Clinical trial NCT02756949: Smart Linkage-to-HIV Care Via a Smartphone App
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Viral Load
Patient Compliance
Antiretroviral Therapy
Cell Phone
Keywords: HIV
Viral load
CD4 count
mHealth
Smartphone
Linkage to care
Retention in care
Antiretroviral treatment
Randomized controlled trial
Johannesburg
Mobile app
Treatment adherence
Lead sponsor: World Bank
Sponsor class: OTHER
Collaborators: name: Wits Reproductive Health and HIV Institute
name: National Health Laboratory Service South Africa
name: Department for International Development, United Kingdom
First posted: 2016-04-29
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
timeFrame: Recruitment +8 months
Secondary outcomes:
measure: Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
timeFrame: Recruitment +8 months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health and HIV Institute
state: Gauteng
Study officials:
affiliation: Wits Reproductive Health and HIV Institute
name: Francois Venter, Prof
role: STUDY_DIRECTOR
References:
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 Africa: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 2;7(4):e12652. doi: 10.2196/12652.
citation: 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/mhealth.8376.
citation: Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.