HIV/AIDSNCT03836625

CareConekta: A Smartphone App to Improve Engagement in HIV Care

A study testing CareConekta in people with HIV/AIDS and Pregnancy Related, run by Vanderbilt University at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: HIV/AIDS, Pregnancy Related
What is being tested?: CareConekta
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteSouth Africa
Study dates: 9 Dec 2019to 30 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

We will only enroll participants attending the Gugulethu Community Health Centre, near Cape Town, South Africa
HIV-positive
adult (≥18 years)
pregnant (≥28 weeks)
own a smartphone that meets the technical requirements
willing to opt-in to installation of CareConekta on her personal phone and to mobility tracking
demonstrate the ability to read simple text language
willing to be randomized

Who cannot join

If an interested participant meets all of the inclusion criteria, there are no additional exclusion criteria

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Gugulethu Community Health Centre
Cape Town

Other trials in South Africa

About this study

Official title: CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa

Population mobility is common in South Africa, but important research gaps exist describing this mobility and its impact on engagement in HIV care, particularly among pregnant and postpartum women. Through this study, the investigators propose to test a smartphone application - CareConekta - to conduct essential formative work on mobility and evaluate this app as an intervention to facilitate engagement in HIV care during times of mobility. This work is critical to adapting CareConekta for widespread use, providing critical information about mobility during the peripartum period and the impact on engagement in HIV care, and piloting this intervention to improve engagement.

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 common in South Africa, but important research gaps exist describing this mobility and its impact on engagement in HIV care. Postpartum women and their infants in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile. The investigators recently developed a beta version of a smartphone application (app) - CareConekta - that detects a user's smartphone location to allow for prospective characterization of mobility. Through this three-year study, the investigators propose to test CareConekta to conduct essential formative work on mobility and evaluate an intervention - the CareConekta app plus text notifications and optional staff phone calls and/or WhatsApp messages - to facilitate engagement in HIV care during times of mobility. After first adapting CareConekta to use appropriate smartphone technology for the local population, the investigators will characterize mobility among South African women during the peripartum period and its impact on engagement in HIV care. The investigators also will evaluate the acceptability, feasibility, and initial efficacy of using CareConekta as an intervention to improve engagement in HIV care. The investigators will work with a South African technology company with a strong connection to the South African Department of Health to adapt the app prior to enrolling study participants. The study will observe mobility within an observational cohort and will then assess the impact of the intervention among participants who travel during the study period. This work is critical to adapting an existing app for widespread use, providing critical information about mobility during the peripartum period and the impact on engagement in HIV care, and piloting an intervention to improve engagement. This study will lay the necessary groundwork for a larger efficacy trial of the intervention within different geographic settings.

Conditions: HIV/AIDS, Pregnancy Related
Being tested: CareConekta
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.

CareConektaOther
CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.

Study groups in NCT03836625
Study group	Role	What they receive
Control	No intervention	The control arm will receive standard CareConekta, which will track their mobility with no additional features.
Intervention	Experimental	The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled >50 km from the study site for >7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested. Receives: Other: CareConekta

What is being measured

The primary outcome is the main question the study is designed to answer.

Mobility Prevalence
The investigators will report the number of participants who travel during the study period (defined as 3 or more nights away from home), over the denominator of all participants who completed follow-up.
Measured: Baseline to End of Study (up to 2 years)
Median Number of Trips Per Person
Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.
Measured: Baseline to End of Study (up to 2 years)
CareConekta Feasibility: Same Phone at Follow-up
The number of participants who report using the same phone from enrollment at follow-up
Measured: Baseline to End of Study (up to 2 years)

Secondary outcomes (10)

