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临床试验/NCT04431154
NCT04431154已完成不适用

Financial Incentives to Promote Linkage to Care and Viral Suppression Following HIV Testing: a Randomized Controlled Trial

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2020年7月20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
99
试验地点
1
主要终点
Viral suppression at 6 months

研究概览

简要总结

This study aims to test if small incentives promote linkage to care and 6-month viral suppression among individuals recently tested for HIV at selected sites within Johannesburg, South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive either the standard of care (SOC) for linkage to care or to receive financial incentives for confirmatory testing, linkage to care and viral suppression.

详细描述

This study is in collaboration with Ezintsha, a sub-division of Wits Reproductive Health and HIV Institute (WRHI) in South Africa. This study will leverage on the existing research infrastructure of Ezintsha, including, HIVSS testing through the STAR initiative (Self-Test Africa), as well as HIV positive persons identified through other Ezintsha research studies and at Eztinsha affiliated health clinics.

This study will use a randomized trial design to test the effectiveness of incentives to increase confirmatory testing, linkage to care and viral suppression. The aim of this study is to determine whether HIV-infected men and women are more likely to achieve or maintain HIV virologic suppression if offered financial incentives vs. no incentives (standard of care).

Individuals who report receiving a reactive HIVSS test result on the STAR programme, or a HIV reactive test in another research study or at a affiliated clinic, will be randomized into one of two groups: a) a control group that receives the standard of care (SOC) for linkage to care; and b) an intervention group that receives financial incentives for confirmatory testing, linkage to care, and viral suppression.

研究设计

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

入选标准

  • •Reported HIV positive
  • •Have a personal and/or valid phone number, that will remain active for 6 months
  • •Have a phone with WhatsApp, or text message feature
  • •Understand the Informed Consent form

排除标准

  • •Unwilling to provide informed consent
  • •Any condition which would make the participant unsuitable or unsafe for enrollment, i.e. being unable to see or read by forgetting to bring reading glasses, being intoxicated or acute sickness

研究组 & 干预措施

Experimental: Usual care

No Intervention

Participants randomized to this arm will receive the standard of care (SOC) following the STAR program protocol in various sites in Johannesburg. This will include provision of an HIV self-screening test kit, the standard linkage officer follow-up call following report of a positive HIVSS test and an invitation to i) participate in study visit 1 to have their positive HIVSS result confirmed and complete blood collection for viral load PCR testing and to ii) participate in study visit 2 at 6 months for Viral Load PCR. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing.

Experimental: Incentives and linkage promotion

Experimental

Participants randomized to this arm will receive the same standard HIV self-screen test kit and linkage officer follow-up call including the invitation to i) participate in study visit 1 and ii) study visit 2. In addition, they will receive a financial incentive if they complete a confirmatory HIV test at visit 1 and if they demonstrate viral suppression at study visit 2, approximately 6 months after positive HIVSS result. They will also receive monthly reminders and incentives to pick up HIV medication. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing.

干预措施: Provision of HIV self-screen kit with incentives and linkage promotion (Behavioral)

结局指标

主要结局

Viral suppression at 6 months

时间窗: approximately 6 months

Viral suppression (plasma HIV RNA \<400 copies/mL) at approximately 6 months after a positive HIV result

次要结局

  • Confirmatory testing(approximately 4 weeks)
  • ART initiation(approximately 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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