Clinical trial NCT03157908: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: South Africa
Retention in care
Pregnancy
Mobile health
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2017-05-17
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: DEVICE_FEASIBILITY

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.

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:

-

Primary outcomes:
measure: Feasibility questionnaire
timeFrame: 3 months
measure: Acceptability questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Medical record review to assess potential efficacy
timeFrame: 3 months
measure: Spatial analysis of GPS data
timeFrame: 3 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Community Health Centre
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kate Clouse, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Tamsin K Phillips, MPH
role: PRINCIPAL_INVESTIGATOR
References: