Integrated community-based versus facility-based care for people with HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-COMM): an open-label, multicountry, cluster-randomised trial

Background In sub-Saharan Africa, the burden of diabetes and hypertension is high, alongside a high prevalence of HIV. Whether these conditions can be managed in an integrated way in the community is unknown. We aim to compare integrated community-based care with integrated facility-based care for people with HIV, diabetes, and hypertension in Tanzania and Uganda. Methods This open-label, multicountry, cluster-randomised trial was conducted in 14 primary care facilities across Tanzania and Uganda. Adults aged 18 years or older with a diagnosis of HIV, type 2 diabetes, or hypertension (or a combination); receiving regular care at the health facility for at least 6 months; considered clinically stable; living within the catchment area and planning to stay for at least 6 months; and willing to receive care in the community were enrolled. In each facility, patients were grouped into clusters of 8–14. Each group was randomly assigned (1:1) using an online data management system, to integrated facility care or community care. In facility care, participants shared the same registration and waiting areas, were managed by the same physicians and health-care workers, and used the same pharmacy and laboratory services. In community care, a nurse and a trained lay worker supported the groups at focal points in the community with groups meeting once per month. Follow-up was 12 months. The first coprimary endpoint was a composite of blood pressure or fasting glucose control (defined as blood pressure