Actively Recruiting

Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT06662747

Vaginal Microbiome Research Consortium for Africa

Led by University of Cape Town · Updated on 2025-08-03

200

Participants Needed

2

Research Sites

263 weeks

Total Duration

On this page

Sponsors

U

University of Cape Town

Lead Sponsor

D

Desmond Tutu HIV Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Vaginal Microbiome Research Consortium for Africa

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female at birth
  • Able and willing to give informed consent and understand sampling procedures
  • Not pregnant
  • HIV negative by study testing
  • Aged 18 to 40 years
  • Planning to remain in the study area for 10 weeks
  • Willing and able to provide contact information for follow-up
  • Willing and able to attend all 3 nurse visits and return weekly self-swabs
  • Sexually active in the last 3 months with penile-vaginal intercourse at least once
Not Eligible

You will not qualify if you...

  • Male at birth
  • Unwilling to provide consent
  • Pregnant or actively trying to conceive during the 10-week study
  • Living with HIV or having untreated STIs (chlamydia, gonorrhea, trichomoniasis) or bacterial vaginosis (Nugent score > 3)
  • Currently on antibiotics or used antibiotics in the past 4 weeks
  • Younger than 18 or older than 40 years
  • Receiving treatment for gynecological chronic diseases
  • Any medical condition or factor that prevents participation, including cervical cancer
  • Any mental health condition that impairs consent or participation
  • Enrolled in another clinical study that prohibits co-enrollment

AI-Screening

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Trial Site Locations

Total: 2 locations

1

KEMRI

Kisumu, Kisumu County, Kenya, 40100

Actively Recruiting

2

Desmond Tutu Health Foundation

Cape Town, Western Cape, South Africa, 7975

Actively Recruiting

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Research Team

J

Jo-Ann S Passmore, PhD

CONTACT

T

Tanya Pidwell, MSc Hons

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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