Gut and Vaginal Microbiota Profile Study for HIV Women
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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HIV women （including pregnant）;
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sign consent paper
Exclusion Criteria:
- virgin or maiden
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100070 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Wei Lyu, MD, No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PekingUMCH-K2675