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Willingness to self-collect vaginal swabs at a pharmacy clinic is of interest as a venue to increase sexually transmissible infections (STIs) screening for chlamydia, gonorrhoea and trichomonas. Women self-collected vaginal swabs at the pharmacy, completed questionnaires and received STI results within 2 h. Women with STIs were offered free treatment. A total of 313 of 777 (40.3%) women consented and prevalence for any STI was 3.9%. Questionnaires demonstrated acceptability for self-collection at the pharmacy, with 63% (95% CI 57.3–68) and 32.3% (95% CI 27.4–37.8) indicating they ‘strongly agreed’ or ‘agreed’ that they felt comfortable with pharmacy collection, respectively. Self-collected vaginal swabs for STI testing for women who were at a pharmacy were feasible and acceptable to women.

PURPOSE: This study compared performance of Atlas io(®) diagnostic platform, a point-of-care (POC) PCR assay for Chlamydia trachomatis (CT), to Aptima Combo 2™, a standard of care laboratory-based nucleic acid amplification assay (NAAT), and evaluated patient attitudes toward POC testing. METHODS: Women ≥14 years undergoing CT screening/testing were recruited from an urban adolescent primary care practice (Teen Health Center, THC) and a sexually transmitted disease (STD) clinic. Participants provided self-obtained vaginal swabs for testing with the Atlas io(®) platform and Aptima Combo 2™ testing and completed a questionnaire assessing attitudes toward POC testing. RESULTS: Of 296 women recruited, 284 (192 from the STD clinic, 92 from THC) had Aptima Combo 2™ and Atlas io(®) results available; 273 completed the questionnaire. Average age was 27.4 years (SD 10.8). Sensitivity and specificity of the Atlas io(®) test were 83.9% (26/31 specimens; 95% CI, 70.9–96.8%) and 98.8% (250/253 specimens; 95% CI, 97.5–100%), respectively. When specimens with discrepant results were included in analyses, adjudicated sensitivity and specificity were 92.9% (26/28 specimens; 95% CI, 83.3 to 100%) and 98.8% (253/256 specimens; 95% CI, 97.5 to 100%), respectively. A majority (70%) of women preferred to collect vaginal self-swab if a POC test were available. Most (61%) were willing to wait up to 20 minutes and 26% were willing to wait up to 40 minutes for results, if they could be treated before leaving clinic. CONCLUSION: A POC PCR test detecting CT had high sensitivity and specificity when testing prospective, vaginal swab samples. Availability of CT results during patients’ visits may decrease time to treatment.

Many health agencies now recommend routine HIV and syphilis testing for pregnant women and most-at-risk populations such as men who have sex with men. With the increased availability of highly sensitive, low cost rapid point-of-care tests, the ability to meet those recommendations has increased, granting wider access to quick and accurate diagnoses. Using blood specimens collected from a Baltimore City Health Department (BCHD) sexually transmitted infection clinic, we evaluated the SD Bioline HIV/Syphilis Duo, a rapid test that simultaneously detects antibodies to HIV and syphilis and has the potential to further benefit clinics and patients by reducing costs, testing complexity, and patient wait times. SD DUO HIV sensitivity and specificity, when compared to BCHD results, were 91.7 and 99.5%, respectively. SD DUO syphilis sensitivity and specificity, when compared to rapid plasma reagin, were 85.7 and 96.8%, respectively, and 69.7 and 99.7%, respectively, when compared to Treponema pallidum particle agglutination (TPPA). SD DUO syphilis sensitivity and specificity, when compared to a traditional screening algorithm, improved to 92.3 and 100%, respectively, and improved to 72.9 and 99.7%, respectively, when compared to a reverse screening algorithm. The HIV component of the SD DUO performed moderately well. However, results for the SD DUO syphilis component, when compared to TPPA, support the need for further testing and assessment.

Solana® (Quidel) is a new rapid (40 min.) point-of-care (POC) test for qualitative detection of Trichomonas vaginalis (TV) DNA. The assay has two steps: 1) specimen preparation, and 2) amplification and detection using isothermal Helicase-Dependent Amplification (HDA). The objective was to demonstrate the performance of Solana for vaginal swabs and female urines based on comparison to wet mount and TV culture. Performance was also compared to the Aptima-TV assay.Urine and four clinician-collected vaginal swabs were collected. The first two were used for FDA composite reference (wet mount; InPouch TV Culture). The third swab was used for Solana. Sensitivity/specificity were based on the reference method. A specimen was considered positive if either test was positive. The fourth swab was for Aptima-TV.Vaginal swabs and urines were obtained from 501 asymptomatic and 543 symptomatic women. Prevalence of TV by was 11.5%. For swabs, Solana® demonstrated high sensitivity and specificity from asymptomatic (100%/98.9%) and symptomatic (98.6%/98.5%) women, as well as for urines from asymptomatic (98.0%/98.4%) and symptomatic (92.9%/97.9%) women, compared to the reference method. Compared to Aptima-TV, the sensitivity/specificity was 89.7%/99.0% for swabs and 100%/98.9% for urines.The Solana® assay performed well compared to the reference assays.

In 2016, the rate of USA gonorrhoea and chlamydia cases increased by 18.6% and 6.9% respectively. Most people infected are asymptomatic and are not treated immediately, which negatively affects sexually transmissible infection (STI)/HIV rates. Men and women were asked to provide self-collected oropharyngeal specimens for STI testing (n = 79). Over 75% reported the collection of the swab was ‘easy’ or ‘very easy’ to use; 90% were willing to test for STIs at home in the future. Self-collecting oropharyngeal swabs for STI testing is acceptable among men and women. Future research should test the effect of self-collecting pharyngeal swabs on STI testing behaviours and results.