Timing of Travel
The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.
Measured: Baseline to End of Study (up to 2 years)
Permanent Move
Was the move permanent (yes/no)
Measured: Baseline to End of Study (up to 2 years)
CareConekta Feasibility: GPS Disabled During the Study Period
The number of participants who disabled GPS during the study period
Measured: Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Reported Sharing Phone
The number of participants who reported sharing their phone with another person during the study period
Measured: Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Ever Opened App
The number of participants who reported opening the CareConekta app at least once after enrollment visit
Measured: Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities
The number of participants who reported using the CareConekta app to locate a new health facility.
Measured: Baseline to End of Study (up to 2 years)
CareConekta Initial Efficacy -- Maternal Engagement in HIV Care
The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and maternal retention in care and viral suppression 6 months after delivery.
Measured: 6 months after delivery
CareConekta Initial Efficacy -- Infant Outcomes
The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and vertical HIV transmission and completion of 10-week infant HIV PCR test.
Measured: 10 weeks after delivery, study end
Impact of Mobility -- Maternal Engagement in HIV Care
In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and engagement in HIV care for the mother (defined as retention in care and viral suppression six months after delivery).
Measured: 6 months after delivery
Impact of Mobility -- Infant Outcomes
In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and completion of routine early infant diagnosis.
Measured: 10 weeks after delivery, study end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 201930 Nov 2021

First posted11 Feb 2019
Study start9 Dec 2019
Primary completion30 Nov 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03836625
Sponsor's protocol ID: 181640
Other IDs: R34MH118028
Status last verified: Jan 2023
First submitted: 22 Jan 2019
Last updated: 1 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified datasets will be made available by request, subject to agreement to (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology and established security measures; (3) a plan for the dissemination of results; (4) appropriate authorship and recognition of all partners; and (5) a commitment to destroy or return the data after analyses are completed.

Publications

Noholoza S, Phillips TK, Madwayi S, Mrubata M, Camlin CS, Myer L, Clouse K. Smartphone Ownership and Usage Among Pregnant Women Living With HIV in South Africa: Secondary Analysis of CareConekta Trial Data. JMIR Form Res. 2023 Jun 22;7:e43855. doi: 10.2196/43855.
PubMed 37347521
Clouse K, Noholoza S, Madwayi S, Mrubata M, Camlin CS, Myer L, Phillips TK. The Implementation of a GPS-Based Location-Tracking Smartphone App in South Africa to Improve Engagement in HIV Care: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 May 19;11:e44945. doi: 10.2196/44945.
PubMed 37204838
Clouse K, Noholoza S, Ngcobo N, Madwayi S, Mrubata M, Camlin CS, Myer L, Phillips TK. Cohort profile: CareConekta: a pilot study of a smartphone application to improve engagement in postpartum HIV care in South Africa. BMJ Open. 2022 Nov 22;12(11):e064946. doi: 10.1136/bmjopen-2022-064946.
PubMed 36414286
Clouse K, Phillips TK, Camlin C, Noholoza S, Mogoba P, Naidoo J, Langford R, Weiss M, Seebregts CJ, Myer L. CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa. Trials. 2020 Mar 12;21(1):258. doi: 10.1186/s13063-020-4190-x.
PubMed 32164771

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa
ClinicalTrials.gov ID: NCT03836625
Acronym / sponsor ID: 181640
Conditions: HIV/AIDS, Pregnancy Related
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: University of Cape Town, University of California, San Francisco, National Institute of Mental Health (NIMH)
Study start: 9 Dec 2019 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 11 Feb 2019 (actual)
Results: Posted 1 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–The control arm will receive standard CareConekta, which will track their mobility with no additional features.
Intervention	Experimental	Other: CareConektaThe intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled >50 km from the study site for >7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

We will only enroll participants attending the Gugulethu Community Health Centre, near Cape Town, South Africa
HIV-positive
adult (≥18 years)
pregnant (≥28 weeks)
own a smartphone that meets the technical requirements

Key exclusion criteria (1 listed)

If an interested participant meets all of the inclusion criteria, there are no additional exclusion criteria

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 that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.	Other	Intervention

Primary outcome

Mobility Prevalence
Time frame: Baseline to End of Study (up to 2 years)
The investigators will report the number of participants who travel during the study period (defined as 3 or more nights away from home), over the denominator of all participants who completed follow-up.
Median Number of Trips Per Person
Time frame: Baseline to End of Study (up to 2 years)
Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.
CareConekta Feasibility: Same Phone at Follow-up
Time frame: Baseline to End of Study (up to 2 years)
The number of participants who report using the same phone from enrollment at follow-up

