Integrating HIV, Diabetes, and Hypertension services in Africa: study protocol for a cluster randomized trial in Tanzania and Uganda.

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. Health care 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, i.e. separate clinics, waiting and counselling areas, a separate pharmacy and separate medical records. The trial has 2 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 (i.e. that the upper limit of the one-sided 95% confidence interval of the difference between the two arms will not exceed 10%). To allow for loss 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, health care providers and other stakeholders. Trial registration: ISRCTN43896688 Strengths of this trial • This is the largest trial of its kind with replication in over 30 health facilities and 2 countries. • It was designed, implemented and is being monitored in partnership with patient representatives, health care providers, policy makers and other stakeholders. • The trial is measuring objective markers of effectiveness and is multidisciplinary. Limitations of this trial • The trial has a relatively short follow-up of 12 months and cannot estimate effect against mortality or other longer-term outcomes. • The trial cannot be blinded – both health care providers and patients know the intervention being delivered at each health facility

Integrated management of HIV, diabetes and hypertension in sub Saharan Africa: a pragmatic multi-country cluster-randomised trial

Introduction: In Africa, health care provision for chronic conditions is fragmented. We evaluated integrated management of HIV, diabetes and hypertension in Dar es Salaam, Tanzania and Kampala, Uganda. Methods: We conducted a pragmatic, cluster-randomised trial. Primary health care facilities were randomised to provide either integrated or standard care. In integrated care, participants with HIV, diabetes or hypertension were managed by the same healthcare workers, used the same pharmacy, had similarly designed medical records, shared the same registration and waiting area and had an integrated laboratory service. In standard care , these services were delivered vertically for each condition. Analyses used Generalised Estimating Equations. Recruitment was between 30th June 2020 and 1st April 2021 and follow-up was for 12 months. This trial is registered: ISCRTN 43896688. Findings: 32 health facilities were randomised. Just 3% of patients declined to join. Among participants with diabetes, hypertension or both, mean age (standard deviation) was 60.1 (12.7) years in the integrated care arm and 57.7 (12.2) in the standard care arm; among participants with HIV, these figures were 42.6 (11.2) and 42.7 (10.8) respectively. Among participants with diabetes, hypertension or both, the proportion alive and retained in care at study end was 1254/1409 (89.0%) in integrated care and 1457/1623 (89.8%) in standard care. The differences (95% CI were -0.65% (-5.76, 4.46; p=0.80) unadjusted and - 0.60% (-5.46, 4.26; p=0.81) adjusted. Among participants with HIV, the proportion who had plasma viral load <1,000 copies per ml was 1412/1456 (97.0%) in integrated care and 1451/1491 (97.3%) in standard care. The differences were -0.37% (One-sided 95% CI -1.99, 1.26; p-value for non-inferiority <0.0001 unadjusted) and -0.36% (-1.99, 1.28; p-value for non-inferiority <0.0001 adjusted). Conclusion: In sub-Saharan Africa, integrated chronic care services could improve outcomes for people with diabetes or hypertension without adversely affect outcomes for people with HIV