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

World Bank

Status: Completed

Conditions: Antiretroviral Therapy; Cell Phone; Patient Compliance; HIV Infections; Viral Load

Treatments: Device: Smartphone; Other: Smartphone application

Study type: Interventional

Funder types: Other

Identifiers

NCT02756949

7173708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

353 participants in 2 patient groups

Smartphone-enabled app for linkage to care

Experimental group

Description:

Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.

Treatment:

Other: Smartphone application

Device: Smartphone

Standard of care

No Intervention group

Description:

Participants in this arm are randomised to receive standard of care services.