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临床试验/NCT02417636
NCT02417636已完成不适用

Impact of Task Shifting Type II for ART Delivery on Patient and Process Outcomes in Uganda

Infectious Diseases Institute2 个研究点 分布在 1 个国家目标入组 1,760 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,760
试验地点
2
主要终点
Treatment-limiting events that could occur on first-line ART

研究概览

简要总结

PUBLIC HEALTH EVALUATION PROTOCOL on Impact of Task Shifting Type II for ART Delivery on Patient and Process Outcomes in Uganda

详细描述

SECTION 1: PROTOCOL SUMMARY Title: Impact of Task Shifting Type II for ART Delivery on Patient and Process Outcomes in Uganda Rationale: Health care worker shortages remain a major impediment to the scale-up of antiretroviral therapy (ART) in sub-Saharan Africa [1]. Sub-Saharan Africa suffers from the world's most pronounced crisis in human resources for health with 36 of 57 countries currently facing significant health worker shortages [2]. The health workforce crisis is further exacerbated by the HIV epidemic which thwarts efforts to expand and provide universal access to HIV/AIDS prevention, care and treatment. The shortage of health workers in sub-Saharan Africa presents a great challenge in service delivery, particularly in the scale up of antiretroviral therapy. According to the World Health Organization the global deficit of trained health care workers needed to provide essential health services in order to achieve the Millennium Development Goals, including the scaling up of biomedical interventions for HIV/AIDS is greater than 4 million [2]. In an attempt to meet the demand for ART services, the World Health Organization is coordinating a global effort to strengthen and expand the current health workforce and recommends task shifting as one potential strategy to meet the enormous demand for health care workers to provide HIV/AIDS care and treatment. This is particularly important at this time when patients are staying on ART for longer periods. Task shifting will allow physicians to see only severely ill patients thus freeing up their time for other duties. In addition, more patients can initiate ART because there are more available health workers to attend to them. There is however a need for empirical evidence to support the implementation of task shifting. For example, one critical question is whether candidate health worker cadres for task shifting of ART initiation and monitoring, will perform as well as doctors/clinicians. Country-specific evidence regarding this question is necessary for developing a task-shifting policy before initiating policy reforms in Uganda. Under PEPFAR funding a Public Health Evaluation (PHE) will be conducted in selected health facilities to determine the impact of implementing the WHO Global Recommendations and Guidelines on Task Shifting of HIV treatment from doctors and clinical officers to nurses.

Although task shifting for HIV treatment occurs de facto in several countries [3-10] , it is rarely institutionalized or allowed by national policies. Reliable data are necessary to better understand how and whether to include this strategy in national policy and operational guidelines.

The Investigators propose to conduct a randomized field intervention study to address the question of whether nurse-initiated and monitored ART is associated with inferior outcomes compared with clinician-initiated and maintained ART in treatment-naive, HIV positive individuals.

The findings of this study will contribute knowledge of how best to increase access to quality life-saving HIV treatment as well as improve health care worker skills and strengthen health system efficiency.

Primary Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Individuals will be eligible for the study if they:
  • are 18 years or older
  • have a confirmed HIV+ diagnosis at an accredited health facility according to the National HIV Testing Algorithm
  • are ART naive (except for short course mother-to-child transmission prophylaxis and post exposure prophylaxis not less than 6 months prior to study enrollment)
  • are clinically stable (no serious opportunistic infection, no other chronic condition)
  • are eligible for ART according to the Uganda National Treatment Guidelines

排除标准

  • Individuals will not be eligible for the study if they
  • have more than grade 3 laboratory results for renal function, liver enzymes and hematology according to the National Institutes of Health Division of AIDS toxicity grading scale
  • are unwilling to give informed consent
  • anticipate moving from their current residence in the subsequent 24 months and
  • reside outside of a 40km radius (or more than 1 hour drive) of the selected study site.

结局指标

主要结局

Treatment-limiting events that could occur on first-line ART

时间窗: 12 months

The primary study outcome is a composite endpoint of possible treatment-limiting events that could occur on first-line ART. These include virologic failure (viral load measure of ≥ 1000 copies/ml after 6 months of treatment), toxicity failure, loss to follow up and all-cause mortality.

次要结局

未报告次要终点

研究者

发起方
Infectious Diseases Institute
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Infectious Diseases Institute

Principal Investigator

Makerere University

研究点 (2)

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