IGHID 11920 - More Than a Machine: Exploring the Ancillary Systems and Processes Required to Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Western Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Number of Tests Performed Successfully Each Clinic Day
研究概览
简要总结
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.
The central hypothesis is that implementation of PoC HIV-1 testing without accompanying modifications to clinic triage and flow, laboratory processes, and existing protocols guiding adherence counseling and regimen change, will not result in significant improvement in clinical outcomes in PLWH.
详细描述
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.
In Phase 1, the study team will perform/record the following:
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Administer a basic demographic and health questionnaire
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Record routine clinical parameters during visit to include:
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Current ARV and prophylaxis regimen
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Last CD4 and VL, if available
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Clinical illness since last visit
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Document the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).
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Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results by phone or at next visit.
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Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received.
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Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload
In Phase 2, the study team will perform/record the following:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic
排除标准
- •Patients unwilling or unable to provide informed consent
结局指标
主要结局
Number of Tests Performed Successfully Each Clinic Day
时间窗: Each clinic day for up to six months
HIV viral load tests performed at peripheral health center
Number of Tests Performed Successfully each Month
时间窗: Each month for up to six months
HIV viral load tests performed at peripheral health center
次要结局
- Machine Down-Time and Maintenance(Each clinic day (i.e. weekly) during the 6 months of Phase 2 when the Xpert is operational)
- Mean and median time-to-result(Up to 90 days after blood draw, after which considered not returned)
- Mean Time Clients Spend in Clinic(Each clinic day for up to 9 months)
- Provider Perception of Workload(Pre- and post-intervention (approximately 6 months apart))
- Proportion of Eligible Patients Electing to Stay to Receive Results(Each month for up to six months)