Objectives To establish temporal links between vaginal microbiota (VMB) data and incident clinical events, frequent longitudinal vaginal sampling is required. Self-collection of swabs at the participant’s home may be useful to avoid overburdening research clinics and participants. One-off vaginal self-sampling for STI or cervical cancer screening programmes has been shown to be feasible and acceptable to women in multiple studies, including in sub-Saharan Africa, but the feasibility and acceptability of frequent longitudinal vaginal sampling in the context of VMB sequencing studies is unknown.
Methods Twelve participants of a randomised clinical trial in Kigali, Rwanda, self-collected vaginal swabs three times a week for a month. We studied feasibility by comparing DNA concentrations, proportions of samples with >1000 16S rRNA amplicon sequencing reads and VMB composition outcomes of self-collected swabs with clinician-collected swabs. We evaluated the acceptability of self-collection using structured face-to-face interviews and a focus group discussion.
Results The participants collected vaginal swabs at 131 different time points. One woman stopped self-sampling after one try due to a social harm. All self-sampled swabs generated >1000 rRNA amplicon sequencing reads, and the DNA concentration of self-sampled swabs and clinician-sampled swabs did not differ significantly (Kruskal-Wallis p=0.484). Self-sampled and clinician-sampled swabs generated similar VMB composition data. Participants reported feeling very comfortable during self-sampling (11/12; 91.7%) and that self-sampling had become easier over time (12/12; 100%). They mentioned reduced travel time and travel costs as advantages of self-sampling at home.
Conclusions Frequent longitudinal vaginal sampling at home is feasible and acceptable to participants, even in the context of a low-resource setting, as long as adequate counselling is provided.
Trial registration number NCT02459665.
- sexual health
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Handling editor Nigel Field
Contributors JvdW obtained the research funding and wrote the study protocol and data collection documents. SA, M-MU and JvdW collected the primary data. M-MU performed the focus group discussion (FGD). MCV developed the analytical approach, performed the experiments, analysed the FGD, performed the statistical analyses and wrote the first version of the manuscript. All authors commented on and approved the final manuscript.
Funding This work was funded by the DFID/MRC/Wellcome Trust Joint Global Health Trials Scheme as a Development Project (grant reference MR/M017443/1; grant title: 'Preparing for a clinical trial of interventions to maintain normal vaginal microbiota for preventing adverse reproductive health outcomes in Africa').
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval All participants provided written informed consent, including separate consent for participation in the focus group discussion. Participants were reimbursed for each study visit at the clinic but not for self-sampling. The study was sponsored by the University of Liverpool and approved by the National Ethics Committee of Rwanda (reference nr. 121/RNEC/2015) and the University of Liverpool Committee on Research Ethics (reference nr. RETH000828), and registered on ClinicalTrials.gov.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Participants were not explicitly asked for consent related to use of their data by external parties or use that does not address the research questions described in the approved study protocol (publicly available at https://datacat.liverpool.ac.uk/). Data were therefore deposited in a controlled access repository at the University of Liverpool. Data can be requested by emailing the Research Data Management team (email@example.com) and the data steward (Professor Janneke van de Wijgert; firstname.lastname@example.org). Requests will be submitted to the University of Liverpool ethics committee (email@example.com) for approval.
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