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临床试验/NCT01630304
NCT01630304Unknown不适用

WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS

University of British Columbia1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
700
试验地点
1
主要终点
Patient retention in care

研究概览

简要总结

The purpose of this study is to determine whether weekly text-messages improve retention in care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).

详细描述

Patient retention in care is critical to the success of programs funded by the President's Emergency Relief Plan for HIV/AIDS (PEPFAR). High levels of patient retention after first clinical contact contribute to the timely initiation of antiretroviral therapy (ART) and better health outcomes for patients. With the dramatic proliferation of cell phone use in Africa, telecommunications technology offers new opportunities to improve retention using a low-cost, culturally appropriate format. In Kenya (WelTel Kenya1), a weekly short message service (SMS) text message led to improved ART adherence and viral load suppression. This study, WelTel Retain, will evaluate the effect of WelTel on retaining pre-ART patients in care and determine the cost-effectiveness of the intervention. Specific objectives include: 1) determining if the WelTel SMS intervention improves patient retention in the first stage of HIV care; 2) determining whether the WelTel SMS intervention improves 12-month retention; and 3) evaluating the cost-effectiveness of the WelTel SMS intervention. We will fulfil these objectives by conducting a randomized controlled trial at the Kibera Community Health Centre in Nairobi, Kenya. Over one year, HIV positive individuals newly enrolling at the clinic will be recruited and randomly allocated to an intervention or control arm at a 1:1 ratio. Intervention arm participants will receive a weekly SMS 'check-in' to which they will be required to respond within 48 hours. An HIV clinician will follow-up and triage any problems that are identified. The control arm will receive standard of care. Patients will be followed for one year. The WelTel Retain study will contribute critical information on the effectiveness of an mHealth program to engage patients in care during the first year of HIV care. This research has the potential to demonstrate that the WelTel SMS intervention is an effective, feasible retention strategy, which can contribute significantly to the long-term success of PEPFAR-funded programs and towards a sustainable global HIV/AIDS response.

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

入选标准

  • evidence of HIV infection
  • newly enrolling at the Kibera Community Health Centre
  • own or have sufficient access to a cell phone; able to operate a cell phone using simple text-messaging*
  • able and willing to provide informed assent/consent to participate *If a participant does not own a phone but has sufficient access to a cell phone (through a partner, relative, etc.), the participant would be able to either 1) use the accessed phone to respond to the text messages themselves; or, if they are unable to text themselves 2) have their partner, relative etc. respond on their behalf.

排除标准

  • individuals will be excluded if they do not meet all of the inclusion criteria.
  • individuals transferring from other clinics who are already taking ART will also be excluded.

结局指标

主要结局

Patient retention in care

时间窗: 12 months

次要结局

  • Enrolment in HIV care and treatment program(2 months)
  • First ART eligibility assessment(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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