Trial Outcomes & Findings for LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men (NCT NCT03177512)

Last Updated: 2021-05-11

Results Overview

System Usability Scale: a validated 10-measure scale that assesses subjective usability of a system, or, in this case, an app. Range of scale is 0-100, with higher scores indicating higher acceptability.

Recruitment status

COMPLETED

Study phase

Target enrollment

61 participants

Primary outcome timeframe

3 months

Results posted on

2021-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	LYNX Mobile App LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Overall Study STARTED	40	21
Overall Study COMPLETED	31	18
Overall Study NOT COMPLETED	9	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LYNX Mobile App n=40 Participants LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control n=21 Participants Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.	Total n=61 Participants Total of all reporting groups
Age, Continuous	20.23 years STANDARD_DEVIATION 2.55 • n=5 Participants	20.52 years STANDARD_DEVIATION 2.73 • n=7 Participants	20.33 years STANDARD_DEVIATION 2.59 • 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	21 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	14 Participants n=7 Participants	43 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/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized White	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Other/multiple	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Declined to answer	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Participants in the LYNX Mobile App arm who completed assessment at month 3. Two participants answered "Declined to answer" - SUS was calculated out of 32 complete responses.

Outcome measures

Outcome measures
Measure	LYNX Mobile App n=32 Participants LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Acceptability	75.63 units on a scale Standard Deviation 14.59	—

PRIMARY outcome

Timeframe: 3 months

Population: Feasibility was only assessed in the intervention arm. One participant was missing from the paradata and not included in the denominator.

Opened the app at least once by Month 3 time point

Outcome measures

Outcome measures
Measure	LYNX Mobile App n=39 Participants LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point	38 Participants	—

SECONDARY outcome

Timeframe: 6 months

Population: Frequency of app use was only assessed in the intervention arm. One participant was missing from the paradata and not included in the denominator.

Number of login sessions

Outcome measures

Outcome measures
Measure	LYNX Mobile App n=39 Participants LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Frequency of App Use	15.16 Number of login sessions Standard Deviation 11.73	—

SECONDARY outcome

Timeframe: 6 months

Population: Analysis only included participants in the intervention arm. One participant was missing from the paradata and not included in the denominator.

Use of each app component based on paradata from the mobile app

Outcome measures

Outcome measures
Measure	LYNX Mobile App n=39 Participants LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Number of Participants Using Different Parts of the App PrEP facts	12 Participants	—
Number of Participants Using Different Parts of the App Home page	38 Participants	—
Number of Participants Using Different Parts of the App Diary	37 Participants	—
Number of Participants Using Different Parts of the App Testing	37 Participants	—
Number of Participants Using Different Parts of the App Navigation Chat	33 Participants	—
Number of Participants Using Different Parts of the App Navigation PrEP	35 Participants	—
Number of Participants Using Different Parts of the App SexPro	34 Participants	—
Number of Participants Using Different Parts of the App Activity calendar	32 Participants	—
Number of Participants Using Different Parts of the App Insights	29 Participants	—
Number of Participants Using Different Parts of the App Sex trends	30 Participants	—
Number of Participants Using Different Parts of the App Testing map	30 Participants	—
Number of Participants Using Different Parts of the App Encounter	29 Participants	—
Number of Participants Using Different Parts of the App Profile	27 Participants	—
Number of Participants Using Different Parts of the App PrEP map	23 Participants	—
Number of Participants Using Different Parts of the App Top 5	23 Participants	—
Number of Participants Using Different Parts of the App Badges	24 Participants	—
Number of Participants Using Different Parts of the App PrEP videos	5 Participants	—

SECONDARY outcome

Timeframe: 6 months

Population: Only includes participants in the intervention arm, as home test kits could only be ordered through the app for participants in the LYNX mobile app arm

Number of Participants who ordered HIV/STI home testing kits, condom and lube

Outcome measures

Outcome measures
Measure	LYNX Mobile App n=40 Participants LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube Oraquick testing kit orders	38 participants	—
Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube STI testing kit orders	37 participants	—
Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube Condom orders	29 participants	—
Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube Lube orders	19 participants	—

SECONDARY outcome

Timeframe: 6 months

Population: Participants analyzed included those who had completed at least one follow-up survey

Self-report HIV testing during 6 month study

Outcome measures

Outcome measures
Measure	LYNX Mobile App n=35 Participants LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control n=18 Participants Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Number of Participants Reporting HIV Testing Over 6 Months	28 Participants	11 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants analyzed included those who completed at least one follow-up visit

Self-report of PrEP use

Outcome measures

Outcome measures
Measure	LYNX Mobile App n=34 Participants LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.	Control n=18 Participants Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
PrEP Uptake as Measured by Self Report	5 Participants	4 Participants

Adverse Events

LYNX Mobile App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Albert Liu

Bridge HIV, San Francisco Department of Public Health

Phone: 628-217-7408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place