Gut and Vaginal Microbiota Profile Study for HIV Women
A Cohort Study Among HIV Infected Women：Exploring the Regulatory Mechanism of Gut and Vaginal Microbiota in HPV Infection and Cervical Lesion
1 other identifier
observational
400
1 country
1
Brief Summary
Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually contributes to variable cervical lesions. we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
August 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
December 9, 2025
October 1, 2025
12 years
November 28, 2022
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HPV infection incidence
To collect 400 analyzable samples from women with HIV, including HPV screening, fecal and vaginal microflora samples. Cervical HPV screening will be collected as required in standard containers and stored for transport to the central laboratory.the rates of HPV infection.
0, 6m, 12m, 24m, 36m
cervical lesions
To collect 400 analyzable samples from women with HIV, including vaginal cleanliness assessment and TCT examination. vaginal swab samples will be collected as required in standard containers and stored for transport to the central laboratory.Variable cervical lesions, including CIN I-III and neoplasma.
0, 6m, 12m, 24m, 36m
Eligibility Criteria
Women with HIV Infection from 6 HIV care centers across CHINA, including Beijing, Zhejiang, Guangxi, Yunan, Shanxi and Shandong.
You may qualify if:
- HIV women （including pregnant）;
- sign consent paper
You may not qualify if:
- virgin or maiden
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100070, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Lyu, MD
No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2022
First Posted
August 16, 2023
Study Start
January 1, 2017
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
June 30, 2030
Last Updated
December 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share