Gut and Vaginal Microbiota Profile Study for HIV Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age14+
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
HIV women （including pregnant）;
sign consent paper
Disqualifiers
virgin or maiden
Trial population
Women with HIV Infection from 6 HIV care centers across CHINA, including Beijing, Zhejiang, Guangxi, Yunan, Shanxi and Shandong.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
- Other intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
HPV infection incidence
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.
Time frame
0, 6m, 12m, 24m, 36m2
cervical lesions
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.
Time frame
0, 6m, 12m, 24m, 36mSponsors and contacts
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Source ClinicalTrials.gov