Trial Outcomes & Findings for Mobile-Based Application "MyChoices" (NCT NCT03179319)
NCT ID: NCT03179319
Last Updated: 2020-12-16
Results Overview
System Usability Scale: a validated scale that assesses subjective usability of a system, or, in this case, an app. The System Usability Scale consists of a 10 item questionnaire with five response options; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the app is acceptable, and a score above 68 is considered above average.
COMPLETED
NA
60 participants
3 months
2020-12-16
Participant Flow
Participant milestones
| Measure |
MyChoices
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
3 Month Visit
|
37
|
20
|
|
Overall Study
COMPLETED
|
34
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
MyChoices
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
Baseline Characteristics
Mobile-Based Application "MyChoices"
Baseline characteristics by cohort
| Measure |
MyChoices
n=40 Participants
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
n=20 Participants
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.25 years
STANDARD_DEVIATION 2.08 • n=5 Participants
|
21.95 years
STANDARD_DEVIATION 2.26 • n=7 Participants
|
21.48 years
STANDARD_DEVIATION 2.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Boston, MA
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Bronx, NY
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Chapel Hill, NC
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome; One person had missing data for this item.
System Usability Scale: a validated scale that assesses subjective usability of a system, or, in this case, an app. The System Usability Scale consists of a 10 item questionnaire with five response options; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the app is acceptable, and a score above 68 is considered above average.
Outcome measures
| Measure |
MyChoices
n=36 Participants
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
Acceptability: System Usability Scale
|
75.76 score on a scale
Standard Deviation 10.72
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Error in paradata collection resulted in missing app data for 7 participants
Number of individuals who logged into app at least one time after set up
Outcome measures
| Measure |
MyChoices
n=33 Participants
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
Feasibility: Frequency of Logins
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsSelf-report having tested for HIV over follow up
Outcome measures
| Measure |
MyChoices
n=38 Participants
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
n=20 Participants
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV
|
27 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 monthsSelf-report of participants reporting PrEP initiation anytime over study follow up
Outcome measures
| Measure |
MyChoices
n=38 Participants
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
n=20 Participants
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome. Due to data collection error in the app (which was subsequently fixed), we are missing data from 7 participants.
The total number of times that participants selected distinct components (e.g., testing plan, ordering, FAQs) of the app were summed
Outcome measures
| Measure |
MyChoices
n=33 Participants
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
Number of Times Participants Used Distinct App Components
|
100.58 App components used
Standard Deviation 86.09
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome. Due to data collection error in the app (which was subsequently fixed), we are missing data from 7 participants.
We a priori identified the primary app components (i.e., HIV test plan, location search, ordering supplies, FAQs) and report the number of participants using these app components at least once over follow up
Outcome measures
| Measure |
MyChoices
n=33 Participants
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
App Content and Functionality Most Utilized
HIV test plan
|
30 Participants
|
—
|
|
App Content and Functionality Most Utilized
Location search
|
26 Participants
|
—
|
|
App Content and Functionality Most Utilized
FAQs
|
22 Participants
|
—
|
|
App Content and Functionality Most Utilized
Ordering supplies
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome.
Number of Participants who ordered at least one HIV home testing kit over follow up
Outcome measures
| Measure |
MyChoices
n=40 Participants
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing.
|
Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
|
|---|---|---|
|
Number of HIV Home Testing Kits Ordered
|
25 Participants
|
—
|
Adverse Events
MyChoices
Standard of Care
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