HOSENG 试验 - 在农村莱索托挨家挨户进行 HIV 检测活动中为拒检和失访人群提供口腔自我检测对检测覆盖率的影响：一项基于群组的随机临床试验方案。 - Suppr

The HOSENG trial - Effect of the provision of oral self-testing for absent and refusing individuals during a door-to-door HIV-testing campaign on testing coverage: protocol of a cluster-randomized clinical trial in rural Lesotho.

机构信息

Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Socinstrasse 57, 4051, Basel, Switzerland.

University of Basel, 4051, Basel, Switzerland.

出版信息

Trials. 2019 Aug 13;20(1):496. doi: 10.1186/s13063-019-3469-2.

BACKGROUND

HIV-testing coverage remains below the targeted 90% despite efforts and resources invested. Home-based HIV-testing is a key approach endorsed by the World Health Organization (WHO), especially to reach individuals who might not seek testing otherwise. Although acceptance of testing during such campaigns is high, coverage remains low due to absent household members. This cluster-randomized trial aims to assess increase in testing coverage using oral HIV self-testing (HIVST) among individuals who are absent or decline testing during home-based HIV-testing.

METHODS

The HOSENG (HOme-based SElf-testiNG) trial is a cluster-randomized, parallel-group, superiority trial in two districts of Lesotho, Southern Africa. Clusters are stratified by district, village size, and village access to the nearest health facility. Cluster eligibility criteria include: village is in catchment area of one of the study facilities, village authority provides consent, and village has a registered, capable, and consenting village health worker (VHW). In intervention clusters, HIV self-tests are provided for eligible household members who are absent or decline HIV-testing in the presence of the campaign team. In control clusters, standard of care for absent and refusing individuals applies, i.e., referral to a health facility. The primary outcome is HIV-testing coverage among individuals aged 12 years or older within 120 days after enrollment. Secondary objectives include HIV-testing coverage among other age groups, and uptake of the different testing modalities. Statistical analyses will be conducted and reported in line with CONSORT guidelines. The HOSENG trial is linked to the VIBRA (Village-Based Refill of ART) trial. Together, they constitute the GET ON (GETting tOwards Ninety) research project.

DISCUSSION

The HOSENG trial tests whether oral HIVST may be an add-on during door-to-door testing campaigns towards achieving optimal testing coverage. The provision of oral self-test kits, followed up by VHWs, requires little additional human resources, finances and logistics. If cost-effective, this approach should inform home-based HIV-testing policies not only in Lesotho, but in similar high-prevalence settings.

TRIAL REGISTRATION

ClinicalTrials.gov, (ID: NCT03598686 ). Registered on 25 July 2018. More information is available at www.getonproject.wordpress.com .

背景

尽管投入了努力和资源，但艾滋病毒检测覆盖率仍未达到 90%的目标。家庭为基础的艾滋病毒检测是世界卫生组织（世卫组织）认可的一个关键方法，特别是为了接触那些可能不会主动寻求检测的人。尽管此类运动中的检测接受率很高，但由于家庭成员不在，覆盖率仍然很低。这项整群随机试验旨在评估使用口腔艾滋病毒自我检测（HIVST）增加检测覆盖率，对象是在家庭为基础的 HIV 检测中缺席或拒绝检测的个人。

方法

HOSENG（基于家庭的自我检测）试验是在南部非洲莱索托的两个地区进行的整群随机、平行组、优效性试验。群组按地区、村庄规模和村庄到达最近卫生设施的情况进行分层。群组入选标准包括：村庄位于研究设施的一个服务区内，村庄当局同意，并且村庄有注册、有能力和同意的村庄卫生工作者（VHW）。在干预群组中，将为在运动小组在场时缺席或拒绝 HIV 检测的符合条件的家庭成员提供艾滋病毒自检。在对照组中，适用于缺席和拒绝的个人的标准是转诊到医疗机构。主要结局是在入组后 120 天内，12 岁及以上个体的 HIV 检测覆盖率。次要目标包括其他年龄组的 HIV 检测覆盖率，以及不同检测方式的采用率。将按照 CONSORT 指南进行统计分析和报告。HOSENG 试验与 VIBRA（基于村庄的 ART 补充）试验相关联。它们共同构成了 GET ON（迈向 90%）研究项目。