Trial record 1 of 1 for:
COMPARE LYNX MyChoices | HIV/AIDS
Comparison of Men's Prevention Apps to Research Efficacy (COMPARE)
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| ClinicalTrials.gov Identifier: NCT03965221 |
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Recruitment Status :
Completed
First Posted : May 28, 2019
Last Update Posted : July 28, 2022
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Sponsor:
Public Health Foundation Enterprises, Inc.
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
The Children's Hospital at Montefiore (CHAM)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Brown University
RAIN, Inc.
Information provided by (Responsible Party):
Albert Liu, Public Health Foundation Enterprises, Inc.
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV/AIDS Sexually Transmitted Diseases Pre-exposure Prophylaxis Risk Reduction | Behavioral: LYNX Behavioral: MyChoices | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 381 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Comparison of Men's Prevention Apps to Research Efficacy |
| Actual Study Start Date : | October 14, 2019 |
| Actual Primary Completion Date : | May 31, 2022 |
| Actual Study Completion Date : | May 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: LYNX
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.
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Behavioral: LYNX
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. |
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Experimental: MyChoices
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.
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Behavioral: 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. |
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No Intervention: Standard of Care
Provision of referrals to local HIV/STI testing and PrEP resources.
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Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Efficacy for HIV testing: Proportion who complete >= 1 HIV test [ Time Frame: 12 months post baseline ]Proportion who complete >= 1 HIV test
- Efficacy for PrEP uptake: Proportion who uptake PrEP [ Time Frame: 12 months post baseline ]Proportion who uptake PrEP
- Efficacy for STI testing: Proportion who complete >=1 STI test [ Time Frame: 12 months post baseline ]Proportion who complete >=1 STI test
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 15 Years to 29 Years (Child, Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Cisgender men |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965221
Locations
| United States, Florida | |
| University of South Florida, Infectious Diseases | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| PRISM Health | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Ayar @ Core | |
| Chicago, Illinois, United States, 60612 | |
| United States, Massachusetts | |
| Fenway Health Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Montefiore Children's Hospital | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| RAIN, Inc | |
| Charlotte, North Carolina, United States, 28202 | |
| United States, Pennsylvania | |
| Adolescent Initiative at Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Public Health Foundation Enterprises, Inc.
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
The Children's Hospital at Montefiore (CHAM)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Brown University
RAIN, Inc.
Investigators
| Principal Investigator: | Albert Y Liu, MD, MPH | San Francisco Department of Public Health | |
| Principal Investigator: | Katie B Biello, PhD, MPH | Brown University |
| Responsible Party: | Albert Liu, Director, Clinical Research, Public Health Foundation Enterprises, Inc. |
| ClinicalTrials.gov Identifier: | NCT03965221 |
| Other Study ID Numbers: |
19-0260 5U19HD089881 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 28, 2019 Key Record Dates |
| Last Update Posted: | July 28, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Albert Liu, Public Health Foundation Enterprises, Inc.:
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PrEP HIV Testing Sexually Transmitted Infections |
Mobile app Young men who have sex with men Technology |
Additional relevant MeSH terms:
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Sexually Transmitted Diseases Communicable Diseases Infections Disease Attributes Pathologic Processes |