Response to Antibiotic Treatment of Bacterial Vaginosis Predicts the Effectiveness of LACTIN-V (Lactobacillus crispatus CTV-05) in the Prevention of Recurrent Disease.

OBJECTIVES: Live biotherapeutic products (LBPs) containing vaginal Lactobacillus crispatus are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment. METHODS: A post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial (L. crispatus CTV-05) explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 Food and Drug Administration guidance) 2 days after completion of treatment with vaginal metronidazole gel on the effectiveness of an 11-week LACTIN-V dosing regimen to prevent BV recurrence by 12 and 24 weeks. RESULTS: At enrollment, 88% of participants had achieved postantibiotic clinical BV cure. The effect of LACTIN-V on BV recurrence compared with placebo differed by initial clinical BV cure status. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (95% confidence interval, 0.35-0.77) among participants with initial clinical BV cure after metronidazole treatment and 1.34 (95% confidence interval, 0.47-2.23) among participants without postantibiotic clinical BV cure. Among women receiving LACTIN-V, those who had achieved postantibiotic clinical BV cure at enrollment reached higher levels of detectable L. crispatus CTV-05 compared with women failing to achieve postantibiotic clinical BV cure. CONCLUSIONS: LACTIN-V seems to only decrease BV recurrence in women with clinical cure of BV after initial antibiotic treatment. Future trials of LBPs should consider limiting enrollment to these women.

Expanding the pipeline for multipurpose prevention technologies: compounds with potential activity to prevent or treat HIV and other STIs.

BACKGROUND: Continued high incidence of HIV and other STIs, paired with rising antibiotic resistance to a number of existing treatments, warrants the development of new pharmaceutical approaches for STI prevention. Multipurpose prevention technologies (MPTs) offer an innovative approach for expanding HIV/STI prevention. The majority of MPT product candidates currently in development include HIV prevention, while only half include compounds active against non-HIV STIs. METHODS: This narrative review focuses on compounds in preclinical development (in vitro and in vivo) through phase 3 clinical trials with activity against one or more of the following infections: HIV, HSV-1, HSV-2, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, and Trichomonas vaginalis. Bacterial vaginosis is included due to its association with increased risk of STIs. The focus is on compounds with novel mechanisms of action and prophylactic and/or therapeutic potential. Articles published in PubMed between 2011 and 2021, NIH RePorter and conference abstracts and proceedings between 2020 and 2021 were searched. Excluded from the review are compounds that are already being used in MPT product candidates. MAIN RESULTS: There is a growing pipeline of compounds targeting viral STIs, many of which have successfully transitioned from preclinical to clinical stages of development. However, the product development pipeline remains limited for compounds that target bacterial STIs. CONCLUSIONS: The paucity of new pharmaceutical approaches for STI prevention, particularly non-HIV STIs, remains a public health gap. Future funding priorities should include STI prevention research. Despite limited attention to STI prevention in the development of MPTs, many research institutions worldwide are working on discoveries of new compounds, exploring new indications for existing drugs or on innovative drug delivery mechanisms. Our findings can be used to connect researchers across the globe to advance the development of compounds that have potential as active pharmaceutical ingredients in future MPTs.

Treatment Success Following Standard Antibiotic Treatment for Bacterial Vaginosis Is Not Associated With Pretreatment Genital Immune or Microbial Parameters.

Background: Bacterial vaginosis (BV) is a proinflammatory genital condition associated with adverse reproductive health outcomes, including increased HIV incidence. However, BV recurrence rates are high after standard antibiotic treatment. While the composition of the vaginal microbiota before BV treatment may be linked to BV recurrence, it is unclear whether the preceding genital immune milieu is predictive of treatment success. Methods: Here we assessed whether baseline vaginal soluble immune factors or the composition of the vaginal microbiota predicted treatment success 1 month after metronidazole treatment in 2 separate cohorts of women with BV, 1 in the United States and 1 in Kenya; samples within 48 hours of BV treatment were also available for the US cohort. Results: Neither soluble immune factors nor the composition of the vaginal microbiota before BV treatment was associated with treatment response in either cohort. In the US cohort, although the absolute abundances of key vaginal bacterial taxa pretreatment were not associated with treatment response, participants with sustained BV clearance had a more pronounced reduction in the absolute abundance of Gardnerella vaginalis immediately after treatment. Conclusions: Pretreatment immune and microbial parameters were not predictive of BV treatment success in these clinical cohorts.