Our previous pilot study during 2010–2013, based on the IWantTheKit (IWTK) home self-collection program for sexually transmitted infections (STIs), showed that voluntary risk score tool predicted STIs well in female volunteers compared to their male counterparts. Risk score became a required part of the IWTK program in August 2013. We investigated association of IWTK risk score and presence of STI in 592 male participants living in Maryland and Washington DC from August 2013 to April 2015. The risk score quiz includes questions on demographic and sexual risk behavior. Data were analyzed using the Cochran-Armitage test for trend to determine if prevalence of STIs (Chlamydia, gonorrhea, or trichomoniasis) increased with the higher risk score category. Overall, 57% of participants were aged

The www.iwantthekit.org provides Internet-based, at-home sexually transmitted infection screening. The Web site implemented an automated test result access system. To evaluate potential deleterious effects of the new system, we analyzed demographics, Web site usage, and treatment. The post-Web site design captured more participant information and no decrease in requests, kit return, or treatment adherence.

Men were enrolled in a study to assess the performance and acceptability of self-collected penile meatal swabs as compared to clinician-collected urethral swabs for sexually transmitted infections (STIs). We expected penile-meatal swabs to perform favorably to urethral swabs for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) detection by nucleic acid amplification assays (NAATs). Of 203 swab pairs tested; for CT, penile-meatal swab sensitivity was 96.8% and specificity was 98.8%. NG sensitivity and specificity were 100% and 98.9%, respectively. For TV, sensitivity was 85.0% and specificity was 96.7%. For MG sensitivity and specificity were 79.3% and 99.4%, respectively. No significant statistical differences between sample type accuracy (CT: P =0.625; NG: P =0.248; TV: P =0.344; and MG: P =0.070) existed. Most men, 90.1%, reported self-collection of penile-meatal swabs as "Very Easy" or "Easy". Self-collected penile-meatal swabs appeared acceptable for NAAT STI detection and an acceptable collection method by men.

We evaluate the feasibility and accuracy of existing point-of-care HIV tests performed by an untrained patient compared with the routinely used HIV point-of-care test offered to patients in 2 urban emergency departments (EDs).From April 2008 through December 2009, patients who had completed a standard HIV oral fluid test performed by a trained health care professional and who were unaware of their results were recruited to perform a rapid point-of-care HIV test. Patients were given a choice of the oral fluid or the fingerstick blood point-of-care test. Evaluation of acceptability to perform the mechanics of the test was accessed by questionnaire. For the "self-test," the participant obtained his or her own sample and performed the test. The patient's results were compared with standard oral fluid results obtained by the health care professional.Overall, 478 of 564 (85%) patients receiving a standard oral fluid HIV test volunteered, with a mean age of 38 to 39 years. Ninety-one percent of participants chose oral fluid and 9% chose blood (P.05). Self-test results were 99.6% concordant with health care professionals' test results. For the self-testers, 94% of oral fluid testers and 84.4% of blood testers reported trusting the self-administered test result "very much." Furthermore, 95.6% of the oral fluid group and 93.3% of the blood group would "probably" or "definitely" perform a test at home, if available.This study demonstrated that a significant proportion of patients offered a self-HIV point-of-care test volunteered and preferred using oral fluid. Patients' results agreed with standard HIV point-of-care results. The majority of participants trusted their results and would perform a point-of-care HIV test at home, given the opportunity.

Objectives: To determine whether women who collect self-collected vaginal swabs at home demonstrated a higher positivity of Chlamydia trachomatis than women in family planning clinics. Methods: Collection kits for vaginal swabs were internet requested, collected at home, and mailed to a laboratory for testing; questionnaires were completed about acceptability and sexual risk history. Infected women received treatment at participating clinics. Age-specific prevalences were compared to those from family planning clinics. Results: Chlamydia positivity was 10.3% for 1171 females mailing swabs; prevalences ranged from 3.3% to 5.5% in family planning. Positivity for internet age groups was much higher than those for family planning age groups. The positivity for internet participants ranged from a low of 4.4% in Baltimore in 2005 to a high of 15.2% Baltimore in 2007. Family planning clinic prevalence in Baltimore and Maryland ranged from a low of 3.3% in Baltimore in 2006 to a high of 5.5% in Baltimore in 2008. The median age for all years for internet users in Baltimore and Maryland combined was 23 years; the median age for all years for attendees to family planning clinics who had chlamydia testing performed was 23 years. Conclusions: Internet recruited women demonstrated higher positivity of chlamydia than those in family planning, providing new options for chlamydia screening programs.

Background: Internet-based screening for sexually transmitted infections (STIs) has been acceptable to women, and can reach high-risk populations. No prior published data describe internet-based screening for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in men. We studied whether internet-based screening was acceptable and reached a high-risk population, and what risk factors were associated with STI positivity. Methods: The website, www.iwantthekit.org, encouraged men 14 years of age to request a home self-sampling kit and a questionnaire on risk factors and acceptability of internet-based screening. Penile swabs and urine samples were tested for C. trachomatis, N. gonorrhoeae, and T. vaginalis using a nucleic acid amplification test. Risk factors and acceptability were examined using chi squared tests and logistic regression. Results: Of 501 samples received for testing, 106 (21%) were positive for at least one STI, 64 (13%) for chlamydia, 4 (1%) for gonorrhea, and 49 (10%) for trichomonas. In multivariable analyses, age, race, household income, and frequency of condom use were independently associated with infection with at least one STI. Of the total respondents, 34% had a prior STI; 29% reported having a partner with an STI, but only 13% reported always using a condom. Among the men who participated in this study, 77% preferred a self-administered specimen versus attending a clinic, 89% reported that swab use was easy, and 89% reported that they would use internet-based screening again. Conclusions: Men who accessed internet-based screening had known risk factors for STIs and had a high prevalence of infection. Internet-based screening was acceptable and could reach these high-risk men who might not otherwise be reached through traditional means.

Objectives: To explore African American mothers' and daughters' practices and influences related to vaginal douching. Design and Sample: Our overall study used a sequential mixed-method design with 3 phases. Phase 1, the focus of this report, used grounded theory methods and in-depth, semistructured individual interviews. Two generations of African American girls and women: 24 girls (“daughters”) aged 14–18 and 17 women (“mothers” or “mother figures”) aged 22–43, recruited from 1 adolescent health clinic in Baltimore, MD. Measures: In-depth interviews were taped and transcribed and data analysis used the constant comparison method. Results: Daughters were much less likely to douche or to have been exposed to douching information than mothers. Many mothers and daughters were influenced by health care providers and/or family members to not initiate, to decrease, or to stop douching. Women who currently douche often do so because of the perception of improved smell and cleanliness around menstruation and sexual intercourse. Conclusions: These data indicate that although some women continue to believe that vaginal douching has therapeutic value, others have been influenced to stop or not start douching by family and health care providers. Health care providers should continue efforts to educate patients on the risks of vaginal douching.

The Internet provides patients, as well as clinicians with immediate, confidential access to information about sexually transmitted diseases (STDs).1,2 Young individuals are avid users of the Internet and usage has been considered to be a risk factor for STDs.3–7 Data indicate that there are 246,402,574 North American Internet users.8

A community-based intervention, Focus-on-Kids (FOK) has demonstrated risk-behaviour reduction of urban youth. We modified FOK to Focus-on-Teens (FOT) for high schools. High school adolescents ( n = 1190) were enrolled over successive school semesters. The small-group sessions were presented during the school-lunch hours. Confidential surveys were conducted at baseline, immediate, six-, and 12-month postintervention for demographics, parental communication/monitoring, sexual risk behaviours and sexually transmitted diseases (STDs)/HIV/condom-usage knowledge. Sexually active participants were encouraged to volunteer for urine-based STDs testing at the School-Based Health Centres. Many (47.4%) students reported having had sexual intercourse at baseline. Overall behaviours changed towards ‘safer’ sex behaviours (intent-to-use and using condoms, communicating with partner/parents about sex/condoms/STDs) with time ( P < 0.05). Proportion of students with complete correct knowledge of STDs/HIV increased to 88% at time 4 from 80% at baseline after adjusting for age, gender and sexual activity ( P < 0.05). High prevalence of STDs was detected in 875 participants who reported for urine testing at time 1: trichomonas, 11.8%; chlamydia, 10.1% and gonorrhoea, 4.1%. Prevalence decreased significantly for 310 participants who re-tested; chlamydia: 27.4% to 6.1% and gonorrhoea: 11.3% to 3.2%. FOT was successfully implemented as an STDs/HIV risk-reduction intervention. Sustained improvements of knowledge about STDs/HIV/condom usage, decreases in sexual risk behaviours supported the effectiveness of this intervention.

It has been well established that Chlamydia trachomatis screening among women in most settings is cost-effective.1–8 Populations studied have included women attending family planning clinics,2–5 sexually transmitted disease (STD) clinics,4 emergency departments,1 youth clinics,5 gynecology clinics,5 student health centers,3 and military recruits6,7 and population based screening of 15- to 29-year-old women.8 Most of the analyses assumed asymptomatic status of women.3,5–8 Two analyses, however, compared several strategies, with some of the strategies taking symptom status into account and others screening everyone the same way regardless of symptom status.1,2 Many analyses took the health care system perspective.1–3,5 However, 2 conducted analyses from the military perspective,6,7 and 2 used the societal perspective.4,8 In most previous analyses, either an endocervical specimen was tested4,5 or a urine specimen was tested.1,3,6–8 Consequently, many previous analyses did not evaluate the impact of omitting the speculum examination on the cost-effectiveness outcome.1,3–7 The Aptima Combo 2 (AC2) test is among a new generation of tests that use nucleic acid amplification and is FDA-cleared for use on endocervical, urine, and vaginal specimens. Because most Chlamydia infections are asymptomatic,9–12 many women who seek screening have no symptoms. Unless they are due for an annual Papanicolaou (Pap) smear, asymptomatic women who are screened with a vaginal or urine AC2 test do not require a speculum examination, omission of which can save time and money. The objective of this study was to evaluate the cost-effectiveness of several Chlamydia screening strategies and to incorporate conditions where a speculum examination may not be necessary.

BACKGROUND Testing for Chlamydia trachomatis by nucleic acid amplification tests (NAATs) using self-collected vaginal swabs (VS) is acceptable and accurate. The objectives were to implement an educational Internet-based program for women to facilitate home screening, to determine whether women would request and use self-collected VS kits, to determine associated risk factors for infection, and to determine satisfaction with the process. METHODS The website, www.iwantthekit.org, was designed to encourage women > or =14 years to obtain home-sampling kits. Kits could be obtained in the community, requested by Internet/e-mail, or telephone. Users mailed the self-collected VS to the laboratory. Swabs were tested by 3 NAAT assays. Respondents called for results. RESULTS Forty-one of 400 (10.3%) women were chlamydia positive; 95.1% were treated. Questionnaires indicated 89.5% preferred self-collection, 93.5% rated collection easy/very easy, and 86.3% would use the Internet program again. Black race and age

Background Self-obtained penile-meatal swabs and urine specimens have been used for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) for outreach screening in men. Objective To compare the sensitivity of self-collected male penile-meatal swabs and urine for the detection of CT , NG and TV . Methods Matching penile-meatal swabs and urines were collected at home after recruitment to the study; via the internet programme, http://www.iwantthekit.org. The instructions directed the participant to place the tip of a Copan flocked swab at the meatal opening of the urethra to collect the penile-meatal sample. Two ml of urine was collected after the swab onto a Copan sponge-on-a-shaft collection device. Both swab and urine were placed into individual Aptima transport media tubes and mailed to the laboratory for testing. All specimens were tested for CT and NG using the GenProbe Aptima Combo2 Assay and for TV using GenProbe Aptima Analyte Specific Reagents with TV oligonucleotides. Results Of 634 men, 86 (13.6%) were positive for CT, 9 (1.4%) were positive for NG and 56 (9.3%) positive for TV. For CT, swab sensitivity was 81/86 (94.2%), and urine sensitivity was 66/86 (76.7%). For NG, swab sensitivity was 9/9 (100%) and urine sensitivity was 8/9 (88.9%). For TV, swab sensitivity was 45/56 (80.4%) and urine sensitivity was 22/56 (39.3%). Conclusions Self-obtained penile-meatal swabs provided for the detection of more CT, NG and TV, than urine specimens.

Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection worldwide, and improved diagnostic methods are critical for controlling this pathogen. Diagnostic assays that can be used in conjunction with routine chlamydia/gonorrhea nucleic acid-based screening are likely to have the most impact on disease control. Here we describe the performance of the new BD T. vaginalis Q x (TVQ) amplified DNA assay, which can be performed on the automated BD Viper system. We focus on data from vaginal swab samples, since this is the specimen type routinely used for traditional trichomonas testing and the recommended specimen type for chlamydia/gonorrhea screening. Vaginal swabs were obtained from women attending sexually transmitted disease or family planning clinics at 7 sites. Patient-collected vaginal swabs were tested by the TVQ assay, and the Aptima T. vaginalis (ATV) assay was performed using clinician-collected vaginal swabs. Additional clinician-collected vaginal swabs were used for the wet mount and culture methods. Analyses included comparisons versus the patient infection status (PIS) defined by positive results with the wet mount method or culture, direct comparisons assessed with κ scores, and latent class analysis (LCA) as an unbiased estimator of test accuracy. Data from 838 women, 116 of whom were infected with T. vaginalis , were analyzed. The TVQ assay sensitivity and specificity estimates based on the PIS were 98.3% and 99.0%, respectively. The TVQ assay was similar to the ATV assay (κ = 0.938) in direct analysis. LCA estimated the TVQ sensitivity and specificity as 98.3 and 99.6%, respectively. The TVQ assay performed well using self-collected vaginal swabs, the optimal sample type, as recommended by the CDC for chlamydia/gonorrhea screening among women.

Background Clinicians and developers identify sensitivity as an important quality in a point-of-care test (POCT) for sexually transmissible infections (STIs). Little information exists regarding what patients want for STI POCTs. Methods: A qualitative study, encompassing five focus groups among attendees of STI and adolescent health centres in Baltimore, Maryland, and Cincinnati, Ohio, were conducted between March 2008 and April 2009. Discussion topics included advantages and disadvantages of having a POCT, perceived barriers to using POCTs in the clinic setting and at home, priorities for the development of new POCTs for STIs, and envisioned characteristics of an ideal POCT. All discussions were recorded and transcribed. A qualitative content analysis was performed to examine frequencies or patterns of recurring codes, which were regrouped and indexed to identify salient themes. Results: Patients attending STI and adolescent outpatient clinics are in favour of diagnostic tests that are rapid, easy to read and simple to use. Home testing options for POCTs were acceptable and provided better confidentiality, privacy and convenience, but clinic-based POCTs were also acceptable because they offer definitive results and ensure immediate treatment. Barriers to home POCTs centred on cost and the ability to read and perform the test correctly at home. Opinions did not differ by patient ethnicity, except that Hispanic participants questioned the reliability of home test results, wanted high sensitivity and desired bilingual instructions. Conclusions: Patients attending STI and adolescent medical centres are in favour of STI POCTs if they are affordable, rapid, easy to read and simple to use.

Tests for Chlamydia trachomatis and Neisseria gonorrhoeae , which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being ≥99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being ≥99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts.

Submission of self-collected penile samples collected at home could remove barriers that men face in getting tested for sexually transmitted infections (STIs).From December 2006 to July 2012, sexually active men aged ≥14 years were recruited by an educational internet program (http://www.iwantthekit.org) which offered free testing for Trichomonas vaginalis infection. Kits were ordered online and swabs were sent via US mail to the laboratory and tested by nucleic acid amplification tests. Demographics and sexual risk factors were accessed by questionnaires. Men called or were contacted to receive their results. Risk factors for trichomonas infection were determined by multivariate logistic regressionOf 4398 men requesting kits, 1699 (38.6%) returned swabs by mail (55.4% returned in 2012). Forty-one percent of men were aged25 years, 43% were black subjects and 45% were white. The overall prevalence for trichomonas in the 1699 men was 3.7%; the highest prevalence by age group was for men aged 40-49 years (5.2%) and, by year, 216 men screened in 2008 had the highest prevalence (12.5%). Risk factors for 919 men whose risk information was collected by questionnaire (prevalence 6.0%) indicated that 9.6% had a concurrent chlamydia infection. Significantly associated risks factors included: black race (adjusted OR 2.67), residence in Illinois (OR 12.02), age 30-39 years (OR 6.63) and age40 years (OR 5.31).A fairly high prevalence of trichomonas and sexual risk factors were demonstrated from internet recruitment of men. This method of engaging men to get screened for trichomonas may augment screening in STI clinics.

To compare the effectiveness and cost-effectiveness of a promising new point-of-care (POC) chlamydia test with traditional nucleic acid amplification testing (NAAT), and to determine the characteristics that would make a POC test most cost-effective.A decision tree was constructed to model chlamydia screening visits to a sexually transmitted disease clinic by a hypothetical cohort of 10,000 women. The model incorporated programmatic screening costs, treatment costs and medical costs averted through prevention of pelvic inflammatory disease (PID) and its sequelae. Parameter values and costs were estimated for each node in the decision tree based on primary data, published data and unpublished health data.For the base-case scenario (POC sensitivity 92.9%; 47.5% of women willing to wait 40 min for test results; test cost $33.48), POC was estimated to save US$5050 for each case of PID averted compared with NAAT. One-way sensitivity analyses indicated that POC would dominate NAAT if the POC test cost isUS$41.52 or if POC sensitivity is ≥ 87.1%. In a probabilistic sensitivity analysis (Monte Carlo simulations, 10 000 iterations), 10.8% of iterations indicated that the POC strategy dominated the NAAT strategy. The mean incremental cost-effectiveness ratio indicated that the POC strategy would save US$28 in total, and avert 14 PID cases.A promising new chlamydia POC test is likely to be cost-effective compared with traditional NAAT. The POC test sensitivity, cost and proportion of women willing to wait for the POC test result are key elements to determining the cost-effectiveness of any new POC test strategy.

Objectives Chlamydia trachomatis (CT) rates and incidence continue to increase, and university students are known to engage in high-risk activities, but studies of CT prevalence in this population are limited by poor screening rates. Utilisation of self-obtained sample (SoS) kits in private student residencies may reduce screening barriers. The authors sought to determine the relative effectiveness, and comparative effectiveness, of two SoS kit distribution mechanisms: one which provided kits directly to students and another encouraging students to order kits from a website. Methods During 2010–2011, residents of six university dormitories were provided training sessions describing CT, the project and SoS kit use. Students in three dormitories were provided kits, and the remaining students directed to the website (http://www.iwantthekit.org). Results Of 391 resident students, 163 were provided with kits and 175 were directed to the website. Of provided kits, 12 (8 women) were returned and 2 (16.7%; both women) were positive. Of only three internet-requested kits, all were returned (all women) and none were positive. In a post-project survey examining non-participation, 26.2% of students were unaware of the project (no difference by dormitory or gender) and 58.5% of women cited prior testing as part of a medical exam. Conclusions Though direct kit distribution was more effective in student screening engagement, overall participation was poor despite widespread advertising. The methodology of online testing and SoS kits has been well validated elsewhere, but research is needed to successfully engage university students in screening and refine SoS target populations in light of changing healthcare policies.

Dry-shipped and mailed vaginal swabs collected at home have been used in research studies for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV) by nucleic acid amplification tests (NAATs) in screening programs. A verification study was performed to compare the limit of detection of CT, GC, and TV on swabs that were dry-shipped to paired swabs that were wet-shipped in transport media through the US mail. The Centers for Disease Control and Prevention prepared inocula in sterile water to mock simulated urogenital swabs with high to low concentrations of CT and GC. Replicate swabs were inoculated with 100 μL of dilutions and were dry transported or placed into commercial transport media ("wet") for mailing for NAAT testing. The University of Alabama prepared replicate concentrations of TV, which were similarly shipped and tested by NAAT. All paired dry and wet swabs were detectable for CT. For GC, all paired dry and wet swabs were detectable for GC at concentrations ≥ 10(3). At 10(2) and 10 CFU/mL, the 10 replicate GC results were variably positive. For TV, wet and dry shipped concentrations >10(2) TV/mL tested positive, while results at 10 TV/mL were negative for dry swabs. Holding replicate dry swabs at 55 (○)C 5 days before testing did not affect results. NAATs were able to detect CT, GC, and TV on dry transported swabs. Using NAATs for testing home-collected, urogenital swabs mailed in a dry state to a laboratory may be useful for outreach screening programs.

BACKGROUND Submission of self-obtained vaginal samples (SOVs) collected at home could remove barriers that women face in getting tested for sexually transmitted infections (STIs). Internet recruitment of SOVs is highly acceptable. METHODS Sexually active women ≥14 years were recruited by an educational Internet program, available at: www.iwantthekit.org (IWTK), which offered free testing for trichomonas as part of a panel, which also offered testing for chlamydia and gonorrhea. Kits were ordered online, SOVs were sent through US mail to the laboratory, and tested by nucleic acid amplification tests. Demographics and sexual risk factors were accessed by questionnaires. Women called or were contacted to receive their results. RESULTS Of women requesting kits, 1525 (43%) returned swabs by mail. In all, 61% were

Although the Centers for Disease Control and Prevention have recommended population-wide Chlamydia trachomatis screening of sexually active women less than 26 years of age, more than half of sexually active young women are not routinely screened. A Website (IWTK, www.iwantthekit.org), was developed in 2004 to promote home-based sample collection.A decision tree was designed to model a hypothetical cohort of 10,000 women per year who order an internet-based C. trachomatis screening kit. We compared the incremental cost-effectiveness of 2 screening strategies: self-sampling via the IWTK website, and traditional, clinic-based screening by the same cohort of women who used IWTK. Probabilities and costs were estimated for each node in the decision tree. Estimates were derived from primary data, published data, and unpublished health data.The internet-based screening strategy prevented 35.5 more cases of pelvic inflammatory disease and saved an additional $41,000 in direct medical costs as compared with the clinic-based screening strategy.Our model estimates demonstrated that an internet-based, self-swab screening strategy was cost-effective compared with the traditional, clinic-based screening strategy. Assuming that the popularity of the use of the internet as a resource for information about healthcare and sexually transmitted infections leads to an increased use of IWTK, the public health benefit of this cost-effective strategy will be even greater.

Background A point-of-care test (POCT) for sexually transmitted infections (STIs), which offers immediate diagnosis resulting in patients receiving diagnosis and treatment in a single visit, has the ability to address some of the STI control needs. However, needs assessment from STI experts and end users about currently available STI POCTs and their future new development has not been evaluated since World Health Organization Sexually Transmitted Diseases Diagnostics Initiative was formed over 15 years ago. Therefore, our objective was to explore the perceptions of the ideal types of STI POCT for use in health care settings. Methodology/Principal Findings A qualitative study, encompassing eight focus groups, was conducted from March 2008 through April 2009. Participants included 6 STD clinic directors, 63 clinicians, and 7 public health/laboratory/epidemiology professionals in the STI field. Discussion topics included currently available POCT, perceived barriers to using POCT in clinics, priority STI for the development of new POCT, and characteristics of the ideal POCT. All discussions were recorded and transcribed verbatim. Themes raised as barriers for current POCT included complexity, long time frames of the so-called “rapid” test, multiple time-driven steps, requiring laboratory technician, difficulty in reading result, interruption of workflow, unreliability, and invasiveness. Chlamydia trachomatis was identified as the priority organism for development of a new STI POCT. Themes indicated for the ideal POCT included rapid turnaround (up to 20 minutes), ease of use, non-invasive, accurate (preferred sensitivity and specificity in the range of high 90s), Clinical Laboratory Improvement Amendments (CLIA)-waived, user-friendly (for both patients and staff), compact, durable, and sturdy. Conclusions/Significance Focus group discussions with STI experts and professionals highlighted chlamydia as the top priority pathogen for POCT development, and identified the qualities of new POCT for STIs. Participants endorsed ease of use, rapid turnaround and high accuracy as essential characteristics of an ideal POCT.

