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Vaginal Microbiome Research Consortium for Africa

Launched by UNIVERSITY OF CAPE TOWN · Oct 25, 2024

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

The Vaginal Microbiome Research Consortium for Africa is a clinical trial aimed at understanding the different types of bacteria and fungi found in the vaginal area of women across various regions in Africa. The study focuses on healthy women to see how their vaginal microbial communities change, how these communities can relate to lower levels of inflammation, and what types of human papillomavirus (HPV) are present in these areas. Additionally, samples collected during the study will be stored for future research, helping to create a valuable resource for understanding women's health in the region.

To be eligible for this study, participants must be biologically female, aged between 18 and 40 years, and willing to provide consent for the trial. They should not be pregnant, living with HIV, or currently taking antibiotics. Participants should also have been sexually active in the last three months and must be able to attend three nurse visits over the study period. If you choose to participate, you can expect to provide self-samples weekly and attend regular check-ins with the study team to help contribute to important research that could benefit women's health in Africa.

Gender

FEMALE

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

About University Of Cape Town

The University of Cape Town (UCT) is a leading research institution in South Africa, renowned for its commitment to advancing medical science and improving public health outcomes. With a strong emphasis on innovation and interdisciplinary collaboration, UCT conducts a wide range of clinical trials aimed at addressing critical health challenges both locally and globally. The university's dedicated research teams leverage cutting-edge methodologies and ethical standards to ensure the integrity and efficacy of their studies, fostering an environment that promotes scientific excellence and enhances the understanding of various medical conditions. Through its robust partnerships with healthcare institutions and community organizations, UCT is poised to make significant contributions to the field of clinical research and the development of effective therapeutic interventions.

Locations

Cape Town, Western Cape, South Africa

Kisumu, , Kenya

Patients applied

0 patients applied

Trial Officials

Brian R Kullin, PhD

Study Director

Research Officer

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported