An open-label cluster randomised trial to evaluate the effectiveness of a counselling intervention on linkage to care among HIV-infected patients in Uganda: Study design.
An open-label cluster randomised trial to evaluate the effectiveness of a counselling intervention on linkage to care among HIV-infected patients in Uganda: Study design.
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DOI：
10.1016/j.conctc.2016.12.003
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发表时间：
2017-03
影响因子：
1.5
通讯作者：
Grosskurth H
中科院分区：
文献类型：
--
作者：
Ruzagira E;Baisley K;Kamali A;Grosskurth H
家庭艾滋病毒咨询和检测（HBHCT）是高度可接受的，并有可能增加撒哈拉以南非洲的艾滋病毒检测率。然而，缺乏数据说明可将通过HBHCT确定的艾滋病毒阳性者与护理有效联系起来的战略。本试验旨在评估两个简短的家庭为基础的咨询会议的有效性联系到照顾，提供后，通过HBHCT确定的艾滋病毒阳性患者在马萨卡区，乌干达的农村社区转介护理。将28个社区（群组）随机分配到对照组（仅转诊）和干预组（转诊和后续咨询）（n = 14个群组/组）。随机化根据与区首府的距离（≤10 km vs > 10 km）和集群规模（较大的单个村庄vs合并的小村庄）进行分层，并限制以确保所选集群特征的平衡。产生了一份可能的分配名单，并在一个公开仪式上随机选出一份。HBHCT正在向所有成年人（≥18岁）提供，尚未接受护理的艾滋病毒阳性者有资格参加。在入学后一个月和两个月提供干预。在登记后6个月评估的主要结果是：在艾滋病毒诊断后6个月内与艾滋病毒护理联系的个人比例和联系时间。主要分析将基于个体水平数据。本研究将提供证据，说明咨询干预措施对通过HBHCT确定感染艾滋病毒的成年人与护理联系的影响。正在进行的定性子研究的结果将有助于解释试验结局。
Home-based HIV counselling & testing (HBHCT) is highly acceptable and has the potential to increase HIV testing uptake in sub-Saharan Africa. However, data are lacking on strategies that can effectively link HIV-positive individuals identified through HBHCT to care. This trial was designed to assess the effectiveness of two brief home-based counselling sessions on linkage to care, provided subsequent to referral for care among HIV-positive patients identified through HBHCT in a rural community in Masaka district, Uganda. 28 communities (clusters) were randomly allocated to control (referral only) and intervention (referral and follow-up counselling) arms (n = 14 clusters/arm). Randomisation was stratified on distance from the district capital (≤10 km vs > 10 km) and cluster size (larger single village vs combined small villages), and restricted to ensure balance on selected cluster characteristics. A list of possible allocations was generated and one randomly selected at a public ceremony. HBHCT is being offered to all adults (≥18 years), and HIV-positive individuals not yet in care are eligible for enrolment. The intervention is provided at one and two months post-enrolment. Primary outcomes, assessed 6 months after enrolment, are: the proportion of individuals linking to HIV care within 6 months of HIV diagnosis and time to linkage. The primary analysis will be based on individual-level data. This study will provide evidence on the impact of a counselling intervention on linkage to care among adults identified with HIV infection through HBHCT. Interpretation of the trial outcomes will be aided by results from an on-going qualitative sub-study.