Use of self-obtained vaginal specimens processed by nucleic acid amplification tests (NAATs) has significantly increased the utilization of nontraditional locations for Chlamydia trachomatis and Neisseria gonorrhoeae screening programs. One important emerging source of such venues includes home-based self-sampling kits available via the Internet. The objective of our study was to evaluate the performance of three commercially available NAATs (Becton-Dickinson ProbeTec SDA, Gen-Probe Aptima Combo2 TMA, and Roche Amplicor PCR) for detection of C. trachomatis and N. gonorrhoeae in vaginal samples obtained via an Internet-based screening program. From July 2004 to August 2005, 500 self-collected vaginal swabs were tested for C. trachomatis and N. gonorrhoeae by using all three NAATs. Another 500 samples were collected between August 2005 and November 2007 and tested by ProbeTec and Combo2; PCR testing was discontinued due to low specificity for N. gonorrhoeae . All tests were conducted according to the manufacturers' procedures; the “gold standard” for an infected C. trachomatis or N. gonorrhoeae patient was defined as ≥2 positive NAAT results. Of the first 500 swabs submitted, 46 were C. trachomatis infected (9.2%) and 5 were N. gonorrhoeae infected (1.0%), and 3 of these were coinfected (0.6%). All C. trachomatis and N. gonorrhoeae Combo2-positive/ProbeTec-negative samples were confirmed as true positives by an alternative NAAT. For C. trachomatis , ProbeTec, Combo2, and PCR had sensitivities of 82.6%, 100%, and 100%, with specificities of 100%, 100%, and 99.3%, respectively. For N. gonorrhoeae , ProbeTec, Combo2, and PCR had sensitivities of 80%, 100%, and 100%, with specificities of 100%, 100%, and 98.8%, respectively. Of the total 1,000 swabs submitted, 92 were C. trachomatis infected (9.2%) and 15 were N. gonorrhoeae infected (1.5%), and 7 of these were coinfected (0.7%). There were no ProbeTec-positive/Combo2-negative samples. For C. trachomatis , ProbeTec and Combo2 had sensitivities of 81.5% and 100%, with specificities of 100% and 100%, respectively. For N. gonorrhoeae , ProbeTec and Combo2 had sensitivities of 80% and 100%, with specificities of 100% and 100%, respectively. Overall, ProbeTec had 17 C. trachomatis false-negative results (1.7%) and 3 N. gonorrhoeae false-negative results (0.3%), while Combo2 had none. Our results were consistent with the sensitivities and specificities stated by the manufacturers. NAATs perform well for detection of chlamydia and gonorrhea with self-obtained vaginal swabs shipped in a dry state to a laboratory. For 1,000 self-collected vaginal swabs tested by NAATs, the sensitivities for C. trachomatis and N. gonorrhoeae for Combo2 were 100% and 100%, while they were 81.5% and 80%, respectively, for ProbeTec. For 500 PCR samples, the C. trachomatis sensitivity was 100% and the N. gonorrhoeae sensitivity was 100%, with specificities of 99.3% and 98.8%, respectively.

Introduction In our previous pilot study on the internet I Want The Kit (IWTK) home self-collection program for sexually transmitted infections (STIs), a voluntary risk score tool predicted STIs well for the female volunteers but not for the males. We investigated the association of IWTK risk score and the presence of STIs in male users when the risk score quiz became mandatory for the program. Methods A six-question quiz which includes demographic and sexual risk behaviour became a mandatory part of IWTK in August 2103. This analysis was restricted to male participants living in Maryland and Washington DC using IWTK August 2013–April 2015. Cochran-Armitage trend test was performed to determine if the prevalence of STIs (chlamydia, gonorrhoea, or trichomonas infection) increased with the higher score of risk score category. Results Overall, 592 male participants submitted specimens for STI testing and completed risk score quizzes. The majority (57%) were Conclusions After excluding potential selection bias, IWTK risk score tool predicted the presence of STIs for male users and could potentially be used for identifying hotspots for STI intervention. Disclosure of interest statement The research group has received research funding from U54EB007958, NIBIB, NIH; AI068613–01, NIH, NIAID.

Introduction Urethral swabs are used for culture of gonorrhoea (NG) in males and for detection of chlamydia (CT) and NG by nucleic acid amplification tests (NAATs). We hypothesised self-collected penile swabs would perform as well as urethral swabs for detection of CT, NG, trichomonas (TV) and mycoplasma (MG). Methods Men having urethral swabs obtained for NG culture in the STD clinic volunteered to collect penile swabs. Urethral swabs were placed into NAAT transport media; then self-collected penile swabs were placed in transport media. NAATs were performed for CT, NG, TV, and MG for urethral and penile swabs. Acceptability questionnaires were given. Results For 203 urethral/penile pairs, there were 32 penile positive for CT (15.8%), 31 urethral positive for CT (15.3%); [sensitivity 96.8% and specificity 98.8% compared to urethral swabs]. There were 29 penile positives for NG (14.3%) and 27 urethral positives for NG (13.3%); [sensitivity 100%, specificity 98.9%]. 25 were Gram stain positive; 21 by culture. For TV, there were 23 penile positives (11.3%), 20 urethral positives (9.9%); [sensitivity 85.0%, specificity 96.7%]. For MG, 24 penile swabs were positive (11.8%); and 29 urethral were positive (14.3%); [sensitivity 79.3%, specificity 99.4%]. CT: 2 samples were penile+/urethral-, 1 was penile-/urethral+. NG: 2 samples were penile+/urethral-. TV: 6 samples were penile+/urethral-, 3 were penile-/urethral+. MG: 1 pair was penile+/urethral-, 6 were penile-/urethral+. There were no significant differences between self-collected penile swabs and clinician-collected urethral swabs for NAATs (p = 0.625 for CT; p = 0.248 for NG; p = 0.344 for TV; and P = 0.070 for MG). 100% of men preferred penile swabs for diagnosis. Conclusions Self-collected penile swabs were as accurate as urethral swabs for the detection of sexually transmitted infections for NAAT assays and could expedite express visits in a busy STD clinic. Penile swabs show promise as a method of utilising one sample for multiple STIs. Disclosure of interest statement The research group has previously received research funding from GenProbe/Hologic. No pharmaceutical grants were received in the development of this study.

