Skip to content

Smart Linkage-to-HIV Care Via a Smartphone App

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02756949
Acronym
SmartLtC
Enrollment
353
Registered
2016-04-29
Start date
2015-10-31
Completion date
2017-06-30
Last updated
2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HIV, Viral load, CD4 count, mHealth, Smartphone, Linkage to care, Retention in care, Antiretroviral treatment, Randomized controlled trial, Johannesburg, Mobile app, Treatment adherence

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.

Interventions

OTHERSmartphone 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.

DEVICESmartphone

Sponsors

Wits Reproductive Health and HIV Institute
CollaboratorOTHER
National Health Laboratory Service South Africa
CollaboratorUNKNOWN
Department for International Development, United Kingdom
CollaboratorOTHER_GOV
World Bank
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Recruitment +8 monthsTo 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

MeasureTime frameDescription
Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Recruitment +8 monthsTo 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.

Countries

South Africa

Participant flow

Recruitment details

Participants were recruited at 5 public HIV testing sites (1 community health center, 3 clinics, and 1 tertiary hospital) in inner city Johannesburg, South Africa. Recruitment happened from October 2015 to June 2016. HIV positive individuals were pre-screened for trial suitability and recruited if eligible upon screening.

Pre-assignment details

Of the 4537 individuals approached about the study, 90 declined to participate and 4094 were found ineligible during pre-screening and screening, leaving 353 for randomization. 8 standard of care arm participants were later removed from analysis due to erroneous sending of SMS reminders for their 6-month clinic appointment leaving 345 for analysis.

Participants by arm

ArmCount
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. 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. Smartphone
181
Standard of Care
Participants in this arm are randomised to receive standard of care services.
164
Total345

Baseline characteristics

CharacteristicSmartphone-enabled App for Linkage to CareStandard of CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
181 Participants164 Participants345 Participants
Country of birth181 Participants164 Participants345 Participants
Education level
Attended/completed tertiary
24 Participants29 Participants53 Participants
Education level
Completed secondary school
98 Participants85 Participants183 Participants
Education level
Primary only
8 Participants6 Participants14 Participants
Education level
Some secondary school
51 Participants44 Participants95 Participants
Employment status
Full time
82 Participants79 Participants161 Participants
Employment status
Part time
37 Participants22 Participants59 Participants
Employment status
Self-employed
10 Participants16 Participants26 Participants
Employment status
Student
3 Participants7 Participants10 Participants
Employment status
Unemployed
49 Participants40 Participants89 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
South Africa
181 participants164 participants345 participants
Sex: Female, Male
Female
121 Participants103 Participants224 Participants
Sex: Female, Male
Male
60 Participants61 Participants121 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1810 / 164
other
Total, other adverse events
0 / 1810 / 164
serious
Total, serious adverse events
0 / 1810 / 164

Outcome results

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.

Time frame: Recruitment +8 months

Population: Eight standard of care participants removed from analysis due to contamination of the intervention.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Smartphone-enabled App for Linkage to CareLinkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Linked to HIV care88 Participants
Smartphone-enabled App for Linkage to CareLinkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Not linked93 Participants
Standard of CareLinkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Linked to HIV care74 Participants
Standard of CareLinkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Not linked90 Participants
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.

Time frame: Recruitment +8 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Smartphone-enabled App for Linkage to CareLinkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Linked to HIV care44 Participants
Smartphone-enabled App for Linkage to CareLinkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Not linked39 Participants
Standard of CareLinkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Linked to HIV care22 Participants
Standard of CareLinkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)Not linked47 Participants

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026