Study of gut and vaginal microbiota in women living with HIV

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

This study looks at how the balance of bacteria in the vagina affects the risk of HPV infection and cervical issues in women living with HIV in China.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 14 Years and up
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05996016 on ClinicalTrials.gov

What this trial studies

This observational study focuses on women living with HIV infection to explore the relationship between vaginal microbiota imbalance and susceptibility to HPV infection, which can lead to cervical lesions. The study aims to gather data on HPV prevalence and its associated cervical lesion incidence among this population in China. By investigating the microbiota profiles, researchers hope to clarify the causal relationship between vaginal microbiota and cervical disease in women with HIV. The findings could provide insights into potential preventive measures for cervical lesions in this vulnerable group.

Who should consider this trial

Good fit: Ideal candidates for this study are women living with HIV, including those who are pregnant.

Not a fit: Patients who are virgins or maidens will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and prevention of cervical lesions in women living with HIV.

How similar studies have performed: While there is limited data on HPV prevalence in women living with HIV in China, similar studies in other regions have shown promising results regarding the relationship between microbiota and cervical health.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* virgin or maiden

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Wei Lyu, MD — No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China
• Study coordinator: Wei Lyu, MD

Conditions HPV; HIV Infections; Vaginal Microbiota; Women With HPV infection; vaginal microbiota; gut microbiota