HIV, Pre-Exposure Prophylaxis, Risk Reduction, Sexually Transmitted Diseases
Conditions
Keywords
PrEP, HIV Testing, STI Testing, Mobile app, Technology, Young men who have sex with men
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).
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.
Interventions
BEHAVIORALLYNX 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.
Sponsors
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
Public Health Foundation Enterprises, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
15 Years to 24 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Frequency of App Use | 6 months | Number of login sessions |
| PrEP Uptake as Measured by Self Report | 6 months | Self-report of PrEP use |
| Number of Participants Reporting HIV Testing Over 6 Months | 6 months | Self-report HIV testing during 6 month study |
| Number of Participants Using Different Parts of the App | 6 months | Use of each app component based on paradata from the mobile app |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Control Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. | 21 |
| Total | 61 |
Baseline characteristics
| Characteristic | LYNX Mobile App | Control | Total |
|---|---|---|---|
| Age, Continuous | 20.23 years STANDARD_DEVIATION 2.55 | 20.52 years STANDARD_DEVIATION 2.73 | 20.33 years STANDARD_DEVIATION 2.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 7 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 14 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 9 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized Declined to answer | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other/multiple | 7 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 14 Participants | 34 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 40 Participants | 21 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 21 |
| other Total, other adverse events | 0 / 40 | 0 / 21 |
| serious Total, serious adverse events | 0 / 40 | 0 / 21 |
Outcome results
Primary
Acceptability
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LYNX Mobile App | Acceptability | 75.63 units on a scale | Standard Deviation 14.59 |
Primary
Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point
Opened the app at least once by Month 3 time point
Time frame: 3 months
Population: Feasibility was only assessed in the intervention arm. One participant was missing from the paradata and not included in the denominator.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LYNX Mobile App | Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point | 38 Participants |
Secondary
Frequency of App Use
Number of login sessions
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LYNX Mobile App | Frequency of App Use | 15.16 Number of login sessions | Standard Deviation 11.73 |
Secondary
Number of Participants Reporting HIV Testing Over 6 Months
Self-report HIV testing during 6 month study
Time frame: 6 months
Population: Participants analyzed included those who had completed at least one follow-up survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LYNX Mobile App | Number of Participants Reporting HIV Testing Over 6 Months | 28 Participants |
| Control | Number of Participants Reporting HIV Testing Over 6 Months | 11 Participants |
Secondary
Number of Participants Using Different Parts of the App
Use of each app component based on paradata from the mobile app
Time frame: 6 months
Population: Analysis only included participants in the intervention arm. One participant was missing from the paradata and not included in the denominator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Sex trends | 30 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Testing map | 30 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Encounter | 29 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Profile | 27 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | PrEP map | 23 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Home page | 38 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Diary | 37 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Testing | 37 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Navigation Chat | 33 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Navigation PrEP | 35 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | SexPro | 34 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Activity calendar | 32 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Insights | 29 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Top 5 | 23 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | Badges | 24 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | PrEP facts | 12 Participants |
| LYNX Mobile App | Number of Participants Using Different Parts of the App | PrEP videos | 5 Participants |
Secondary
Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube
Number of Participants who ordered HIV/STI home testing kits, condom and lube
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LYNX Mobile App | Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube | Oraquick testing kit orders | 38 participants |
| LYNX Mobile App | Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube | STI testing kit orders | 37 participants |
| LYNX Mobile App | Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube | Condom orders | 29 participants |
| LYNX Mobile App | Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube | Lube orders | 19 participants |
Secondary
PrEP Uptake as Measured by Self Report
Self-report of PrEP use
Time frame: 6 months
Population: Participants analyzed included those who completed at least one follow-up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LYNX Mobile App | PrEP Uptake as Measured by Self Report | 5 Participants |
| Control | PrEP Uptake as Measured by Self Report | 4 Participants |