CareConekta: A Smartphone App to Improve Engagement in HIV Care

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836625
• Other study ID #: 181640
• Secondary ID: R34MH118028
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2023
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
South Africa	Gugulethu Community Health Centre	Cape Town

Sponsors (4)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Mental Health (NIMH), University of California, San Francisco, University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	Permanent Move	Was the move permanent (yes/no)	Baseline to End of Study (up to 2 years)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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