Clinical trial NCT06741631: MyPEEPS LITE Trial
Official title: MyPEEPS LITE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Northwestern University
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-12-19
Enrollment: 2500
Sex: MALE
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV Incidence
timeFrame: Baseline, 6 month follow up, 12 month follow up.
measure: Total Condomless Anal Sex Occurring in the Context of Insufficient PrEP Protection
timeFrame: Baseline, 6 month follow up, 12 month follow up.
Secondary outcomes:
measure: Self-Reported PrEP Initiation
timeFrame: Baseline, 6 month follow up, 12 month follow up.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Robert Garofalo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Dustin Duncan, ScD
role: PRINCIPAL_INVESTIGATOR
References: