CareConekta: A Smartphone App to Improve Engagement in HIV Care

Vanderbilt University

Status: Completed

Conditions: Pregnancy Related; HIV/AIDS

Treatments: Other: CareConekta

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03836625

R34MH118028 (U.S. NIH Grant/Contract)

181640

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control

No Intervention group

Description:

The control arm will receive standard CareConekta, which will track their mobility with no additional features.

Intervention

Experimental group

Description:

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.

Treatment:

Other: CareConekta