Digital HPV education to increase vaccine uptake among low income women.

Objective: The objective of this formative study was to gather women's perspectives in the design and communication modalities of a health kiosk set within a Planned Parenthood setting to promote patient education about the Human papillomavirus (HPV) and to motivate uptake of the HPV vaccine. Methods: Twenty-four women aged 18-35 participated in in-depth one-on-one interviews at a Planned Parenthood health center, which were analyzed in code-associated categories using NVivo11 Pro. Results: Most women showed receptivity to using an on-site health kiosk, as well as QR codes linked to text messages, to receive HPV-related health information outside of the clinic setting and reminders. Participants provided suggestions for kiosk design and communication modalities. Conclusions: Among low-income women we interviewed at Planned Parenthood, increasing HPV vaccination rates necessitates engaging digital health tools which incorporate both the preferences and needs of vulnerable populations. Innovation: Designing a point-of-service health kiosk that 1) draws on user preferences early in the design phase, 2) integrates multiple communication technologies, and 3) disseminates culturally grounded HPV vaccination decisions narratives that are tailored to vaccination awareness level is a promising approach in reducing barriers to HPV vaccine education and vaccine uptake among low-income women at safety-net clinics.

Motivators and Barriers to HPV Vaccination: A Qualitative Study of Underserved Women Attending Planned Parenthood.

Human papilloma virus (HPV) is the most common sexually transmitted infection in the United States. Disease-associated strains of HPV can cause genital warts and six cancer types. HPV-associated cervical cancer disproportionately impacts medically underserved women including Black and Latina women with respect to incidence, prevalence, and mortality rates. Although safe and effective vaccines are available, HPV vaccination rates remain low among low-income individuals and women of color. The current study examined individual and structural motivators and barriers to HPV vaccination among medically underserved women utilizing a Planned Parenthood health center in Southeast Pennsylvania. Guided by narrative engagement theory (NET), qualitative interviews (N = 24) were used to elicit HPV vaccine decision stories from both vaccinated and unvaccinated women. Using a phronetic iterative data analysis approach, we identified three motivators to vaccinate against HPV: (1) receiving an explicit vaccine recommendation from a healthcare provider (a structural determinant), (2) feeling empowered to take control of one's health (an individual determinant), and (3) knowing someone infected with HPV (an individual determinant). Among unvaccinated participants, barriers to HPV vaccination included: (1) not receiving an explicit vaccine recommendation from a healthcare provider (a structural determinant), (2) low perceived risk for acquiring HPV or that HPV is not severe (an individual determinant), and (3) lack of maternal support to vaccinate (a structural determinant). Healthcare providers are optimally positioned to fill the gap in prior missed vaccine opportunities and empower women by recommending HPV vaccination.

Evaluation of the Performance of a Point-of-Care Test for Chlamydia and Gonorrhea.

Importance: Rates of chlamydial and gonococcal infection continue to increase in the United States, as do the associated costs of untreated infections. Improved diagnostic technologies that support testing and treating in 1 clinical visit are critical to advancing efforts to control the rates of chlamydial and gonococcal infection. Objective: To evaluate the clinical performance of a point-of-care (POC) molecular diagnostic assay for the detection of chlamydia and gonorrhea. Design, Setting, and Participants: A noninterventional, cross-sectional clinical study was conducted from September 18, 2018, through March 13, 2019, at sexually transmitted infection (STI), HIV, family planning, and obstetrics and gynecology clinics where STI screening is routine, using a convenience sample and comparing commercially available assays with a new 30-minute POC assay. Patients included were those eligible for STI screening or diagnostic testing who had not taken antibiotics effective against chlamydia or gonorrhea within the previous 28 days. Four vaginal swab samples were collected from women and a first-catch urine sample was obtained from men. Main Outcomes and Measures: A composite infection status was used to classify participants as infected if 2 or more comparator results were positive, as not infected if 2 or more comparator samples were negative, and as unevaluable if 1 result was invalid and the other 2 results did not agree with each other. Results: Swab samples from 1523 women (median age, 27 years [interquartile range, 17-37 years]), 817 (53.6%) of whom presented with symptoms, and 922 men (median age, 29 years [interquartile range, 17-41 years]), 308 (33.4%) of whom were symptomatic, were tested. For chlamydia, sensitivity of the new POC assay was 96.1% (95% CI, 91.2%-98.3%) for women and 92.5% (95% CI, 86.4%-96.0%) for men. For gonorrhea, sensitivity estimates were 100.0% (95% CI, 92.1%-100.0%) for women and 97.3% (95% CI, 90.7%-99.3%) for men. For chlamydia, specificity of the new POC assay was 99.1% (95% CI, 98.4%-99.5%) for women and 99.3% (95% CI, 98.4%-99.7%) for men. For gonorrhea, specificity estimates were 99.9% (95% CI, 99.5%-100%) for women and 100% (95% CI, 95.5%-100%) for men. Non-laboratory-trained personnel performed 94.8% of all tests (2318 of 2445) during the study. Conclusions and Relevance: This study suggests that self-obtained vaginal swab samples were associated with performance equivalent to laboratory-based molecular diagnostics, which can support use of this POC assay in many settings. The availability of an easy-to-use, rapid (30-minute) molecular test for accurate detection of chlamydia and gonorrhea has the power to facilitate testing and treatment in a single patient visit for these STIs.