Background The website http://www.iwantthekit.org/ (IWTK) began offering self-administered rectal swab kits in addition to vaginal swab kits in January 2009 to test for Chlamydia trachomatis , Neisseria gonorrhoeae , and Trichomonas vaginalis . Methods Swab samples were collected at home by participants and sent by US mail and tested by NAAT (Gen-Probe) assays. Participants submitted separate questionnaires for the vaginal and rectal kits. Data were analysed by STATA, version 11. Results In 1084 questionnaires from women submitting vaginal swabs to the IWTK program since 2009, 194 (17.9%) reported anal intercourse (AI) in the last 90 days. Of these women, only 113 (58.2%) also ordered and returned rectal kits for testing. An additional 95 kits were ordered and returned by women who did not report recent AI (82), did not return a vaginal swab (5), or did not answer the AI question on the vaginal questionnaire (8). From a total of 406 rectal kits ordered by women overall, 208 (51.2%) were returned; three had no consent form; thus, 205 were tested. Of those tested, 26 (12.7%) were positive for chlamydia, 5 (2.4%) were positive for gonorrhoea, and 13 (6.3%) were positive for trichomoniasis. Two of these samples were positive for both Chlamydia and gonorrhoea, two for both chlamydia and trichomonas, and one for all three STIs. The total number of women testing positive for any rectal STI was 38 (18.5%), and 35 of these women also received and returned vaginal swabs, 34 of which were tested. Of those tested, 24 (70.5%) were positive for at least one of the three STIs vaginally, indicating that women who tested positive for rectal STIs were at very high risk for vaginal STIs. Of the 38 women with rectal STIs, the median age was 22 yr. and the median age of first rectal sex was 20 yr. Questionnaires demonstrated 93.6% were single, 62.5% were Black, and 21.9% were White. Of the women with rectal STIs, 67.7% reported no symptoms, 12.0% reported no rectal partners in previous yr, 56.0% reported one partner, and 32% reported 2–4 partners. Only 16.0% reported having a new rectal partner in the last 3 months. Half (50.0%) reported never using condoms, 15.4% reported they always used condoms, 15.4% reported using condoms most of the time, and 19.2% reported using condoms some of the time. Conclusions Public health officials should be aware that AI and rectal STIs are not uncommon among sexually active women. Future STI screening programs should consider rectal infections.

Background Alaska has one of the highest rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in the United States. Alaska Native people, women and youth (ages 15–29) are disproportionately affected. Alaska Native health organisations have jurisdictions over large geographic areas, containing small isolated communities where a perceived lack of confidentiality and privacy is an identified barrier to accessing Sexually Transmitted Disease (STD) testing. The Alaska Native Tribal Health Consortium (ANTHC) has partnered with the “ I Want the Kit ” programme (IWTK) at Johns Hopkins University (JHU) to provide a discrete and reliable STD testing alternative. Methods Alaska residents 14 years of age and older can request a no-cost STD testing kit online or by phone, which is mailed via U.S. Postal Service. After collection, the kit is returned in a prepaid envelope to JHU where it is tested for Chlamydia, gonorrhoea and Trichomonas . JHU reports all testing results to ANTHC, where a nurse notifies all participants of their results and refers positive cases for treatment. IWTK Alaska focuses its advertising efforts in rural Alaskan areas where the disease burden can be high and the barriers to accessing confidential healthcare are greatest. Results In 2012, JHU received a total of 439 home testing kit requests from Alaska of which 161 (37%) were returned. Alaska Native and/or American Indian participants comprised 30% and Whites 53% of kits tested; other minority groups made up the remaining 17% of kits tested. The ages of individuals who returned kits ranged from 16 to 63 years, with a median age of 28 years. Among the 161 kits tested, 14 (8.6%) tested positive for Chlamydia, two of these also tested positive for gonorrhoea, and four kits were positive for Trichomonas. Conclusion This web-based STD testing option increases access to STD testing by alleviating privacy and confidentiality concerns.

Background One internationally accepted method for the molecular epidemiologic typing of Neisseria gonorrhoeae is Neisseria gonorrhoeae Multi Antigen Sequence Typing (NG-MAST). NG-MAST utilises DNA sequencing of two variable regions of the N. gonorrhoeae genome to classify gonococcal isolates into strain types. Method We assessed the genetic diversity of N. gonorrhoeae isolates in Baltimore (N = 277) spanning the years 2009–2011 compared to San Francisco (N = 539) from 2005–2011, using NG-MAST. All isolates in this project were obtained from the CDC Gonococcal Isolate Surveillance Project (GISP). San Francisco strains were mostly from MSM, while the Baltimore isolates were mostly from a heterosexual population. Results NG-MAST results from isolates across that time period revealed a surprising degree of sequence type turnover within the Baltimore area. When compared to the data from San Francisco, the N. gonorrhoeae genetic diversity trends revealed minimal overlap in sequence families between the two metropolitan areas; SF8238, SF210, and SF 2992 were present in both populations. However, a pair-wise comparison of other strain families revealed two relatively distinct populations; the most prevalent strain families in San Francisco were SF437, SF23, SF3935, and SF1407, while those in Baltimore were SF8234, SF8240, SF865, and SF8262. Conclusion These data may imply that the traditional understanding of a gonococcal transmission pattern from west to east cannot accurately depict the strain flow of N. gonorrhoeae isolates within these populations. Our data revealed a large amount of strain turnover in both metropolitan areas by year. This raises questions about the entry and transmission of N. gonorrhoeae within the U.S., and the implications of this turnover in regards to the evolution of this organism.

Background Copan Liquid Amies Elution Swab (ESwab™) Collection and Transport System incorporates maintenance medium which can sustain the viability of Neisseria gonorrhoeae (NG). Swab specimens placed in the tube and stored at room temperature (RT°) can be cultured within 24 hours, and aliquots for nucleic acid amplification tests (NAATs) can be processed within five days. Methods Clinicians at a Baltimore City Health Department STD clinic used standard-of-care aluminium shaft swabs with polyester tips to collect urethral swabs from men, smeared a slide for Gram stain, and placed NG positive (by smear) swabs into investigational ESwab™ tubes. The ESwab™ collection swab applicator was then broken off into the tube and the cap was closed. Culture was performed after tube sat from 5 to 28 hours at RT°. Tube was vortexed for 5 seconds; 100 μl was inoculated to MTM plate, streaked for isolation, and incubated in appropriate conditions for 48–72 hours; 100 μl was placed into Gen-Probe® Unisex transport tube for testing by APTIMA® COMBO 2 assay. Results Of 35 swabs, 26 (74%) were culture positive for presumptive NG (Gram negative diplococci, oxidase positive). Colony counts ranged from 1 to > 500 colonies. 35 (100%) swabs were positive for NG by Gen-Probe® APTIMA® COMBO 2 assay. Six (17%) were also positive for Chlamydia trachomatis (CT) by Gen-Probe® assay. Conclusion Although quality of collected clinical specimen and quantity of NG on the swab are significant variables in obtaining reliable culture results, the ESwab™ System was able to maintain NG viability for at least 24 hours, and stabilised nucleic acids for Gen-Probe® testing. The ability to maintain culture viability of NG up to 24 hours until NAAT testing is completed could eliminate the necessity to perform cultures on all patients who are being screened for NG, with cultures maintained only for susceptibility testing for NAAT+ patients.

