HIV/AIDSCOMPARENCT03965221
Comparison of Men's Prevention Apps to Research Efficacy
A study testing LYNX and MyChoices in people with HIV/AIDS and Sexually Transmitted Diseases, run by Public Health Foundation Enterprises, Inc. at 8 sites in United States.
Trial summary
A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis). Read more about this study
- Who is it for?
- Ages 15 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Sexually Transmitted Diseases, Pre-exposure Prophylaxis
- What is being tested?
- LYNX and MyChoices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Oct 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15 to 29 years.
- Assigned male sex at birth and male identified.
- Self-report being HIV uninfected or HIV status-unknown at screening.
- Self-report having not had an HIV test in the past 3 months.
- Self-report not currently taking PrEP.
- Self-report at least one episode of anal intercourse with a male or transfemale partner during the last 12 months.
Show all 9Show fewer
- Able to understand, read, and speak English.
- Owns or leases a phone with Android platform or iOS platform, has an active data plan Has phone setting in English or Spanish, or willing to use an English or Spanish phone setting over the course of the study (Spanish setting is only for bilingual participants who speak both English and Spanish fluently)
- Willing and able to attend an in-person baseline study visit in one of the study site areas, or willing to attend a remote online baseline study visit
Who cannot join
- Currently enrolled in another HIV intervention study.
- Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.
- Enrollment in Aims 2 and 3 of the prior MyChoices (UNC IRB# 17-0256) or LYNX (UNC IRB# 17-0170) studies
- 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.
- Not willing and/or not able to download the MyChoices and LYNX apps onto their phone
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
PRISM Health
Atlanta, Georgia, 30322
Fenway Health Center
Boston, Massachusetts, 02215
RAIN, Inc
Charlotte, North Carolina, 28202
Ayar @ Core
Chicago, Illinois, 60612
Baylor College of Medicine
Houston, Texas, 77030
Adolescent Initiative at Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of South Florida, Infectious Diseases
Tampa, Florida, 33606
Montefiore Children's Hospital
The Bronx, New York, 10467
About this study
A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).
Read the detailed description
COMPARE 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. In years 1-2 of the iTech grant, the investigators optimized and pilot tested using a similar study design and identical study outcomes, two distinct mobile apps called LYNX and MyChoices. Each app is designed to increase HIV testing and PrEP uptake among YMSM. In this study, the individual apps are being tested in this follow-on research study to evaluate for efficacy. YMSM will be randomized to receive either MyChoices, LYNX, or SOC. LYNX uses the Information-Motivation-Behavior Skills (IMB) model and is a highly interactive mobile app to promote accurate risk perception, increase HIV/STI testing, and linkage to PrEP. MyChoices is guided by the Social Cognitive Theory (SCT) model, is adapted from HealthMindr and developed using iterative feedback from youth refined to maximize acceptability among YMSM. It includes three major functions that are designed to promote self-efficacy, self-regulation, goal-setting and environmental influences to impact behavior change. The SOC includes information on HIV testing and PrEP with the provision of referrals to local HIV/STI testing and PrEP resources.
- Being tested
- LYNX, MyChoices
- Keywords
- PrEP, HIV Testing, Sexually Transmitted Infections, Mobile app, Young men who have sex with men, Technology
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYNXBehavioural
Access to the LYNX mobile app which includes the Sex Pro score tool, sex diary, badges, PrEP information and video testimonials, HIV/STI testing reminders and geo-location features, and asynchronous chat feature.
MyChoicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LYNX | Experimental | LYNX is developed using IMB model and engages youth through entering sexual diary data, earning badges, and calculating a personalized sexual protection (Sex Pro) score, which informs and motivates youth around HIV/STI testing and PrEP uptake. Behavioral skills are built through HIV/STI testing reminders, presenting options for home HIV testing and/or linkage to nearby testing services, and access to an online chat with support for HIV/STI testing and PrEP referral. Receives: Behavioral: LYNX |
| MyChoices | Experimental | MyChoices is adapted from an app for adult MSM, HealthMindr, developed using SCT. The app aims to increase HIV testing and PrEP uptake by increasing self- regulation, self-reflection, and self-efficacy around HIV testing and PrEP uptake. Brief surveys about sexual risk and protective health behaviors within the app are used to assist users in tracking and self-monitoring their behaviors and creating a personalized HIV testing plan. Quizzes, videos and infographics as well as "Help me Choose," "Ordering," and geofencing functions are used to maximize self-efficacy around HIV prevention and uptake of PrEP. Receives: Behavioral: MyChoices |
| Standard of Care | No intervention | Provision of referrals to local HIV/STI testing and PrEP resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Proportion who complete >= 1 HIV test
Measured: 6 months post baseline
Efficacy for PrEP uptake: Proportion who uptake PrEP
Proportion who uptake PrEP
Measured: 6 months post baseline
Efficacy for STI testing: Proportion who complete >=1 STI test
Proportion who complete >=1 STI test
Measured: 6 months post baseline
Secondary outcomes (3)
Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Proportion who complete >= 1 HIV test
Measured: 12 months post baseline
Efficacy for PrEP uptake: Proportion who uptake PrEP
Proportion who uptake PrEP
Measured: 12 months post baseline
Efficacy for STI testing: Proportion who complete >=1 STI test
Proportion who complete >=1 STI test
Measured: 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start14 Oct 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Adolescent Trials Network for HIV/AIDS Interventions, Adolescent and Young Adult Research (AYAR), CORE Center, Children's Hospital of Philadelphia, Baylor College of Medicine, University of South Florida, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Fenway Community Health, San Francisco Department of Public Health, University of North Carolina, Chapel Hill, Children's Hospital at Montefiore, National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), Brown University, RAIN, Inc.
- Responsible party
- Principal investigator, Albert Liu, Public Health Foundation Enterprises, Inc.
- Investigators
- Albert Y Liu, MD, MPH, Principal investigator, San Francisco Department of Public HealthKatie B Biello, PhD, MPH, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965221
- Sponsor's protocol ID
- 19-0260
- Other IDs
- 5U19HD089881
- Acronym
- COMPARE
- Status last verified
- Jul 2022
- First submitted
- 17 May 2019
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be available to outside individuals through contacting the multiple principal investigators (MPIs) at two different times. The first will be after all of the baseline data is collected. The investigators will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the investigators will welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
Publications
Biello KB, Mayer KH, Scott H, Valente PK, Hill-Rorie J, Buchbinder S, Ackah-Toffey L, Sullivan PS, Hightow-Weidman L, Liu AY. The Effects of MyChoices and LYNX Mobile Apps on HIV Testing and Pre-Exposure Prophylaxis Use by Young US Sexual Minority Men: Results From a National Randomized Controlled Trial. JMIR Public Health Surveill. 2025 Feb 5;11:e63428. doi: 10.2196/63428.
PubMed 39908084
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Men's Prevention Apps to Research Efficacy
- ClinicalTrials.gov ID
- NCT03965221
- Acronym / sponsor ID
- COMPARE / 19-0260
- Keywords
- PrEP, HIV Testing, Sexually Transmitted Infections, Mobile app, Young men who have sex with men, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Collaborators
- Adolescent Trials Network for HIV/AIDS Interventions, Adolescent and Young Adult Research (AYAR), CORE Center, Children's Hospital of Philadelphia, Baylor College of Medicine, University of South Florida, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Fenway Community Health, San Francisco Department of Public Health, University of North Carolina, Chapel Hill, Children's Hospital at Montefiore, National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), Brown University, RAIN, Inc.
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).
