Clinical trial NCT06931106: Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
PrEP
MSM
Behavior Changes
Keywords: HIV
pre-exposure prophylaxis
men who have sex with men
health action process approach
economic incentive
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 360
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: PrEP Initiation
timeFrame: 3 months
Secondary outcomes:
measure: PrEP adherence
timeFrame: 3 months
measure: Intention to pay for PrEP
timeFrame: 3 months
measure: PrEP-related stigma
timeFrame: 3 months
measure: Changes in condomless sex
timeFrame: 3 months
measure: Changes in sexual partner numbers
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Peking University
name: Wangnan Cao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: