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.

Whether these conditions can be managed in an integrated way in the community is unknown.

这些疾病是否可以在社区中以综合方式管理尚不清楚。

We aim to compare integrated community-based care with integrated facility-based care for people with HIV, diabetes, and hypertension in Tanzania and Uganda.

我们旨在比较在坦桑尼亚和乌干达针对HIV、糖尿病和高血压患者实施的综合社区护理与综合设施护理的效果。

Methods

This open-label, multicountry, cluster-randomised trial was conducted in 14 primary care facilities across Tanzania and Uganda.

这是一项开放标签、多国参与的群组随机试验，研究在坦桑尼亚和乌干达的14个初级保健设施进行。

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.

年龄在18岁或以上的成年人，被诊断为HIV、2型糖尿病或高血压（或组合）；在卫生设施接受常规护理至少6个月；被认为是临床稳定的；居住在服务区域内并计划至少停留6个月；并且愿意在社区接受护理的被纳入研究。

In each facility, patients were grouped into clusters of 8-14.

在每个设施中，患者被分为8-14人的小组。

Each group was randomly assigned (1:1) using an online data management system, to integrated facility care or community care.

每个组别通过在线数据管理系统随机分配（1:1），接受综合设施护理或社区护理。

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.

在设施护理中，参与者共享相同的登记和等候区，由相同的医生和医疗工作者管理，并使用相同的药房和实验室服务。

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.

在社区护理中，一名护士和一名受过培训的非专业人员在社区的关键点支持小组，小组每月聚会一次。

Follow-up was 12 months.

随访期为12个月。

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).

第一个共同主要终点是血压或空腹血糖控制的综合指标（定义为单纯高血压患者的血压<140/90 mm Hg，单纯糖尿病患者的空腹血糖<7·0 mmol/L，或同时患有这两种疾病的患者两种指标均得到控制），第二个终点是单纯HIV感染患者的血浆病毒载量抑制（定义为<1000 copies/mL或无法检测到的病毒载量）。

Both endpoints were assessed in the intention-to-treatpopulation.

这两个终点都在意向治疗人群中进行了评估。

Generalised estimating equation models accounted for clustering.

广义估计方程模型考虑了群集效应。

This trial was registered with the ISRCTN registry, ISRCTN15319595 (completed).

这项试验已在ISRCTN注册处注册，注册号为ISRCTN15319595（已完成）。

Results

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).

2023年1月30日至10月6日期间，识别出2940名HIV、糖尿病或高血压（或这些疾病的组合）患者，他们居住地点足够接近，可以被分组，并在参与机构有预约。765名（26.0%）患者未接受筛查，2175名（74.0%）患者接受了资格筛查。203名（9.3%）患者不符合条件，4名（0.2%）未同意，104名（4.8%）无法被分入可行的群组。1864名（63.4%）患者被分配到124个群组中，群组被随机分配（62个接受社区护理，62个接受设施护理）。

There were more females than males (1302 [76·6%] of 1700 vs 398 [23·4%]).

女性患者多于男性患者（1700名患者中有1302名，占76.6%，而男性患者有398名，占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.

在患有糖尿病或高血压（或两者兼有）的患者中，社区护理组的602人中有38人（6.3%）被排除在外，设施护理组的609人中有43人（7.1%）被排除在外，而在HIV感染者中，社区护理组的242人中有9人（3.7%）被排除，设施护理组的247人中有10人（4.0%）被排除。

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).

在患有高血压或糖尿病（或两者兼有）的患者中，社区护理组的574人中有317人（55.2%）实现了血压或空腹血糖控制，设施护理组的571人中有304人（53.2%）实现了控制；调整后的风险差异为1.80（95% 置信区间 -4.52至8.12）；p=0.58。而在仅患有HIV的患者中，大多数患者达到了病毒抑制（社区护理组的229人中有227人（99.1%），设施护理组的232人中有229人（98.7%）；调整后的风险差异为0.44（-1.12至1.99）；p<0.0001，显示非劣效性。

There were seven deaths in each study group.

每个研究组中各有七人死亡。

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.

在撒哈拉以南非洲，综合社区护理可以为糖尿病或高血压患者提供高标准的护理，而不会对HIV患者的预后产生不利影响。

funding

National Institute for Health and Care Research.

国家健康与护理研究机构。