CareConekta: A Smartphone App to Improve Engagement in HIV Care

NCT ID: NCT03836625

Last Updated: 2023-02-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2021-11-30

Brief Summary

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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

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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.

Conditions

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HIV/AIDS Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

CareConekta

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cape Town

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Kate Clouse

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kate Clouse, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Nursing

Locations

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Gugulethu Community Health Centre

Cape Town, , South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type DERIVED
PMID: 37347521 (View on PubMed)

Clouse 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.

Reference Type DERIVED
PMID: 37204838 (View on PubMed)

Clouse 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.

Reference Type DERIVED
PMID: 36414286 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32164771 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R34MH118028

Identifier Type: NIH

Identifier Source: secondary_id

View Link

181640

Identifier Type: -

Identifier Source: org_study_id

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