Gut and Vaginal Microbiota Profile Study for HIV Women

August 10, 2023 updated by: Peking Union Medical College Hospital

A Cohort Study Among HIV Infected Women：Exploring the Regulatory Mechanism of Gut and Vaginal Microbiota in HPV Infection and Cervical Lesion

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually contributes to variable cervical lesions. Besides the HPV co-infection, microbiota study recently reveals that the changes of vaginal bacteria spectrum might also be related with cervical disease in WLHIV. However, data on HPV prevalence in WLHIV and its associated cervical lesion incidence is still limited in China. Moreover, the causal relationship between vaginal microbiota and cervical lesion in WLHIV is not clear. Here, we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Wei Lyu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Women with HIV Infection from 6 HIV care centers across CHINA, including Beijing, Zhejiang, Guangxi, Yunan, Shanxi and Shandong.

Description

Inclusion Criteria:

  • HIV women （including pregnant）;
  • sign consent paper

Exclusion Criteria:

  • virgin or maiden

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV infection incidence
Time Frame: 0, 6m, 12m, 24m, 36m
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
Time Frame: 0, 6m, 12m, 24m, 36m
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Wei Lyu, MD, No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2022

Primary Completion (Estimated)

November 9, 2024

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUMCH-K2675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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