Smart Linkage-to-HIV Care Via a Smartphone App

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Do Smartphones Increase Linkage to and Retention in Care in Newly Diagnosed HIV-positive Patients in Johannesburg, South Africa: A Multisite Randomised Controlled Trial

Conditions
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HIV Infections, Viral Load, Patient Compliance, Antiretroviral Therapy, Cell Phone

Intervention / Treatment
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* Other: Smartphone application
* Device: Smartphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone-enabled app for linkage to care<br>Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results. | Other: Smartphone application<br>* 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.<br>* Other names: Customised smartphone app;Device: Smartphone<br> <br> |
| No Intervention: Standard of care<br>Participants in this arm are randomised to receive standard of care services. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 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. | Recruitment +8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 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. | Recruitment +8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Viral load, CD4 count, mHealth, Smartphone, Linkage to care, Retention in care, Antiretroviral treatment, Randomized controlled trial, Johannesburg, Mobile app, Treatment adherence