Point-of-care tests for sexually transmissible infections: what do 'end users' want?

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.

Characteristics and predictors of women who obtain rescreening for sexually transmitted infections using the www.iwantthekit.org screening programme.

Professional organizations recommend rescreening chlamydia-infected women. The iwantthekit Internet-screening programme offered rescreening opportunities by using iwantthekit. Mailed, home-collected vaginal swabs were tested for chlamydia, gonorrhoea, and trichomoniasis by nucleic acid amplification tests. Demographics and risk behaviours of repeat users were determined from questionnaires. Predictors of repeat users were measured in a matched case-control study. Of 1747 women, 304 (17%), who used iwantthekit, indicated they had used the kit previously. Mean age was 24.7 ± 5.7 years and 69% were African-American. Repeat iwantthekit users were more likely to be aged ≥ 20 years (OR=2.10); were more likely to have been treated for a sexually transmitted infection (OR=2.32); less likely to drink alcohol before sex (OR=0.63); and to never use condoms (OR=0.43). Of repeat users, 84.2% had a negative prior test and 15.8% had a positive. At current test, 13.2% were infected. Previous trichomoniasis was associated with current trichomoniasis (p<0.05). The iwantthekit may offer rescreening opportunities for previously infected women.

Minding the Gap: An approach to determine critical drivers in the development of Point of Care diagnostics.

INTRODUCTION: A point of care test (POCT) for Chlamydia trachomatis detection is an urgent public health need. Technology advances in diagnostics have made solutions possible. Yet no reliable POCT exist. Our goal was to address the gap between chlamydia POCT needs and successful POCT development by determining which characteristics of POCT tests are most critical and if any flexibility in the attributes assigned those characteristics exist between technology developer and end user. METHODS: We employed a process known as WALEX (Warfare Analysis Laboratory Exercise) in combination with Design of Experiment (DOE) methodology using discrete choice experiments (DCE), to describe the attributes of the most realistic, rather than the most ideal POCT. The WALEX was conducted as interactive oral and simultaneous electronic discussion among experts with differing expertise, but linked by a common interest in development of a chlamydia POCT. RESULTS: Our studies demonstrated which features of the ideal chlamydia POCT were considered critical to test acceptance by users and which were open to negotiation. In particular, end users were more lenient on the requirement for the fastest ideal test and the lowest one time instrument costs, if the requirement for higher throughput, lowest cost and vaginal sample source collection were preserved. DOE methods used in forced choice question design provided confirmation of opinions derived from oral and electronic WALEX comments CONCLUSIONS: The WALEX in combination with DCE helped us achieve our goal in identifying the gaps in the chlamydia POCT and determining the most realistic solutions to bridge those gaps.

Trichomonas vaginalis infection in women who submit self-obtained vaginal samples after internet recruitment.

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 <25 years, 52% were black, and 80% were single. Vaginal discharge was reported by 44%, prevalence for trichomonas was 10% (10% for chlamydia, 1% for gonorrhea), and 18% had at least one prevalent STI. Multivariate logistic regression demonstrated several significantly associated risks factors as follows: adjusted odds ratio for black race was 2.69; for residence of Illinois, 3.85; for not having health insurance, 1.57; for lack of a bachelor's degree, 5.53; for having 2 to 15 partners, 1.60; for having ≥16 partners in previous year, 3.51; for being bisexual, 2.0; for not always using condoms, 3.04; and for having a partner who had a previous STI, 1.71. Age was not associated with trichomonas infection. All infected women were treated. CONCLUSIONS: A high prevalence of trichomonas and high sexual risk factors were demonstrated. Internet recruitment was a useful method of screening women for trichomonas infection.

Chlamydia trachomatis age-specific prevalence in women who used an internet-based self-screening program compared to women who were screened in family planning clinics.

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.

Internet-based screening for sexually transmitted infections to reach nonclinic populations in the community: risk factors for infection in men.

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.

Cardiac EASE (Ensuring Access and Speedy Evaluation) - the impact of a single-point-of-entry multidisciplinary outpatient cardiology consultation program on wait times in Canada.

BACKGROUND: Universal access to health care is valued in Canada but increasing wait times for services (eg, cardiology consultation) raise safety questions. Observations suggest that deficiencies in the process of care contribute to wait times. Consequently, an outpatient clinic was designed for Ensuring Access and Speedy Evaluation (Cardiac EASE) in a university group practice, providing cardiac consultative services for northern Alberta. Cardiac EASE has two components: a single-point-ofentry intake service (prospective testing using physician-approved algorithms and previsit triage) and a multidisciplinary clinic (staffed by cardiologists, nurse practitioners and doctoral-trained pharmacists). OBJECTIVES: It was hypothesized that Cardiac EASE would reduce the time to initial consultation and a definitive diagnosis, and also increase the referral capacity. METHODS: The primary and secondary outcomes were time from referral to initial consultation, and time to achieve a definitive diagnosis and management plan, respectively. A conventionally managed historical control group (three-month pre-EASE period in 2003) was compared with the EASE group (2004 to 2006). The conventional referral mechanism continued concurrently with EASE. RESULTS: A comparison between pre-EASE (n=311) and EASE (n=3096) revealed no difference in the mean (+/- SD) age (60+/-16 years), sex (55% and 52% men, respectively) or reason for referral, including chest pain (31% and 40%, respectively) and arrhythmia (27% and 29%, respectively). Cardiac EASE reduced the time to initial cardiac consultation (from 71+/-45 days to 33+/-19 days) and time to a definitive diagnosis (from 120+/-86 days to 51+/-58 days) (P<0.0001). The annual number of new referrals increased from 1512 in 2002 to 2574 in 2006 due to growth in the Cardiac EASE clinic. The number of patients seen through the conventional referral mechanism and their wait times remained constant during the study period. CONCLUSIONS: Cardiac EASE reduced wait times, increased capacity and shortened time to achieve a diagnosis. The EASE model could shorten wait times for consultative services in Canada.

Cardiac EASE (Ensuring Access and Speedy Evaluation)--design of a single point of entry and a multidisciplinary team to reduce waiting times in the Canadian health care system.

Out-patient cardiac consultation in academic group practices often lacks a coordinated intake process, making it difficult to perform prospective testing or to direct undifferentiated consultations to the cardiologist with the shortest waiting list. We created a programmatic approach, with a single point of entry to improve the efficiency of cardiology consultation, without departing from the Canada Health Act. The purpose of this paper is to describe the design of Cardiac EASE.