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Smart Linkage-to-HIV Care Via a Smartphone App (SmartLtC)

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ClinicalTrials.gov Identifier: NCT02756949
Recruitment Status : Completed
First Posted : April 29, 2016
Results First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Collaborators:
Wits Reproductive Health and HIV Institute
National Health Laboratory Service South Africa
Department for International Development, United Kingdom
Information provided by (Responsible Party):
World Bank

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Viral Load Patient Compliance Antiretroviral Therapy Cell Phone Other: Smartphone application Device: Smartphone Not Applicable

Detailed Description:
This evaluation of a newly designed smartphone application (app) for linkage to care, HIV treatment adherence and retention in care, is taking place at five Johannesburg health facilities. Intervention allocation is random with individuals either receiving the smartphone app or standard of care. The trial is motivated by evidence from elsewhere that sending lab results via app acceptable, and loss of patients in need of HIV care can be reduced with mobile Health interventions. There is a growing number of smartphones in South Africa (at the time of baseline assessment, about 40% of the surveyed population had an Android smartphone with data, and the majority of new phones are smartphones). The trial's objectives are: a) Test whether routine linkage to HIV care at public sector services is improved by providing HIV positive clients with a smartphone-enabled app when compared to standard of care; b) Determine HIV treatment initiation rates between intervention and control arm; c) Test the feasibility and acceptability of receiving lab results via app; d) Assess secondary effects from improved participant information, including return rates after falling out of care, participant satisfaction, and rates of repeat blood tests; e) Determine knowledge levels on HIV care; and f) Assess the effect in priority groups for better linkage to care (male HIV cases and HIV positive youth). If data allow, a cost-benefit analysis will also be conducted.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Do Smartphones Increase Linkage to and Retention in Care in Newly Diagnosed HIV-positive Patients in Johannesburg, South Africa: A Multisite Randomised Controlled Trial
Actual Study Start Date : October 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Smartphone-enabled app for linkage to care
Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.
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.
Other Names:
  • App
  • Customised smartphone app

Device: Smartphone
No Intervention: Standard of care
Participants in this arm are randomised to receive standard of care services.



Primary Outcome Measures :
  1. Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) [ Time Frame: Recruitment +8 months ]
    To test whether linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.


Secondary Outcome Measures :
  1. Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) [ Time Frame: Recruitment +8 months ]
    To test whether among individuals aged 18-30 years linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed HIV positive clients presenting at selected public health facilities, irrespective of CD4 count
  • Access to an Android smartphone with data
  • Willing to pay the (very small) cost to access their laboratory result
  • Age - 18 years and older
  • Proof of ID/passport/refugee number (for identification/security, and to confirm the single patient identifier)
  • Can read English or Zulu
  • Ability and willingness to sign informed consent

Exclusion Criteria:

  • Clients presenting for antenatal care services, as these women will be enrolled in the national MomConnect program
  • Refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756949


Locations
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South Africa
Wits Reproductive Health and HIV Institute
Johannesburg, Gauteng, South Africa, 2001
Sponsors and Collaborators
World Bank
Wits Reproductive Health and HIV Institute
National Health Laboratory Service South Africa
Department for International Development, United Kingdom
Investigators
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Study Director: Francois Venter, Prof Wits Reproductive Health and HIV Institute
  Study Documents (Full-Text)

Documents provided by World Bank:
Statistical Analysis Plan  [PDF] March 29, 2016

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: World Bank
ClinicalTrials.gov Identifier: NCT02756949    
Other Study ID Numbers: 7173708
First Posted: April 29, 2016    Key Record Dates
Results First Posted: October 24, 2019
Last Update Posted: October 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by World Bank:
HIV
Viral load
CD4 count
mHealth
Smartphone
Linkage to care
Retention in care
Antiretroviral treatment
Randomized controlled trial
Johannesburg
Mobile app
Treatment adherence
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases