NCT06931106Not yet recruiting
Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model
Behavioral Intervention to Enhance HIV Pre-Exposure Prophylaxis Service Utilization Among Men Who Have Sex With Men in China Based on Health Action Process Approach and Conditional Economic Incentives
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 1 Apr 2025
- Start date
- Jul 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- Peking University
- Diseases
- HIV
- NCT number
- NCT06931106
What you commit to
- Study type: Interventional
- Planned participants: 360
- From Jul 2025 to the primary completion date, Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Confirmed HIV-positive status or unknown serostatus with refusal of HIV testing;
- Severe mental illness or neurological disorders impairing informed consent process.
Lab values
- Clinically significant health conditions contraindicating PrEP use (e.g., creatinine clearance \<60 mL/min, documented hypersensitivity to PrEP components);
Who the study is looking for
- ≥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.
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.