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临床试验/NCT02756949
NCT02756949已完成不适用

Do Smartphones Increase Linkage to and Retention in Care in Newly Diagnosed HIV-positive Patients in Johannesburg, South Africa: A Multisite Randomised Controlled Trial

World Bank1 个研究点 分布在 1 个国家目标入组 353 人开始时间: 2015年10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
发起方
入组人数
353
试验地点
1
主要终点
Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)

研究概览

简要总结

This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their results. Message prompts will also be used to alert patients that their results are ready and provide information on how to link to care, and assistance to re-link to care if they fall out of the health system for any reason. Prompts will be sent to patients to remind health care workers if they are due for repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6 months. The control group received standard of care.

详细描述

This evaluation of a newly designed smartphone application (app) for linkage to care, HIV treatment adherence and retention in care, is taking place at five Johannesburg health facilities. Intervention allocation is random with individuals either receiving the smartphone app or standard of care. The trial is motivated by evidence from elsewhere that sending lab results via app acceptable, and loss of patients in need of HIV care can be reduced with mobile Health interventions. There is a growing number of smartphones in South Africa (at the time of baseline assessment, about 40% of the surveyed population had an Android smartphone with data, and the majority of new phones are smartphones). The trial's objectives are: a) Test whether routine linkage to HIV care at public sector services is improved by providing HIV positive clients with a smartphone-enabled app when compared to standard of care; b) Determine HIV treatment initiation rates between intervention and control arm; c) Test the feasibility and acceptability of receiving lab results via app; d) Assess secondary effects from improved participant information, including return rates after falling out of care, participant satisfaction, and rates of repeat blood tests; e) Determine knowledge levels on HIV care; and f) Assess the effect in priority groups for better linkage to care (male HIV cases and HIV positive youth). If data allow, a cost-benefit analysis will also be conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Newly diagnosed HIV positive clients presenting at selected public health facilities, irrespective of CD4 count
  • •Access to an Android smartphone with data
  • •Willing to pay the (very small) cost to access their laboratory result
  • •Age - 18 years and older
  • •Proof of ID/passport/refugee number (for identification/security, and to confirm the single patient identifier)
  • •Can read English or Zulu
  • •Ability and willingness to sign informed consent

排除标准

  • •Clients presenting for antenatal care services, as these women will be enrolled in the national MomConnect program
  • •Refusal to participate

研究组 & 干预措施

Smartphone-enabled app for linkage to care

Experimental

Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.

干预措施: Smartphone application (Other)

Smartphone-enabled app for linkage to care

Experimental

Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.

干预措施: Smartphone (Device)

Standard of care

No Intervention

Participants in this arm are randomised to receive standard of care services.

结局指标

主要结局

Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)

时间窗: Recruitment +8 months

To test whether linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.

次要结局

  • Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)(Recruitment +8 months)

研究者

发起方
World Bank
申办方类型
Other
责任方
Sponsor

研究点 (1)

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