近日，英国伦敦大学学院Shabbar Jaffar团队研究了撒哈拉以南非洲地区艾滋病毒、糖尿病和高血压患者的综合社区护理与机构护理。相关论文于2026年3月14日发表在《柳叶刀》杂志上。

在撒哈拉以南非洲，糖尿病和高血压的疾病负担居高不下，同时HIV感染率也较高。目前尚不清楚能否在社区层面对这些疾病进行整合管理。该研究旨在坦桑尼亚和乌干达比较HIV、糖尿病和高血压患者接受社区整合护理与医疗机构整合护理的效果。

这项开放标签、多国、整群随机试验在坦桑尼亚和乌干达的14家初级医疗机构开展。纳入标准为：年满18周岁、确诊HIV、2型糖尿病或高血压（或合并症）；在医疗机构接受常规诊疗至少6个月；临床状况稳定；居住于服务覆盖范围内且计划居住至少6个月；愿意接受社区护理。每家机构将患者分为8-14人的整群组，通过在线数据管理系统按1:1比例随机分配至医疗机构整合护理组或社区护理组。医疗机构护理组采用共享挂号候诊区、统一医护团队及共用药房实验室服务模式；社区护理组由护士和受过培训的社区工作者每月组织一次社区集中点互助活动。随访期12个月。第一个共同主要终点是血压或空腹血糖控制复合指标（定义为：单纯高血压患者血压<140/90 mm Hg，单纯糖尿病患者空腹血糖<7.0 mmol/L，或合并症患者两项指标均达标）；第二个共同主要终点是单纯HIV感染者的血浆病毒载量抑制（定义为<1000拷贝/mL或病毒载量检测不到）。意向治疗人群分析采用广义估计方程校正整群效应。试验已在ISRCTN平台注册（ISRCTN15319595，已完成）。

2023年1月30日至10月6日期间，共筛选出2940例符合空间邻近条件可组成整群的HIV、糖尿病或高血压（或合并症）患者，均与参研机构有预约记录。其中765例（26.0%）未接受筛查，2175例（74.0%）接受资格筛查，203例（9.3%）不合格，4例（0.2%）未签署知情同意书，104例（4.8%）无法组成有效整群。最终1864例（63.4%）患者组成124个整群随机分配（社区组62群，医疗机构组62群）。女性占比高于男性（1700例中1302例[76.6%] vs 398例[23.4%]）。糖尿病/高血压患者中，社区组602例排除38例（6.3%），医疗机构组609例排除43例（7.1%）；HIV感染者中，社区组242例排除9例（3.7%），医疗机构组247例排除10例（4.0%）。高血压/糖尿病患者中，两组血压或空腹血糖控制复合指标无显著差异（社区组574例中317例[55.2%] vs 医疗机构组571例中304例[53.2%]；校正风险差1.80 [95% CI -4.52至8.12]；p=0.58），而单纯HIV感染者病毒抑制率均较高（社区组229例中227例[99.1%] vs 医疗机构组232例中229例[98.7%]；校正风险差0.44 [-1.12至1.99]；非劣效性p<0.0001）。各组均有7例死亡。

研究结果表明，在撒哈拉以南非洲，社区整合护理可使糖尿病/高血压患者达到高标准护理水平，且不会对HIV感染者的治疗效果产生不利影响。

附：英文原文

Title: 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

Author: Francis X Kasujja, Faith Aikaeli, Anupam Garrib, Erik van Widenfelt, Ivan Namakoola, Sokoine Kivuyo, James A Prior, Josephine Birungi, Faith Moyo, Duolao Wang, Stavia Turyahabwe, Gerald Mutungi, Mina Nakawuka Ssali, Omary Said Ubuguyu, Stephen Watiti, Said Aboud, Marie Claire Van Hout, Geoff Gill, Nelson K Sewankambo, Peter G Smith, Sayoki Mfinanga, Kaushik Ramaiya, Moffat J Nyirenda, Shabbar Jaffar

Issue&Volume: 2026/03/14

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.

DOI: 10.1016/S0140-6736(25)02641-8

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02641-8/abstract