Lancet. 2026 Mar 14;407(10533):1084-1094. doi: 10.1016/S0140-6736(25)02641-8.
ABSTRACT
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 <140/90 mm Hg in participants with hypertension alone, fasting glucose <7·0 mmol/L in those with diabetes alone, or both indicators controlled in those with both conditions) and the second was plasma viral load suppression for participants with HIV alone (defined as <1000 copies per mL or undetectable viral load). Both endpoints were assessed in the intention-to-treat population. Generalised estimating equation models accounted for clustering. This trial was registered with the ISRCTN registry, ISRCTN15319595 (completed).
FINDINGS: Between Jan 30 and Oct 6, 2023, 2940 patients with HIV, diabetes, or hypertension (or a combination of these conditions) who lived close enough together to be placed into a group were identified as having appointments to attend at the participating facilities. 765 (26·0%) patients were not screened and 2175 (74·0%) were screened for eligibility. 203 (9·3%) patients were ineligible, four (0·2%) did not consent, and 104 (4·8%) could not be grouped into viable clusters. 1864 (63·4%) patients were assigned into 124 groups, and groups were randomised (62 to community care and 62 to facility care). There were more females than males (1302 [76·6%] of 1700 vs 398 [23·4%]). Among those with diabetes or hypertension (or both), 38 (6·3%) of 602 in the community care group versus 43 (7·1%) of 609 in the facility care group were excluded, with nine (3·7%) of 242 versus ten (4·0%) of 247 excluded among participants with HIV. The composite of blood pressure or fasting glucose control did not significantly differ between the two groups in participants with hypertension or diabetes (or both; 317 [55·2%] of 574 in the community care group vs 304 [53·2%] of 571 in the facility care group; adjusted risk difference 1·80 [95% CI -4·52 to 8·12]; p=0·58), whereas most participants with HIV alone reached viral suppression (227 [99·1%] of 229 vs 229 (98·7%) of 232; adjusted risk difference 0·44 [-1·12 to 1·99]; pnon-inferiority<0·0001). There were seven deaths in each study group.
INTERPRETATION: In sub-Saharan Africa, integrated community care could reach a high standard of care for people with diabetes or hypertension without adversely affecting outcomes for people with HIV.
FUNDING: National Institute for Health and Care Research.
PMID:41831847 | DOI:10.1016/S0140-6736(25)02641-8
