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Completed

NCT Number: NCT03836625

CareConekta: A Smartphone App to Improve Engagement in HIV Care

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • If an interested participant meets all of the inclusion criteria, there are no additional exclusion criteria

Treatment and study plan

CareConekta

Other

CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.

Primary outcomes

  1. Mobility Prevalence

    Time frame: 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.

  2. Median Number of Trips Per Person

    Time frame: 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.

  3. CareConekta Feasibility: Same Phone at Follow-up

    Time frame: Baseline to End of Study (up to 2 years)

    The number of participants who report using the same phone from enrollment at follow-up

Secondary outcomes

  1. Timing of Travel

    Time frame: Baseline to End of Study (up to 2 years)

    The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.

  2. Permanent Move

    Time frame: Baseline to End of Study (up to 2 years)

    Was the move permanent (yes/no)

  3. CareConekta Feasibility: GPS Disabled During the Study Period

    Time frame: Baseline to End of Study (up to 2 years)

    The number of participants who disabled GPS during the study period

  4. CareConekta Feasibility -- Participant Reported Sharing Phone

    Time frame: Baseline to End of Study (up to 2 years)

    The number of participants who reported sharing their phone with another person during the study period

  5. CareConekta Feasibility -- Participant Ever Opened App

    Time frame: Baseline to End of Study (up to 2 years)

    The number of participants who reported opening the CareConekta app at least once after enrollment visit

  6. CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities

    Time frame: Baseline to End of Study (up to 2 years)

    The number of participants who reported using the CareConekta app to locate a new health facility.

  7. CareConekta Initial Efficacy -- Maternal Engagement in HIV Care

    Time frame: 6 months after delivery

    The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and maternal retention in care and viral suppression 6 months after delivery.

  8. CareConekta Initial Efficacy -- Infant Outcomes

    Time frame: 10 weeks after delivery, study end

    The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and vertical HIV transmission and completion of 10-week infant HIV PCR test.

  9. Impact of Mobility -- Maternal Engagement in HIV Care

    Time frame: 6 months after delivery

    In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and engagement in HIV care for the mother (defined as retention in care and viral suppression six months after delivery).

  10. Impact of Mobility -- Infant Outcomes

    Time frame: 10 weeks after delivery, study end

    In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and completion of routine early infant diagnosis.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of California, San Francisco
  • University of Cape Town

Registry information

Official study title

CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2019
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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