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

• Sponsor: Public Health Foundation Enterprises, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT03177512
• Collaborator: Cook County Health & Hospitals System (Other), Duke University (Other), Emory University (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), San Francisco Department of Public Health (Other), University of California, San Francisco (Other), University of North Carolina, Chapel Hill (Other), University of South Florida (Other)
• Enrollment: 61
• Locations: 2
• Arms: 2
• Actual Duration (Months): 12.8
• Patients Per Site: 30.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

This study is testing the acceptability and feasibility of a highly interactive mobile application (app) to promote HIV/sexually transmitted infection (STI) testing and uptake of pre-exposure prophylaxis (PrEP) among young men who have sex with men (YMSM).

Condition or Disease	Intervention/Treatment	Phase
HIV; Sexually Transmitted Diseases; Risk Reduction; Pre-Exposure Prophylaxis	Behavioral: LYNX Mobile App	N/A

Detailed Description

Using the Information-Motivation-Behavior Skills (IMB) model, we have developed LYNX, a highly interactive mobile app to promote accurate risk perception and increase HIV/STI testing and linkage to PrEP among young men who have sex with men (YMSM). Key components of the app include Sex Pro (a personalized HIV risk score), a sex diary to facilitate accurate data collection; HIV/STI testing information and reminders; access to home HIV/STI testing options; a geospatial-based locator of HIV/STI testing sites and PrEP clinics; PrEP information and videos; and online PrEP navigation.

This study is part of the iTech NIH U19, which has an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing and Pre-exposure Prophylaxis (PrEP) for Young Men Who Have Sex With Men
• Actual Study Start Date: Oct 25, 2018
• Actual Primary Completion Date: Nov 18, 2019
• Actual Study Completion Date: Nov 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LYNX Mobile App	Behavioral: 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.
No Intervention: Control Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.

Outcome Measures

Primary Outcome Measures

1. Acceptability [3 months]

   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.

2. Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point [3 months]

   Opened the app at least once by Month 3 time point

Secondary Outcome Measures

1. Frequency of App Use [6 months]

   Number of login sessions

2. Number of Participants Using Different Parts of the App [6 months]

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

3. Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube [6 months]

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

4. Number of Participants Reporting HIV Testing Over 6 Months [6 months]

   Self-report HIV testing during 6 month study

5. PrEP Uptake as Measured by Self Report [6 months]

   Self-report of PrEP use

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 24 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• No HIV test in the past 3 months (self-reported).

• Not known to be HIV-infected (self-reported).

• Not currently taking PrEP (self-reported).

• Owns an Apple operating system (iOS) or Android mobile phone and willing and able to download the LYNX app onto their phone.

• Willing and able to attend an in-person baseline visit in the Tampa or Chicago area.

• Able to understand, read, and speak English.

• Participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months

• Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following:

1. at least one episode of condomless anal sex with an HIV-positive or unknown HIV status male or transfemale partner during the last 6 months; or

2. Anal sex with 2 or more male and/or transfemale partners during the last 6 months; or

3. Exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or

4. Sex with a male or transfemale partner and has had an STI during the last 6 months.

Exclusion Criteria:

• Currently enrolled in another HIV intervention study

• Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product

• Enrollment in an earlier phase of LYNX study

• Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Florida, Department of Pediatrics	Tampa	Florida	United States	33606
2	The CORE Center, Cook County Health and Hospitals System	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Public Health Foundation Enterprises, Inc.
• Cook County Health & Hospitals System
• Duke University
• Emory University
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• San Francisco Department of Public Health
• University of California, San Francisco
• University of North Carolina, Chapel Hill
• University of South Florida

Investigators

• Study Chair: Albert Liu, M.D., MPH, Bridge HIV, San Francisco Department of Public Health
• Study Chair: Hyman Scott, M.D., MPH, Bridge HIV, San Francisco Department of Public Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 28, 2018

More Information

Publications

None provided.

