An interventional study of Smartphone application and Smartphone in HIV Infections, Viral Load and Patient Compliance, sponsored by World Bank. Completed at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-24.
Sponsored by World Bank · Not applicable, Interventional, and Supportive care
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 353 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →World Bank is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.
Other: Smartphone application · Device: Smartphone
Participants in this arm are randomised to receive standard of care services.
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.
Also known as: App, Customised smartphone app
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
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
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.
| Milestone | Smartphone-enabled App for Linkage to Care | Standard of Care |
|---|---|---|
| Started | 181 | 172 |
| Completed | 181 | 164 |
| Not completed | 0 | 8 |
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.
| Participants | Smartphone-enabled App for Linkage to Care | Standard of Care |
|---|---|---|
| Linked to HIV care | 88 | 74 |
| Not linked | 93 | 90 |
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.
| Participants | Smartphone-enabled App for Linkage to Care | Standard of Care |
|---|---|---|
| Linked to HIV care | 44 | 22 |
| Not linked | 39 | 47 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Smartphone-enabled App for Linkage to Care | 0/181 (0%) | 0/181 (0%) | 0/181 (0%) |
| Standard of Care | 0/164 (0%) | 0/164 (0%) | 0/164 (0%) |
35% of the participants were male and 44% were aged 18-29 years. 48% of participants were employed full time and 96% had at least attended secondary school. 57% were South Africa born and 36% Zimbabwean. The 2 trial arms were well balanced for these participants' characteristics.
| Age, Categorical(Participants) | Smartphone-enabled App for Linkage to Care | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 181 | 164 | 345 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Smartphone-enabled App for Linkage to Care | Standard of Care | Total |
|---|---|---|---|
| Female | 121 | 103 | 224 |
| Male | 60 | 61 | 121 |
| Race and Ethnicity Not Collected(Participants) | Smartphone-enabled App for Linkage to Care | Standard of Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Smartphone-enabled App for Linkage to Care | Standard of Care | Total |
|---|---|---|---|
| South Africa | 181 | 164 | 345 |
| Country of birth(Participants) | Smartphone-enabled App for Linkage to Care | Standard of Care | Total |
|---|---|---|---|
| Count of participants | 181 | 164 | 345 |
| Education level(Participants) | Smartphone-enabled App for Linkage to Care | Standard of Care | Total |
|---|---|---|---|
| Primary only | 8 | 6 | 14 |
| Some secondary school | 51 | 44 | 95 |
| Completed secondary school | 98 | 85 | 183 |
| Attended/completed tertiary | 24 | 29 | 53 |
| Employment status(Participants) | Smartphone-enabled App for Linkage to Care | Standard of Care | Total |
|---|---|---|---|
| Full time | 82 | 79 | 161 |
| Part time | 37 | 22 | 59 |
| Unemployed | 49 | 40 | 89 |
| Self-employed | 10 | 16 | 26 |
| Student | 3 | 7 | 10 |
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