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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Device: CareConekta

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Gugulethu Community Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone app; All participants in this pilot study will install the smartphone app for testing	Device: CareConekta; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	3 months
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?	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: University of Cape Town
• Investigators: Principal Investigator: Kate Clouse, PhD, MPH, Vanderbilt University Medical Center; Principal Investigator: Tamsin K Phillips, MPH, University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): January 18, 2018
• Study Completion (Actual): January 18, 2018

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy; South Africa; Mobile health; Retention in care
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 170510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No