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Clinical Trials/NCT03157908
NCT03157908
Completed
Not Applicable

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 site in 1 country4 target enrollmentJuly 12, 2017
ConditionsHIV/AIDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Vanderbilt University Medical Center
Enrollment
4
Locations
1
Primary Endpoint
Acceptability questionnaire
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2017
End Date
January 18, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kate Clouse

Assistant Professor of Medicine

Vanderbilt University Medical Center

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Acceptability questionnaire

Time Frame: 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

Time Frame: 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?

Secondary Outcomes

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

Study Sites (1)

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