Gut and Vaginal Microbiota Profile Study for HIV Women

Recruiting

• Conditions: HPV; Vaginal Microbiota; HIV Infections

• Registration Number: NCT05996016
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-09
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-16
• Last Update Posted: 2023-08-16
• Primary Completion: 2024-11-09
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• virgin or maiden

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV infection incidence	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.
cervical lesions	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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China