Antiretroviral Therapy, Cell Phone, HIV Infections, Patient Compliance, Viral Load
Conditions
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
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Recruitment +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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Recruitment +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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 345 |
Baseline characteristics
| Characteristic | Smartphone-enabled App for Linkage to Care | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 181 Participants | 164 Participants | 345 Participants |
| Country of birth | 181 Participants | 164 Participants | 345 Participants |
| Education level Attended/completed tertiary | 24 Participants | 29 Participants | 53 Participants |
| Education level Completed secondary school | 98 Participants | 85 Participants | 183 Participants |
| Education level Primary only | 8 Participants | 6 Participants | 14 Participants |
| Education level Some secondary school | 51 Participants | 44 Participants | 95 Participants |
| Employment status Full time | 82 Participants | 79 Participants | 161 Participants |
| Employment status Part time | 37 Participants | 22 Participants | 59 Participants |
| Employment status Self-employed | 10 Participants | 16 Participants | 26 Participants |
| Employment status Student | 3 Participants | 7 Participants | 10 Participants |
| Employment status Unemployed | 49 Participants | 40 Participants | 89 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Africa | 181 participants | 164 participants | 345 participants |
| Sex: Female, Male Female | 121 Participants | 103 Participants | 224 Participants |
| Sex: Female, Male Male | 60 Participants | 61 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 164 |
| other Total, other adverse events | 0 / 181 | 0 / 164 |
| serious Total, serious adverse events | 0 / 181 | 0 / 164 |
Outcome results
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smartphone-enabled App for Linkage to Care | Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Linked to HIV care | 88 Participants |
| Smartphone-enabled App for Linkage to Care | Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Not linked | 93 Participants |
| Standard of Care | Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Linked to HIV care | 74 Participants |
| Standard of Care | Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Not linked | 90 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smartphone-enabled App for Linkage to Care | Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Linked to HIV care | 44 Participants |
| Smartphone-enabled App for Linkage to Care | Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Not linked | 39 Participants |
| Standard of Care | Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Linked to HIV care | 22 Participants |
| Standard of Care | Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) | Not linked | 47 Participants |