Perceptions on Point-of-Care Tests for Sexually Transmitted Infections - Comparison between Frontline Clinicians and Professionals in Industry.

OBJECTIVES: To determine if a gap exists between sexually transmitted infection (STI) clinicians and industry professionals regarding perceptions of the ideal types and characteristics of STI point-of-care tests (POCTs). METHODS: Our online survey design contained sections on demographics; barriers of use for available STI POCTs; characteristics of an ideal POCT, including prioritizing pathogens for targets; and "building your own POCT". Practicing clinicians and academic experts from two venues, STI-related international conference attendees and U.S. STD clinic clinicians, were invited to participate in the clinician survey. Professionals from industry in the STI diagnostic field were invited to participate in the industry survey. Chi-square test and conditional logistical regression were used for data analysis. RESULTS: Clinician survey participants (n=218) identified "the time frame required" (39.9%), "complexity" (31.2%), and "interruption of work flow" (30.3%) as the top three barriers making it difficult to use STI POCTs, while the industry survey participants (n=107) identified "complexity" (65.4%), "unreliability" (53.3%), and "difficulty in reading results" (34.6%) as the top three barriers (all p values <0.05). Sensitivity was always the most important attribute to be considered for a new STI POCT by both participant groups. Participants of the clinician group chose cost as the second priority attribute, while those of the industry group chose specificity as the second priority. CONCLUSION: We identified differences in the perceptions regarding barriers and ideal attributes for STI POCTs between frontline clinical providers and industry personnel. Tailored training is warranted to inform scientists, biomedical engineers, and other industry experts about characteristics that clinicians desire for STI POCTs.

What do we know about males and emergency contraception? A synthesis of the literature.

CONTEXT: Unintended pregnancy rates are high in the United States. It is important to know whether improving males' access to emergency contraceptive pills may help prevent unintended pregnancy, especially in cases of -condom failure. METHODS: A search of the PubMed, PsycINFO and Cumulative Index of Nursing and Allied Health Literature databases was conducted to identify studies published from January 1980 to April 2011 concerning males and emergency contraception. Forty-three studies met the specified criteria and examined relevant knowledge, attitudes, beliefs, intentions or behaviors, from the perspectives of males, clinicians or pharmacists. RESULTS: The proportion of males who were familiar with emergency contraception ranged from 38% among teenagers to 65-100% among adults. Small proportions reported that they and their partner had used or discussed using emergency contraceptive pills (13-30%) or that they themselves had ever purchased them (11%). Most providers (77-85%) reported general knowledge about emergency contraceptives, but the proportions who knew the time frame within which the pills can be prescribed were smaller (28-63%). Most males approved of emergency contraceptive use following contraceptive failure (74-82%) or unprotected sex (59-65%), or in cases of rape (85-91%), but both pharmacists and college students reported concerns that females might feel pressured to use the method. No study examined clinicians' attitudes and behaviors (e.g., counseling or advance provision) regarding males and emergency contraception. CONCLUSIONS: Studies are needed to determine whether male involvement in emergency contraception can reduce rates of unintended pregnancy and to assess health professionals' ability to counsel males about the method.

What qualities are most important to making a point of care test desirable for clinicians and others offering sexually transmitted infection testing?

BACKGROUND: To investigate the possible effects of different levels of attributes of a point-of-care test (POCT) on sexually transmitted infection (STI) professionals' decisions regarding an ideal POCT for STI(s). METHODS: An online survey was designed based on a large-scale in-depth focus discussion study among STI experts and professionals. The last section of the survey "build your own POCT" was designed by employing the discrete choice experiment approach. Practicing clinicians from two venues, STI-related international conference attendees and U.S. STD clinic clinicians were invited to participate in the survey. Conditional logistical regression modeling was used for data analysis. RESULTS: Overall, 256 subjects took the online survey with 218 (85%) completing it. Most of the participants were STD clinic clinicians who already used some POCTs in their practice. "The time frame required" was identified as a major barrier that currently made it difficult to use STI POCTs. Chlamydia trachomatis was the organism chosen as the top priority for a new POCT, followed by a test that would diagnose early seroconversion for HIV, and a syphilis POCT. Without regard to organism type selected, sensitivity of 90-99% was always the most important attribute to be considered, followed by a cost of $20. However, when the test platform was prioritized for early HIV seroconversion or syphilis, sensitivity was still ranked as most important, but specificity was rated second most important. CONCLUSIONS: STI professionals preferred C. trachomatis as the top priority for a new POCT with sensitivity over 90%, low cost, and a very short completion time.

Perceptions of an ideal point-of-care test for sexually transmitted infections--a qualitative study of focus group discussions with medical providers.

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.

The use of focus groups to design an internet-based program for chlamydia screening with self-administered vaginal swabs: what women want.

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.

Internet-based screening for Chlamydia trachomatis to reach non-clinic populations with mailed self-administered vaginal swabs.

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 <25 years were associated independently with being chlamydia positive, while use of birth control and non-consensual sex were protective. Thirty-six of 41 (87.8%) positive samples were positive by all 3 NAATs, 5/41 (12.2%) were positive by only 2 NAATs, and none were positive by only 1 NAAT. The Internet/e-mail request method was better than the community pick-up approach because 97.2% of kit requests were e-mailed and 87.5% of kits returned for testing were e-mail requested. CONCLUSIONS: Women will use the Internet to request and use home-sampling kits for chlamydia. NAAT testing performed well on dry-transported VS. High prevalence was detected and questionnaires indicated high-risk sexual behavior.