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撒哈拉以南非洲地区艾滋病毒、糖尿病和高血压综合管理(INTE-AFRICA):一项实用的集群随机对照试验。

Integrated management of HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-AFRICA): a pragmatic cluster-randomised, controlled trial.

机构信息

National Institutes for Medical Research, Dar es Salaam, Tanzania; Barcelona Institute for Global Health Hospital Clinic, University of Barcelona, Barcelona, Spain.

The AIDS Support Organisation, Mulago Hospital Complex, Kampala, Uganda; Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine (MRC/UVRI & LSHTM), Uganda Research Unit, Entebbe, Uganda; School of Psychology and Public Health, La Trobe University, Melbourne, VIC, Australia.

出版信息

Lancet. 2023 Oct 7;402(10409):1241-1250. doi: 10.1016/S0140-6736(23)01573-8.


DOI:10.1016/S0140-6736(23)01573-8
PMID:37805215
Abstract

BACKGROUND: In sub-Saharan Africa, health-care provision for chronic conditions is fragmented. The aim of this study was to determine whether integrated management of HIV, diabetes, and hypertension led to improved rates of retention in care for people with diabetes or hypertension without adversely affecting rates of HIV viral suppression among people with HIV when compared to standard vertical care in medium and large health facilities in Uganda and Tanzania. METHODS: In INTE-AFRICA, a pragmatic cluster-randomised, controlled trial, we randomly allocated primary health-care facilities in Uganda and Tanzania to provide either integrated care or standard care for HIV, diabetes, and hypertension. Random allocation (1:1) was stratified by location, infrastructure level, and by country, with a permuted block randomisation method. In the integrated care group, participants with HIV, diabetes, or hypertension were managed by the same health-care workers, used the same pharmacy, had similarly designed medical records, shared the same registration and waiting areas, and had an integrated laboratory service. In the standard care group, these services were delivered vertically for each condition. Patients were eligible to join the trial if they were living with confirmed HIV, diabetes, or hypertension, were aged 18 years or older, were living within the catchment population area of the health facility, and were likely to remain in the catchment population for 6 months. The coprimary outcomes, retention in care (attending a clinic within the last 6 months of study follow-up) for participants with either diabetes or hypertension (tested for superiority) and plasma viral load suppression for those with HIV (>1000 copies per mL; tested for non-inferiority, 10% margin), were analysed using generalised estimating equations in the intention-to-treat population. This trial is registered with ISCRTN 43896688. FINDINGS: Between June 30, 2020, and April 1, 2021 we randomly allocated 32 health facilities (17 in Uganda and 15 in Tanzania) with 7028 eligible participants to the integrated care or the standard care groups. Among participants with diabetes, hypertension, or both, 2298 (75·8%) of 3032 were female and 734 (24·2%) of 3032 were male. Of participants with HIV alone, 2365 (70·3%) of 3365 were female and 1000 (29·7%) of 3365 were male. Follow-up lasted for 12 months. Among participants with diabetes, hypertension, or both, the proportion alive and retained in care at study end was 1254 (89·0%) of 1409 in integrated care and 1457 (89·8%) of 1623 in standard care. The risk differences were -0·65% (95% CI -5·76 to 4·46; p=0·80) unadjusted and -0·60% (-5·46 to 4·26; p=0·81) adjusted. Among participants with HIV, the proportion who had a plasma viral load of less than 1000 copies per mL was 1412 (97·0%) of 1456 in integrated care and 1451 (97·3%) of 1491 in standard care. The differences were -0·37% (one-sided 95% CI -1·99 to 1·26; p<0·0001 unadjusted) and -0·36% (-1·99 to 1·28; p<0·0001 adjusted). INTERPRETATION: In sub-Saharan Africa, integrated chronic care services could achieve a high standard of care for people with diabetes or hypertension without adversely affecting outcomes for people with HIV. FUNDING: European Union Horizon 2020 and Global Alliance for Chronic Diseases.

摘要

背景:在撒哈拉以南非洲,慢性病的医疗服务是分散的。本研究的目的是确定与标准垂直护理相比,艾滋病毒、糖尿病和高血压的综合管理是否能提高糖尿病或高血压患者的护理保留率,而不会对艾滋病毒患者的病毒抑制率产生不利影响,在乌干达和坦桑尼亚的中大型卫生机构中。

方法:在 INTE-AFRICA 中,一项务实的集群随机对照试验,我们随机分配乌干达和坦桑尼亚的初级保健设施,为艾滋病毒、糖尿病和高血压提供综合护理或标准护理。按地点、基础设施水平和国家分层进行随机分配(1:1),采用随机块随机化方法。在综合护理组中,患有艾滋病毒、糖尿病或高血压的患者由同一名卫生保健工作者管理,使用同一家药房,具有类似设计的医疗记录,共享相同的注册和等候区,并提供综合实验室服务。在标准护理组中,这些服务分别针对每种疾病垂直提供。如果患者患有确诊的艾滋病毒、糖尿病或高血压,年龄在 18 岁或以上,居住在卫生设施的集水区内,并且有可能在 6 个月内留在集水区内,则有资格参加试验。主要结局是检测糖尿病或高血压(检测优越性)的患者的护理保留率(在研究随访的最后 6 个月内就诊)和艾滋病毒患者的血浆病毒载量抑制率(检测非劣效性,10%的差距)>1000 拷贝/ml),在意向治疗人群中使用广义估计方程进行分析。该试验在 ISCRTN 43896688 注册。

结果:2020 年 6 月 30 日至 2021 年 4 月 1 日期间,我们随机分配了 32 个卫生设施(乌干达 17 个,坦桑尼亚 15 个),共 7028 名符合条件的参与者,分为综合护理组或标准护理组。在患有糖尿病、高血压或两者的患者中,3032 名患者中有 2298 名(75.8%)为女性,3032 名中有 734 名(24.2%)为男性。在单独患有艾滋病毒的患者中,3365 名患者中有 2365 名(70.3%)为女性,3365 名中有 1000 名(29.7%)为男性。随访持续 12 个月。在患有糖尿病、高血压或两者的患者中,综合护理组有 1409 名患者中有 1254 名(89.0%)和标准护理组中有 1623 名患者中有 1457 名(89.8%)在研究结束时存活并得到保留。风险差异为-0.65%(95%CI-5.76 至 4.46;p=0.80)未调整和-0.60%(-5.46 至 4.26;p=0.81)调整。在患有艾滋病毒的患者中,综合护理组中有 1456 名患者中有 1412 名(97.0%)和标准护理组中有 1491 名患者中有 1451 名(97.3%)的患者血浆病毒载量小于 1000 拷贝/ml。差异为-0.37%(单侧 95%CI-1.99 至 1.26;p<0.0001 未调整)和-0.36%(-1.99 至 1.28;p<0.0001 调整)。

解释:在撒哈拉以南非洲,综合慢性病护理服务可以为糖尿病或高血压患者提供高标准的护理,而不会对艾滋病毒患者的治疗结果产生不利影响。

资金来源:欧盟地平线 2020 计划和全球慢性疾病联盟。

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