MyPEEPS LITE Trial

Columbia University

Status: Enrolling

Conditions: HIV/AIDS

Treatments: Behavioral: MyPEEPS Mobile

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06741631

UH3AI169658 (U.S. NIH Grant/Contract)

AAAV4619

Details and patient eligibility

About

This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=2,500), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.

Full description

In direct response to RFA-AI-21-018, Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional), we proposed to harness innovative electronic methods to conduct a large, rigorous national study collecting and contextualizing epidemiological HIV incidence data in Young Men who have Sex with Men (YMSM) and testing the efficacy of MyPEEPS Mobile, an evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence. We proposed to establish a large national cohort of 2,500 racially and ethnically diverse YMSM 16-29 years old, the age YMSM are most susceptible to HIV acquisition to identify theoretically-driven correlates of HIV seroconversion among a key population experiencing a disproportionate number of new HIV diagnoses.

Randomized controlled trials (RCTs) are considered the gold standard for estimating treatment efficacy because randomization mitigates risk of bias by balancing measured and unmeasured confounders across treatment groups. However, RCTs are costly, time-consuming, and can be challenging to conduct in certain context. We are therefore integrating the robust epidemiological data that we collected during the UG3 phase into the clinical trial design. That integration is a potentially appealing way to generate an external comparator cohort to increase the power of our RCT to estimate the effect of MyPEEPS Mobile on HIV incidence.

Enrollment: 2,500 estimated patients

Sex: Male

Ages: 16 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be between 16-29 years of age;
• Sex assigned at birth is male and identify gender as male or non-binary;
• Understand and read English;
• Live within US and its territories;
• Own or have access to a smartphone;
• Self-report anal sex with someone who has a penis in the last 12 months; and
• Be HIV-negative or status unknown

Exclusion criteria

• Individuals who identify as transgender

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,500 participants in 2 patient groups

Control

No Intervention group

Description:

Participants randomized to the control arm will receive standard of care. This consists of HIV home testing every 6 months, information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP, referrals to the local PrEP clinic, and referrals for local sexually transmitted disease testing.

Intervention

Experimental group

Description:

Participants randomized to the intervention arm will have access to MyPEEPS Mobile for the next 6 months. MyPEEPS Mobile is a secure web app with content delivered through games, scenarios, and role-plays within 22 mobile activities (true/ false questions, multiple choice, matching, videos).

Treatment:

Behavioral: MyPEEPS Mobile