Smart Linkage-to-HIV Care Via a Smartphone App

NCT02756949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2019-10-24

Study results available
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Summary

This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their results. Message prompts will also be used to alert patients that their results are ready and provide information on how to link to care, and assistance to re-link to care if they fall out of the health system for any reason. Prompts will be sent to patients to remind health care workers if they are due for repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6 months. The control group received standard of care.

Conditions

  • HIV Infections
  • Viral Load
  • Patient Compliance
  • Antiretroviral Therapy
  • Cell Phone

Interventions

OTHER

Smartphone application

Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.

DEVICE

Smartphone

Sponsors & Collaborators

  • Wits Reproductive Health and HIV Institute

    collaborator OTHER
  • National Health Laboratory Service South Africa

    collaborator UNKNOWN
  • Department for International Development, United Kingdom

    collaborator OTHER_GOV
  • World Bank

    lead OTHER

Principal Investigators

  • Francois Venter, Prof · Wits Reproductive Health and HIV Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-02-28
Completion
2017-06-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02756949 on ClinicalTrials.gov