Universal Testing, Expanded Treatment, and Incidence of HIV Infection in Botswana
Universal Testing, Expanded Treatment, and Incidence of HIV Infection in Botswana
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DOI：
10.1056/nejmoa1812281
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发表时间：
2019-07-18
影响因子：
158.5
通讯作者：
Lockman, S.
中科院分区：
文献类型：
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作者：
Makhema, Joseph;Wirth, Kathleen E.;Lockman, S.
在博茨瓦纳 30 个社区进行的这项社区随机试验中，将一系列服务（社区范围内的 HIV 检测、与护理的联系、CD4 计数较高的参与者的抗逆转录病毒治疗以及男性包皮环切术）与标准护理进行了比较。在接受捆绑服务的社区中，发现艾滋病毒感染事件数量有所减少，艾滋病毒病毒载量显着下降。 背景 通过增加抗逆转录病毒治疗 (ART) 和男性包皮环切术的社区覆盖率来降低人口水平的人类免疫缺陷病毒 (HIV) 感染发病率的可行性尚不清楚。方法 2013 年至 2018 年，我们在博茨瓦纳的 30 个农村或城郊社区进行了一项配对、社区随机试验。干预组中 15 个村庄的参与者接受了 HIV 检测和咨询、与护理的联系、ART（开始时 CD4 计数高于标准护理）以及增加获得男性包皮环切服务的机会。标准护理组还包括 15 个村庄。通用 ART 于 2016 年中期在这两个群体中推出。我们从每个社区约 20% 的家庭中随机抽取参与者样本，并通过大约每年进行一次的测试来测量 HIV 感染的发病率。预先指定的主要分析是艾滋病毒发病率的排列检验。使用成对分层 Cox 模型计算 95% 置信区间。结果 在 12,610 名参与者（符合资格的家庭成员的 81%）中，29% 的人艾滋病毒呈阳性。在 8974 名 HIV 阴性者（每组 4487 名）中，95% 的人在中位 29 个月的时间里重新进行了 HIV 感染检测。干预组共有 57 名参与者和标准护理组有 90 名参与者感染了 HIV（年化 HIV 发病率分别为 0.59% 和 0.92%）。通过置换检验，干预组与标准护理组相比，未经调整的 HIV 发病率为 0.69（P=0.09）（95% 置信区间 [CI]，配对分层 Cox 模型为 0.46 至 0.90）。在六个社区（每组三个）进行的一项试验结束调查显示，干预组中 HIV-1 RNA 水平为 400 拷贝/毫升或更低的 HIV 阳性参与者的百分比（18 个百分点，从 70% 到 88%）显着高于标准护理组（8 个百分点，从 75% 到 83%）（相对风险，1.12；95% CI，1.09 到1.16）。接受包皮环切术的男性比例在干预组中增加了 10 个百分点，在标准护理组中增加了 2 个百分点（相对风险，1.26；95% CI，1.17 至 1.35）。结论 扩大艾滋病毒检测、与护理的联系以及抗逆转录病毒治疗的覆盖范围与人群病毒抑制的增加有关。 （由总统艾滋病紧急救援计划和其他机构资助；Ya Tsie ClinicalTrials.gov 编号，NCT01965470。）。）
In this community-randomized trial in 30 communities in Botswana, a bundle of services (community-wide HIV testing, linkage to care, antiretroviral treatment in participants with a higher CD4 count, and male circumcision) were compared with standard care. A numerical decrease in incident HIV infection and a significant decrease in HIV viral load were observed in the communities receiving the bundle of services.Background The feasibility of reducing the population-level incidence of human immunodeficiency virus (HIV) infection by increasing community coverage of antiretroviral therapy (ART) and male circumcision is unknown. Methods We conducted a pair-matched, community-randomized trial in 30 rural or periurban communities in Botswana from 2013 to 2018. Participants in 15 villages in the intervention group received HIV testing and counseling, linkage to care, ART (started at a higher CD4 count than in standard care), and increased access to male circumcision services. The standard-care group also consisted of 15 villages. Universal ART became available in both groups in mid-2016. We enrolled a random sample of participants from approximately 20% of households in each community and measured the incidence of HIV infection through testing performed approximately once per year. The prespecified primary analysis was a permutation test of HIV incidence ratios. Pair-stratified Cox models were used to calculate 95% confidence intervals. Results Of 12,610 enrollees (81% of eligible household members), 29% were HIV-positive. Of the 8974 HIV-negative persons (4487 per group), 95% were retested for HIV infection over a median of 29 months. A total of 57 participants in the intervention group and 90 participants in the standard-care group acquired HIV infection (annualized HIV incidence, 0.59% and 0.92%, respectively). The unadjusted HIV incidence ratio in the intervention group as compared with the standard-care group was 0.69 (P=0.09) by permutation test (95% confidence interval [CI], 0.46 to 0.90 by pair-stratified Cox model). An end-of-trial survey in six communities (three per group) showed a significantly greater increase in the percentage of HIV-positive participants with an HIV-1 RNA level of 400 copies per milliliter or less in the intervention group (18 percentage points, from 70% to 88%) than in the standard-care group (8 percentage points, from 75% to 83%) (relative risk, 1.12; 95% CI, 1.09 to 1.16). The percentage of men who underwent circumcision increased by 10 percentage points in the intervention group and 2 percentage points in the standard-care group (relative risk, 1.26; 95% CI, 1.17 to 1.35). Conclusions Expanded HIV testing, linkage to care, and ART coverage were associated with increased population viral suppression. (Funded by the President's Emergency Plan for AIDS Relief and others; Ya Tsie ClinicalTrials.gov number, NCT01965470.).)