Clinical trial NCT03836625: CareConekta: A Smartphone App to Improve Engagement in HIV Care
Official title: CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Pregnancy Related
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: University of California, San Francisco
name: National Institute of Mental Health (NIMH)
First posted: 2019-02-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mobility Prevalence
timeFrame: Baseline to End of Study (up to 2 years)
measure: Median Number of Trips Per Person
timeFrame: Baseline to End of Study (up to 2 years)
measure: CareConekta Feasibility: Same Phone at Follow-up
timeFrame: Baseline to End of Study (up to 2 years)
Secondary outcomes:
measure: Timing of Travel
timeFrame: Baseline to End of Study (up to 2 years)
measure: Permanent Move
timeFrame: Baseline to End of Study (up to 2 years)
measure: CareConekta Feasibility: GPS Disabled During the Study Period
timeFrame: Baseline to End of Study (up to 2 years)
measure: CareConekta Feasibility -- Participant Reported Sharing Phone
timeFrame: Baseline to End of Study (up to 2 years)
measure: CareConekta Feasibility -- Participant Ever Opened App
timeFrame: Baseline to End of Study (up to 2 years)
measure: CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities
timeFrame: Baseline to End of Study (up to 2 years)
measure: CareConekta Initial Efficacy -- Maternal Engagement in HIV Care
timeFrame: 6 months after delivery
measure: CareConekta Initial Efficacy -- Infant Outcomes
timeFrame: 10 weeks after delivery, study end
measure: Impact of Mobility -- Maternal Engagement in HIV Care
timeFrame: 6 months after delivery
measure: Impact of Mobility -- Infant Outcomes
timeFrame: 10 weeks after delivery, study end
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Community Health Centre
Study officials:
affiliation: Vanderbilt University School of Nursing
name: Kate Clouse, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.