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.

中文翻译：

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马拉维渔民艾滋病毒和血吸虫病检测和治疗的联合干预措施：三臂、整群随机试验。


背景技术 未确诊的艾滋病毒和血吸虫病在非洲大湖地区的渔民中非常普遍。我们的目的是评估湖边干预措施对艾滋病毒和男性生殖器血吸虫病服务的整合对马拉维渔民血吸虫病患病率、艾滋病毒抗逆转录病毒疗法（ART）的使用以及自愿男性医疗包皮环切术（VMMC）的效果。方法 我们在马拉维曼戈切的 45 个湖岸捕鱼社区（集群）中进行了三臂、整群随机试验。集群在地理上由其家乡社区定义为渔民离开船只的地方（即登陆地点）。符合资格的参与者是居住在集群中的男性渔民（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) 到增强护理标准 (SOC)，该标准通过信息传单邀请海滩诊所提供 HIV 检测和转诊，并使用吡喹酮进行血吸虫病推定治疗;同伴教育（PE），其中一名指定的渔民负责解释研究传单，以促进为其船员提供服务；或同伴分发教育（PDE），其中同伴教育者解释传单并向船员分发艾滋病毒自检套件。海滩诊所团队和渔民并未被掩盖干预措施的分配情况；然而，在最终分析之前，调查人员一直处于蒙蔽状态。共同主要复合结果是在光学显微镜下从 10 mL 尿液滤液中观察到至少有一个埃及血吸虫卵的参与者的比例，以及自我报告在第 28 天开始 ART 或安排 VMMC 的比例。 按意向治疗对结果进行分析；对缺失结果进行多重插补；使用调整基线不平衡和聚类的随机效应二项式模型来计算每个结果的未调整和调整风险差异、风险比 (RR) 和 95% CI 以及集群内相关系数。该试验已在 ISRCTN 注册，ISRCTN14354324。结果 2022 年 3 月 1 日至 2023 年 1 月 29 日期间，接受资格评估的 69 个集群中的 45 个集群 (65·2%) 参加了试验，每组 15 个集群。在基线筛查的 6036 名渔民中，有 5207 名 (86·3%) 符合参与资格：增强 SOC 组中 1991 年的 1745 名 (87·6%)，PE 组中的 2061 名渔民 1687 名 (81·9%)，以及1984 年 PDE 组中的 1775 (89·5%)。与增强 SOC 组中的活动性血吸虫病患病率（1745 名渔民中的 292 名 [16·7%]）相比，PDE 组中 1775 名渔民中的 241 名（13·6%）（调整后的 RR 0·80 [95% CI 0· 69-0·94]；p=0·0054) 和 PE 组 1687 名渔民中的 263 名 (15·6%) (0·92 [0·79-1·07]；p=0·28) 患有血吸虫病第 28 天。增强 SOC 组中有 230 例 (13·2%)，PE 组中有 281 例 (16·7%)，PDE 组有 215 例 (12·1%) 开始 ART 或计划进行 VMMC。 PDE 干预后，ART 启动或 VMMC 安排并未显着增加 (0·88 [0·74-1·05)； p=0·15），并且与增强 SOC 组相比，PE 干预后略有增加（1·16 [0·99-1·37]；p=0·069）。该试验中没有报告严重不良事件。 解释 我们发现，利用同伴教育来增加 ART 和 VMMC 的采用的证据微弱，但有强有力的证据表明，增加艾滋病毒自检套件的分发可以促进对服务的高度参与并降低活动性血吸虫病的患病率，这表明有很大的潜力在马拉维各地难以到达的社区扩大规模。资助威康信托基金和英国国家健康研究所。