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HPV Infection and Vaginal Microecology in Immunosuppressed Women

Study on HPV Infection and Vaginal Microecology in Immunosuppressed Women

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06619743
Enrollment
10000
Registered
2024-10-01
Start date
2024-10-01
Completion date
2029-12-31
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer, Cervical Cancer, HIV Infections, HPV Infection

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.

Interventions

None listed

Sponsors

Lan Zhu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Detection rate of cervical intraepithelial neoplasia grade 2 or above (CIN2+) in women infected with HIV within 5 years5 yearsDetection 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 years5 yearsDetection rate of cervical intraepithelial neoplasia grade 3 and above (CIN3+) in women infected with HIV within 5 years

Contacts

Primary ContactRoujie Huang
hroujie@163.com+8618373153750
Backup ContactLan Zhu, MD
zhu_julie@vip.sina.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026