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

Peking University

Status: Not yet enrolling

Conditions: MSM; HIV; Behavior Changes; PrEP

Treatments: Behavioral: HAPA and CEI behavioral intervention; Behavioral: HAPA-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06931106

IRB00001052-24167

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ≥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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 3 patient groups

Intervention group-B

Experimental group

Description:

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

Treatment:

Behavioral: HAPA and CEI behavioral intervention

Control group

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: HAPA-based intervention