TY - JOUR
T1 - Integrating HIV, diabetes and hypertension services in Africa
T2 - Study protocol for a cluster randomised trial in Tanzania and Uganda
AU - Mfinanga, Sayoki Godfrey
AU - Nyirenda, Moffat J.
AU - Mutungi, Gerald
AU - Mghamba, Janneth
AU - Maongezi, Sarah
AU - Musinguzi, Joshua
AU - Okebe, Joseph
AU - Kivuyo, Sokoine
AU - Birungi, Josephine
AU - Van Widenfelt, Erik
AU - Van Hout, Marie Claire
AU - Bachmann, Max
AU - Garrib, Anupam
AU - Bukenya, Dominic
AU - Cullen, Walter
AU - Lazarus, Jeffrey V.
AU - Niessen, Louis Wihelmus
AU - Katahoire, Anne
AU - Shayo, Elizabeth Henry
AU - Namakoola, Ivan
AU - Ramaiya, Kaushik
AU - Wang, Duolao
AU - Cuevas, L. E.
AU - Etukoit, Bernard M.
AU - Lutale, Janet
AU - Meshack, Shimwela
AU - Mugisha, Kenneth
AU - Gill, Geoff
AU - Sewankambo, Nelson
AU - Smith, Peter G.
AU - Jaffar, Shabbar
N1 - Funding Information:
Funding This work is funded by the EU Horizon 2020 programme, grant number 825 698.
Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2021/10/13
Y1 - 2021/10/13
N2 - Introduction HIV programmes in sub-Saharan Africa are well funded but programmes for diabetes and hypertension are weak with only a small proportion of patients in regular care. Healthcare provision is organised from stand-alone clinics. In this cluster randomised trial, we are evaluating a concept of integrated care for people with HIV infection, diabetes or hypertension from a single point of care. Methods and analysis 32 primary care health facilities in Dar es Salaam and Kampala regions were randomised to either integrated or standard vertical care. In the integrated care arm, services are organised from a single clinic where patients with either HIV infection, diabetes or hypertension are managed by the same clinical and counselling teams. They use the same pharmacy and laboratory and have the same style of patient records. Standard care involves separate pathways, that is, separate clinics, waiting and counselling areas, a separate pharmacy and separate medical records. The trial has two primary endpoints: retention in care of people with hypertension or diabetes and plasma viral load suppression. Recruitment is expected to take 6 months and follow-up is for 12 months. With 100 participants enrolled in each facility with diabetes or hypertension, the trial will provide 90% power to detect an absolute difference in retention of 15% between the study arms (at the 5% two-sided significance level). If 100 participants with HIV infection are also enrolled in each facility, we will have 90% power to show non-inferiority in virological suppression to a delta=10% margin (ie, that the upper limit of the one-sided 95% CI of the difference between the two arms will not exceed 10%). To allow for lost to follow-up, the trial will enrol over 220 persons per facility. This is the only trial of its kind evaluating the concept of a single integrated clinic for chronic conditions in Africa. Ethics and dissemination The protocol has been approved by ethics committee of The AIDS Support Organisation, National Institute of Medical Research and the Liverpool School of Tropical Medicine. Dissemination of findings will be done through journal publications and meetings involving study participants, healthcare providers and other stakeholders.
AB - Introduction HIV programmes in sub-Saharan Africa are well funded but programmes for diabetes and hypertension are weak with only a small proportion of patients in regular care. Healthcare provision is organised from stand-alone clinics. In this cluster randomised trial, we are evaluating a concept of integrated care for people with HIV infection, diabetes or hypertension from a single point of care. Methods and analysis 32 primary care health facilities in Dar es Salaam and Kampala regions were randomised to either integrated or standard vertical care. In the integrated care arm, services are organised from a single clinic where patients with either HIV infection, diabetes or hypertension are managed by the same clinical and counselling teams. They use the same pharmacy and laboratory and have the same style of patient records. Standard care involves separate pathways, that is, separate clinics, waiting and counselling areas, a separate pharmacy and separate medical records. The trial has two primary endpoints: retention in care of people with hypertension or diabetes and plasma viral load suppression. Recruitment is expected to take 6 months and follow-up is for 12 months. With 100 participants enrolled in each facility with diabetes or hypertension, the trial will provide 90% power to detect an absolute difference in retention of 15% between the study arms (at the 5% two-sided significance level). If 100 participants with HIV infection are also enrolled in each facility, we will have 90% power to show non-inferiority in virological suppression to a delta=10% margin (ie, that the upper limit of the one-sided 95% CI of the difference between the two arms will not exceed 10%). To allow for lost to follow-up, the trial will enrol over 220 persons per facility. This is the only trial of its kind evaluating the concept of a single integrated clinic for chronic conditions in Africa. Ethics and dissemination The protocol has been approved by ethics committee of The AIDS Support Organisation, National Institute of Medical Research and the Liverpool School of Tropical Medicine. Dissemination of findings will be done through journal publications and meetings involving study participants, healthcare providers and other stakeholders.
KW - Diabetes & endocrinology
KW - HIV & AIDS
KW - Hypertension
KW - Public health
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U2 - 10.1136/bmjopen-2020-047979
DO - 10.1136/bmjopen-2020-047979
M3 - Article
C2 - 34645657
AN - SCOPUS:85117881401
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - e047979
ER -