Recovery and Resilience in the Canal Community: Economic Impacts and Solutions During the COVID-19 Pandemic.

BACKGROUND: Public health pandemics, such as COVID-19, not only impact the physical health and wellbeing of communities but also often have far-reaching effects on their social, psychological, environmental, and economic welfare. The coronavirus pandemic has highlighted the significant inequities experienced among those who are Black, Indigenous, and People of Color (BIPOC), especially in the areas of housing instability, unemployment, and debt accrual. This study investigates the socioeconomic impacts of COVID-19 on residents of the Canal neighborhood ("The Canal"), a low-income Latinx community in Marin County, California. This study also uplifts mitigation strategies already underway to facilitate post-pandemic recovery efforts. METHODS: This study utilized a mixed-methods, community participatory approach in which community leaders from a local nonprofit, Canal Alliance, administered a survey assessing the impact of COVID-19 on Canal residents. Additionally, community stakeholders including nonprofits, small businesses, and public officials were interviewed, and their field notes were analyzed through exploratory open coding. RESULTS: On a macro level, the data showed that Canal residents were severely impacted by COVID-19 in the form of massive job loss (61.2% of respondents were unemployed or underemployed) as well as financial stress related to eviction, housing instability, and debt accrual (78.8% of respondents struggled to cover rent and often had to borrow money from friends and family). CONCLUSIONS: In spite of the severe socioeconomic impacts of COVID-19 on The Canal, there is a significant opportunity for recovery and growth because of an overwhelming investment by residents, community-based organizations, and public officials to support those who have been financially impacted by the pandemic. Some key areas of policy focus include expansion of affordable housing, pandemic-resistant workforce development, and restructuring of social services to increase accessibility. This report will explore recommendations related to strategic funding of community-based programs as well as short-term and long-term solutions for economic recovery.

Sustained effect of LACTIN-V (Lactobacillus crispatus CTV-05) on genital immunology following standard bacterial vaginosis treatment: results from a randomised, placebo-controlled trial.

BACKGROUND: Bacterial vaginosis might increase HIV risk by eliciting genital inflammation and epithelial barrier disruption, whereas vaginal Lactobacillus crispatus is associated with immune quiescence and HIV protection. We investigated the effect of a live biotherapeutic containing L crispatus CTV-05 (LACTIN-V) on genital immunology and key vaginal bacteria. METHODS: This substudy included women aged 18-45 years who participated in the randomised, placebo-controlled, phase 2b trial of LACTIN-V to reduce bacterial vaginosis recurrence, conducted at four universities and hospitals in the USA. Women with negative results for sexually transmitted infection, pregnancy, and urinary tract infection were provided a 5-day course of vaginal metronidazole 0·75% gel. Those who met at least three of four clinical Amsel criteria for bacterial vaginosis and had a Nugent score of 4-10 from Gram staining were eligible. Participants in the LACTIN-V trial were randomly assigned (2:1) to receive either LACTIN-V or placebo, applied vaginally once per day for 5 days during the first week and then twice per week for 10 more weeks. Follow-up visits occurred 4, 8, 12, and 24 weeks after enrolment. Soluble immune factors and the absolute abundance of bacterial taxa were assayed by mutliplex ELISA and quantitative PCR. The primary outcomes were vaginal levels of IL-1α and soluble E-cadherin at 24 weeks (ie, 13 weeks after treatment cessation). FINDINGS: Between Feb 21, 2020 and March 18, 2021, we characterised genital immune parameters and the vaginal microbiota in a subset of 66 highly adherent participants who were randomly selected, with no exclusion criteria, from those who had attended all study follow-up visits (n=166) in the larger LACTIN-V clinical trial (n=288). 32 (48%) participants received LACTIN-V and 34 (52%) received placebo. LACTIN-V treatment was significantly associated with lower concentrations of the proinflammatory cytokine IL-1α (ß coefficient 0·310, SE 0·149; p=0·042) and soluble E-cadherin (0·429, 0·199; p=0·035), a biomarker of epithelial barrier disruption. INTERPRETATION: Vaginal administration of LACTIN-V following standard bacterial vaginosis therapy resulted in a sustained reduction in genital inflammation and a biomarker of epithelial integrity. The potential of LACTIN-V to reduce HIV susceptibility merits further investigation. FUNDING: Canadian Institutes of Health Research and the National Institutes of Health National Institute of Allergy and Infectious Diseases.

