Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population (Connect4Care)
Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies
Retention in care and virologic suppression are the key final steps of the HIV treatment cascade. Poor or intermittent retention has been associated with later initiation of antiretroviral therapy, virologic failure, and death. Regular HIV care has also been associated with a decrease in HIV transmission risk behavior. Despite the proven health and prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the United States are estimated to meet current retention in care standards and even fewer - only about 25% - are estimated to be virologically suppressed.
The Behavioral Model for Vulnerable Populations provides a useful framework for understanding broad areas that may impact adherence to care and treatment. Individual-level domains include vulnerable (e.g., depression, stigma), enabling (e.g., social support, positive affect), and need (e.g., co-morbidities) factors, and structural domains include, for example, features or the clinic and the provider-patient relationship.
Short message service (SMS) technology represents a new and exciting tool to help retain HIV-infected patients in care and treatment. SMS interventions have been deployed successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan Africa, where two randomized trials have showed clear benefits. A pilot study conducted in our clinic suggests that use of SMS messages to promote adherence to care and treatment in the urban HIV-infected poor is both feasible and acceptable.
The investigators believe that combining SMS technology with content-specific messages designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations can improve retention in care and virologic suppression for an urban public hospital population living with HIV, thus the investigators propose the following specific aims.
Specific Aim 1: Determine whether a behavioral theory-based SMS intervention improves virologic suppression [primary outcome] and retention in care [secondary outcome] for a vulnerable urban HIV-infected population through a randomized trial of this technology compared to SMS appointment reminders alone. Retention in care will also be analyzed as a mediator of virologic suppression. Exploratory outcomes include time to virologic suppression, sustained virologic suppression, emergency department utilization and antiretroviral adherence, as well as levels of depression, positive affect, social support and empowerment.
Specific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of patient use of this technology, and; 3) the preferred frequency and content of intervention messages.
Specific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Francisco、California、美国、94110
- San Francisco General Hospital Positive Health Program
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- HIV-infected
- Age 18 or over
- English-speaking
- Able to give informed consent
- Have a cell phone and willing to send/receive up to 25 text messages/month
- Detectable viral load plus either 1) new to clinic (no more than 2 primary care visits) or 2) history of poor retention (one missed visit or lack of six-month visit constancy in the past year)
Exclusion Criteria:
- HIV-uninfected
- Under age 18
- Monolingual speaker of a language other than English
- Unable to give informed consent
- Undetectable viral load
- Perfect appointment adherence
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Text Messages + Appointment Reminders
Participants in the intervention arm will receive supportive, informational, or motivational text messages three times a week for one year in addition to text message reminders about HIV primary care appointments.
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The intervention consists of supportive, informational, and motivational text messages three times a week targeting the following domains: promoting a sense of connectedness to the clinic, fostering social support, building empowerment, ameliorating negative affect, cultivating positive affect, and promoting healthy behaviors and adherence to antiretroviral medication.
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有源比较器:Appointment Reminders
Participants in the control arm will receive text messages reminding them of HIV primary care appointments 48 hours before the scheduled appointment.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Viral Load
大体时间:12 month
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12 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Missed Visit Proportion
大体时间:12 month
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Number of missed or "no show" visits divided by number of scheduled appointments
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12 month
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Appointment Adherence
大体时间:12 month
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Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)
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12 month
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Visit Constancy
大体时间:12 month
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At least one kept visit in each six-month period
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12 month
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Attended All Scheduled Visits
大体时间:12 month
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Attended all scheduled visits
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12 month
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Time to Virologic Suppression
大体时间:12 month
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12 month
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Sustained virologic suppression
大体时间:12 month
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12 month
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合作者和调查者
调查人员
- 首席研究员:Katerina Christopoulos, MD、University of California, San Francisco
出版物和有用的链接
一般刊物
- Christopoulos KA, Riley ED, Tulsky J, Carrico AW, Moskowitz JT, Wilson L, Coffin LS, Falahati V, Akerley J, Hilton JF. A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial. BMC Infect Dis. 2014 Dec 31;14:718. doi: 10.1186/s12879-014-0718-6.
- Christopoulos KA, Riley ED, Carrico AW, Tulsky J, Moskowitz JT, Dilworth S, Coffin LS, Wilson L, Peretz JJ, Hilton JF. A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Clin Infect Dis. 2018 Aug 16;67(5):751-759. doi: 10.1093/cid/ciy156.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- R01DA032057 (美国 NIH 拨款/合同)
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