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临床试验/NCT03454373
NCT03454373已完成不适用

Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

University of California, Berkeley3 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
800
试验地点
3
主要终点
The proportion of PLHIV linked to HIV care at 3 months

研究概览

简要总结

This protocol is for the long term follow-up study of "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy (ART) in Tanzania", a 3-arm randomized controlled trial led by Professor Sandra McCoy at the University of California Berkeley and Dr. Prosper Njau at the Tanzanian Ministry of Health and Social Welfare. The investigators will determine the long-term effectiveness of short-term incentives for ART adherence and retention in care. The study will also determine whether incentives can also be used to re-engage PLHIV with HIV care after they have fallen out of care.

详细描述

This study will build on preliminary data from a randomized study conducted in Shinyanga, Tanzania which found that short-term cash and food assistance improved ART adherence and retention in care among food insecure people living with HIV infection (PLHIV) after 6 and 12 months of follow-up. The investigators will now determine the long-term effectiveness of these incentive strategies. In this 2-year study, investigators will first determine 24-month adherence and retention outcomes using medical and pharmacy records for the 781 PLHIV who were alive at the end of the previous study, which concluded after 12 months of follow-up (Aim 1). Then, leveraging an existing program of home based care, investigators will determine the prevalence of undocumented transfers and deaths among the subset of patients found to be lost to follow-up or transferred in clinic records. Investigators will use these data from home visits to adjust estimates of the interventions' effectiveness on retention in HIV care and mortality (Aim 2). Among the PLHIV found to be disengaged from care, investigators will conduct a pilot study of a one-time cash incentive to encourage PLHIV to re-engage with care, with the goal of mitigating the barriers posed by transportation and opportunity costs (Aim 3). At the conclusion of the project, investigators will understand the long-term effectiveness of cash and food incentives for adherence and retention, and whether they can also be used for re-linking PLHIV to care, data highly relevant to 'Treat All' programs in Fast Track countries.

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

  • Study participant in the prior study "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania" (NCT01957917)
  • Alive and willing to provide written informed consent
  • Not currently enrolled in HIV care services

排除标准

  • 未提供

结局指标

主要结局

The proportion of PLHIV linked to HIV care at 3 months

时间窗: 3 months

Initial re-engagement in care, defined as as the proportion of PLHIV who have completed (attended) a HIV primary care visit at the clinic of the PLHIV's choosing within 3 months of the incentive offer to return to care.

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

Sandra McCoy

Assistant Adjunct Professor

University of California, Berkeley

研究点 (3)

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