Metronidazole treatment rapidly reduces genital inflammation through effects on bacterial vaginosis-associated bacteria rather than lactobacilli.

BackgroundBacterial vaginosis (BV) causes genital inflammation and increases HIV risk, whereas a vaginal microbiota dominated by Lactobacillus species is associated with immune quiescence and relative HIV protection. BV treatment reduces genital inflammation, but it is unclear whether this reduction is driven by a decrease in BV-associated bacteria or an increase in Lactobacillus species.METHODSTo evaluate the short-term effect of standard BV treatment on genital immunology and the vaginal microbiota, vaginal swabs were collected immediately before and after metronidazole treatment for BV and analyzed with multiplex ELISA, metagenomic sequencing, and quantitative PCR.RESULTSTopical metronidazole treatment rapidly reduced vaginal levels of proinflammatory cytokines, chemokines, and soluble immune markers of epithelial barrier disruption. Although the vaginal microbiota shifted to dominance by L. iners or L. jensenii, this proportional shift was primarily driven by a 2 to 4 log10-fold reduction in BV-associated bacteria absolute abundance. BV treatment induced no change in the absolute abundance of L. crispatus or L. iners and only minor (<1 log10-fold) increases in L. gasseri and L. jensenii that were not independently associated with reduced inflammation in multivariable models.CONCLUSIONThe genital immune benefits that are associated with Lactobacillus dominance after BV treatment were not directly attributable to an absolute increase in lactobacilli, but rather to the loss of BV-associated bacteria.Trial REGISTRATIONParticipants were recruited as part of a randomized controlled trial (ClinicalTrials.gov NCT02766023) from 2016 to 2019.FUNDINGCanadian Institutes of Health Research (PJT-156123) and the National Institute of Allergy and Infectious Diseases (HHSN2722013000141 and HHSN27200007).

Connecting the Dots: Translating the Vaginal Microbiome Into a Drug.

A Lactobacillus-dominated vaginal microbiota (VMB) has been associated with health and considered an important host defense mechanism against urogenital infections. Conversely, depletion of lactobacilli and increased microbial diversity, amplifies the risk of adverse gynecologic and obstetric outcomes. A common clinical condition that exemplifies dysbiosis is bacterial vaginosis (BV). BV is currently treated with antibiotics, but frequently recurs, due in part to persistent dysbiosis and failure of lactobacilli to repopulate the vagina. New treatment options are needed to address BV. The VMB is relatively simple and optimally dominated by one or several species of Lactobacillus. Lactobacillus crispatus is strongly associated with vaginal health and depleted in dysbiosis. Replenishing the dysbiotic VMB with protective L. crispatus CTV-05 is a promising approach to prevent recurrent infections and improve women's health. Here we discuss confirmation of this approach with the microbiome-based biologic drug, LACTIN-V (L. crispatus CTV-05), focusing on prevention of BV recurrence.

Towards a roadmap to advance non-hormonal contraceptive multipurpose prevention technologies: strategic insights from key stakeholders†.