Background Diagnosis of syphilis is problematic and an accurate rapid point of care (POC) test could be useful in busy STD clinics. There are no FDA Cleared POC tests for Syphilis serology in the USA. Objective To determine the performance of a new, rapid point of care (POC) test, Syph-Check, which is not yet FDA cleared, for the serological diagnosis of Treponema pallidum in female and male STD patients. Methods Men and women >18 yr visiting the Baltimore City Health Department STD clinic were consented to enrol in a trial to determine the accuracy of a new, innovative POC test for syphilis (Veda, manufactured in France) that used a cassette format to test syphilis serology. The Syph-Check One-Step Syphilis test is a point of care, rapid immunoassay screening test for qualitative detection of IgG and IgM antibodies to Treponema pallidum in finger stick blood, plasma, and serum. This product can be used as an initial screening test or as a confirmatory diagnostic test, but is not FDA cleared for use in screening blood or plasma donors. The assay was performed in the STD clinic, required only 20 min to perform, and required no instrumentation. RPR and TPPA tests were performed to determine the sensitivity and specificity of the Syph-Check POC test. Results 194 men and 205 women were enrolled. Of the 399 samples tested, 33 were positive and 366 were negative by the Syph-Check. There were 14 positives and 385 negatives by RPR confirmatory testing. Overall sensitivity compared to RPR testing was 85.7% (95% CI 60.3% to 97.5%) and specificity was 94.5% (95% CI 91.9% to 96.5%). There were 32 positives and 367 negatives by TPPA confirmatory testing. Overall sensitivity compared to TPPA was 43.8% (95% CI 27.5% to 61.1%) and specificity was 94.8% (95% CI 92.2% to 96.8%). Conclusions The Syph-Check POC test was moderately accurate compared to the RPR test, but not as sensitive compared to TPPA. A more accurate POC test for syphilis could be useful for clinicians to test clinic patients and provide immediate screening results for syphilis to patients during an office or clinic visit.

testing. This approach could increase testingwhen a pelvic exam is not performed. However, neither pH nor sialidase has optimal sensitivity and specificity compared to standard clinical criteria. Trust in self-BV test results increased when young women had the opportunity to try the test and discuss results with the clinician. Trust in self-testing was similar for TV and BV, suggesting that trust is not impacted by perceived severity or stigma associated with either diagnosis. The pH test is already marketed for over the counter use; thus, youngwomenwill likely have access to self-testing strategies for vaginitis in the future, but may continue to rely on clinicians for testing. Sources of Support: NIH/NIAID/K23 A1063182; NIBIB/1U54 B007958.

Background: In the USA, reported cases of chlamydia (Chlamydia trachomatis) continue to rise despite substantial funding for screening. National gonorrhoea (Neisseria gonorrhoeae) rates have remained relatively stable, with clusters associated with metropolitan areas. Rural areas are no exception, as every county in Illinois reported cases of chlamydia in 2007. Morbidity associated with infection remains a public health concern, with costs of $US2.5+ billion annually. Novel screening interventions must be examined for their ability to reach those at risk who are missed by traditional methods. Methods: The website Iwantthekit.org was modified to allow residents from 25 contiguous counties in Central Illinois to request a self-collected sample kit. Returned kits were tested for chlamydia and gonorrhoea. The initial study period was 12 months. Results: During the study period, 343 kits were requested from 20 counties and 39.9% were satisfactorily returned for analysis. Positivity rates for chlamydia and gonorrhoea were 5.8% and 1.2%, respectively, for females and 1.9% and 0% for males. Males comprised 37.7% of all internet samples (compared with 23.4% for traditional screening venues) and 40.4% of all internet samples submitted by whites (compared with only 17.2% of traditional screening). Conclusions: The female positivity rate was comparable to those seen in other screening venues and the method successfully engaged at-risk males. Overall, participation was low and the costs associated with the program outweighed the averted costs associated with the few cases identified. While this methodology resulted in sample requests from a wide area, it must be utilised by more individuals to become cost-effective.

Objective: To ascertain the opinions, concerns and perceptions of sexually active women to guide the development of an internet-based chlamydia outreach and screening program using self-administered vaginal swabs as a first step to prevention. Methods: Seven focus groups were conducted by trained facilitators. Questions were designed to initially open the discussion and elicit the members’ own perceptions. Secondary, more probing questions were asked later to confirm participants’ responses and elicit truthful answers. The main discussion topics were women’s ideas about internet recruitment for chlamydia screening, preferred genital sample type, self-sampling at home using vaginal swabs and using the mail to return specimens. Participants were 42 women, aged 14–49 years. Structured discussions were facilitated using open-ended questions about access to chlamydia testing via the internet. Data were collected and reviewed for common themes and emphasis. Results: All women actively participated in the discussions, providing valuable information. The concepts of self-sampling and the overall project were viewed positively, along with draft advertisements, questionnaires and self-sampling instructions; some modifications were suggested. Common themes included offering free kits available within their community or by direct mail, as well as pre-addressed, stamped mailers for returning the kit to the laboratory for testing. Commonly perceived obstacles and potential risks included: maintenance of confidentiality; situations of embarrassment; and ensuring simplicity of packaging. Women indicated confidence in their ability to collect vaginal specimens and willingness to call for their test results. Conclusions: Focus-group surveys were a useful tool and provided valuable feedback to inform the design of a specialised website to educate and facilitate access to chlamydia screening through home sampling.