CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mobility Prevalence
研究概览
简要总结
Population mobility is common in South Africa, but important research gaps exist describing this mobility and its impact on engagement in HIV care, particularly among pregnant and postpartum women. Through this study, the investigators propose to test a smartphone application - CareConekta - to conduct essential formative work on mobility and evaluate this app as an intervention to facilitate engagement in HIV care during times of mobility. This work is critical to adapting CareConekta for widespread use, providing critical information about mobility during the peripartum period and the impact on engagement in HIV care, and piloting this intervention to improve engagement.
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 common in South Africa, but important research gaps exist describing this mobility and its impact on engagement in HIV care. Postpartum women and their infants in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile. The investigators recently developed a beta version of a smartphone application (app) - CareConekta - that detects a user's smartphone location to allow for prospective characterization of mobility. Through this three-year study, the investigators propose to test CareConekta to conduct essential formative work on mobility and evaluate an intervention - the CareConekta app plus text notifications and optional staff phone calls and/or WhatsApp messages - to facilitate engagement in HIV care during times of mobility. After first adapting CareConekta to use appropriate smartphone technology for the local population, the investigators will characterize mobility among South African women during the peripartum period and its impact on engagement in HIV care. The investigators also will evaluate the acceptability, feasibility, and initial efficacy of using CareConekta as an intervention to improve engagement in HIV care. The investigators will work with a South African technology company with a strong connection to the South African Department of Health to adapt the app prior to enrolling study participants. The study will observe mobility within an observational cohort and will then assess the impact of the intervention among participants who travel during the study period. This work is critical to adapting an existing app for widespread use, providing critical information about mobility during the peripartum period and the impact on engagement in HIV care, and piloting an intervention to improve engagement. This study will lay the necessary groundwork for a larger efficacy trial of the intervention within different geographic settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •We will only enroll participants attending the Gugulethu Community Health Centre, near Cape Town, South Africa
- •HIV-positive
- •adult (≥18 years)
- •pregnant (≥28 weeks)
- •own a smartphone that meets the technical requirements
- •willing to opt-in to installation of CareConekta on her personal phone and to mobility tracking
- •demonstrate the ability to read simple text language
- •willing to be randomized
排除标准
- •If an interested participant meets all of the inclusion criteria, there are no additional exclusion criteria
结局指标
主要结局
Mobility Prevalence
时间窗: Baseline to End of Study (up to 2 years)
The investigators will report the number of participants who travel during the study period (defined as 3 or more nights away from home), over the denominator of all participants who completed follow-up.
Median Number of Trips Per Person
时间窗: Baseline to End of Study (up to 2 years)
Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.
CareConekta Feasibility: Same Phone at Follow-up
时间窗: Baseline to End of Study (up to 2 years)
The number of participants who report using the same phone from enrollment at follow-up
次要结局
- Permanent Move(Baseline to End of Study (up to 2 years))
- CareConekta Feasibility: GPS Disabled During the Study Period(Baseline to End of Study (up to 2 years))
- Impact of Mobility -- Maternal Engagement in HIV Care(6 months after delivery)
- CareConekta Feasibility -- Participant Reported Sharing Phone(Baseline to End of Study (up to 2 years))
- CareConekta Initial Efficacy -- Infant Outcomes(10 weeks after delivery, study end)
- Timing of Travel(Baseline to End of Study (up to 2 years))
- CareConekta Feasibility -- Participant Ever Opened App(Baseline to End of Study (up to 2 years))
- CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities(Baseline to End of Study (up to 2 years))
- CareConekta Initial Efficacy -- Maternal Engagement in HIV Care(6 months after delivery)
- Impact of Mobility -- Infant Outcomes(10 weeks after delivery, study end)
研究者
Kate Clouse
Assistant Professor
Vanderbilt University