OBJECTIVE Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians. The primary and secondary outcomes were to compare the investigational test with reference methods for the three most common causes of vaginitis and compare clinician-collected with self-collected swabs. METHODS We conducted a cross-sectional study in which women with symptoms of vaginitis were recruited at ten clinical centers and consented to the investigation between May and September 2015. The woman collected a vaginal swab, sheathed, and then handed it to the clinician. These swabs were to evaluate how self-collected swabs compared with clinician-collected swabs. The clinician collected an investigational test swab and reference test swabs. From 1,740 symptomatic patients, clinician-collected and self-collected vaginal swabs were evaluated by the molecular test and six tests. The reference methods for bacterial vaginosis were Nugent’s score and Amsel’s criteria for intermediate Nugent results. The reference methods for Candida infection were isolation of any potential Candida microorganisms from inoculation of two culture media: chromogenic and Sabouraud agar and sequencing. The reference methods for trichomoniasis were wet mount and culture. RESULTS For clinician-collected swabs, by reference methods, bacterial vaginosis was diagnosed in 56.5%, vaginal candidiasis in 32.8%, trichomoniasis in 8%, and none of the three infections in 24% with a coinfection rate of 20%. The investigational test sensitivity was 90.5% (95% confidence interval [CI] 88.3–92.2%) and specificity was 85.8% (95% CI 83.0–88.3%) for bacterial vaginosis. The investigational test sensitivity was 90.9% (95% CI 88.1–93.1%) and specificity was 94.1% (95% CI 92.6–95.4%) for the Candida group. Sensitivity for Candida glabrata was 75.9% (95% CI 57.9–87.8%) and specificity was 99.7% (95% CI 99.3–99.9%). Investigational test sensitivity was 93.1% (95% CI 87.4–96.3%) and specificity was 99.3% (95% CI 98.7–99.6%) for trichomoniasis. Results from self-collected swabs were similar to clinician-collected swabs. CONCLUSION A molecular-based test using vaginal swabs collected by clinicians or patients can accurately diagnose most common bacterial, fungal, and protozoan causes of vaginitis. Women and their clinicians seeking accurate diagnosis and appropriate selection of efficacious treatment for symptoms of vaginitis might benefit from this molecular test.

Rationale Most research in mental health and abortion has examined factors associated with post-abortion psychological health. However, research that follows women from before to after their abortion consistently finds that depressive, anxiety, and stress symptoms are highest just before an abortion compared to any time afterwards. Objective This finding suggests that studies investigating psychosocial factors related to pre-abortion mental health are warranted. Methods The current study uses data from 353 women seeking abortions at three community reproductive health clinics to examine predictors of pre-abortion psychological health. Drawing from three perspectives in the abortion and mental health literature, common risks, stress and coping, and sociocultural context, we conducted multivariable analyses to examine the contribution of important factors on depressive, anxiety, and stress symptoms just before an abortion, including sociodemographics, abortion characteristics, childhood adversities, recent adversities with an intimate partner, relationship context, future pregnancy desires, and perceived abortion stigma. Results Childhood and partner adversities, including reproductive coercion, were associated with negative mental health symptoms, as was perceived abortion stigma. Before perceived abortion stigma was entered into the model, 18.6 %, 20.7 %, and 16.8% of the variance in depressive, anxiety, and stress symptoms respectively, was explained. Perceived abortion stigma explained an additional 13.2 %, 9.7 %, and 10.7 % of the variance in depressive, anxiety, and stress symptoms pre-abortion. Conclusion This study, one of the first to focus on pre-abortion mental health as an outcome, suggests that addressing stigma among women seeking abortions may significantly lower their psychological distress.

Trichomoniasis is the most prevalent curable sexually transmitted disease (STD). It has been associated with preterm birth and the acquisition and transmission of HIV. Recently, nucleic acid amplification tests (NAAT) have been FDA cleared in the United States for detection of Trichomonas vaginalis in specimens from both women and men. This study reports the results of a multicenter study recently conducted using the Xpert TV (T. vaginalis) assay to test specimens from both men and women. On-demand results were available in as little as 40 min for positive specimens. A total of 1,867 women and 4,791 men were eligible for inclusion in the analysis. In women, the performance of the Xpert TV assay was compared to the patient infected status (PIS) derived from the results of InPouch TV broth culture and Aptima NAAT for T. vaginalis. The diagnostic sensitivities and specificities of the Xpert TV assay for the combined female specimens (urine samples, self-collected vaginal swabs, and endocervical swabs) ranged from 99.5 to 100% and 99.4 to 99.9%, respectively. For male urine samples, the diagnostic sensitivity and specificity were 97.2% and 99.9%, respectively, compared to PIS results derived from the results of broth culture for T. vaginalis and bidirectional gene sequencing of amplicons. Excellent performance characteristics were seen using both female and male specimens. The ease of using the Xpert TV assay should result in opportunities for enhanced screening for T. vaginalis in both men and women and, hopefully, improved control of this infection.

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