HIV/AIDS, Pregnancy Related
Conditions
Brief summary
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.
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.
Interventions
OTHERCareConekta
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.
Sponsors
University of Cape Town
University of California, San Francisco
National Institute of Mental Health (NIMH)
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. We will only enroll participants attending the Gugulethu Community Health Centre, near Cape Town, South Africa 2. HIV-positive 3. adult (≥18 years) 4. pregnant (≥28 weeks) 5. own a smartphone that meets the technical requirements 6. willing to opt-in to installation of CareConekta on her personal phone and to mobility tracking 7. demonstrate the ability to read simple text language 8. willing to be randomized
Exclusion criteria
* If an interested participant meets all of the inclusion criteria, there are no additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mobility Prevalence | 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 | 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 | Baseline to End of Study (up to 2 years) | The number of participants who report using the same phone from enrollment at follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Permanent Move | Baseline to End of Study (up to 2 years) | Was the move permanent (yes/no) |
| CareConekta Feasibility: GPS Disabled During the Study Period | Baseline to End of Study (up to 2 years) | The number of participants who disabled GPS during the study period |
| CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities | Baseline to End of Study (up to 2 years) | The number of participants who reported using the CareConekta app to locate a new health facility. |
| CareConekta Feasibility -- Participant Reported Sharing Phone | Baseline to End of Study (up to 2 years) | The number of participants who reported sharing their phone with another person during the study period |
| CareConekta Initial Efficacy -- Infant Outcomes | 10 weeks after delivery, study end | 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. |
| Impact of Mobility -- Maternal Engagement in HIV Care | 6 months after delivery | 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). |
| Impact of Mobility -- Infant Outcomes | 10 weeks after delivery, study end | 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. |
| CareConekta Initial Efficacy -- Maternal Engagement in HIV Care | 6 months after delivery | 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. |
| CareConekta Feasibility -- Participant Ever Opened App | Baseline to End of Study (up to 2 years) | The number of participants who reported opening the CareConekta app at least once after enrollment visit |
| Timing of Travel | Baseline to End of Study (up to 2 years) | The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control The control arm will receive standard CareConekta, which will track their mobility with no additional features. | 93 |
| 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. | 100 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Investigator withdrawn at/near time of enrollment | 6 | 1 |
| Overall Study | Lost to Follow-up | 9 | 9 |
| Overall Study | Refused follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 31 years | 32 years | 32 years |
| Age, Customized Age 18-24 years | 14 Participants | 10 Participants | 24 Participants |
| Age, Customized Age 25-29 years | 21 Participants | 22 Participants | 43 Participants |
| Age, Customized Age 30-34 years | 39 Participants | 29 Participants | 68 Participants |
| Age, Customized Age 35 years and older | 26 Participants | 32 Participants | 58 Participants |
| Birthplace In South Africa, but not Western Cape Province | 70 Participants | 57 Participants | 127 Participants |
| Birthplace Outside of South Africa | 3 Participants | 3 Participants | 6 Participants |
| Birthplace Western Cape Province, South Africa | 27 Participants | 33 Participants | 60 Participants |
| Education Any tertiary education | 5 Participants | 6 Participants | 11 Participants |
| Education Completed high school | 37 Participants | 31 Participants | 68 Participants |
| Education Never completed primary school | 1 Participants | 1 Participants | 2 Participants |
| Education Primary school only | 3 Participants | 5 Participants | 8 Participants |
| Education Some high school | 54 Participants | 50 Participants | 104 Participants |
| Employment Currently employed | 42 Participants | 34 Participants | 76 Participants |
| Employment Not currently employed | 58 Participants | 59 Participants | 117 Participants |
| On antiretroviral therapy prior to first antenatal visit Missing | 4 Participants | 3 Participants | 7 Participants |
| On antiretroviral therapy prior to first antenatal visit No | 20 Participants | 25 Participants | 45 Participants |
| On antiretroviral therapy prior to first antenatal visit Yes | 76 Participants | 65 Participants | 141 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Africa | 100 Participants | 93 Participants | 193 Participants |
| Sex: Female, Male Female | 100 Participants | 93 Participants | 193 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 1 / 100 |
| other Total, other adverse events | 0 / 93 | 0 / 100 |
| serious Total, serious adverse events | 0 / 93 | 0 / 100 |
Outcome results
Primary
CareConekta Feasibility: Same Phone at Follow-up
The number of participants who report using the same phone from enrollment at follow-up
Time frame: Baseline to End of Study (up to 2 years)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | CareConekta Feasibility: Same Phone at Follow-up | No | 31 Participants |
| Control | CareConekta Feasibility: Same Phone at Follow-up | Yes | 52 Participants |
| Control | CareConekta Feasibility: Same Phone at Follow-up | Missing | 1 Participants |
| Intervention | CareConekta Feasibility: Same Phone at Follow-up | No | 33 Participants |
| Intervention | CareConekta Feasibility: Same Phone at Follow-up | Yes | 55 Participants |
| Intervention | CareConekta Feasibility: Same Phone at Follow-up | Missing | 1 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.
