HPV Infection and Vaginal Microecology in Immunosuppressed Women

September 27, 2024 updated by: Lan Zhu

Study on HPV Infection and Vaginal Microecology in Immunosuppressed Women

This study intends to establish a screening cohort for HPV infection and related tumors in areas with high incidence of HIV infection, explore the screening of cervical cancer and anal cancer and the prognosis management model of precancerous lesions in HIV-infected women, and provide a scientific basis for the formulation of malignant tumor screening policies for this population in my country. In addition, this study intends to characterize the cervical, vaginal, and intestinal microecological characteristics of women with different HIV/HPV infection status, so as to explore the impact of cervical, vaginal, and intestinal microecological characteristics on persistent HPV infection or CIN/cancer progression.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10000

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HIV-infected women

Description

Inclusion Criteria:

  • HIV positive female, ≥18 years old
  • HIV infection is sexually transmitted
  • Have an intact cervix
  • Have not received cervical cancer screening in the past 1 year
  • No previous treatment for CIN/cervical cancer
  • No clinical pregnancy symptoms

Exclusion Criteria:

  • Women who have had a previous cervical resection
  • Unable to complete all screening processes independently
  • Unable or unwilling to accept follow-up
  • For subjects in vaginal microecology studies, women who used antibiotics within 2 weeks before collecting vaginal secretions, had sexual intercourse within 3 days, or used vaginal medication or vaginal douching within 48 hours need to be further excluded.

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
Detection rate of cervical intraepithelial neoplasia grade 2 or above (CIN2+) in women infected with HIV within 5 years
Time Frame: 5 years
Detection rate of cervical intraepithelial neoplasia grade 2 or above (CIN2+) in women infected with HIV within 5 years
5 years
Detection rate of cervical intraepithelial neoplasia grade 3 and above (CIN3+) in women infected with HIV within 5 years
Time Frame: 5 years
Detection rate of cervical intraepithelial neoplasia grade 3 and above (CIN3+) in women infected with HIV within 5 years
5 years

Collaborators and Investigators

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

Sponsor

Lan Zhu

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K6758

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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