Overcoming the HIV Pre-Exposure Prophylaxis Uptake Barrier With A Health Action Process Approach and Conditional Economic Incentives Among Men Who Have Sex With Men in 3 Chinese Cities: Protocol for a Randomized Controlled Trial.

Background: Despite high pre-exposure prophylaxis (PrEP) awareness and willingness among Chinese men who have sex with men (MSM), actual uptake remains critically low. The health action process approach (HAPA) is a 2-phase theory that addresses both the motivational and volitional phases of health behavior change, making it suitable for tackling the intention-behavior gap in PrEP use. In China, where PrEP is not covered by national health insurance, financial barriers further hinder uptake. Group-based conditional economic incentives (GCEIs) represent an innovative strategy to address cost-related disincentives by leveraging peer influence. Objective: This randomized controlled trial aims to evaluate the effectiveness of HAPA-driven interventions, both alone and combined with GCEI, to enhance PrEP initiation and adherence among high-risk, PrEP-naive MSM in China. Methods: High-risk HIV-negative MSM naïve to PrEP were recruited via community-based organizations in 3 Chinese cities. Participants underwent individual randomization to 3 arms: (1) HAPA-based cognitive behavioral intervention featuring tailored WeChat messages and 2 structured motivational interviews targeting stage-specific barriers; (2) combined HAPA intervention with GCEI linked to peer group initiation rates, incorporating facilitated offline group activities; or (3) standard care control receiving nonpersonalized HIV prevention information. The physician-prescribed PrEP initiation rate at 3 months serves as the primary outcome. Secondary outcomes include PrEP adherence, HIV risk perception, PrEP-related stigma, and intervention acceptability. Analysis follows intention-to-treat principles using mixed-effects models. Results: The study protocol received ethics approval in December 2024 and was funded in December 2025. As of August 2025, 3 community-based organizations in Mianyang, Zibo, and Hohhot have agreed to participate. Preliminary testing has led to refinements in the WeChat mini-program, questionnaires, and motivational interview scripts. Data collection commenced in October 2025 and is projected to be completed by August 2026. As of February 2026, baseline recruitment is complete, with 381 eligible participants enrolled and randomized. The baseline characteristics were balanced across the 3 arms. Outcome data will be collected after the intervention. Data analysis is ongoing, with full results expected to be published before December 2026. Conclusions: This study rigorously tests a novel intervention integrating the HAPA with a GCEI model. 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 combining theory-driven behavioral techniques with peer-group economic incentives for HIV prevention.