Time frame: Baseline to End of Study (up to 2 years)
Population: Participants who reported travel (n=54)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Median Number of Trips Per Person | 1 trip |
| Intervention | Median Number of Trips Per Person | 1 trip |
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.
Time frame: Baseline to End of Study (up to 2 years)
Population: The number of participants who reported travel during the study period (defined as 3 or more nights away from home)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Mobility Prevalence | Traveled no | 54 Participants |
| Control | Mobility Prevalence | Traveled yes | 30 Participants |
| Intervention | Mobility Prevalence | Traveled no | 65 Participants |
| Intervention | Mobility Prevalence | Traveled yes | 24 Participants |
Secondary
CareConekta Feasibility: GPS Disabled During the Study Period
The number of participants who disabled GPS during the study period
Time frame: Baseline to End of Study (up to 2 years)
Population: The total number of participants who completed follow-up (n=173)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | CareConekta Feasibility: GPS Disabled During the Study Period | No | 74 Participants |
| Control | CareConekta Feasibility: GPS Disabled During the Study Period | I don't know | 1 Participants |
| Control | CareConekta Feasibility: GPS Disabled During the Study Period | Yes | 8 Participants |
| Control | CareConekta Feasibility: GPS Disabled During the Study Period | Missing | 1 Participants |
| Intervention | CareConekta Feasibility: GPS Disabled During the Study Period | Yes | 5 Participants |
| Intervention | CareConekta Feasibility: GPS Disabled During the Study Period | No | 82 Participants |
| Intervention | CareConekta Feasibility: GPS Disabled During the Study Period | Missing | 1 Participants |
| Intervention | CareConekta Feasibility: GPS Disabled During the Study Period | I don't know | 1 Participants |
Secondary
CareConekta Feasibility -- Participant Ever Opened App
The number of participants who reported opening the CareConekta app at least once after enrollment visit
Time frame: Baseline to End of Study (up to 2 years)
Population: All participants who completed follow-up (n=173)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | CareConekta Feasibility -- Participant Ever Opened App | No | 4 Participants |
| Control | CareConekta Feasibility -- Participant Ever Opened App | Yes | 80 Participants |
| Intervention | CareConekta Feasibility -- Participant Ever Opened App | No | 12 Participants |
| Intervention | CareConekta Feasibility -- Participant Ever Opened App | Yes | 77 Participants |
Secondary
CareConekta Feasibility -- Participant Reported Sharing Phone
The number of participants who reported sharing their phone with another person during the study period
Time frame: Baseline to End of Study (up to 2 years)
Population: Total number of participants who completed follow-up (n=173)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | CareConekta Feasibility -- Participant Reported Sharing Phone | No | 77 Participants |
| Control | CareConekta Feasibility -- Participant Reported Sharing Phone | Yes | 7 Participants |
| Intervention | CareConekta Feasibility -- Participant Reported Sharing Phone | No | 71 Participants |
| Intervention | CareConekta Feasibility -- Participant Reported Sharing Phone | Yes | 18 Participants |
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.
Time frame: Baseline to End of Study (up to 2 years)
Population: Number of participants who reported opening app during study period (n=157)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities | No | 69 Participants |
| Control | CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities | Yes | 11 Participants |
| Intervention | CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities | No | 68 Participants |
| Intervention | CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities | Yes | 9 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.
Time frame: 10 weeks after delivery, study end
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.
Time frame: 6 months after delivery
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.
Time frame: 10 weeks after delivery, study end
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).
Time frame: 6 months after delivery
Secondary
Permanent Move
Was the move permanent (yes/no)
Time frame: Baseline to End of Study (up to 2 years)
Population: Total number of trips per person, by study arm
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | Permanent Move | Yes | 5 Trips |
| Control | Permanent Move | No | 28 Trips |
| Intervention | Permanent Move | Yes | 1 Trips |
| Intervention | Permanent Move | No | 26 Trips |
Secondary
Timing of Travel
The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.
Time frame: Baseline to End of Study (up to 2 years)
Population: Number of trips reported (n=60)
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | Timing of Travel | Traveled before delivery | 4 Trips |
| Control | Timing of Travel | Traveled after delivery | 29 Trips |
| Intervention | Timing of Travel | Traveled before delivery | 9 Trips |
| Intervention | Timing of Travel | Traveled after delivery | 18 Trips |