Dovel Kathryn, Shaba Frackson, Nyirenda Mike, Offorjebe O Agatha, Balakasi Kelvin, Phiri Khumbo, Nichols Brooke, Tseng Chi-Hong, Bardon Ashley, Ngona Khumbo, Hoffman Risa
Division of Infectious Diseases, Department of Medicine, University of California Los Angeles, 10833 Le Conte Ave, 37-121 CHS, Los Angeles, CA, 90095, USA.
Partners in Hope, PO Box 302, Lilongwe, Malawi.
Trials. 2018 Sep 17;19(1):498. doi: 10.1186/s13063-018-2878-y.
Throughout sub-Saharan Africa HIV-testing rates remain low. Barriers to testing, such as inconvenient service hours and long wait times, lack of privacy, and fear of unwanted disclosure, continue to impede service utilization. HIV self-testing (HIVST) is one strategy that addresses these barriers and has been shown to increase use of HIV-testing when distributed through community-based settings. However, the scalability of HIVST is limited because it has yet to be fully integrated into existing health systems and routine care. To address this gap, we designed a study to test the effect of offering HIVST to routine outpatient department (OPD) clients on uptake of HIV-testing as compared to standard of care and optimized standard of care.
METHODS/DESIGN: This is a non-blinded, multi-site, cluster-randomized control trial. The health facility is the unit of randomization (cluster). Fifteen facilities were randomized to one of three arms: (1) Standard of care using routine provider-initiated testing and counseling (PITC); (2) Optimized standard of care using optimized PITC defined by additional training, job aids, and monitoring of PITC strategies with OPD providers and support staff; and (3) HIVST defined by HIVST demonstrations for OPD clients, HIVST kit distribution, and private spaces for HIVST kit use and/or interpretation. The primary outcome is the proportion of OPD clients tested for HIV on the day that they accessed OPD services. Secondary outcome measures are the proportion of OPD clients newly identified as HIV-positive and antiretroviral therapy (ART) initiation. Costs and cost-effectiveness will be evaluated. Nested studies will determine the acceptability of facility-based HIVST among OPD clients and health care providers, the presence of adverse events, such as coercion to test or unwanted status disclosure, and a process evaluation to determine feasibility and scale-up of facility-based HIVST for the future.
This study protocol tests whether facility-based HIVST can positively contribute to HIV-testing among OPD clients in resource-limited settings. This will be one of the first studies to test the integration of HIVST into facility-based, primary health services in sub-Saharan Africa.
ClinicalTrials.gov, ID: NCT03271307 . Registered on 31 August 2017. Pan African Clinical Trials: PACTR201711002697316 . Registered on 1 November 2017.
在撒哈拉以南非洲地区，艾滋病毒检测率一直很低。检测障碍，如服务时间不便、等待时间长、缺乏隐私以及担心信息被不当泄露，持续阻碍着服务的利用。艾滋病毒自我检测（HIVST）是一种消除这些障碍的策略，并且已证明通过社区环境进行分发时可提高艾滋病毒检测的使用率。然而，HIVST的可扩展性有限，因为它尚未完全融入现有的卫生系统和常规护理中。为了填补这一空白，我们设计了一项研究，以测试与标准护理和优化标准护理相比，向常规门诊部（OPD）患者提供HIVST对艾滋病毒检测接受度的影响。
方法/设计：这是一项非盲法、多地点、整群随机对照试验。卫生设施是随机分组单位（整群）。15个设施被随机分配到三个组之一：（1）使用常规提供者发起的检测和咨询（PITC）的标准护理；（2）使用优化PITC的优化标准护理，优化PITC由额外培训、工作辅助工具以及对OPD提供者和支持人员的PITC策略监测来定义；（3）HIVST，由为OPD患者进行HIVST演示、分发HIVST试剂盒以及提供用于使用和/或解读HIVST试剂盒的私密空间来定义。主要结局是OPD患者在就诊当天接受艾滋病毒检测的比例。次要结局指标是新确诊为艾滋病毒阳性的OPD患者比例和抗逆转录病毒治疗（ART）启动情况。将评估成本和成本效益。嵌套研究将确定基于设施的HIVST在OPD患者和医疗保健提供者中的可接受性、是否存在不良事件，如强制检测或不当状态披露，以及进行过程评估以确定未来基于设施的HIVST的可行性和扩大规模情况。
本研究方案测试了在资源有限的环境中，基于设施的HIVST是否能对OPD患者的艾滋病毒检测产生积极影响。这将是首批测试将HIVST纳入撒哈拉以南非洲地区基于设施的初级卫生服务的研究之一。
ClinicalTrials.gov，标识符：NCT03271307。于2017年8月31日注册。泛非临床试验：PACTR201711002697316。于2017年11月1日注册。
