NCT06662747 Vaginal Microbiome Research Consortium for Africa
| NCT ID | NCT06662747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cape Town |
| Condition | Healthy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-10-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-10-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 * 18-40 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 Criteria: * 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
Contact & Investigator
Brian R Kullin, PhD
STUDY DIRECTOR
Research Officer
Frequently Asked Questions
Who can join the NCT06662747 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06662747 currently recruiting?
Yes, NCT06662747 is actively recruiting participants. Contact the research team at jo-ann.passmore@uct.ac.za for enrollment information.
Where is the NCT06662747 trial being conducted?
This trial is being conducted at Kisumu, Kenya, Cape Town, South Africa.
Who is sponsoring the NCT06662747 clinical trial?
NCT06662747 is sponsored by University of Cape Town. The principal investigator is Brian R Kullin, PhD at Research Officer. The trial plans to enroll 200 participants.