The development of non-hormonal contraceptives is critical to increase options for women. In combination with prevention against sexually transmitted infections, they can become an important component of multipurpose prevention technologies (MPTs) which address multiple reproductive health needs with a single product. Resulting from multiple rounds of expert consultations, this framework aims to guide the development of non-hormonal contraceptive MPTs. Key informant interviews with experts in family planning and HIV and STI prevention and MPT product developers and funders from around the globe were conducted, reviewed, and coded. Identified key themes were discussed by experts at the November 2019 Eunice Kennedy Shriver National Institute of Child Health and Human Development Contraceptive Development Meeting in Houston, Texas. Seven action strategies were identified to address key research gaps and priorities for advancing the field. They highlight the importance of identifying target populations, a systematic approach to collaborative research, and leveraging knowledge from other fields, including regulatory and patenting, manufacturing, and commercialization expertise. Employing expanded target product profiles and setting go/no-go decisions for non-hormonal MPTs will help to prioritize the most promising candidates in the drug development pipeline. Further, they call for optimizing investments and engagement of stakeholders from public and private sectors. These action strategies aim to facilitate collaboration and innovation amongst multidisciplinary MPT stakeholders. Paramount to success will be enhancing strategic alliances and reconciling the essential social-behavioral context and market forces that drive product use with the complexities of research and development, regulatory approval, and commercialization.

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.

BACKGROUND: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12. RESULTS: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups. CONCLUSIONS: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

Understanding Nonadherence with Hydroxychloroquine Therapy in Systemic Lupus Erythematosus.

OBJECTIVE: Hydroxychloroquine (HCQ) is a cornerstone to managing systemic lupus erythematosus (SLE), yet adherence to medication is poor. We sought to measure the association of adherence with 5 "dimensions of adherence" as articulated by the World Health Organization for chronic conditions: the patient's socioeconomic status, and patient-, condition-, therapy-, and healthcare system-related factors. Our longterm goal is to generate evidence to design effective interventions to increase adherence. METHODS: The retrospective cohort study included Kaiser Permanente Northern California patients ≥ 18 years old during 2006-2014, with SLE and ≥ 2 consecutive prescriptions for HCQ. Adherence was calculated from the medication possession ratio and dichotomized as < 80% versus ≥ 80%. Predictor variables were obtained from the electronic medical record and census data. We used multivariable logistic regression to estimate adjusted OR and 95% CI. RESULTS: The study included 1956 patients. Only 58% of patients had adherence ≥ 80%. In adjusted analyses, socioeconomic variables did not predict adherence. Increasing age (65-89 yrs compared with ≤ 39 yrs: OR 1.44, 95% CI 1.07-1.93), white race (p < 0.05), and the number of rheumatology visits in the year before baseline (≥ 3 compared with 0 or 1: OR 1.47, 95% CI 1.18-1.83) were positively associated with adherence. The rheumatologist and medical center providing care were not associated with adherence. CONCLUSION: At our setting, as in other settings, about half of patients with SLE were not adherent to HCQ therapy. Differences in adherence by race/ethnicity suggest the possibility of using tailored interventions to increase adherence. Qualitative research is needed to elucidate patient preferences for adherence support.

A strategic action framework for multipurpose prevention technologies combining contraceptive hormones and antiretroviral drugs to prevent pregnancy and HIV.

