Background

In settings with high HIV prevalence and treatment coverage, such as Botswana, it is unknown whether uptake of HIV prevention and treatment interventions can be increased further. We sought to determine whether a community-based intervention to identify and rapidly treat people living with HIV, and support male circumcision could increase population levels of HIV diagnosis, treatment, viral suppression, and male circumcision in Botswana.

Methods

The Ya Tsie Botswana Combination Prevention Project study was a pair-matched cluster-randomised trial done in 30 communities across Botswana done from Oct 30, 2013, to June 30, 2018. 15 communities were randomly assigned to receive HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care. The first primary endpoint of HIV incidence has already been reported. In this Article, we report findings for the second primary endpoint of population uptake of HIV prevention services, as measured by proportion of people known to be HIV-positive or tested HIV-negative in the preceding 12 months; proportion of people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised. A longitudinal cohort of residents aged 16–64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates. Differences in intervention uptake over time by randomisation group were tested via paired Student's t test. The study has been completed and is registered with ClinicalTrials.gov (NCT01965470).

Findings

In the six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015. In the same communities, 10 791 (86%) of 12 489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities). At study end, in intervention communities, 1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities. After accounting for baseline differences, at study end the proportion of people living with HIV who were diagnosed was significantly higher in intervention communities (absolute increase of 9% to 93%) compared with standard-of-care communities (absolute increase of 2% to 88%; prevalence ratio [PR] 1·08 [95% CI 1·02–1·14], p=0·032). Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07–1·17], p=0·018; viral suppression 1·13 [1·09–1·17], p=0·017; male circumcision 1·26 [1·17–1·35], p=0·029).

Interpretation

It is possible to achieve very high population levels of HIV testing and treatment in a high-prevalence setting. Maintaining these coverage levels over the next decade could substantially reduce HIV transmission and potentially eliminate the epidemic in these areas.

Funding

US President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention.

中文翻译：

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博茨瓦纳社区干预后人群对艾滋病毒检测、治疗、病毒抑制和男性包皮环切术的接受情况（Ya Tsie/BCPP）：一项整群随机试验。

 背景

在博茨瓦纳等艾滋病毒流行率和治疗覆盖率较高的地区，尚不清楚是否可以进一步提高艾滋病毒预防和治疗干预措施的采用率。我们试图确定以社区为基础的干预措施，以识别和快速治疗艾滋病毒感染者，并支持男性包皮环切术，是否可以提高博茨瓦纳艾滋病毒诊断、治疗、病毒抑制和男性包皮环切术的人口水平。

 方法

Ya Tsie 博茨瓦纳联合预防项目研究是一项配对整群随机试验，于 2013 年 10 月 30 日至 2018 年 6 月 30 日在博茨瓦纳 30 个社区进行。15 个社区被随机分配接受艾滋病毒预防和治疗干预措施，包括加强艾滋病毒检测、早期抗逆转录病毒治疗 (ART) 和加强男性包皮环切服务，15 人接受了标准护理。 HIV 发病率的第一个主要终点已经报告。在本文中，我们报告了人口接受艾滋病毒预防服务的第二个主要终点的调查结果，以过去 12 个月内已知艾滋病毒呈阳性或检测呈艾滋病毒阴性的人口比例来衡量；被诊断出并接受抗逆转录病毒治疗的艾滋病毒感染者的比例；接受抗逆转录病毒治疗并抑制病毒的艾滋病毒感染者的比例；以及接受割礼的艾滋病毒阴性男性的比例。从 15 个社区约 20% 的家庭样本中随机抽取 16-64 岁的居民进行纵向队列研究，以评估研究成果的基线吸收情况；我们还对之前未参加纵向队列的所有居民进行了研究结束调查，以提供研究结束覆盖率估计。通过配对学生t检验测试了随机分组随时间推移干预措施吸收的差异。该研究已完成并在 ClinicalTrials.gov 注册（NCT01965470）。

 发现

在参与研究结束调查的六个社区中，自 2013 年 10 月 30 日起，2625 名居民（n=1304 来自标准护理社区，n=1321 来自干预社区）被纳入基线的 20% 纵向队列，至 2015 年 11 月 24 日。在同一社区，12 489 名之前未登记在纵向队列中的合格居民中，有 10 791 人（86%）参加了 2017 年 3 月 30 日至 2 月 25 日的研究结束调查， 2018 年（5896 人接受干预，4895 人接受标准护理社区）。研究结束时，在干预社区，1228 名艾滋病毒感染者（1353 人中的 91%）正在接受抗逆转录病毒治疗；在干预社区，1166 名艾滋病毒感染者（1321 名有可用病毒载量的人中的 88%）受到病毒抑制，673 名艾滋病毒阴性男性（1673 名艾滋病毒感染者中的 40%）接受了包皮环切术。考虑到基线差异后，在研究结束时，与标准护理社区（绝对增加 2% 至 93%）相比，干预社区中被诊断出艾滋病毒感染者的比例显着更高（绝对增加 9% 至 93%）。 88%；患病率 [PR] 1·08 [95% CI 1·02–1·14]，p=0·032）。两组的 ART、病毒抑制和男性包皮环切的人口水平均较基线有所增加，干预社区的增幅更大（ART PR 1·12 [95% CI 1·07–1·17]，p=0·018；病毒抑制 1·13 [1·09–1·17]，p=0·017；男性包皮环切 1·26 [1·17–1·35]，p=0·029）。

 解释

在高流行率环境中实现非常高的人群艾滋病毒检测和治疗水平是可能的。在未来十年保持这些覆盖水平可以大大减少艾滋病毒的传播，并有可能消除这些地区的流行病。

 资金

美国总统通过疾病控制和预防中心制定的艾滋病紧急救援计划。