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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
None - observational study only
Diagnostic testNo interventions, diagnostics tests for HIV, pregnancy, STIs and BV only
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
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