Misra Shriya, Madonsela Thandanani, Thomas Katherine K, Grabow Cole, Lenn Meena, Morton Jennifer F, Reither Klaus, Lynen Lutgarde, van Heerden Alastair, Essack Zaynab, Bosman Shannon, Shapiro Adrienne E
SYNAPSE Research Collective, Wits Health Consortium, Pietermaritzburg, South Africa.
Centre for Community-Based Research, Human Sciences Research Council, Pietermaritzburg, KwaZulu-Natal, South Africa.
BMJ Open. 2025 Aug 12;15(8):e100927. doi: 10.1136/bmjopen-2025-100927.
INTRODUCTION: Tuberculosis (TB) remains the leading cause of infectious disease deaths, particularly among people living with HIV (PWH). Despite being preventable, TB preventive therapy (TPT) uptake is low in high-burden regions like South Africa, where new guidelines have expanded TPT eligibility and introduced shorter, more effective regimens like 3 months of weekly rifapentine and isoniazid (3HP). As differentiated service delivery models for HIV care have proven effective, there is increasing recognition that decentralising TPT delivery may improve coverage and completion. This study explores whether a community-based TPT delivery strategy can enhance uptake and completion of TPT compared with traditional clinic-based services. METHOD AND ANALYSIS: We will conduct a household-randomised, non-blinded, controlled trial. Persons eligible for TPT will be recruited from the TB TRIAGE+Trial study, a community-based household TB screening study. Households containing at least one person eligible for TPT will be randomised 1:1 to either community-based TPT or standard-of-care clinic referral for TPT. At enrolment, all participants will be provided with a 2-week supply of TPT in the community. Participants randomised to the community arm will receive the entire course of TPT in a single dispense (12 weeks of 3HP or 6 months of isoniazid, if 3HP is contraindicated). Clinic-arm participants will be referred to their local clinic for the remainder of their course of TPT and will collect TPT refills on the clinic-determined schedule. Our primary outcome is the proportion of participants who complete a course of TPT. Secondary outcomes include overall adherence to TPT, predictors of adherence with TPT, participant satisfaction with the assigned TPT delivery method and adverse events. ETHICS AND DISSEMINATION: The study and its tools were approved by the Human Sciences Research Councils Research Ethics Committee (approval number: 2/25/10/23), based in Pretoria, Gauteng, South Africa, as well as the University of Washington Institutional Review Board (Study 00018448). Study findings will be shared through the community advisory group and local stakeholder meetings, relevant international and local meetings/conferences and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT06214910. Date and version: 3.0, 30 July 2024.
引言：结核病（TB）仍然是传染病死亡的主要原因，尤其是在艾滋病毒感染者（PWH）中。尽管结核病是可预防的，但在南非等高负担地区，结核病预防性治疗（TPT）的采用率较低，在这些地区，新指南扩大了TPT的适用范围，并引入了更短、更有效的治疗方案，如每周一次利福喷丁和异烟肼治疗3个月（3HP）。由于差异化的艾滋病毒护理服务提供模式已被证明是有效的，人们越来越认识到将TPT服务去中心化可能会提高覆盖率和完成率。本研究探讨与传统的基于诊所的服务相比，基于社区的TPT服务提供策略是否能提高TPT的采用率和完成率。 方法与分析：我们将进行一项家庭随机、非盲、对照试验。符合TPT条件的人员将从TB TRIAGE+试验研究中招募，这是一项基于社区的家庭结核病筛查研究。至少有一名符合TPT条件人员的家庭将按1:1随机分为接受基于社区的TPT或接受TPT的标准护理诊所转诊。在入组时，所有参与者将在社区获得为期2周的TPT供应。随机分配到社区组的参与者将一次性获得整个TPT疗程（如果3HP禁忌，则为12周的3HP或6个月的异烟肼）。诊所组的参与者将被转诊到当地诊所完成剩余的TPT疗程，并将按照诊所确定的时间表领取TPT补充剂。我们的主要结局是完成TPT疗程的参与者比例。次要结局包括对TPT的总体依从性、TPT依从性的预测因素、参与者对指定的TPT服务提供方式的满意度以及不良事件。 伦理与传播：该研究及其工具已获得位于南非豪登省比勒陀利亚的人类科学研究理事会研究伦理委员会（批准号：2/25/10/23）以及华盛顿大学机构审查委员会（研究00018448）的批准。研究结果将通过社区咨询小组和当地利益相关者会议、相关的国际和当地会议/研讨会以及同行评审出版物进行分享。 试验注册号：NCT06214910。日期和版本：3.0，2024年7月30日。
Public Health Action. 2022-12-21
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