CareConekta: A Pilot Study of a Smartphone App in South Africa
2018年1月23日 更新者:Kate Clouse、Vanderbilt University Medical Center
A Pilot Study to Assess the Acceptability and Feasibility of a Smartphone App to Improve Retention in Postpartum HIV Care in South Africa
Population mobility is frequent in South Africa and disrupts the continuity of HIV care.
Postpartum, HIV-positive women are at elevated risk of dropping out of HIV care and are highly mobile.
This pilot study aims to engage peripartum, HIV-positive women as potential users to evaluate a novel smartphone application to assist these women with linkage to new HIV facilities and prospectively describe the mobility of this population.
研究概览
详细说明
South Africa is home to the world's largest antiretroviral therapy (ART) program, but sustaining high retention along the HIV care continuum has proven challenging in the country and throughout the wider region.
Population mobility is frequent in South Africa and mobility likely disrupts retention in HIV care.
In the absence of a facility-linked national electronic health data system, clinic switching as unreported transfers also obscures the true magnitude of loss to follow-up, hindering national evaluation efforts.
Postpartum women in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile, partly due to cultural traditions of returning to one's rural home after giving birth.
To address these challenges to retention in care, the investigators will enroll 30 peripartum, HIV-positive women as potential users to assess the acceptability and feasibility of deploying in a real-world setting a novel mHealth application to improve retention in HIV care.
The app will operate on users' own smartphones and will serve two primary functions: 1) as a service tool to inform postpartum, HIV-positive women of ART services in their area so that they may access continued HIV care, even while traveling, and 2) as a research tool to prospectively characterize travel and mobility patterns of these women.
During this pilot study, women will be passively followed for 90 days following app installation at enrollment.
After 90 days, they will be interviewed to determine acceptability and feasibility, and electronic user data will be analyzed.
This information will be used to develop an app poised for nationwide adoption.
The research team comprises leaders in the study of HIV implementation science, maternal/child health and biomedical informatics, with experience designing effective mobile health (mHealth) interventions in low-resources settings.
This pilot study aims to engage potential users to test a smartphone application that both improves linkage to HIV care and provides essential research data to inform future health system strengthening efforts.
研究类型
介入性
注册 (实际的)
4
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Cape Town、南非
- Gugulethu Community Health Centre
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Willing to enroll and provide written informed consent
- ≥18 years old
- HIV-positive
- Pregnant (>36 weeks gestation)
- Able to read basic written English
- Currently own a smartphone that meets the technical requirements
- Willing to opt-in to installation of the app on her personal phone and to mobility tracking
Exclusion Criteria:
-
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:设备可行性
- 分配:不适用
- 介入模型:单组作业
- 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:Smartphone app
All participants in this pilot study will install the smartphone app for testing
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CareConekta is a smartphone app developed in parallel with a series of focus group discussions that uses global positioning system (GPS) data to identify the user's location to meet two primary functions: (1) to allow the participant to locate ART facilities in South Africa that are near her current location, and (2) to trace mobility prospectively.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Feasibility questionnaire
大体时间:3 months
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Feasibility will be assessed via a face-to-face questionnaire to address the following questions:
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3 months
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Acceptability questionnaire
大体时间:3 months
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Acceptability will be assessed via a face-to-face questionnaire to address the following questions:
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Medical record review to assess potential efficacy
大体时间:3 months
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The investigators will assess paper and electronic medical records to assess if the receipt of a notification results in linkage to a facility, as recorded through self-report and patient records.
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3 months
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Spatial analysis of GPS data
大体时间:3 months
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The investigators will analyze the GPS data collected in during the pilot study to determine the characteristics of peripartum women's mobility patterns.
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3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Kate Clouse, PhD, MPH、Vanderbilt University Medical Center
- 首席研究员:Tamsin K Phillips, MPH、University of Cape Town
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月12日
初级完成 (实际的)
2018年1月18日
研究完成 (实际的)
2018年1月18日
研究注册日期
首次提交
2017年5月15日
首先提交符合 QC 标准的
2017年5月16日
首次发布 (实际的)
2017年5月17日
研究记录更新
最后更新发布 (实际的)
2018年1月25日
上次提交的符合 QC 标准的更新
2018年1月23日
最后验证
2018年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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