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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. [ABSTRACT FROM AUTHOR]

Objectives To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence. Design Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial. Setting Research clinic in Kigali, Rwanda. Participants Rwandan women with high sexual risk. Interventions Women diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet. Outcome measures Adherence and acceptability were assessed by structured face-to- face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to- face interviews in randomised women and women attending recruitment sessions (n=131). Results Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher’s exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients. Conclusions High-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes. [ABSTRACT FROM AUTHOR]

Background: Hormonal contraception has been associated with a reduced risk of vaginal dysbiosis, which in turn has been associated with reduced prevalence of sexually transmitted infections (STIs), including HIV. Vaginal rings are used or developed as delivery systems for contraceptive hormones and antimicrobial drugs for STI and HIV prevention or treatment. We hypothesized that a contraceptive vaginal ring (CVR) containing oestrogen enhances a lactobacilli-dominated vaginal microbial community despite biomass accumulation on the CVR’s surface. Methods: We enrolled 120 women for 12 weeks in an open-label NuvaRing® study at Rinda Ubuzima, Kigali, Rwanda. Vaginal and ring microbiota were assessed at baseline and each ring removal visit by Gram stain Nugent scoring (vaginal only), quantitative PCR for Lactobacillus species, Gardnerella vaginalis and Atopobium vaginae, and fluorescent in situ hybridization to visualize cell-adherent bacteria. Ring biomass was measured by crystal violet staining. Results: Bacterial vaginosis (BV) prevalence was 48% at baseline. The mean Nugent score decreased significantly with ring use. The presence and mean log10 concentrations of Lactobacillus species in vaginal secretions increased significantly whereas those of G. vaginalis and presence of A. vaginae decreased significantly. Biomass accumulated on the CVRs with a species composition mirroring the vaginal microbiota. This ring biomass composition and optical density after crystal violet staining did not change significantly over time. Conclusions: NuvaRing® promoted lactobacilli-dominated vaginal microbial communities in a population with high baseline BV prevalence despite the fact that biomass accumulated on the rings. [ABSTRACT FROM AUTHOR]

Background: Introduction of contraceptive vaginal rings (CVRs) could expand the contraceptive method mix reducing the unmet need for family planning in Rwanda, but data on acceptability of CVRs from low and middle-income countries are lacking. Methods: This study explores acceptability of contraceptive vaginal ring (NuvaRing) use in Kigali, Rwanda using a mixed methods approach. We collected quantitative and qualitative data before, during and after conducting a clinical trial, using Case Report Forms, Interviewer Administered Questionnaires, In Depth Interviews and Focus Group Discussions. We analyzed the data using an existing theoretical framework including product attributes, relationship attributes and sexual encounter attributes as well as the contextual environment. Results: Our data showed that initial worries reduced over time with actual ring use and ring insertions and removals were described as easy. Most women did not feel the ring during daily activities, appreciated the lack of perceived negative side effects and the increased lubrication. Relationship attributes and sexual encounter attributes such as sexual comfort played a significant role in ring acceptability of the participants and their partners. The contextual environment including Rwandan cultural norms around sexuality positively influenced the acceptance of the NuvaRing. Overall satisfaction was high. Conclusions: Acceptability of the Nuvaring was high among study participants and represents a promising option that could contribute to lowering the unmet need for family planning in Rwanda. [ABSTRACT FROM AUTHOR]

