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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Pregnancy Related
• Intervention / Treatment: Other: 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 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• 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: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. We will only enroll participants attending the Gugulethu Community Health Centre, near Cape Town, South Africa
2. HIV-positive
3. adult (≥18 years)
4. pregnant (≥28 weeks)
5. own a smartphone that meets the technical requirements
6. willing to opt-in to installation of CareConekta on her personal phone and to mobility tracking
7. demonstrate the ability to read simple text language
8. willing to be randomized

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control arm will receive standard CareConekta, which will track their mobility with no additional features.
Experimental: Intervention; The 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.	Other: CareConekta; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timing of Travel	The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.	Baseline to End of Study (up to 2 years)
Permanent Move	Was the move permanent (yes/no)	Baseline to End of Study (up to 2 years)
CareConekta Feasibility: GPS Disabled During the Study Period	The number of participants who disabled GPS during the study period	Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Reported Sharing Phone	The number of participants who reported sharing their phone with another person during the study period	Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Ever Opened App	The number of participants who reported opening the CareConekta app at least once after enrollment visit	Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities	The number of participants who reported using the CareConekta app to locate a new health facility.	Baseline to End of Study (up to 2 years)
CareConekta Initial Efficacy -- Maternal Engagement in HIV Care	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.	6 months after delivery
CareConekta Initial Efficacy -- Infant Outcomes	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.	10 weeks after delivery, study end
Impact of Mobility -- Maternal Engagement in HIV Care	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).	6 months after delivery
Impact of Mobility -- Infant Outcomes	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.	10 weeks after delivery, study end

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Institute of Mental Health (NIMH); University of California, San Francisco; University of Cape Town
• Investigators: Principal Investigator: Kate Clouse, PhD, MPH, Vanderbilt University School of Nursing

Publications and helpful links

General Publications

• Clouse 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• 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: 181640; R34MH118028 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Anytime, by request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

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