Background

Despite longstanding guidelines endorsing isoniazid preventive therapy (IPT) for people with HIV, uptake is low across sub-Saharan Africa. Mid-level health managers oversee IPT programmes nationally; interventions aimed at this group have not been tested. We aimed to establish whether providing structured leadership and management training and facilitating subregional collaboration and routine data feedback to mid-level managers could increase IPT initiation among people with HIV compared with standard practice.

Methods

We conducted a cluster randomised trial in Uganda among district-level health managers. We randomly assigned clusters of between four and seven managers in a 1:1 ratio to intervention or control groups. Our intervention convened managers into mini-collaboratives facilitated by Ugandan experts in tuberculosis and HIV, and provided business leadership and management training, SMS platform access, and data feedback. The control was standard practice. Participants were not masked to trial group, but study statisticians were masked until trial completion. The primary outcome was IPT initiation rates among adults with HIV in facilities overseen by participants over a period of 2 years (2019–21). We conducted prespecified analyses that excluded the third quarter of 2019 (Q3-2019) to understand intervention effects independent of a national 100-day IPT push tied to a financial contingency during Q3-2019. This trial is registered with ClinicalTrials.gov (NCT03315962), and is ongoing.

Findings

Between Nov 15, 2017, and March 14, 2018, managers from 82 of 82 eligible districts (61% of Uganda's 135 districts) were enrolled and randomised: 43 districts to intervention, 39 to control. Intervention delivery took place between Dec 6, 2017, and Feb 2, 2022. Over 2 years, IPT initiation rates were 0·74 versus 0·65 starts per person-year in intervention versus control groups (incidence rate ratio [IRR] 1·14, 95% CI 0·88–1·46; p=0·16). Excluding Q3-2019, IPT initiation was higher in the intervention group versus the control group: 0·32 versus 0·25 starts per person-year (IRR 1·27, 95% CI 1·00–1·61; p=0·026).

Interpretation

Following an intervention targeting managers in more than 60% of Uganda's districts, IPT initiation rates were not significantly higher in intervention than control groups. After accounting for large increases in IPT from a 100-day push in both groups, the intervention led to significantly increased IPT rates, sustained after the push and during the COVID-19 pandemic. Our findings suggest that interventions centred on mid-level health managers can improve IPT implementation on a large, subnational scale, and merit further exploration to address key public health challenges for which strong evidence exists but implementation remains suboptimal.

Funding

National Institute of Allergy and Infectious Diseases.

中文翻译：

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促进乌干达艾滋病毒感染者接受异烟肼预防性治疗的中级健康管理者干预措施：一项整群随机试验

背景

尽管长期的指导方针支持对艾滋病毒感染者进行异烟肼预防性治疗 (IPT)，但在撒哈拉以南非洲地区的吸收率很低。中层卫生管理人员在全国监督 IPT 项目；针对这一群体的干预措施尚未经过测试。我们旨在确定与标准实践相比，提供结构化的领导和管理培训以及促进次区域协作和向中层管理人员提供常规数据反馈是否可以增加 HIV 感染者的 IPT 启动。

方法

我们在乌干达的区级卫生管理人员中开展了一项整群随机试验。我们以 1:1 的比例将 4 到 7 名经理随机分配到干预组或对照组。我们的干预将管理人员召集到由乌干达结核病和艾滋病毒专家推动的小型合作组织中，并提供业务领导和管理培训、SMS 平台访问和数据反馈。控制是标准做法。参与者没有被掩盖到试验组，但研究统计学家被掩盖直到试验完成。主要结果是 2 年（2019-21 年）期间参与者监督的设施中 HIV 感染者的 IPT 启动率。我们进行了预先指定的分析，排除了 2019 年第三季度（2019 年第三季度），以了解独立于 2019 年第三季度期间与财务意外事件相关的全国 100 天 IPT 推动的干预效果。该试验已在 ClinicalTrials.gov (NCT03315962) 注册，并且正在进行中。

发现

在 2017 年 11 月 15 日至 2018 年 3 月 14 日期间，来自 82 个符合条件的地区中的 82 个（乌干达 135 个地区的 61%）的管理人员被纳入并随机分组：43 个地区进行干预，39 个地区进行控制。干预实施发生在 2017 年 12 月 6 日至 2022 年 2 月 2 日之间。在 2 年内，干预组与对照组的 IPT 启动率分别为 0·74 和 0·65 次/人年（发生率比 [IRR] 1· 14, 95% CI 0·88–1·46；p=0·16)。不包括 2019 年第三季度，干预组的 IPT 启动率高于对照组：0·32 次与 0·25 次/人年（IRR 1·27，95% CI 1·00–1·61；p=0 ·026)。

解释

在针对乌干达 60% 以上地区的管理人员进行干预后，干预组的 IPT 启动率并未显着高于对照组。在考虑到两组在 100 天推动后 IPT 的大幅增加后，干预导致 IPT 率显着增加，并在推动后和 COVID-19 大流行期间持续。我们的研究结果表明，以中层卫生管理者为中心的干预措施可以改善大规模、次国家级的 IPT 实施，并值得进一步探索以解决存在强有力证据但实施仍不理想的关键公共卫生挑战。

资金

国家过敏和传染病研究所。