HPV Infection and Vaginal Microecology in Immunosuppressed Women

Not yet recruiting

• Conditions: HIV Infections; HPV Infection; Cervical Cancer; Anal Cancer

• Registration Number: NCT06619743
• Lead Sponsor: Lan Zhu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study Start: 2024-10-01
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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