JMIR Publications

ABSTRACT

Background:

Despite high pre-exposure prophylaxis (PrEP) awareness and willingness among Chinese men who have sex with men (MSM), actual uptake remains critically low. This intention-behavior gap significantly hinders Human Immunodeficiency Virus (HIV) prevention efforts.

Objective:

This randomized controlled trial evaluates the effectiveness of Health Action Process Approach (HAPA) -driven interventions to enhance PrEP initiation and adherence in this high-risk population.

Methods:

High-risk HIV-negative MSM naive to PrEP will be recruited via community-based organizations. Participants will undergo individual randomization to three arms: (1) HAPA-based behavioral intervention featuring tailored WeChat messages and two structured motivational interviews targeting stage-specific barriers; (2) Combined HAPA intervention with group-based conditional economic incentives (GCEI) linked to peer group initiation rates, incorporating facilitated offline group activities; or (3) Standard care control. The physician-prescribed PrEP initiation rate at three months serves as primary outcome. Secondary outcomes include PrEP adherence, HIV risk perception, PrEP-related stigma, and intervention acceptability. Analysis will follow intention-to-treat principles using mixed-effects models.

Results:

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Conclusions:

This study rigorously tests a novel intervention integrating the HAPA–targeting distinct motivational and volitional phases of PrEP use–with a GCEI model leveraging peer influence. By addressing both individual cognitive-behavioral barriers and financial disincentives within a supportive group context, this approach offers a potentially scalable strategy to bridge the PrEP uptake gap in China. Findings will provide critical evidence on the added value of combining theory-driven behavioral techniques with peer-group economic incentives for HIV prevention. Clinical Trial: This study was registered at ClinicalTrials.gov (NCT06931106).