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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое HAPA and CEI behavioral intervention
  The 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 fo
• Поведенческое HAPA-based intervention
  This 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 st

Первичные конечные точки

• PrEP Initiation [Срок оценки: 3 months]

Вторичные конечные точки (5)

• PrEP adherence [Срок оценки: 3 months]
• Intention to pay for PrEP [Срок оценки: 3 months]
• PrEP-related stigma [Срок оценки: 3 months]
• Changes in condomless sex [Срок оценки: 3 months]
• Changes in sexual partner numbers [Срок оценки: 3 months]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06931106 · IRB00001052-24167

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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