Sensitivity and specificity of placental proteins for gestational age screening: An exploratory study.

OBJECTIVE: To examine the possibility that serum or urine concentrations of pregnancy-associated plasma protein A (PAPP-A), a disintegrin and metalloproteinase 12 (ADAM-12), placental growth factor (PlGF), human placental lactogen (HPL), glypican-3, pregnancy specific beta-1-glycoprotein 1 (PSG-1) or prolactin could predict gestational age (GA) >70 days, the currently recommended limit for medical abortion in the United States. STUDY DESIGN: In this exploratory observational study, we collected serum and urine specimens from 245 healthy individuals with singleton intrauterine pregnancies at GA <40 weeks by ultrasound. We assayed the serum specimens for all seven proteins and the urine specimens for PAPP-A and ADAM-12. We used scatterplots and receiver operating characteristic curves to identify a concentration for each protein that would differentiate GAs above and below 70 days. RESULTS: All seven proteins showed significant ability to distinguish GAs >70 days from earlier gestations. A PAPP-A concentration ≥5.591 ng/ml provided 100% sensitivity and 90% specificity for identifying GAs >70 days. An ADAM-12 concentration of ≥3.11 ng/ml provided 98.5% sensitivity and 77% specificity for identifying GAs >70 days. Serum concentrations of the other compounds showed less diagnostic discrimination. PAPP-A was not detected in urine, and urinary ADAM-12 concentrations were not useful in identifying GAs above 70 days. CONCLUSION: PAPP-A and ADAM-12 showed considerable promise as bases for a sensitive and specific serum test for identifying pregnancies with GA >70 days. If these results are confirmed by future research, such a test could obviate the need for routine ultrasound before medical abortion. IMPLICATIONS: Two placental proteins, PAPP-A and ADAM-12, showed considerable promise as bases for a serum test for identifying pregnancies with gestational age >70 days. Such a test could be highly useful in screening patients for eligibility for medical abortion.

Clinical Validation of a Test for the Diagnosis of Vaginitis.

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.

Clinical evaluation of a new Pap test-based method for screening of Chlamydia trachomatis and Neisseria gonorrhoeae using liquid-based cytology media.

OBJECTIVES: The majority of chlamydial and gonococcal infections in women are asymptomatic and, if left untreated, may result in serious sequelae. Simple and accurate testing of men and women at risk for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) is the single most effective strategy for control of sexually transmitted infections. New tests using easy-to-acquire samples, such as the Papanicolaou (Pap) test, need to be validated in an effort to expand and improve detection. The objective of this study was to determine the performance of a new nucleic acid amplification test using two liquid-based cytology media for the detection of CT and GC. METHODS: The study was conducted in two phases at 11 geographically diverse, high- and low-prevalence sites. Three endocervical reference swabs as well as an endocervical SurePath or PreservCyt liquid cytology specimen sampled with a broom or brush/spatula were collected in a randomized order from each subject. Reference endocervical swabs were tested with three Food and Drug Administration-approved methods and compared to two new automated tests, the CT Q Amplified DNA Assay (CTQ) and the GC Q Amplified DNA Assay (GCQ). RESULTS: For the SurePath phase, 1838 subjects were enrolled. The sensitivity and specificity of the CTQ assay were 95.0% and 99.7%, respectively, and the GCQ assay was 100% for both. In the PreservCyt phase, 2164 subjects were enrolled. The sensitivity and specificity of the CTQ assay were 94.1% and 99.8%, respectively, and the GCQ assay was 95.3% and 99.95%, respectively. There was no significant difference in the results. CONCLUSIONS: In this investigation, high sensitivity and specificity of the CTQ and GCQ assays were demonstrated for samples collected in either of two liquid-based cytology media when compared with endocervical swabs. The results were similar in both collection methods (broom or brush/spatula) and in high- and low-risk populations.

Type-specific identification of anogenital herpes simplex virus infections by use of a commercially available nucleic acid amplification test.

Herpes infections are among the most common sexually transmitted infections (STI), but diagnostic methods for genital herpes have not kept pace with the movement toward molecular testing. Here, we describe an FDA-approved molecular assay that identifies and types herpes simplex virus (HSV) infections for use in routine clinical settings. Paired samples from anogenital lesions were tested using the BD ProbeTec HSV Q(x) (HSVQ(x)) system, HSV culture and, a laboratory-developed PCR assay. Family planning, obstetrics/gynecology (OB/GYN), or sexually transmitted disease (STD) clinics in the United States served as recruitment sites. Sensitivity and specificity estimates, head-to-head comparisons, measures of agreement, and latent-class analyses were performed to provide robust estimates of performance. A total of 508 participants (174 men and 334 women) with anogenital lesions were included; 260 HSV-2 and 73 HSV-1 infections were identified. No differences in test performance based on gender, clinic type, location of the lesion, or type of lesion were observed. The sensitivity of HSV-2 detection ranged from 98.4 to 100% depending on the analytical approach, while the specificity ranged from 80.6%, compared to the less sensitive culture method, to 97.0%, compared to PCR. For HSV-1, the sensitivity and specificity ranges were 96.7 to 100% and 95.1 to 99.4%, respectively. This assay may improve our ability to accurately diagnose anogenital lesions due to herpes infection.