Background: Contraceptive vaginal rings could play a role in expanding the contraceptive method mix and in preparing communities for the introduction of HIV prevention and multipurpose rings. Methods: We conducted an open label single-centre randomised clinical trial of intermittent versus continuous use of NuvaRing® in Kigali, Rwanda, in 2013–2014. We randomised 120 HIV-negative women 1:1 to intermittent use (three rings with a ring-free week in between rings) or continuous use (four rings without ring-free weeks). Women underwent an interview, counselling, and a speculum examination, and were tested for pregnancy, bacterial vaginosis (BV) by Nugent scoring, yeasts and trichomonads on wet mount, and sexually transmitted infections. Findings: Only one woman withdrew early. Deliberate ring removals were rare, but spontaneous ring expulsions occurred during 14% of ring use periods. There were no incident pregnancies, serious adverse events, serious social harms, or early discontinuations for safety reasons. Systemic side effects were uncommon, and local side effects were not significantly differently distributed between groups except for lower abdominal pain (P = 0.013). The incidence of vaginal yeasts during ring use was high: 22% of intermittent users and 27% of continuous users had incident vaginal yeasts at one or multiple ring removal visits (P = 0.666), and symptomatic vaginal yeast cases were more common in the continuous than intermittent users (P = 0.031). In contrast, mean Nugent scores improved over time in both groups. Conclusions: Intermittent and continuous NuvaRing® use were safe in Rwandan women and improved Nugent scores over time. However, attention should be paid to ring expulsions and to a potential increased risk of vaginal candidiasis. [ABSTRACT FROM AUTHOR]

Background: Research is ongoing to develop multipurpose vaginal rings to be used continuously for contraception and to prevent Human Immunodeficiency Virus (HIV) infection. Contraceptive vaginal rings (CVRs) are available in a number of countries and are most of the time used intermittently i.e. three weeks out of a 4-week cycle. Efficacy trials with a dapivirine-containing vaginal ring for HIV prevention are ongoing and plans to develop multi-purpose vaginal rings for prevention of both HIV and pregnancy have been elaborated. In contrast with the CVRs, multi-purpose vaginal rings will have to be used continuously. Women who continuously use a CVR will no longer have menses. Furthermore, some safety aspects of CVR use have never been studied in-depth in the past, such as the impact of the vaginal ring on the vaginal microbiota, biofilm formation and induction of inflammation. We studied acceptability and these novel aspects of safety in Rwandan women. Although significant progress has been made over the past decade, Rwanda still has a high unmet need for contraception (with 47% unplanned births) and a generalized HIV epidemic, and CVRs are not yet available. Methods: We will conduct an open label, single centre, randomized controlled trial. A total of 120 HIV-negative women will be randomized to intermittent CVR use (to allow menstruation) or continuous CVR use. Women will be followed for a maximum of 14 weeks. In parallel, we will conduct a qualitative study using in-depth interview and focus group discussion methodology. Discussion: In addition to evaluating the safety and acceptability of intermittent and continuous CVR use in Rwandan women, we hope that our findings will inform the development of future multipurpose vaginal rings, will prepare Rwandan study populations for future clinical trials of multipurpose vaginal rings, and will pave the way for introduction of CVRs on African markets. Trial registration: Clinicaltrials.gov NCT01796613. Registered 14 February 2013. [ABSTRACT FROM AUTHOR]

Objectives: We evaluated the performance of an enzymatic point-of-care rapid test for Chlamydia trachomatis (CT) (the BioChekSwab CT Rapid Test, EnZtek Diagnostics, Rio Vista, California, USA), which detects CT's Peptidase 123CBV enzyme and provides a result 15 min after specimen collection.Methods: Two endocervical swabs, including one BioChekSwab, per person were obtained from 137 women who participated in a reproductive health study in Rwanda. The BioChekSwab was processed according to the manufacturer's instructions. A substrate was squirted over the swab by the study physician immediately after collection, and another reagent was released over the swab tip at arrival in the laboratory. The test was considered positive if a blue colour developed within 2 min. The other regular flocked endocervical swab was processed at the Institute of Tropical Medicine (ITM), Belgium, using a testing algorithm: Abbott RealTime CT/Neisseria gonorrhoeae (NG) assay with the confirmation of positive results by an in-house real-time PCR assay.Results: Of the 137 women, nine were CT positive by the testing algorithm. All nine positive results were missed by the BioChekSwab assay and four false-positive results were obtained. The sensitivity was therefore 0% (95% CI 0% to 33.6%) and the specificity was 96.9% (95% CI 92.2% to 99.1%).Conclusions: The BioChekSwab Rapid Test, although ISO13485 certified and Conformitée Européenne (CE) labelled, lacked any sensitivity in our setting. [ABSTRACT FROM AUTHOR]