Smart Linkage-to-HIV Care Via a Smartphone App

HIV Infections Clinical Trial

— SmartLtC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756949
• Other study ID #: 7173708
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: April 2019
• Source: World Bank
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
South Africa	Wits Reproductive Health and HIV Institute	Johannesburg	Gauteng

Sponsors (4)

Lead Sponsor	Collaborator
World Bank	Department for International Development, United Kingdom, National Health Laboratory Service South Africa, Wits Reproductive Health and HIV Institute

Country where clinical trial is conducted

South Africa, 

References & Publications (2)

Venter W, Coleman J, Chan VL, Shubber Z, Phatsoane M, Gorgens M, Stewart-Isherwood L, Carmona S, Fraser-Hurt N. Improving Linkage to HIV Care Through Mobile Phone Apps: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jul 17;6(7):e155. doi: 10.2196 — View Citation

Venter WDF, Fischer A, Lalla-Edward ST, Coleman J, Lau Chan V, Shubber Z, Phatsoane M, Gorgens M, Stewart-Isherwood L, Carmona S, Fraser-Hurt N. Improving Linkage to and Retention in Care in Newly Diagnosed HIV-Positive Patients Using Smartphones in South — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Smart Linkage to Care : Evaluation Report