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

Not Applicable

Not yet recruiting

• Conditions: HIV; PrEP; MSM; Behavior Changes

• Registration Number: NCT06931106
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-17
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-06-04
• Study Start: 2025-07
• Primary Completion: 2026-07
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PrEP Initiation	3 months	The primary outcome indicators of this study is the rate of PrEP initiation, based on PrEP prescriptions issued by doctors.

Secondary Outcome Measures

Name	Time	Method
PrEP adherence	3 months	Secondary outcome indicators include the rate of PrEP adherence after initiating (based on self-reported adherence and the medication calendar in the program). Self-reported adherence: Assessed via validated questionnaires (e.g., visual analog scales or Likert scales) integrated into the mini-program, capturing missed doses, timing, and barriers. Medication calendar: Digitally tracked in the mini-program, recording daily PrEP intake with automated reminders and timestamped logs.; Adherence rate calculated as the proportion of prescribed doses taken (e.g., ≥80% adherence threshold).
Intention to pay for PrEP	3 months	Structured questionnaires evaluating willingness to use three PrEP types (daily oral, on-demand, long-acting injectable) and maximum acceptable out-of-pocket payment (Likert scales (1-5) for willingness).
PrEP-related stigma	3 months	10-item HIV Pre-Exposure Prophylaxis Stigma Scale (HPSS) will be used to measure the PrEP-related stigma. The response format is 5-point Likert scale (1 = strongly disagree; 5 = strongly agree).
Changes in condomless sex	3 months	Retrospective self-reporting: Number of condomless acts in the past 3 months.
Changes in sexual partner numbers	3 months	Retrospective self-reporting: Number of sexual partners in the past 3 months