HIV/AIDS, Pre-exposure Prophylaxis, Risk Reduction, Sexually Transmitted Diseases
Conditions
Keywords
PrEP, HIV Testing, Sexually Transmitted Infections, Mobile app, Young men who have sex with men, Technology
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).
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.
Interventions
BEHAVIORALLYNX
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.
BEHAVIORALMyChoices
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.
Sponsors
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.
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 29 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy for HIV testing: Proportion who complete >= 1 HIV test | 6 months post baseline | Proportion who complete \>= 1 HIV test |
| Efficacy for PrEP uptake: Proportion who uptake PrEP | 6 months post baseline | Proportion who uptake PrEP |
| Efficacy for STI testing: Proportion who complete >=1 STI test | 6 months post baseline | Proportion who complete \>=1 STI test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy for HIV testing: Proportion who complete >= 1 HIV test | 12 months post baseline | Proportion who complete \>= 1 HIV test |
| Efficacy for PrEP uptake: Proportion who uptake PrEP | 12 months post baseline | Proportion who uptake PrEP |
| Efficacy for STI testing: Proportion who complete >=1 STI test | 12 months post baseline | Proportion who complete \>=1 STI test |
Countries
United States
Outcome results
None listed