Vaginal Microbiome Research Consortium for Africa

ConditionHealthy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorUniversity of Cape Town

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Participants will be recruited via the CRS standard recruiting process. Participants will be informed about the study via social media, flyers and posters. Each site will use a variety of recruitment approaches that works best for the local setting. Recruitment may be conducted through the following possible approaches: community events and mobilisation, partnerships with appropriate programs and via popular social media platforms. Recruitment materials will educate women about HIV, sexual health, and risks in their community, the effectiveness of PrEP for HIV prevention, and the benefits of HIV prevention services. Recruitment will occur over approximately 12 months.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • None - observational study only

    Diagnostic test

    No interventions, diagnostics tests for HIV, pregnancy, STIs and BV only

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Healthy1 intervention

Trial outcomes

Primary outcomes

1

Geographic Insights into Vaginal Microbial Diversity: Characterizing Bacterial and Fungal Community Dynamics in African Women with Stable L. crispatus-Dominated vs. Unstable Microbiota.

The study measures the dynamics of vaginal microbial communities (bacterial and fungal) across different African geographies in women with stable L. crispatus-dominant and unstable microbiota. Specific measurements include the recovery of bacterial and fungal DNA through DNA extraction methods. For bacterial profiling, the analysis includes the use of 16S rRNA gene sequencing targeting the V3-V4 variable regions, while fungal diversity, specifically Candida species, is assessed via Internal Transcribed Spacer (ITS) sequencing. The sequencing data is processed using bioinformatics tools such as QIIME2 and DADA2 for quality control, filtering, and taxonomic assignment. Alpha (within-sample) and beta (between-sample) diversity are measured using metrics including the Shannon index and Bray-Curtis dissimilarity. Additionally, multivariate techniques such as NMDS and PCA are employed to visualize community structures and differences.

Time frame
5 years
2

Explore Vaginal Microbiome Profiles and Their Association with Low Inflammatory States in Women Across Diverse African Geographies.

This study measures vaginal microbial communities associated with low inflammation levels in women across various African geographies. The assessment includes the prevalence of HPV types in different regions, evaluated through statistical tests such as Chi-square and logistic regression to determine geographic variations. The composition of the vaginal microbiota will be analyzed using bioinformatics techniques to report alpha (within-sample) and beta (between-sample) diversity metrics. Significant variations in microbiota profiles across regions will be identified using ANOSIM and PERMANOVA statistical methods. Correlations between specific HPV types and microbiota profiles will be quantified using Spearman or Pearson correlation coefficients to assess their interactions.

Time frame
3 years
3

Geographic Variation in HPV Type Prevalence and Divers.

This study will measure HPV type prevalence and diversity across various geographies, as well as its interaction with vaginal microbiota. HPV prevalence will be quantified using molecular methods including PCR and next-generation sequencing (NGS) for DNA detection and type analysis. Vaginal microbiota will be profiled by extracting microbial DNA from swabs, followed by 16S rRNA gene sequencing or metagenomics. The outcome measures include the calculation of HPV prevalence and diversity, utilizing metrics such as the Shannon index. Additional outcome measures involve statistical analysis to characterize relationships between HPV types and microbiota composition, as well as correlation analysis to identify links between specific HPV types and microbial species. This analysis aims to clarify the role of the microbial community in HPV infection and persistence, with a focus on identifying potential protective effects of specific microbiota profiles.

Time frame
5 years
4

Establishment of a Regional Biobank

Create a biobank of stored samples that can be used in future studies and for the isolation of regionally representative bacterial strains.

Time frame
4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cape Town

Lead sponsor

Desmond Tutu HIV Foundation

Collaborator

Kenya Medical Research Institute

Collaborator