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CareConekta: A Pilot Study of a Smartphone App in South Africa

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
CareConekta
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for HIV/AIDS focused on measuring South Africa, Retention in care, Pregnancy, Mobile health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Gugulethu Community Health Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Smartphone app

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility questionnaire
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?
Acceptability questionnaire
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?

Secondary Outcome Measures

Medical record review to assess potential efficacy
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.
Spatial analysis of GPS data
The investigators will analyze the GPS data collected in during the pilot study to determine the characteristics of peripartum women's mobility patterns.

Full Information

First Posted
May 15, 2017
Last Updated
January 23, 2018
Sponsor
Vanderbilt University Medical Center
Collaborators
University of Cape Town
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1. Study Identification

Unique Protocol Identification Number
NCT03157908
Brief Title
CareConekta: A Pilot Study of a Smartphone App in South Africa
Official Title
A Pilot Study to Assess the Acceptability and Feasibility of a Smartphone App to Improve Retention in Postpartum HIV Care in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
January 18, 2018 (Actual)
Study Completion Date
January 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
University of Cape Town

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
South Africa, Retention in care, Pregnancy, Mobile health

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone app
Arm Type
Experimental
Arm Description
All participants in this pilot study will install the smartphone app for testing
Intervention Type
Device
Intervention Name(s)
CareConekta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility questionnaire
Description
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?
Time Frame
3 months
Title
Acceptability questionnaire
Description
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?
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Medical record review to assess potential efficacy
Description
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.
Time Frame
3 months
Title
Spatial analysis of GPS data
Description
The investigators will analyze the GPS data collected in during the pilot study to determine the characteristics of peripartum women's mobility patterns.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Clouse, PhD, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamsin K Phillips, MPH
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gugulethu Community Health Centre
City
Cape Town
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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CareConekta: A Pilot Study of a Smartphone App in South Africa

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