Gut and Vaginal Microbiota Profile Study for HIV Women

A Cohort Study Among HIV Infected Women：Exploring the Regulatory Mechanism of Gut and Vaginal Microbiota in HPV Infection and Cervical Lesion

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05996016

Enrollment

400

Registered

2023-08-16

Start date

2017-01-01

Completion date

2030-06-30

Last updated

2025-12-09

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

Conditions

HIV Infections, HPV, Vaginal Microbiota

Keywords

HPV, Women With HPV infection, vaginal microbiota, gut microbiota

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

14 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* virgin or maiden

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactWei Lyu, MD

lvweipumch@163.com13501385800

Backup ContactZhang Qing

zhangqingpumch@163.com13207572893

Outcome results