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Not yet recruiting NCT06619743

HPV Infection and Vaginal Microecology in Immunosuppressed Women

Observational HIV Infections HPV Infection Cervical Cancer Anal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: HIV Infections, HPV Infection, Cervical Cancer, Anal Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study on HPV Infection and Vaginal Microecology in Immunosuppressed Women

Overview

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.

Primary outcome measures

  • 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 3 and above (CIN3+) in women infected with HIV within 5 years [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06619743 · K6758

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