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).
Brief Title
Comparison of Men's Prevention Apps to Research Efficacy
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
HIV/AIDS
Sexually Transmitted Diseases
Pre-exposure Prophylaxis
Risk Reduction
Eligibility 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
* 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
Inclusion 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
* 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
Gender
Male
Gender Based
false
Keywords
PrEP
HIV Testing
Sexually Transmitted Infections
Mobile app
Young men who have sex with men
Technology
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
29 Years
Minimum Age
15 Years
NCT Id
NCT03965221
Org Class
Other
Org Full Name
Public Health Foundation Enterprises, Inc.
Org Study Id
19-0260
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Comparison of Men's Prevention Apps to Research Efficacy
Primary Outcomes
Outcome Description
Proportion who complete \>= 1 HIV test
Outcome Measure
Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Outcome Time Frame
6 months post baseline
Outcome Description
Proportion who uptake PrEP
Outcome Measure
Efficacy for PrEP uptake: Proportion who uptake PrEP
Outcome Time Frame
6 months post baseline
Outcome Description
Proportion who complete \>=1 STI test
Outcome Measure
Efficacy for STI testing: Proportion who complete >=1 STI test
Outcome Time Frame
6 months post baseline
Secondary Ids
Secondary Id
5U19HD089881
Secondary Outcomes
Outcome Description
Proportion who complete \>= 1 HIV test
Outcome Time Frame
12 months post baseline
Outcome Measure
Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Outcome Description
Proportion who uptake PrEP
Outcome Time Frame
12 months post baseline
Outcome Measure
Efficacy for PrEP uptake: Proportion who uptake PrEP
Outcome Description
Proportion who complete \>=1 STI test
Outcome Time Frame
12 months post baseline
Outcome Measure
Efficacy for STI testing: Proportion who complete >=1 STI test
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
29
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
Larry Bernstein
Investigator Email
labernst@montefiore.org
Investigator Phone