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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 主要终点
- PrEP Initiation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •≥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.
排除标准
- •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.
研究组 & 干预措施
Intervention group-B
Participants will receive the AI-based HAPA and CEI behavioral intervention.
干预措施: HAPA and CEI behavioral intervention (Behavioral)
Control group
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
Participants will receive HAPA-based behavioral intervention on the We-chat mini progarm.
干预措施: HAPA-based intervention (Behavioral)
结局指标
主要结局
PrEP Initiation
时间窗: 3 months
The primary outcome indicators of this study is the rate of PrEP initiation, based on PrEP prescriptions issued by doctors.
次要结局
- PrEP adherence(3 months)
- Intention to pay for PrEP(3 months)
- PrEP-related stigma(3 months)
- Changes in condomless sex(3 months)
- Changes in sexual partner numbers(3 months)
研究者
Wangnan Cao
Associate Professor
Peking University