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临床试验/NCT05510973
NCT05510973已完成不适用

Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi: A Mixed Methods Non-randomized Cluster Study

Elizabeth Glaser Pediatric AIDS Foundation13 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2021年6月1日最近更新:
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
700
试验地点
13
主要终点
Proportion of AHD patients in care and treatment virally suppressed

研究概览

简要总结

This study will evaluate the implementation of an enhanced package of care, CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], on retention in care and viral suppression ((<50 copies/ml) at 6 and 12 months after AHD care and treatment enrollment. The study will also assess the change in AHD screening, management and service uptake indicators among PLHIV clients before and after implementation of the QI collaborative implementation (QICI) project, evaluate the acceptability and feasibility of the AHD package of care among patients and HCWs providing related health services, and conduct a cost analysis of implementing the enhanced AHD package of care in a hub-and-spoke implementation of care model.

详细描述

Background Despite significant advances in the diagnosis of human immunodeficiency virus (HIV) and expanded access to anti-retroviral therapy (ART), recent data suggest that a third of people living with HIV/AIDS (PLHIV) starting ART do so with advanced HIV disease (AHD), and an increasing number of patients require advanced HIV disease care following a period of disengagement. Despite considerable effort to implement the AHD model in Malawi and bring it to scale, several challenges regarding AHD implementation and outcomes still exist.

Description of Study Intervention:

To optimize the package of care offered to HIV-infected clients with advanced HIV disease in Malawi, a hub-and-spoke model will be designed and implemented to bring AHD services geographically closer to patients. An enhanced package of AHD interventions such as decentralized cluster of differentiation 4 (CD4) tests, Tuberculosis lipoarabinomannan (TB-LAM) and initiation of patients on prophylaxis [TPT and CPT] will be implemented [system strengthening through quality improvement (QI)]. A client and systems focus will identify challenges experienced by providers and clients while at the same time describing the contextual factors that affect the delivery of AHD services. These lessons learnt will be used to optimize client flow, enhance sample transportation regulation and increase client engagement.

Evaluation Description The evaluation will be a mixed method design study: (1) the quantitative component which will be a non-randomized cluster design based on control of intervention vs control sites for outcomes evaluation (2) the qualitative component that will aim at evaluating acceptability and feasibility of the strengthened AHD service provision (3) cost evaluation that will use quantitative methods.

Specific Objectives

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •HIV-infected clients (all ages) meeting the WHO definition for AHD:
  • •CD4 count of <200c/mm3
  • •or WHO clinical stage 3 or 4
  • •or children under the age of 5 on treatment for less than 12 months or unstable on treatment after 12 months

排除标准

  • 未提供

研究组 & 干预措施

Control

No Intervention

standard of care

Intervention

Experimental

Enhanced package of AHD care

干预措施: Enhanced package for AHD care (Other)

结局指标

主要结局

Proportion of AHD patients in care and treatment virally suppressed

时间窗: 6 and 12 months after initiation of ART after AHD diagnosis

Number of AHD patients in care and treatment virally suppressed (\<50 cells/ml) divided by the number of AHD patients in care and treatment

Proportion of AHD patients alive and retained in care

时间窗: 6 and 12 months after initiation on ART after AHD diagnosis

Number of AHD patients alive and retained in care divided by the number of AHD patients initiated on antiretroviral therapy (ART) after diagnosis of AHD

次要结局

  • Cost analysis of implementing the hub and spoke enhanced AHD package of care(12 months after intervention implementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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