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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH118028 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Cape Town | OTHER |
| University of California, San Francisco | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareConekta | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | Baseline to End of Study (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Timing of Travel | The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire. | Baseline to End of Study (up to 2 years) |
| Permanent Move |
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Inclusion Criteria:
Exclusion Criteria:
We will enroll only pregnant women.
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| Name | Affiliation | Role |
|---|---|---|
| Kate Clouse, PhD, MPH | Vanderbilt University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gugulethu Community Health Centre | Cape Town | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37347521 | Derived | 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. | |
| 37204838 | Derived | 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. |
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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.
Anytime, by request
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control arm will receive standard CareConekta, which will track their mobility with no additional features. |
| FG001 | Intervention | 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. CareConekta: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total excludes 7 participants withdrawn by investigators at/soon after enrollment. Data were not included in analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control arm will receive standard CareConekta, which will track their mobility with no additional features. |
| BG001 | Intervention | 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. CareConekta: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants who reported travel during the study period (defined as 3 or more nights away from home) | Posted | Count of Participants | Participants | Baseline to End of Study (up to 2 years) |
|
Throughout study period, median duration = 7.4 months
Adverse events were reported per IRB and sponsor guidelines.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control arm will receive standard CareConekta, which will track their mobility with no additional features. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Clouse | Vanderbilt University | (615) 343-5351 | kate.clouse@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2020 | Oct 27, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Was the move permanent (yes/no)
| 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 | 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 | 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 | 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. | 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. | 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. | 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). | 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. | 10 weeks after delivery, study end |
| 36414286 | Derived | 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. |
| 32164771 | Derived | 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. |
| Death |
|
| Refused follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
|
| On antiretroviral therapy prior to first antenatal visit | Count of Participants | Participants |
|
| Birthplace | Count of Participants | Participants |
|
|
|
| Primary | 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. | Participants who reported travel (n=54) | Posted | Median | Inter-Quartile Range | trip | Baseline to End of Study (up to 2 years) |
|
|
|
| Primary | CareConekta Feasibility: Same Phone at Follow-up | The number of participants who report using the same phone from enrollment at follow-up | Posted | Count of Participants | Participants | Baseline to End of Study (up to 2 years) |
|
|
|
| Secondary | Timing of Travel | The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire. | Number of trips reported (n=60) | Posted | Count of Units | Trips | Baseline to End of Study (up to 2 years) | Trips | Trips |
|
|
|
| Secondary | Permanent Move | Was the move permanent (yes/no) | Total number of trips per person, by study arm | Posted | Count of Units | Trips | Baseline to End of Study (up to 2 years) | Trips | Trips |
|
|
|
| Secondary | CareConekta Feasibility: GPS Disabled During the Study Period | The number of participants who disabled GPS during the study period | The total number of participants who completed follow-up (n=173) | Posted | Count of Participants | Participants | Baseline to End of Study (up to 2 years) |
|
|
|
| Secondary | CareConekta Feasibility -- Participant Reported Sharing Phone | The number of participants who reported sharing their phone with another person during the study period | Total number of participants who completed follow-up (n=173) | Posted | Count of Participants | Participants | Baseline to End of Study (up to 2 years) |
|
|
|
| Secondary | CareConekta Feasibility -- Participant Ever Opened App | The number of participants who reported opening the CareConekta app at least once after enrollment visit | All participants who completed follow-up (n=173) | Posted | Count of Participants | Participants | Baseline to End of Study (up to 2 years) |
|
|
|
| Secondary | 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. | Number of participants who reported opening app during study period (n=157) | Posted | Count of Participants | Participants | Baseline to End of Study (up to 2 years) |
|
|
|
| Secondary | 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. | Not Posted | 6 months after delivery | Participants |
| Secondary | 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. | Not Posted | 10 weeks after delivery, study end | Participants |
| Secondary | 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). | Not Posted | 6 months after delivery | Participants |
| Secondary | 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. | Not Posted | 10 weeks after delivery, study end | Participants |
| 0 |
| 93 |
| 0 |
| 93 |
| 0 |
| 93 |
| EG001 | Intervention | 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. CareConekta: 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. | 1 | 100 | 0 | 100 | 0 | 100 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Missing |
|
| I don't know |
|
| Missing |
|