Public Health Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi; Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, CA, USA; Partners in Hope, Lilongwe, Malawi.
Lancet Glob Health. 2024 Oct;12(10):e1673-e1683. doi: 10.1016/S2214-109X(24)00283-3.
BACKGROUND: Undiagnosed HIV and schistosomiasis are highly prevalent among fishermen in the African Great Lakes region. We aimed to evaluate the efficacy of lakeside interventions integrating services for HIV and male genital schistosomiasis on the prevalence of schistosomiasis, uptake of antiretroviral therapy (ART) for HIV, and voluntary male medical circumcision (VMMC) among fishermen in Malawi. METHODS: We conducted a three-arm, cluster-randomised trial in 45 lakeshore fishing communities (clusters) in Mangochi, Malawi. Clusters were defined geographically by their home community as the place where fishermen leave their boats (ie, a landing site). Eligible participants were male fishermen (aged ≥18 years) who resided in a cluster. Clusters were randomly allocated (1:1:1) through computer-generated random numbers to either enhanced standard of care (SOC), which offered invitation with information leaflets to a beach clinic offering HIV testing and referral, and presumptive treatment for schistosomiasis with praziquantel; peer education (PE), in which a nominated fisherman was responsible for explaining the study leaflet to promote services to his boat crew; or peer distribution education (PDE), in which the peer educator explained the leaflet and distributed HIV self-test kits to his boat crew. The beach clinic team and fishermen were not masked to intervention allocation; however, investigators were masked until the final analysis. Coprimary composite outcomes were the proportion of participants who had at least one Schistosoma haematobium egg observed on light microscopy from 10 mL of urine filtrate and the proportion who had self-reported initiating ART or scheduling VMMC by day 28. Outcomes were analysed by intention to treat; multiple imputation for missing outcomes was done; random-effect binomial models adjusting for baseline imbalance and clustering were used to compute unadjusted and adjusted risk differences, risk ratios (RRs) and 95% CIs, and intracluster correlation coefficients for each outcome. This trial is registered with ISRCTN, ISRCTN14354324. FINDINGS: Between March 1, 2022, and Jan 29, 2023, 45 (65·2%) of 69 clusters assessed for eligibility were enrolled in the trial, with 15 clusters per arm. Of the 6036 fishermen screened at baseline, 5207 (86·3%) were eligible for participation: 1745 (87·6%) of 1991 in the enhanced SOC group, 1687 (81·9%) of 2061 in the PE group, and 1775 (89·5%) of 1984 in the PDE group. Compared with the prevalence of active schistosomiasis in the enhanced SOC group (292 [16·7%] of 1745), 241 (13·6%) of 1775 fishermen in the PDE group (adjusted RR 0·80 [95% CI 0·69-0·94]; p=0·0054) and 263 (15·6%) of 1687 fishermen in the PE group (0·92 [0·79-1·07]; p=0·28) had schistosomiasis at day 28. 230 (13·2%) in the enhanced SOC group, 281 (16·7%) in the PE group, and 215 (12·1%) in the PDE group initiated ART or were scheduled for VMMC. ART initiation or VMMC scheduling was not significantly increased with the PDE intervention (0·88 [0·74-1·05); p=0·15) and was marginally increased with the PE intervention (1·16 [0·99-1·37]; p=0·069) when compared with the enhanced SOC group. No serious adverse events were reported in this trial. INTERPRETATION: We found weak evidence for the use of peer education to increase uptake of ART and VMMC, but strong evidence for the added distribution of HIV self-test kits to promote high engagement with services and reduce the prevalence of active schistosomiasis, suggesting a high potential for scale-up in hard-to-reach communities across Malawi. FUNDING: Wellcome Trust and the UK National Institute for Health Research.
背景:在非洲大湖地区的渔民中,未确诊的 HIV 和血吸虫病高度流行。我们旨在评估湖边干预措施的效果,该措施将 HIV 和男性生殖器血吸虫病的服务整合在一起,以降低马拉维渔民中血吸虫病的流行率、接受抗逆转录病毒治疗 (ART) 的比例,以及自愿接受男性医疗环切术 (VMMC)。
方法:我们在马拉维曼戈奇的 45 个湖滨渔村(集群)进行了一项三臂、集群随机试验。集群通过其作为渔民离开船只的家社区(即登陆点)的地理位置进行定义。符合条件的参与者是居住在集群中的成年男性渔民(年龄≥18 岁)。通过计算机生成的随机数将集群随机分配(1:1:1)到增强的标准护理(SOC)、同伴教育(PE)或同伴分发教育(PDE)组。SOC 组提供邀请,并附有海滩诊所提供 HIV 检测和转介服务以及用吡喹酮进行疑似血吸虫病治疗的信息传单;PE 组中,指定的渔民负责向他的船员解释研究传单,以促进服务;PDE 组中,同伴教育者解释传单并向他的船员分发 HIV 自我检测试剂盒。海滩诊所团队和渔民对干预措施的分配没有进行掩蔽;然而,调查人员在最终分析之前进行了掩蔽。主要复合结局是至少有 10 毫升尿液滤液中观察到 1 个血吸虫卵的参与者比例和自我报告开始接受 ART 或安排 VMMC 的参与者比例。通过意向治疗进行结果分析;对缺失结果进行了多次插补;使用调整基线不平衡和聚类的随机效应二项式模型,计算了每个结局的未调整和调整后的风险差异、风险比 (RR) 和 95%置信区间以及每个结局的组内相关系数。这项试验在 ISRCTN 和 ISRCTN 注册,编号分别为 ISRCTN81664222 和 ISRCTN81664232。
结果:2022 年 3 月 1 日至 2023 年 1 月 29 日,对 69 个符合条件的集群中的 45 个进行了评估,每个组 15 个集群。在基线时筛查的 6036 名渔民中,有 5207 名符合参与条件:增强 SOC 组 1991 名中的 1745 名(87.6%),PE 组 2061 名中的 1687 名(81.9%)和 PDE 组 1984 名中的 1775 名(89.5%)。与增强 SOC 组中活跃性血吸虫病的流行率(1745 名中的 292 名,16.7%)相比,PDE 组 1775 名渔民中(241 名,13.6%)(调整后的 RR 0.80 [95%CI 0.69-0.94];p=0.0054)和 PE 组 1687 名渔民中(263 名,15.6%)(0.92 [0.79-1.07];p=0.28)在第 28 天患有血吸虫病。增强 SOC 组中有 230 名(13.2%)、PE 组中有 281 名(16.7%)和 PDE 组中有 215 名(12.1%)开始接受 ART 或安排 VMMC。与增强 SOC 组相比,PDE 干预并没有显著增加接受 ART 或 VMMC 的人数(0.88 [0.74-1.05);p=0.15),与 PE 干预相比,有轻微增加(1.16 [0.99-1.37];p=0.069)。本试验未报告严重不良事件。
解释:我们发现同伴教育在增加接受 ART 和 VMMC 的比例方面有微弱的证据,但在促进服务高参与度和降低活动性血吸虫病的流行率方面有强有力的证据,这表明在马拉维难以到达的社区有很大的推广潜力。
资金:威康信托基金会和英国国家卫生研究院。
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