Southern Sichuan HIV Cohort Study Protocol

NCT07519538 | Active Not Recruiting DMC

• 1 other identifier: SWMUPH-2025001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-source data-integrated HIV cohort in four cities of southern Sichuan, China: a mixed retrospective-prospective study protocol.

Conditions

HIV - Human Immunodeficiency Virus

Keywords

HIV; China; Viral suppression; Antiretroviral therapy (ART); Cohort study; Real-world evidence

Outcome Measures

Primary Outcomes (1)

• 12-month virological suppression

  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.

  12 months (±60 days) after baseline

Secondary Outcomes (7)

• 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)

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of people living with HIV (PLWH) who receive care at designated HIV treatment institutions across four prefecture-level cities in southern Sichuan Province, China: Luzhou, Zigong, Neijiang, and Yibin. These four cities collectively comprise 23 districts and counties with considerable intra-regional variation in healthcare resources and HIV burden. Participants are recruited from outpatient clinics and community follow-up encounters at the participating study sites. The study employs a consecutive enrolment strategy with quota controls applied by city and age group (\<50, 50-64, ≥65 years) to ensure adequate representation across clinically relevant strata. The ≥65 years age stratum is deliberately oversampled to enable robust subgroup analyses of older adults, who face unique challenges including polypharmacy and age-related comorbidities. The retrospective component includes individuals with historical records from 1 January 2019 to 31 December 2025. The

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest Medical University: lead

Study Sites (1)

Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Based on the study protocol, no biological samples (e.g., blood, tissue, saliva, or other biospecimens) are collected or retained as part of this research. The study exclusively relies on: Passive data sources: Routinely collected electronic medical records (EMRs), CDC surveillance registries, pharmacy dispensing logs, and health insurance claims. Active data collection: Patient-reported outcome questionnaires (administered via tablet or face-to-face) covering mental health, quality of life, stigma, self-management, and treatment preferences. All information is data-based (clinical variables, laboratory results already recorded in medical systems, and questionnaire responses). There is no biobank, blood draw, or specimen storage component.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Public Health

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)