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临床试验/NCT02536768
NCT02536768已完成不适用

Evaluation of the National Department of Health's National Adherence Guidelines for Chronic Diseases in South Africa Using Routinely Collected Data

Boston University1 个研究点 分布在 1 个国家目标入组 8,020 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8,020
试验地点
1
主要终点
Alive and in care using clinical records

研究概览

简要总结

NOTE THAT THE STUDY IS LED BY SOUTH AFRICA NATIONAL DEPARTMENT OF HEALTH AND WORLD BANK WITH SUPPORT FROM BOSTON UNIVERSITY. The South Africa National Department of Health (NDOH) intends to launch its newly developed National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs) throughout South Africa in the coming year. Early implementation of the "minimum package" of interventions described in the Adherence Guidelines for HIV patients will take place at 12 primary health clinics and community health centres in four provinces starting in July 2015. To maximize the learning potential of this early implementation stage, NDOH will match the intervention clinics with 12 comparison clinics and randomly allocate intervention or comparison status within the pairs of clinics. This will allow the outcomes of the interventions to be evaluated using a cluster-randomized design and generate data on the costs of implementation and the potential need for adherence support for the other diseases addressed in the guidelines (tuberculosis, hypertension, and diabetes). This protocol is for the evaluation, which will generate information on the effectiveness of minimum package interventions and help improve the design, implementation, and budgeting of the guidelines.

详细描述

The study will assess the effectiveness of five interventions in the minimum package: 1) Fast track initiation counseling for patients eligible for antiretroviral therapy; 2) Enhanced adherence counseling for unstable patients on HIV treatment; 3) adherence clubs for stable patients on HIV treatment; 4) decentralized medication delivery for stable patients on HIV treatment; and 5) early tracing of all patients who miss an appointment by two weeks. This study will also estimate for each study site an overall "adherence guideline impact" to provide an indication of the effectiveness of the package as a whole.

In addition, the study will estimate the cost of each of the interventions listed above compared to standard of care. Finally, the study will describe the cascade of care for tuberculosis, hypertension, and diabetes, three other chronic diseases for which little information currently exists. To evaluate these interventions the study team will work with the National Department of Health (which will implement the interventions) to randomize 24 clinics in 4 provinces 1:1 to receive the interventions or continue standard of care. All evaluations will use data routinely collected by the clinics, with no study interaction with subjects. A total of 8,256 patients will be enrolled and followed for up to 20 months to estimate short- and long-term outcomes.

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

  • ≥ 18 years old
  • Meet the inclusion criteria for one or more intervention
  • Not resident in the facility's catchment area
  • Recorded intention to transfer care to a different facility within 12 months

排除标准

  • Pregnant and eligible for PMTCT

研究组 & 干预措施

Intervention

Experimental

Minimum package of interventions to improve ART adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits

干预措施: Minimum package of interventions to improve ART adherence (Behavioral)

Comparison

No Intervention

Standard of care HIV treatment

结局指标

主要结局

Alive and in care using clinical records

时间窗: 3-12 months

Patient has attended the clinic between 3 and 12 months after being eligible for an intervention

HIV viral supression using lab data

时间窗: 4-12 months

HIV viral load measure below 400 copies per ml between 4 and 12 months after eligibility for an intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Fox

Professor (Note: Not the PI, but one Co-PI)

Boston University

研究点 (1)

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