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临床试验/NCT04283929
NCT04283929Unknown不适用

Evaluation of the Clinical Impacts and Costs of eHealth in Rwanda Using Innovative Frameworks and Local Capacity Building

National University, Rwanda2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2018年9月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
112
试验地点
2
主要终点
Percentage of ART patients have viral load results in EMR (initial)

研究概览

简要总结

This study will estimate the impact of a suite of clinical decision-support tools on structural, process, and clinical outcomes related to HIV care. The "enhanced EMR" package under investigation will include EMR monitoring tools, data quality control procedures and support, patient reports, alerts, and reminders about patient care. This intervention will be delivered by the Ministry of Health and Rwanda Biomedical Centre and monitored by the study team led by University of Rwanda's School of Public Health and Brown University.

详细描述

Motivation of the study A previous cross sectional analysis of the national HIV program in Rwanda, described the HIV care continuum as a "multitrajectory pathway" with many opportunities for patients to exit and return to care between diagnosis and viral suppression. The authors concluded that the weakest point in the continuum is the transition from diagnosis to linkage to care where only half of newly diagnosed patients link to care within 6 months of receiving their diagnosis.

This study also estimated that 82.2 percent of patients on ART achieve viral suppression. Overall, half of the HIV-positive population in Rwanda in 2013 was assumed to be virally suppressed. This estimate of viral suppression is based on an analysis of EMR data for a subset of 21,995 patients. Correspondence with one of the study authors clarified that 9,680 of these patients were eligible for viral load testing, and 3,066 of eligible patients had recorded viral load data. This suggests that two-thirds of patients eligible for viral load testing do not have viral load results recorded in the EMR. The study do not estimate any type of treatment failure (virologic, immunologic, clinical), and investigators are not aware of any such estimates for Rwanda.

Studies in Botswana, Malawi, Uganda, South Africa, and Cameroon found that 15 to 25 percent of patients had recorded plasma HIV RNA concentrations in excess of 400 copies per mL within 3 years of starting first-line ART. More recently, kenyan study found that among a large cohort of Kenyan patients on ART, 11.6 percent had evidence of immunological treatment failure during the 12-month study period.

In the Kenya study, investigators randomised 7 of 13 clinics using EMRs to an intervention group that received alerts and reminders about immunological treatment failure. The rate of appropriate clinical action in response to treatment failure increased from 30 percent in the control group to 54 percent in the intervention group. The authors also reported a 72 percent relative reduction in the time from the detection of treatment failure to appropriate clinical action. Investigators did not estimate the impact of the CDSS on treatment outcomes such as viral suppression and survival.

With the proposed study in Rwanda, investigators see an opportunity to use low-cost decision support tools to increase the rate of linkage to care from diagnosis, improve data quality and completeness for laboratory data such as viral load, demonstrate the efficacy of these decision support tools for prompting timely clinical intervention following treatment failure, and demonstrate that early intervention can lead to positive clinical outcomes for patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Is a health center with an average (3 month) monthly volume of 50-700 patients
  • Is owned and operated by the public sector or faith-based institutions
  • Has a power source
  • Has network connectivity
  • Has at least 3 computers and 1 printer

排除标准

  • District hospitals (typically with high patient volume)
  • Privately owned facilities
  • Facilities operated by Partners in Health (who already run a version of the intervention)
  • Facilities that only offer PMTCT services
  • Facilities that run OpenMRS version 1.9 (rather than 1.6)

结局指标

主要结局

Percentage of ART patients have viral load results in EMR (initial)

时间窗: 10 months

Denominator: Adult patients on ART completing their 6th month of treatment, thus becoming eligible for viral load monitoring. Numerator: Subset of these patients with VL results in the EMR 2 months after becoming eligible for testing

Rate of linkage to care among HIV-positive patients

时间窗: 12 months

Denominator: All adults (18 or older) with HIV positive test results recorded in the EMR at a study facility. Patients who die in the time between receiving a positive test result and the outcome measurement at 3 months will be excluded. Numerator: Subset of these patients who are linked to care at a study facility within 3 months

Percentage of ART patients with treatment failure experience clinical action

时间窗: 12 months

Denominator: Adult patients who have been on ART for at least 12 months and experience treatment failure: 1. Virologic (viral load ≥ 1000 copies/ml) 2. Immunological (\>50% change in CD4 from highest previous value) Numerator: Subset of these patients who have a recorded clinical action in response to treatment failure within 1 month of the detected treatment failure.

Percentage of patients who experience treatment failure who are fully suppressed 4 months after the point of failure

时间窗: 12 months

Denominator: Adult patients who have been on ART for at least 12 months (first eligible for VL testing at 6 months, first expected result 8 months, retest after 4 months) and were found to have possible treatment failure. Numerator: Subset of these patients who are fully suppressed (viral load \< 1000 copies /ml) 4 months after the point of treatment failure.

次要结局

  • Time from HIV+ test result to linkage to care(3 months)
  • Percentage of ART patients have viral load results in EMR (annual)(12 months)
  • Time from detection of treatment failure to clinical action(11 months)

研究者

发起方
National University, Rwanda
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jeanine Condo

Associate Professor

National University, Rwanda

研究点 (2)

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