Testing and Linkage to HIV Care in China: A Clustered Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 12
- 主要终点
- Receipt of post-test results and counseling following testing completeness
研究概览
简要总结
This study will evaluate the effects of a comprehensive approach (One4All) to increase the percentage of patients that receive their HIV testing results and counseling.
Primary Hypothesis: The One4All approach will increase the proportion of individuals who have completed all tests to confirm HIV diagnosis and received counseling within 30 days of screening HIV+, given they have screened HIV+ on the initial test, from 40% to 60%.
详细描述
The study consists of a cluster randomized trial (CRT) at county hospitals in Guangxi, China to assess the effectiveness of a structural intervention: a new testing algorithm, consisting of rapid point-of-care (POC) HIV and CD4 testing, with viral load (VL) testing in parallel, designed to ensure completeness of diagnostic assessment and accelerate time to ART initiation for patients deemed ART eligible (hereafter called the One4all Test Intervention).
This CRT will be conducted in 12 county general hospitals with an estimated average of 30 participants per hospital, totaling an estimated 360 participants. The unit of randomization is the hospital. Hospitals will be randomized to 1) theOne4all Test Intervention, or 2) the control condition, consisting of the current standard of care (SOC). The efficacy of the intervention will be evaluated at 1, 3, and 12 month follow-up assessments, and the differential efficacy for drug users (DUs) and non-drug users will be examined.
The study population will consist of adult participants who screen positive on an initial HIV enzyme immunoassay (EIA) in the 12 study hospitals. Since the study will be conducted in China, the vast majority of participants will be of Chinese or Asian descent. Women will be included and are expected to represent approximately 26% of the study population.
Eligibility Criteria:
Site Eligibility Criteria: The location of our study is Guangxi Zhuang Autonomous Region (Guangxi). We will select county-level general hospitals in order to ensure sufficient caseload at each hospital and homogeneity across hospitals. Guangxi counties usually have one general hospital (a limited number of counties have two or more general hospitals); this hospital has been designated as the only setting for delivering ART services in the respective county.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participating individuals must:
- •Be at least 18 years old
- •Be an inpatient or outpatient seeking care in study hospitals
- •Test positive on an initial EIA HIV screen
- •Have local residency or intent to live in study area for at least 90 days
排除标准
- •Individuals will be excluded from study participation if they:
- •Do not meet any one or more of the above inclusion criteria
- •Test result negative on initial EIA HIV screen
- •Have previously received confirmation on HIV infection in the study hospital or in any other setting (e.g., CDC clinic, infectious disease hospital, sub-county-level hospital)
- •Are prisoners or detainees at the time of initial screening
- •Are pregnant women (pregnant women are subject to mandatory testing)
结局指标
主要结局
Receipt of post-test results and counseling following testing completeness
时间窗: 30 days
The numerator is the number of HIV-positive participants who have received post-test results and counseling within 30 days of initial screening blood draw. The denominator is the number of participants who screened positive on the initial HIV EIA in the study arm (control or intervention).
次要结局
- Proportion of treatment-eligible participants with CD4 < 350(90 days)
研究者
Walter Ling
Professor and Founding Director Integrated Substance Abuse Programs
University of California, Los Angeles