HIV/AIDSNCT03157908
CareConekta: A Pilot Study of a Smartphone App in South Africa
A study testing CareConekta in people with HIV/AIDS, run by Vanderbilt University Medical Center at 1 site in South Africa.
Trial summary
Population mobility is frequent in South Africa and disrupts the continuity of HIV care. Postpartum, HIV-positive women are at elevated risk of dropping out of HIV care and are highly mobile. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- CareConekta
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Jul 2017to 18 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to enroll and provide written informed consent
- ≥18 years old
- HIV-positive
- Pregnant (>36 weeks gestation)
- Able to read basic written English
- Currently own a smartphone that meets the technical requirements
- Willing to opt-in to installation of the app on her personal phone and to mobility tracking
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Acceptability and Feasibility of a Smartphone App to Improve Retention in Postpartum HIV Care in South Africa
Population mobility is frequent in South Africa and disrupts the continuity of HIV care. Postpartum, HIV-positive women are at elevated risk of dropping out of HIV care and are highly mobile. This pilot study aims to engage peripartum, HIV-positive women as potential users to evaluate a novel smartphone application to assist these women with linkage to new HIV facilities and prospectively describe the mobility of this population.
Read the detailed description
South Africa is home to the world's largest antiretroviral therapy (ART) program, but sustaining high retention along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is frequent in South Africa and mobility likely disrupts retention in HIV care. In the absence of a facility-linked national electronic health data system, clinic switching as unreported transfers also obscures the true magnitude of loss to follow-up, hindering national evaluation efforts. Postpartum women in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile, partly due to cultural traditions of returning to one's rural home after giving birth. To address these challenges to retention in care, the investigators will enroll 30 peripartum, HIV-positive women as potential users to assess the acceptability and feasibility of deploying in a real-world setting a novel mHealth application to improve retention in HIV care. The app will operate on users' own smartphones and will serve two primary functions: 1) as a service tool to inform postpartum, HIV-positive women of ART services in their area so that they may access continued HIV care, even while traveling, and 2) as a research tool to prospectively characterize travel and mobility patterns of these women. During this pilot study, women will be passively followed for 90 days following app installation at enrollment. After 90 days, they will be interviewed to determine acceptability and feasibility, and electronic user data will be analyzed. This information will be used to develop an app poised for nationwide adoption. The research team comprises leaders in the study of HIV implementation science, maternal/child health and biomedical informatics, with experience designing effective mobile health (mHealth) interventions in low-resources settings. This pilot study aims to engage potential users to test a smartphone application that both improves linkage to HIV care and provides essential research data to inform future health system strengthening efforts.
- Conditions
- HIV/AIDS
- Being tested
- CareConekta
- Keywords
- South Africa, Retention in care, Pregnancy, Mobile health
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareConektaDevice
CareConekta is a smartphone app developed in parallel with a series of focus group discussions that uses global positioning system (GPS) data to identify the user's location to meet two primary functions: (1) to allow the participant to locate ART facilities in South Africa that are near her current location, and (2) to trace mobility prospectively.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone app | Experimental | All participants in this pilot study will install the smartphone app for testing Receives: Device: CareConekta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility questionnaire
Feasibility will be assessed via a face-to-face questionnaire to address the following questions:
- What proportion of women eligible to participate chooses to participate in the study?
- Are participants able to install the app on their phones?
- How does real-world access to the internet affect the use of the app?
- When is the optimal time for the participant to receive a notification?
- How many notifications are sent?
- What unexpected problems occurred?
- What are the general usage patterns of the app?
Measured: 3 months
Acceptability questionnaire
Acceptability will be assessed via a face-to-face questionnaire to address the following questions:
- Do women find the app helpful?
- How frequently do women engage with the app and under what circumstances?
- Do women report that they think such an app should be offered to other pregnant women? What about to non-pregnant adults?
- Are there other services that participants would like to see included on future version of the app?
- Do women like the notifications?
Measured: 3 months
Secondary outcomes (2)
Medical record review to assess potential efficacy
The investigators will assess paper and electronic medical records to assess if the receipt of a notification results in linkage to a facility, as recorded through self-report and patient records.