OBJECTIVE: Multipurpose prevention technologies (MPTs) are an innovative class of products that deliver varied combinations of human immunodeficiency virus (HIV) prevention, other sexually transmitted infection (STI) prevention, and contraception. Combining separate strategies for different indications into singular prevention products can reduce the stigma around HIV and STI prevention, improve acceptability of and adherence to more convenient products, and be more cost-effective by addressing overlapping risks. METHODS: This article outlines a strategic action framework developed as an outcome of a series of expert meetings held between 2014 and 2016. The meetings focused on identifying opportunities and challenges for MPTs that combine hormonal contraception (HC) with antiretroviral drugs into single products. The framework aims to present an actionable strategy, by addressing key research gaps and outlining the key areas for progress, to guide current and future HC MPT development. RESULTS: We identified eight primary action areas for the development of impactful HC MPTs, and includes aspects from epidemiology, pharmacology, clinical trial design, regulatory requirements, manufacturing and commercialisation, behavioural science, and investment needs for research and development. CONCLUSION: Overall, the challenges involved with reconciling the critical social-behavioural context that will drive MPT product use and uptake with the complexities of research and development and regulatory approval are of paramount importance. To realise the potential of MPTs given their complexity and finite resources, researchers in the MPT field must be strategic about the way forward; increased support among policy-makers, advocates, funders and the pharmaceutical industry is critical.

Nutrition Education in Internal Medicine Residency Programs and Predictors of Residents' Dietary Counseling Practices.

BACKGROUND: Although physicians are expected to provide dietary counseling for patients with cardiovascular (CV) risk factors such as hypertension, hyperlipidemia, diabetes, and obesity, nutrition education in graduate medical education remains limited. Few studies have recently examined nutrition education and dietary counseling practices in Internal Medicine (IM) residency training. OBJECTIVES: To conduct a contemporary assessment of outpatient nutrition education in IM residency programs in the United States, identify predictors of residents' dietary counseling practices for CV risk factors, and identify barriers for educators in providing nutrition education and barriers for residents in counseling patients. DESIGN: Cross-sectional anonymous surveys were completed by IM program directors (PDs) and residents throughout the United States. Linear regression was used to examine the association between the amount of nutrition education received and the number of instruction methods used by the residents and frequency of residents' dietary counseling for patients with CV risk factors. KEY RESULTS: A total of 40 educators (PDs and ambulatory/primary care PDs) and 133 residents across the United States responded to the survey. About 61% of residents reported having very little or no training in nutrition. Nutrition education in residency, both the amount of education (ß = 0.20, P = .05) and the number of instruction methods used (ß = 0.26, P = .02), predicted frequency of residents' dietary counseling practices independent of nutrition education in medical school, which was also significantly associated with counseling (ß = 0.20, P = .03). Residents' total fruit and vegetable intake likewise predicted frequency of counseling (ß = 0.24, P < .001). Low perceived faculty expertise was a major barrier for educators and was associated with lower level of provided nutrition education (r = -.33, P = .04). Low resident and low perceived clinic preceptors' interests in nutrition were also associated with lower frequency of residents' dietary counseling (r = -.19, P = .04; r = -.18, P = .05). CONCLUSIONS: The provision of nutrition education in IM residency programs and IM residents' dietary counseling for patients need to be systematically assessed nationally. This study's preliminary findings suggest that multimodal nutrition education in IM residency and better resident dietary habits are associated with higher frequency of dietary counseling for patients. Lack of faculty expertise and low faculty and resident interests in patient counseling need to be addressed perhaps by mandating nutrition education in graduate and continuing medical education.

Emerging Technologies to Prevent Pregnancy and Sexually Transmitted Infections in Women.

Worldwide, there continues to be a large unmet need for family planning and sexually transmitted infection (STI) prevention methods. Multipurpose prevention technology (MPT) is a general term encompassing any single prevention methodology targeting more than one STI (including HIV) and/or pregnancy. While innovation has been slow over the past several decades, recent scientific advances have resulted in new products entering clinical trials. This review focuses primarily on multipurpose technologies that are designed to prevent pregnancy and HIV. To examine the current state of MPTs, we outline key discoveries of biologic mechanisms that influence susceptibility of the female genital tract to HIV and STIs, and review the effects of hormonal contraception on HIV susceptibility. We discuss the state of currently available HIV prevention strategies for women, and their interactions with hormonal contraceptive products. Finally, we describe MPTs currently in preclinical and clinical trials and propose ongoing questions requiring research to help advance the field.

