Multi-source Data-integrated HIV Cohort in Four Cities of Southern Sichuan, China: a Mixed Retrospective-prospective Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 12-month virological suppression
研究概览
简要总结
Multi-source data-integrated HIV cohort in four cities of southern Sichuan, China: a mixed retrospective-prospective study protocol.
详细描述
This study is a mixed retrospective-prospective cohort study conducted across four prefecture-level cities in southern Sichuan Province, China: Luzhou, Zigong, Neijiang, and Yibin. These four cities together comprise 23 districts and counties, with HIV care delivered through a network of designated treatment institutions coordinated by local Centers for Disease Control and Prevention (CDC). The region exhibits substantial intra-regional variation in healthcare resources and HIV burden, with molecular epidemiological data showing predominant CRF01_AE (36.9%) and CRF07_BC (41.0%) subtypes and evidence of concentrated transmission clusters among older adults (aged ≥60 years).
Retrospective component Data are extracted from existing electronic medical records (EMRs), CDC surveillance registries, and pharmacy/insurance claims systems for the period from 1 January 2019 to 31 December 2025. This phase reconstructs individual-level historical trajectories of antiretroviral therapy (ART) engagement, laboratory monitoring (CD4, viral load), and clinical outcomes to establish the baseline cohort.
Prospective component From 1 January 2026 to 31 December 2026, newly diagnosed individuals and those transferring into care are enrolled consecutively with quota controls by city and age group (<50, 50-64, ≥65 years). At scheduled clinic visits, trained interviewers administer tablet-based structured questionnaires capturing patient-reported outcomes, including health-related quality of life (MOS-HIV, EQ-5D-5L), mental health (PHQ-9, GAD-7), HIV stigma (Berger Stigma Scale), self-management capacity, social determinants of health, and treatment preferences via a discrete choice experiment (5 attributes, 9 choice sets). Clinical data continue to be collected from routine sources.
Data integration A deterministic linkage procedure uses the unique ART treatment code as the primary key, with probabilistic linkage for records where the code is missing. A linkage failure threshold of 5% triggers manual verification. All data are harmonized (ICD-10 diagnoses, YPID medication codes, standardized laboratory units) and stored on encrypted servers with restricted access.
Sample size Target enrolment is 2,000 participants across the four cities, accounting for an anticipated 15% loss to follow-up. This ensures ≥1,700 participants with complete 12-month outcome data, providing ≥200 virological failure events (assuming a 12% failure rate) to satisfy the "10 events per variable" rule for multivariable analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People living with HIV (PLWH) or AIDS patients who are registered and diagnosed at the participating research centers in Luzhou, Zigong, Neijiang, or Yibin, China
- •Key assessment information (clinical, laboratory, or follow-up data) obtainable during the study period
- •Traceable medical treatment or follow-up records within the retrospective time window (1 January 2019 to 31 December 2025)
- •Able to understand and complete the questionnaire and provide written informed consent (for the prospective component)
- •Residing or visiting within the four southern Sichuan cities, or continuously managed at the local research centers
排除标准
- •Missing key information that cannot be verified or supplemented from original records
- •Unable to complete the questionnaire and no alternative data collection method available
- •Obviously inconsistent or untrustworthy data that cannot be confirmed after verification
- •Not suitable for inclusion under ethical and compliance requirements (e.g., unable to provide consent without a legally authorized representative when required)
研究组 & 干预措施
Southern Sichuan HIV Cohort
People living with HIV (PLWH) enrolled from four prefecture-level cities in southern Sichuan, China (Luzhou, Zigong, Neijiang, and Yibin). Participants are recruited consecutively from outpatient clinics and community follow-up encounters, with quota controls applied by city and age group (<50, 50-64, ≥65 years). All participants receive standard antiretroviral therapy (ART) per Chinese national guidelines. There is no assigned intervention. Data collection includes retrospective extraction of routine clinical, laboratory, and pharmacy records (2019-2025) and prospective collection of patient-reported outcomes (mental health, quality of life, stigma, self-management, treatment preferences) via structured questionnaires at baseline and follow-up visits. The primary outcome is 12-month virological suppression (HIV RNA <50 copies/mL).
结局指标
主要结局
12-month virological suppression
时间窗: 12 months (±60 days) after baseline
Proportion of participants achieving HIV RNA \<50 copies/mL measured at the 12-month assessment window (±60 days). This binary outcome is derived from routinely collected viral load measurements extracted from CDC registries or hospital electronic medical records. If multiple measurements exist within the window, the value closest to the 12-month target date is used. This definition aligns with UNAIDS 95-95-95 targets and Chinese national treatment guidelines.
次要结局
- Virological failure(Up to 24 months (prospective follow-up period))
- Change in CD4 count(Baseline and 12 months (±60 days))
- Treatment persistence(12 months and 24 months)
- Health-related quality of life (MOS-HIV)(Baseline and 12 months (±60 days))
- Depressive symptom severity (PHQ-9)(Baseline and 12 months (±60 days))
- Anxiety symptom severity (GAD-7)(Baseline and 12 months (±60 days))
- HIV-related stigma (Berger Stigma Scale)(Baseline only)
研究者
yingming wang
Master of Public Health
Southwest Medical University