CareConekta: A Smartphone App to Improve Engagement in HIV Care
CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa
2 other identifiers
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
December 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedResults Posted
Study results publicly available
February 1, 2023
CompletedFebruary 1, 2023
January 1, 2023
2 years
January 22, 2019
October 28, 2022
January 5, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Mobility Prevalence
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.
Baseline to End of Study (up to 2 years)
Median Number of Trips Per Person
Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.
Baseline to End of Study (up to 2 years)
CareConekta Feasibility: Same Phone at Follow-up
The number of participants who report using the same phone from enrollment at follow-up
Baseline to End of Study (up to 2 years)
Secondary Outcomes (10)
Timing of Travel
Baseline to End of Study (up to 2 years)
Permanent Move
Baseline to End of Study (up to 2 years)
CareConekta Feasibility: GPS Disabled During the Study Period
Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Reported Sharing Phone
Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Ever Opened App
Baseline to End of Study (up to 2 years)
- +5 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONThe control arm will receive standard CareConekta, which will track their mobility with no additional features.
Intervention
EXPERIMENTALThe intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled \>50 km from the study site for \>7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt Universitylead
- University of Cape Towncollaborator
- University of California, San Franciscocollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Gugulethu Community Health Centre
Cape Town, South Africa
Related Publications (4)
Noholoza S, Phillips TK, Madwayi S, Mrubata M, Camlin CS, Myer L, Clouse K. Smartphone Ownership and Usage Among Pregnant Women Living With HIV in South Africa: Secondary Analysis of CareConekta Trial Data. JMIR Form Res. 2023 Jun 22;7:e43855. doi: 10.2196/43855.
PMID: 37347521DERIVEDClouse K, Noholoza S, Madwayi S, Mrubata M, Camlin CS, Myer L, Phillips TK. The Implementation of a GPS-Based Location-Tracking Smartphone App in South Africa to Improve Engagement in HIV Care: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 May 19;11:e44945. doi: 10.2196/44945.
PMID: 37204838DERIVEDClouse K, Noholoza S, Ngcobo N, Madwayi S, Mrubata M, Camlin CS, Myer L, Phillips TK. Cohort profile: CareConekta: a pilot study of a smartphone application to improve engagement in postpartum HIV care in South Africa. BMJ Open. 2022 Nov 22;12(11):e064946. doi: 10.1136/bmjopen-2022-064946.
PMID: 36414286DERIVEDClouse K, Phillips TK, Camlin C, Noholoza S, Mogoba P, Naidoo J, Langford R, Weiss M, Seebregts CJ, Myer L. CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa. Trials. 2020 Mar 12;21(1):258. doi: 10.1186/s13063-020-4190-x.
PMID: 32164771DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We found that several key challenges impeded our study feasibility. The primary challenge is that during the study period, no participant's smartphone recorded at least one heartbeat per day.
Results Point of Contact
- Title
- Kate Clouse
- Organization
- Vanderbilt University
Study Officials
- PRINCIPAL INVESTIGATOR
Kate Clouse, PhD, MPH
Vanderbilt University School of Nursing
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 22, 2019
First Posted
February 11, 2019
Study Start
December 9, 2019
Primary Completion
November 30, 2021
Study Completion
November 30, 2021
Last Updated
February 1, 2023
Results First Posted
February 1, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Anytime, by request
De-identified datasets will be made available by request, subject to agreement to (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology and established security measures; (3) a plan for the dissemination of results; (4) appropriate authorship and recognition of all partners; and (5) a commitment to destroy or return the data after analyses are completed.