• Responsible Party: Albert Liu, Clinical Research Director, Public Health Foundation Enterprises, Inc.
• ClinicalTrials.gov Identifier: NCT03177512
• Other Study ID Numbers: 17-21876; U19HD089881
• First Posted: Jun 6, 2017
• Last Update Posted: May 11, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Albert Liu, Clinical Research Director, Public Health Foundation Enterprises, Inc.: PrEP; HIV Testing; STI Testing; Mobile app; Technology; Young men who have sex with men
• Additional relevant MeSH terms: Sexually Transmitted Diseases

Study Results

Participant Flow

Arm/Group Title	LYNX Mobile App	Control
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Period Title: Overall Study
STARTED	40	21
COMPLETED	31	18
NOT COMPLETED	9	3

Baseline Characteristics

Arm/Group Title	LYNX Mobile App	Control	Total
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.	Total of all reporting groups
Overall Participants	40	21	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.23 (2.55)	20.52 (2.73)	20.33 (2.59)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	40 100%	21 100%	61 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 27.5%	7 33.3%	18 29.5%
Not Hispanic or Latino	29 72.5%	14 66.7%	43 70.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 5%	1 4.8%	3 4.9%
Black	9 22.5%	6 28.6%	15 24.6%
White	20 50%	14 66.7%	34 55.7%
Other/multiple	7 17.5%	0 0%	7 11.5%
Declined to answer	2 5%	0 0%	2 3.3%

Outcome Measures

1. Primary Outcome

Title	Acceptability
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	LYNX Mobile App	Control
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	32	0
Mean (Standard Deviation) [units on a scale]	75.63 (14.59)

2. Primary Outcome

Title	Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point
Description	Opened the app at least once by Month 3 time point
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	LYNX Mobile App	Control
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	39	0
Count of Participants [Participants]	38 95%

3. Secondary Outcome

Title	Frequency of App Use
Description	Number of login sessions
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	LYNX Mobile App	Control
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	39	0
Mean (Standard Deviation) [Number of login sessions]	15.16 (11.73)

4. Secondary Outcome

Title	Number of Participants Using Different Parts of the App
Description	Use of each app component based on paradata from the mobile app
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	LYNX Mobile App	Control
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	39	0
Home page	38 95%
Diary	37 92.5%
Testing	37 92.5%
Navigation Chat	33 82.5%
Navigation PrEP	35 87.5%
SexPro	34 85%
Activity calendar	32 80%
Insights	29 72.5%
Sex trends	30 75%
Testing map	30 75%
Encounter	29 72.5%
Profile	27 67.5%
PrEP map	23 57.5%
Top 5	23 57.5%
Badges	24 60%
PrEP facts	12 30%
PrEP videos	5 12.5%

5. Secondary Outcome

Title	Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube
Description	Number of Participants who ordered HIV/STI home testing kits, condom and lube
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	LYNX Mobile App	Control
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	40	0
Oraquick testing kit orders	38 95%
STI testing kit orders	37 92.5%
Condom orders	29 72.5%
Lube orders	19 47.5%

6. Secondary Outcome

Title	Number of Participants Reporting HIV Testing Over 6 Months
Description	Self-report HIV testing during 6 month study
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	LYNX Mobile App	Control
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	35	18
Count of Participants [Participants]	28 70%	11 52.4%

7. Secondary Outcome

Title	PrEP Uptake as Measured by Self Report
Description	Self-report of PrEP use
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	LYNX Mobile App	Control
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	34	18
Count of Participants [Participants]	5 12.5%	4 19%

Adverse Events

Time Frame	Adverse event data was collected throughout the duration of the 6 month trial
Arm/Group Title	LYNX Mobile App		Control
Arm/Group Description	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.		Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
All Cause Mortality
	LYNX Mobile App		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/21 (0%)
Serious Adverse Events
	LYNX Mobile App		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	LYNX Mobile App		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.