Vaginal Microbiome Research Consortium for Africa
Vaginal Microbiome Research Consortium for Africa - Pilot
University of Cape Town
200 participants
Oct 15, 2021
OBSERVATIONAL
Conditions
Summary
1. To characterise vaginal microbial community dynamics (bacterial and fungal) from different geographies in Africa to understand the microbial diversity that occurs in women with stable L. crispatus-dominant versus unstable vaginal microbiota. 2. To identify vaginal communities associated with low levels of inflammation in women from different geographies in Africa 3. To examine prevalence and diversity of HPV types circulating in the different geographies and their interaction with the vaginal microbiota 4. To create a biobank of stored samples that can be used in future studies and for the isolation of regionally representative bacterial strains.
Eligibility
Inclusion Criteria9
- Female at birth
- Willing and able to provide informed consent for screening and cognitive ability to understand sampling procedures
- Not pregnant
- HIV negative on testing performed by study staff
- -40 years old
- Planning to stay in the area for the next 10 weeks
- Able and willing to provide adequate locator information for study retention purposes
- Willing and able to return for all 3 nurse visits and return self-swabs to the clinic weekly
- Sexually active for the last 3 months defined as penetrative penile-vaginal intercourse at least once in the last 3 months
Exclusion Criteria10
- Male at birth
- Not willing to provide consent
- Pregnant or actively trying to conceive/become pregnant in the next 10 weeks
- Living with HIV or untreated STIs (CT, NG, TV) or bacterial vaginosis (Nugent > 3)
- Currently taking antibiotics or having been on antibiotic treatment in the previous four weeks
- <18 or >40 years old
- On chronic disease management for gynaecological conditions
- Any medical condition or other factors which would preclude study participation as per principal Investigator's or designee's decision, including but not limited to cancer of the cervix
- Any mental health condition which, in the opinion of the investigator, would preclude comprehension of informed consent, or preclude study participation
- Currently enrolled on any other study prohibiting co-enrolment
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Interventions
No interventions, diagnostics tests for HIV, pregnancy, STIs and BV only
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06662747