Prioritizing multipurpose prevention technology development and investments using a target product profile.

Multipurpose prevention technologies (MPTs) represent a powerful opportunity to address the unmet sexual and reproductive health needs of women in at-risk populations around the world in an efficient and cost-effective manner. The development of MPT products for the combination prevention of pregnancy and sexually transmitted infections (including HIV) is a high-risk/high-gain, expensive process. The associated challenges are compounded by limitations in available resources for the development, evaluation, and delivery of such products. Consequently, an objective process for identifying MPT products with the highest public health impact potential is necessary to serve as the basis of coordinated investment of supporting agencies in the development of such products. Moreover, this process would serve as a framework for product development organizations, guiding their product development strategies. The Scientific Agenda Working Group of the Initiative for Multipurpose Prevention Technologies conducted an MPT pipeline evaluation exercise for the purpose of defining specific MPT product priorities, and to identify MPT technology gaps which need to be addressed in order to achieve development of optimal products. Through a formal and objective process, a set of MPT priority product recommendations emerged, along with several priority MPT gaps. Further, specific MPT development process priorities were identified. The detailed process and summary findings of this exercise are presented here. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.

Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations.

Dye staining of applicators has been shown to be a reliable and objective method to test vaginal insertion in clinical microbicide trials, but different plastics, dyes, and product formulations may impact the accuracy of this method. Reportedly used applicators returned from 3 clinical trials were stained with 1% trypan blue. In a phase 1 study (VivaGel), using gel-filled HTI polypropylene applicators, 1271 (97%) of applicators stained positive. In a phase 1 and a phase 2a study (LACTIN-V) using linear low-density polyethylene applicators to deliver a dry powder formulation, 57 (95%) and 135 (86%) tested positive, respectively. Dye staining of vaginal applicators is an objective low-cost measure suitable for low-resource settings.

Effects of bacterial vaginosis-associated bacteria and sexual intercourse on vaginal colonization with the probiotic Lactobacillus crispatus CTV-05.

OBJECTIVE: Several fastidious bacteria have been associated with bacterial vaginosis (BV), but their role in lactobacilli recolonization failure is unknown. We studied the effect of 7 BV-associated bacterial species and 2 Lactobacillus species on vaginal colonization with Lactobacillus crispatus CTV-05 (LACTIN-V). METHODS: Twenty-four women with BV were given a 5-day course of metronidazole vaginal gel and then randomized 3:1 to receive either LACTIN-V or placebo applied vaginally once daily for 5 initial consecutive days, followed by a weekly application over 2 weeks. Vaginal swabs for L. crispatus CTV-05 culture and 9 bacterium-specific 16S rRNA gene quantitative polymerase chain reaction assays were analyzed on several study visits for the 18 women receiving LACTIN-V. RESULTS: Vaginal colonization with CTV-05 was achieved in 61% of the participants receiving LACTIN-V at either day 10 or day 28 visit and 44% at day 28. Participants not colonized with CTV-05 had generally higher median concentrations of BV-associated bacteria compared to those who colonized. Between enrollment and day 28, the median concentration of Gardnerella vaginalis minimally reduced from 10 to 10 16S rRNA gene copies per swab in women who colonized with CTV-05 but increased from 10 to 10 in those who failed to colonize (P = 0.19). Similarly, the median concentration of Atopobium spp. reduced from 10 16S rRNA gene copies per swab to below limit of detection in women who colonized with CTV-05, but increased from 10 to 10 in those who failed to colonize (P = 0.04). The presence of endogenous L. crispatus at enrollment was found to be significantly associated with a reduced odds of colonization with CTV-05 on day 28 (P = 0.003), and vaginal intercourse during the study significantly impaired successful CTV-05 colonization (P = 0.018). CONCLUSION: Vaginal concentration of certain BV-associated bacteria, vaginal intercourse during treatment, and the presence of endogenous L. crispatus at enrollment predict colonization with probiotic lactobacilli.