10 secondary outcomes

Timing of Travel
Time frame: Baseline to End of Study (up to 2 years)
Permanent Move
Time frame: Baseline to End of Study (up to 2 years)
CareConekta Feasibility: GPS Disabled During the Study Period
Time frame: Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Reported Sharing Phone
Time frame: Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Ever Opened App
Time frame: Baseline to End of Study (up to 2 years)
CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities
Time frame: Baseline to End of Study (up to 2 years)
CareConekta Initial Efficacy -- Maternal Engagement in HIV Care
Time frame: 6 months after delivery
CareConekta Initial Efficacy -- Infant Outcomes
Time frame: 10 weeks after delivery, study end
Impact of Mobility -- Maternal Engagement in HIV Care
Time frame: 6 months after delivery
Impact of Mobility -- Infant Outcomes
Time frame: 10 weeks after delivery, study end

Results and safety

Results posted to the registry on 1 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	99	84
Intervention	101	89

Primary outcome: Mobility Prevalence

Time frame: Baseline to End of Study (up to 2 years). Count of participants. Unit: Participants

Measure	Control n = 84	Intervention n = 89
Traveled yes	30	24
Traveled no	54	65

Population analysed: The number of participants who reported travel during the study period (defined as 3 or more nights away from home)

Primary outcome: Median Number of Trips Per Person

Time frame: Baseline to End of Study (up to 2 years). Median (Inter-Quartile Range). Unit: trip

Measure	Control n = 30	Intervention n = 24
Value	1 (1 to 1)	1 (1 to 1)

Population analysed: Participants who reported travel (n=54)

Primary outcome: CareConekta Feasibility: Same Phone at Follow-up

Time frame: Baseline to End of Study (up to 2 years). Count of participants. Unit: Participants

Measure	Control n = 84	Intervention n = 89
No	31	33
Yes	52	55
Missing	1	1

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout study period, median duration = 7.4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 93 (0%)	0 of 93 (0%)	0 of 93
Intervention	0 of 100 (0%)	0 of 100 (0%)	1 of 100

Limitations and caveats (from the sponsor): We found that several key challenges impeded our study feasibility. The primary challenge is that during the study period, no participant's smartphone recorded at least one heartbeat per day.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37347521Noholoza S, Phillips TK, Madwayi S, Mrubata M, Camlin CS, Myer L, Clouse K. Smartphone Ownership and Usage Among Pregnant Women Living With HIV in South Africa: Secondary Analysis of CareConekta Trial Data. JMIR Form Res. 2023 Jun 22;7:e43855. doi: 10.2196/43855.
Derived from this study: PubMed 37204838Clouse K, Noholoza S, Madwayi S, Mrubata M, Camlin CS, Myer L, Phillips TK. The Implementation of a GPS-Based Location-Tracking Smartphone App in South Africa to Improve Engagement in HIV Care: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 May 19;11:e44945. doi: 10.2196/44945.
Derived from this study: PubMed 36414286Clouse K, Noholoza S, Ngcobo N, Madwayi S, Mrubata M, Camlin CS, Myer L, Phillips TK. Cohort profile: CareConekta: a pilot study of a smartphone application to improve engagement in postpartum HIV care in South Africa. BMJ Open. 2022 Nov 22;12(11):e064946. doi: 10.1136/bmjopen-2022-064946.
Derived from this study: PubMed 32164771Clouse K, Phillips TK, Camlin C, Noholoza S, Mogoba P, Naidoo J, Langford R, Weiss M, Seebregts CJ, Myer L. CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa. Trials. 2020 Mar 12;21(1):258. doi: 10.1186/s13063-020-4190-x.
Individual participant dataSharing planned: Yes. De-identified datasets will be made available by request, subject to agreement to (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology and established security measures; (3) a plan for the dissemination of results; (4) appropriate authorship and recognition of all partners; and (5) a commitment to destroy or return the data after analyses are completed.

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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 School of Nursing

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 and Pregnancy Related, run by Vanderbilt University 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 8 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 1 Feb 2023. 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?

Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mobility Prevalence (time frame: Baseline to End of Study (up to 2 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03836625, which also lists 4 linked publications.

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 1 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.