Trial Outcomes & Findings for CareConekta: A Smartphone App to Improve Engagement in HIV Care (NCT NCT03836625)
NCT ID: NCT03836625
Last Updated: 2023-02-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Baseline to End of Study (up to 2 years)
Results posted on
2023-02-01
Participant Flow
Participant milestones
| Measure |
Control
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
|
Overall Study
COMPLETED
|
84
|
89
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
| Measure |
Control
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
9
|
|
Overall Study
Investigator withdrawn at/near time of enrollment
|
6
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Refused follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=93 Participants
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=100 Participants
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.
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=93 Participants
|
31 years
n=100 Participants
|
32 years
n=193 Participants
|
|
Age, Customized
Age 18-24 years
|
10 Participants
n=93 Participants
|
14 Participants
n=100 Participants
|
24 Participants
n=193 Participants
|
|
Age, Customized
Age 25-29 years
|
22 Participants
n=93 Participants
|
21 Participants
n=100 Participants
|
43 Participants
n=193 Participants
|
|
Age, Customized
Age 30-34 years
|
29 Participants
n=93 Participants
|
39 Participants
n=100 Participants
|
68 Participants
n=193 Participants
|
|
Age, Customized
Age 35 years and older
|
32 Participants
n=93 Participants
|
26 Participants
n=100 Participants
|
58 Participants
n=193 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=93 Participants
|
100 Participants
n=100 Participants
|
193 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=193 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
93 Participants
n=93 Participants
|
100 Participants
n=100 Participants
|
193 Participants
n=193 Participants
|
|
Education
Never completed primary school
|
1 Participants
n=93 Participants
|
1 Participants
n=100 Participants
|
2 Participants
n=193 Participants
|
|
Education
Primary school only
|
5 Participants
n=93 Participants
|
3 Participants
n=100 Participants
|
8 Participants
n=193 Participants
|
|
Education
Some high school
|
50 Participants
n=93 Participants
|
54 Participants
n=100 Participants
|
104 Participants
n=193 Participants
|
|
Education
Completed high school
|
31 Participants
n=93 Participants
|
37 Participants
n=100 Participants
|
68 Participants
n=193 Participants
|
|
Education
Any tertiary education
|
6 Participants
n=93 Participants
|
5 Participants
n=100 Participants
|
11 Participants
n=193 Participants
|
|
Employment
Currently employed
|
34 Participants
n=93 Participants
|
42 Participants
n=100 Participants
|
76 Participants
n=193 Participants
|
|
Employment
Not currently employed
|
59 Participants
n=93 Participants
|
58 Participants
n=100 Participants
|
117 Participants
n=193 Participants
|
|
On antiretroviral therapy prior to first antenatal visit
No
|
25 Participants
n=93 Participants
|
20 Participants
n=100 Participants
|
45 Participants
n=193 Participants
|
|
On antiretroviral therapy prior to first antenatal visit
Yes
|
65 Participants
n=93 Participants
|
76 Participants
n=100 Participants
|
141 Participants
n=193 Participants
|
|
On antiretroviral therapy prior to first antenatal visit
Missing
|
3 Participants
n=93 Participants
|
4 Participants
n=100 Participants
|
7 Participants
n=193 Participants
|
|
Birthplace
Western Cape Province, South Africa
|
33 Participants
n=93 Participants
|
27 Participants
n=100 Participants
|
60 Participants
n=193 Participants
|
|
Birthplace
In South Africa, but not Western Cape Province
|
57 Participants
n=93 Participants
|
70 Participants
n=100 Participants
|
127 Participants
n=193 Participants
|
|
Birthplace
Outside of South Africa
|
3 Participants
n=93 Participants
|
3 Participants
n=100 Participants
|
6 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Control
n=84 Participants
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=89 Participants
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.
|
|---|---|---|
|
Mobility Prevalence
Traveled yes
|
30 Participants
|
24 Participants
|
|
Mobility Prevalence
Traveled no
|
54 Participants
|
65 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Study (up to 2 years)Population: Participants who reported travel (n=54)
Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.
