Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model

Summary

The goal of this clinical trial is to evaluate the effectiveness of a novel, intelligent intervention platform in bridging the "intention-behavior gap" for pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) in China, a population at high risk for HIV infection. The study aims to address the following main questions:

* Can the intervention platform, guided by the Health Action Process Approach (HAPA) and Conditional Economic Incentive (CEI) dual-track theoretical framework, significantly increase PrEP initiation rates among MSM?
* What are the key mechanisms and pathways underlying the transition from PrEP intention to actual usage behavior?

Researchers will compare participants receiving the intelligent intervention platform (intervention group) with those receiving basic PrEP information (control group) to determine the platform's impact on PrEP initiation rates. Participants will:

* Use a mobile health platform equipped with personalized HIV risk assessments, PrEP knowledge resources, action planning tools, peer support features, and economic incentives.
* Complete baseline and follow-up surveys at 3 months and 6 months to assess PrEP initiation, adherence, and related behaviors.
* Engage in peer group activities and receive tailored feedback based on their progress.

This study seeks to provide evidence for scalable and sustainable strategies to improve PrEP uptake and contribute to HIV prevention efforts in high-risk populations.

Conditions

• HIV
• PrEP
• MSM
• Behavior Changes

Interventions

BEHAVIORAL

HAPA and CEI behavioral intervention

The intervention group will receive a 3-month technology-facilitated PrEP intervention and tailored messages will be developed using BCTs based on theoretical guidance. PrEP teleconsultations will be delivered by certified healthcare professionals, including infectious disease specialists, CDC-affiliated prevention officers, and MSM community leaders. Participants will be stratified into peer cohorts through algorithm-driven grouping based on demographic characteristics. Six participants will form a peer group, and the economic incentive amount will be based on the group-level PrEP initiation rates (verified by physician prescriptions). The economic incentive will decrease progressively based on the average completion rate within the group and will be divided into three tiers: 22 USD (completion rate of 80-100%), 11 USD (completion rate of 50-79%), and 0 USD (completion rate \<50%).

BEHAVIORAL

HAPA-based intervention

This group receives information pushes via a mini-program (3 messages per week) and two brief PrEP consultations; the first brief consultation is delivered jointly by community volunteers and a physician immediately after the baseline survey completion, based on a standardized consultation outline, and the second brief consultation is delivered jointly by community volunteers and a physician after the completion of the first monthly assessment (conducted within the mini-program), based on the standardized consultation outline and the results of that monthly assessment.

Sponsors & Collaborators

• Peking University

  lead OTHER

Principal Investigators

• Wangnan Cao, Ph.D · Peking University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-31

Primary Completion

2026-07-31

Completion

2026-08-31