Detailed description
COMPARE 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. In years 1-2 of the iTech grant, the investigators optimized and pilot tested using a similar study design and identical study outcomes, two distinct mobile apps called LYNX and MyChoices. Each app is designed to increase HIV testing and PrEP uptake among YMSM. In this study, the individual apps are being tested in this follow-on research study to evaluate for efficacy. YMSM will be randomized to receive either MyChoices, LYNX, or SOC. LYNX uses the Information-Motivation-Behavior Skills (IMB) model and is a highly interactive mobile app to promote accurate risk perception, increase HIV/STI testing, and linkage to PrEP. MyChoices is guided by the Social Cognitive Theory (SCT) model, is adapted from HealthMindr and developed using iterative feedback from youth refined to maximize acceptability among YMSM. It includes three major functions that are designed to promote self-efficacy, self-regulation, goal-setting and environmental influences to impact behavior change. The SOC includes information on HIV testing and PrEP with the provision of referrals to local HIV/STI testing and PrEP resources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LYNX | Experimental | Behavioral: LYNXLYNX is developed using IMB model and engages youth through entering sexual diary data, earning badges, and calculating a personalized sexual protection (Sex Pro) score, which informs and motivates youth around HIV/STI testing and PrEP uptake. Behavioral skills are built through HIV/STI testing reminders, presenting options for home HIV testing and/or linkage to nearby testing services, and access to an online chat with support for HIV/STI testing and PrEP referral. |
| MyChoices | Experimental | Behavioral: MyChoicesMyChoices is adapted from an app for adult MSM, HealthMindr, developed using SCT. The app aims to increase HIV testing and PrEP uptake by increasing self- regulation, self-reflection, and self-efficacy around HIV testing and PrEP uptake. Brief surveys about sexual risk and protective health behaviors within the app are used to assist users in tracking and self-monitoring their behaviors and creating a personalized HIV testing plan. Quizzes, videos and infographics as well as "Help me Choose," "Ordering," and geofencing functions are used to maximize self-efficacy around HIV prevention and uptake of PrEP. |
| Standard of Care | No intervention | –Provision of referrals to local HIV/STI testing and PrEP resources. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 15 to 29 years.
- Assigned male sex at birth and male identified.
- Self-report being HIV uninfected or HIV status-unknown at screening.
- Self-report having not had an HIV test in the past 3 months.
- Self-report not currently taking PrEP.
Key exclusion criteria (5 listed)
- Currently enrolled in another HIV intervention study.
- Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.
- Enrollment in Aims 2 and 3 of the prior MyChoices (UNC IRB# 17-0256) or LYNX (UNC IRB# 17-0170) studies
- 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.
- Not willing and/or not able to download the MyChoices and LYNX apps onto their phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYNXAccess to the LYNX mobile app which includes the Sex Pro score tool, sex diary, badges, PrEP information and video testimonials, HIV/STI testing reminders and geo-location features, and asynchronous chat feature. | Behavioural | LYNX |
| MyChoicesAccess 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. | Behavioural | MyChoices |
Primary outcome
Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Time frame: 6 months post baseline
Proportion who complete >= 1 HIV test
Efficacy for PrEP uptake: Proportion who uptake PrEP
Time frame: 6 months post baseline
Proportion who uptake PrEP
Efficacy for STI testing: Proportion who complete >=1 STI test
Time frame: 6 months post baseline
Proportion who complete >=1 STI test
3 secondary outcomes
Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Time frame: 12 months post baseline
Efficacy for PrEP uptake: Proportion who uptake PrEP
Time frame: 12 months post baseline
Efficacy for STI testing: Proportion who complete >=1 STI test
Time frame: 12 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 39908084Biello KB, Mayer KH, Scott H, Valente PK, Hill-Rorie J, Buchbinder S, Ackah-Toffey L, Sullivan PS, Hightow-Weidman L, Liu AY. The Effects of MyChoices and LYNX Mobile Apps on HIV Testing and Pre-Exposure Prophylaxis Use by Young US Sexual Minority Men: Results From a National Randomized Controlled Trial. JMIR Public Health Surveill. 2025 Feb 5;11:e63428. doi: 10.2196/63428.
- Individual participant dataSharing planned: Yes. Raw data will be available to outside individuals through contacting the multiple principal investigators (MPIs) at two different times. The first will be after all of the baseline data is collected. The investigators will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the investigators will welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Y Liu, MD, MPH principal investigator
San Francisco Department of Public Health
Katie B Biello, PhD, MPH principal investigator
Brown University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LYNX and MyChoices in people with HIV/AIDS and Sexually Transmitted Diseases, run by Public Health Foundation Enterprises, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy for HIV testing: Proportion who complete >= 1 HIV test (time frame: 6 months post baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03965221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.