Research on vaginal microbiomes in African women
Official title: Vaginal Microbiome Research Consortium for Africa - Pilot
Run by University of Cape Town · NCT06662747 · Data updated 2026-11-12
This study is trying to understand the different types of bacteria in the vagina of young women from South Africa and Kenya to see how they relate to HPV and inflammation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | University of Cape Town Academic / other |
| Locations | 2 sites (Kisumu, Kisumu County and 1 other locations) |
| Status | Recruiting |
| Started | October 15, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | October 31, 2026 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT06662747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy women aged 18-40, HIV negative, and sexually active in the last three months.
✕Probably not a fit
Patients who are male at birth, pregnant, or living with HIV or untreated STIs will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to characterize the dynamics of vaginal microbial communities in women from different regions of Africa, focusing on those with stable Lactobacillus crispatus-dominant microbiota versus unstable types. It will also investigate the prevalence and diversity of HPV types in relation to these microbiota and assess inflammation levels. The study will enroll cohorts of young, healthy women from South Africa and Kenya, following them for 10 weeks to create detailed microbial profiles. Additionally, a biobank will be established to store samples for future research and to isolate regionally representative bacterial strains.
Why it matters
Potential benefit: If successful, this research could lead to the development of targeted treatments for bacterial vaginosis and improved vaginal health for women globally.
How similar studies have gone: While studies on vaginal microbiomes exist, this specific focus on African populations and the establishment of a biobank is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Kemri
Kisumu, Kisumu County, Kenya Recruiting -
Desmond Tutu Health Foundation
Cape Town, Western Cape, South Africa Recruiting
Study contacts
- Study coordinator: Jo-Ann S Passmore, PhD
- Email: jo-ann.passmore@uct.ac.za
- Phone: +27 78 421 2701
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.