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

NCT06931106 | Not Yet Recruiting

• 1 other identifier: IRB00001052-24167
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

HIV; pre-exposure prophylaxis; men who have sex with men; health action process approach; economic incentive

Outcome Measures

Primary Outcomes (1)

• PrEP Initiation

  The primary outcome indicators of this study is the rate of PrEP initiation, based on PrEP prescriptions issued by doctors.

  3 months

Secondary Outcomes (5)

• PrEP adherence

  3 months

• Intention to pay for PrEP

  3 months

• PrEP-related stigma

  3 months

• Changes in condomless sex

  3 months

• Changes in sexual partner numbers

  3 months

Study Arms (3)

Intervention group-B

EXPERIMENTAL

Participants will receive the AI-based HAPA and CEI behavioral intervention.

Behavioral: HAPA and CEI behavioral intervention

Control group

NO INTERVENTION

Participants will receive non-personalized HIV prevention information, including free HIV testing and condom use, following the guidelines provided by the CDC and the operational standards of the community organizations, with weekly information push notifications.

Intervention group-A

EXPERIMENTAL

Participants will receive HAPA-based behavioral intervention on the We-chat mini progarm.

Behavioral: HAPA-based intervention

Interventions

HAPA and CEI behavioral intervention BEHAVIORAL

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%).

Intervention group-B

HAPA-based intervention BEHAVIORAL

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.

Intervention group-A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years at enrollment;
• Assigned male at birth with a history of ≥1 male-male sexual encounter (anal or oral intercourse);
• HIV-negative confirmed by antibody testing at baseline;
• No prior use of PrEP;
• Expressed interest in PrEP intervention and commitment to complete scheduled follow-ups and data collection procedures;
• Mentally competent to provide informed consent and participate in decision-making;
• High HIV risk (meeting ≥1 of the following in the past 6 months): (1) Condomless anal/penile-vaginal intercourse; (2)Shared needle use during illicit drug injection; (3) Sexual contact with HIV-positive partner(s); (4) Newly diagnosed STI; (5) Repeated use of PEP for HIV prevention; or (6) Self-identified as PrEP candidate through voluntary request.

You may not qualify if:

• Confirmed HIV-positive status or unknown serostatus with refusal of HIV testing;
• Clinically significant health conditions contraindicating PrEP use (e.g., creatinine clearance \<60 mL/min, documented hypersensitivity to PrEP components);
• Severe mental illness or neurological disorders impairing informed consent process.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Homosexuality

Interventions

Algenpantucel-L

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Officials

• Wangnan Cao, Ph.D

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Lin

CONTACT

+86 18610528952; linhao@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share