Outcome measures
| Measure |
Control
n=30 Participants
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=24 Participants
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.
|
|---|---|---|
|
Median Number of Trips Per Person
|
1 trip
Interval 1.0 to 1.0
|
1 trip
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: Baseline to End of Study (up to 2 years)The number of participants who report using the same phone from enrollment at follow-up
Outcome measures
| Measure |
Control
n=84 Participants
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=89 Participants
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.
|
|---|---|---|
|
CareConekta Feasibility: Same Phone at Follow-up
No
|
31 Participants
|
33 Participants
|
|
CareConekta Feasibility: Same Phone at Follow-up
Yes
|
52 Participants
|
55 Participants
|
|
CareConekta Feasibility: Same Phone at Follow-up
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (up to 2 years)Population: Number of trips reported (n=60)
The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.
Outcome measures
| Measure |
Control
n=33 Trips
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=27 Trips
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.
|
|---|---|---|
|
Timing of Travel
Traveled before delivery
|
4 Trips
|
9 Trips
|
|
Timing of Travel
Traveled after delivery
|
29 Trips
|
18 Trips
|
SECONDARY outcome
Timeframe: Baseline to End of Study (up to 2 years)Population: Total number of trips per person, by study arm
Was the move permanent (yes/no)
Outcome measures
| Measure |
Control
n=33 Trips
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=27 Trips
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.
|
|---|---|---|
|
Permanent Move
Yes
|
5 Trips
|
1 Trips
|
|
Permanent Move
No
|
28 Trips
|
26 Trips
|
SECONDARY outcome
Timeframe: Baseline to End of Study (up to 2 years)Population: The total number of participants who completed follow-up (n=173)
The number of participants who disabled GPS during the study period
Outcome measures
| Measure |
Control
n=84 Participants
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=89 Participants
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.
|
|---|---|---|
|
CareConekta Feasibility: GPS Disabled During the Study Period
No
|
74 Participants
|
82 Participants
|
|
CareConekta Feasibility: GPS Disabled During the Study Period
Yes
|
8 Participants
|
5 Participants
|
|
CareConekta Feasibility: GPS Disabled During the Study Period
I don't know
|
1 Participants
|
1 Participants
|
|
CareConekta Feasibility: GPS Disabled During the Study Period
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (up to 2 years)Population: Total number of participants who completed follow-up (n=173)
The number of participants who reported sharing their phone with another person during the study period
Outcome measures
| Measure |
Control
n=84 Participants
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=89 Participants
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.
|
|---|---|---|
|
CareConekta Feasibility -- Participant Reported Sharing Phone
No
|
77 Participants
|
71 Participants
|
|
CareConekta Feasibility -- Participant Reported Sharing Phone
Yes
|
7 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (up to 2 years)Population: All participants who completed follow-up (n=173)
The number of participants who reported opening the CareConekta app at least once after enrollment visit
Outcome measures
| Measure |
Control
n=84 Participants
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=89 Participants
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.
|
|---|---|---|
|
CareConekta Feasibility -- Participant Ever Opened App
No
|
4 Participants
|
12 Participants
|
|
CareConekta Feasibility -- Participant Ever Opened App
Yes
|
80 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (up to 2 years)Population: Number of participants who reported opening app during study period (n=157)
The number of participants who reported using the CareConekta app to locate a new health facility.
Outcome measures
| Measure |
Control
n=80 Participants
The control arm will receive standard CareConekta, which will track their mobility with no additional features.
|
Intervention
n=77 Participants
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.
|
|---|---|---|
|
CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities
No
|
69 Participants
|
68 Participants
|
|
CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities
Yes
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 months after deliveryThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeks after delivery, study endThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after deliveryIn 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeks after delivery, study endIn 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.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place