140-6736
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Abstract
Background: In sub-Saharan Africa, health-care provision for chronic conditions is fragmented. The aim of this study was to determine whether integrated management of HIV, diabetes, and hypertension led to improved rates of retention in care for people with diabetes or hypertension without adversely affecting rates of HIV viral suppression among people with HIV when compared to standard vertical care in medium and large health facilities in Uganda and Tanzania. Methods: In INTE-AFRICA, a pragmatic cluster-randomised, controlled trial, we randomly allocated primary health-care facilities in Uganda and Tanzania to provide either integrated care or standard care for HIV, diabetes, and hypertension. Random allocation (1:1) was stratified by location, infrastructure level, and by country, with a permuted block randomisation method. In the integrated care group, participants with HIV, diabetes, or hypertension were managed by the same health-care workers, used the same pharmacy, had similarly designed medical records, shared the same registration and waiting areas, and had an integrated laboratory service. In the standard care group, these services were delivered vertically for each condition. Patients were eligible to join the trial if they were living with confirmed HIV, diabetes, or hypertension, were aged 18 years or older, were living within the catchment population area of the health facility, and were likely to remain in the catchment population for 6 months. The coprimary outcomes, retention in care (attending a clinic within the last 6 months of study follow-up) for participants with either diabetes or hypertension (tested for superiority) and plasma viral load suppression for those with HIV (>1000 copies per mL; tested for non-inferiority, 10% margin), were analysed using generalised estimating equations in the intention-to-treat population. This trial is registered with ISCRTN 43896688. Findings: Between June 30, 2020, and April 1, 2021 we randomly allocated 32 health facilities (17 in Uganda and 15 in Tanzania) with 7028 eligible participants to the integrated care or the standard care groups. Among participants with diabetes, hypertension, or both, 2298 (75·8%) of 3032 were female and 734 (24·2%) of 3032 were male. Of participants with HIV alone, 2365 (70·3%) of 3365 were female and 1000 (29·7%) of 3365 were male. Follow-up lasted for 12 months. Among participants with diabetes, hypertension, or both, the proportion alive and retained in care at study end was 1254 (89·0%) of 1409 in integrated care and 1457 (89·8%) of 1623 in standard care. The risk differences were –0·65% (95% CI –5·76 to 4·46; p=0·80) unadjusted and –0·60% (–5·46 to 4·26; p=0·81) adjusted. Among participants with HIV, the proportion who had a plasma viral load of less than 1000 copies per mL was 1412 (97·0%) of 1456 in integrated care and 1451 (97·3%) of 1491 in standard care. The differences were –0·37% (one-sided 95% CI –1·99 to 1·26; pnon-inferiority<0·0001 unadjusted) and –0·36% (–1·99 to 1·28; pnon-inferiority<0·0001 adjusted). Interpretation: In sub-Saharan Africa, integrated chronic care services could achieve a high standard of care for people with diabetes or hypertension without adversely affecting outcomes for people with HIV.
| Item Type: | Article |
|---|---|
| Additional Information: | Data sharing: Individual participant data that underlie the results reported in this article are available, after deidentification, to researchers who provide a methodologically sound proposal. Proposals should be directed to s.jaffar@ucl.ac.uk. Data will be available for 5 years. The study protocol, statistical analysis plan, and analytic code are available upon request. Source code for software used in the trial is publicly available at https://github.com/inte-africa-trial/inte-edc. Acknowledgments: The INTE-AFRICA project is funded by the European Union's Horizon 2020 research and innovation programme under grant agreement number 825 698 as part of the Global Alliance for Chronic Diseases Scale-Up Research Programme. We thank the patients who participated in this study, health-care providers, managers of the 32 health facilities, and local and national policy makers for their time and support. We also thank the independent members of the steering committees, who gave valuable time to the trial, including Saidi Egwaga, Boniface Richard, Anath Rwebemberas, Ramadhan Mongi, Nathan Kenya-Mugisha, David Guwatudde, and Jerome Kabakyenga. We also thank the independent data safety monitoring committee: Pablo Perel, Andrea Rehman, David Guwatudde, and Sile Molloy. |
| Uncontrolled Keywords: | medicine(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging Faculty of Science > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Medicine and Health Sciences > Research Centres > Population Health |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 12 Oct 2023 00:42 |
| Last Modified: | 25 Oct 2023 02:23 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/93265 |
| DOI: | 10.1016/S0140-6736(23)01573-8 |
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