Measured: 3 months
Spatial analysis of GPS data
The investigators will analyze the GPS data collected in during the pilot study to determine the characteristics of peripartum women's mobility patterns.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start12 Jul 2017
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Kate Clouse, Vanderbilt University Medical Center
- Investigators
- Kate Clouse, PhD, MPH, Principal investigator, Vanderbilt University Medical CenterTamsin K Phillips, MPH, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157908
- Sponsor's protocol ID
- 170510
- Status last verified
- Jan 2018
- First submitted
- 15 May 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Acceptability and Feasibility of a Smartphone App to Improve Retention in Postpartum HIV Care in South Africa
- ClinicalTrials.gov ID
- NCT03157908
- Acronym / sponsor ID
- 170510
- Conditions
- HIV/AIDS
- Keywords
- South Africa, Retention in care, Pregnancy, Mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Population mobility is frequent in South Africa and disrupts the continuity of HIV care. Postpartum, HIV-positive women are at elevated risk of dropping out of HIV care and are highly mobile. This pilot study aims to engage peripartum, HIV-positive women as potential users to evaluate a novel smartphone application to assist these women with linkage to new HIV facilities and prospectively describe the mobility of this population.
Detailed description
South Africa is home to the world's largest antiretroviral therapy (ART) program, but sustaining high retention along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is frequent in South Africa and mobility likely disrupts retention in HIV care. In the absence of a facility-linked national electronic health data system, clinic switching as unreported transfers also obscures the true magnitude of loss to follow-up, hindering national evaluation efforts. Postpartum women in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile, partly due to cultural traditions of returning to one's rural home after giving birth. To address these challenges to retention in care, the investigators will enroll 30 peripartum, HIV-positive women as potential users to assess the acceptability and feasibility of deploying in a real-world setting a novel mHealth application to improve retention in HIV care. The app will operate on users' own smartphones and will serve two primary functions: 1) as a service tool to inform postpartum, HIV-positive women of ART services in their area so that they may access continued HIV care, even while traveling, and 2) as a research tool to prospectively characterize travel and mobility patterns of these women. During this pilot study, women will be passively followed for 90 days following app installation at enrollment. After 90 days, they will be interviewed to determine acceptability and feasibility, and electronic user data will be analyzed. This information will be used to develop an app poised for nationwide adoption. The research team comprises leaders in the study of HIV implementation science, maternal/child health and biomedical informatics, with experience designing effective mobile health (mHealth) interventions in low-resources settings. This pilot study aims to engage potential users to test a smartphone application that both improves linkage to HIV care and provides essential research data to inform future health system strengthening efforts.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Smartphone app | Experimental | Device: CareConektaAll participants in this pilot study will install the smartphone app for testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to enroll and provide written informed consent
- ≥18 years old
- HIV-positive
- Pregnant (>36 weeks gestation)
- Able to read basic written English
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareConektaCareConekta is a smartphone app developed in parallel with a series of focus group discussions that uses global positioning system (GPS) data to identify the user's location to meet two primary functions: (1) to allow the participant to locate ART facilities in South Africa that are near her current location, and (2) to trace mobility prospectively. | Device | Smartphone app |
Primary outcome
Feasibility questionnaire
Time frame: 3 months
Feasibility will be assessed via a face-to-face questionnaire to address the following questions: * What proportion of women eligible to participate chooses to participate in the study? * Are participants able to install the app on their phones? * How does real-world access to the internet affect the use of the app? * When is the optimal time for the participant to receive a notification? * How many notifications are sent? * What unexpected problems occurred? * What are the general usage patterns of the app?
Acceptability questionnaire
Time frame: 3 months
Acceptability will be assessed via a face-to-face questionnaire to address the following questions: * Do women find the app helpful? * How frequently do women engage with the app and under what circumstances? * Do women report that they think such an app should be offered to other pregnant women? What about to non-pregnant adults? * Are there other services that participants would like to see included on future version of the app? * Do women like the notifications?
2 secondary outcomes
Medical record review to assess potential efficacy
Time frame: 3 months
Spatial analysis of GPS data
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Clouse, PhD, MPH principal investigator
Vanderbilt University Medical Center
Tamsin K Phillips, MPH principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareConekta in people with HIV/AIDS, run by Vanderbilt University Medical Center at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility questionnaire (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.