Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorPeking University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥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;
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
HAPA and CEI behavioral intervention
BehavioralThe 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%).
HAPA-based intervention
BehavioralThis 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.
Treatment groups
360 Participants
are divided into 3 treatment groupsGroup A: Intervention group-BExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Group C: Intervention group-AExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
3 monthsSecondary outcomes
1
PrEP adherence
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).
Time frame
3 months2
Intention to pay for PrEP
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).
Time frame
3 months3
PrEP-related stigma
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).
Time frame
3 months4
Changes in condomless sex
Retrospective self-reporting: Number of condomless acts in the past 3 months.
Time frame
3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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