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临床试验/NCT03157908
NCT03157908已完成不适用

A Pilot Study to Assess the Acceptability and Feasibility of a Smartphone App to Improve Retention in Postpartum HIV Care in South Africa

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年7月12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
4
试验地点
1
主要终点
Acceptability questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Smartphone app

Experimental

All participants in this pilot study will install the smartphone app for testing

干预措施: CareConekta (Device)

结局指标

主要结局

Acceptability questionnaire

时间窗: 3 months

Acceptability will be assessed via a face-to-face questionnaire to address the following questions: * Do women find the app helpful? * How frequently do women engage with the app and under what circumstances? * Do women report that they think such an app should be offered to other pregnant women? What about to non-pregnant adults? * Are there other services that participants would like to see included on future version of the app? * Do women like the notifications?

Feasibility questionnaire

时间窗: 3 months

Feasibility will be assessed via a face-to-face questionnaire to address the following questions: * What proportion of women eligible to participate chooses to participate in the study? * Are participants able to install the app on their phones? * How does real-world access to the internet affect the use of the app? * When is the optimal time for the participant to receive a notification? * How many notifications are sent? * What unexpected problems occurred? * What are the general usage patterns of the app?

次要结局

  • Medical record review to assess potential efficacy(3 months)
  • Spatial analysis of GPS data(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kate Clouse

Assistant Professor of Medicine

Vanderbilt University Medical Center

研究点 (1)

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