Abstract
Background:
Point-of-care tests (POCTs) for sexually transmitted infections (STIs) have become increasingly available since the COVID-19 pandemic. There is limited data on the use of these tests in clinical practice, as well as the potential challenges to integrating them into care.
Methods:
We conducted a survey of participants to an international STI conference in July 2023 to better understand use of STI POCTs.
Results:
83% of respondents reported using traditional POCTs (such as gram stain and wet prep) in their practice, and 52% used newer POCTs (most commonly: rapid tests for T. pallidum [26%] and molecular tests for NG/CT [26%]). Newer POCTs were commonly used for symptomatic (77%) and asymptomatic patients (46%), in addition to asymptomatic contacts to people with STIs (51%) and those with increased vulnerabilities (47%). Disclosure of results from newer POCTs occurred during the clinic visit for the majority of respondents (71%). When asked about the most important obstacles to using newer POCTs, cost of the test to the clinical practice or healthcare system was the most cited issue (43%), while concerns regarding changing or establishing new clinic workflows was the second most cited issue (23%). Most participants were “definitely” (58%) or “maybe” (29%) in favor of patient self-tests, however top concerns included lack of follow-up to ensure counseling/appropriate treatment for the patient and their partner.
Conclusions:
To meaningfully adopt newer POCTs, further research is needed to understand practice patterns and barriers to implementation.
INTRODUCTION
Post-COVID-19 pandemic, the global sexually transmitted infection (STI) point-of-care (POC) test (POCT) landscape is rapidly changing. The POCT industry has expanded, telehealth is more prevalent, and medical providers are more familiar with POCTs for infectious diseases. In the U.S., new Clinical Laboratory Improvement Amendments (CLIA)-waived POCTs, including for chlamydia, gonorrhea, and trichomonas have recently been cleared by U.S. Food and Drug Administration (FDA) for use in clinical settings (1–5). Yet, data are limited on how and for which patients newer STI POCTs are being clinically utilised currently, and obstacles to adoption.
Additionally, since the COVID-19 pandemic, providers and the public have become more familiar with POC self-tests (in which the patient both conducts and interprets the test without input from a medical provider) for infectious diseases, often sold over-the-counter (OTC). A POC syphilis self-test was recently FDA-approved (6); self-tests might eventually become available for other STIs as well (3, 7, 8). However, data on the attitudes and concerns of STI experts and practitioners regarding POC self-tests are scarce.
We surveyed participants at an international STI and HIV Congress [International Society for Sexually Transmitted Diseases Research / International Union of Sexually Transmitted Infections joint meetings] in July 2023 regarding newer STI POCTs used in clinical settings as well as POC STI self-tests.
METHODS
Questions were developed with input from U.S.-based STI and STI POCT experts and approved by the Johns Hopkins School of Medicine Institutional Review Board (IRB: NA_00016348). Eighteen questions were entered into Qualtrics. Participants provided informed consent by agreeing to Question 1 on the survey. QR codes and links for the survey were loaded on screens at the conference and pushed out via email by the conference organisers. Descriptive analyses were performed to present the distribution of responses to each survey question among respondents who were included for analysis. Data analyses on questions regarding types, concerns, and obstacles of current clinical use of STI POCTs were restricted to the responses from participants who self-reported that use of STI POCT was applicable to their setting or role. Data analyses on questions regarding type of patients or scenarios for use of newer, highly accurate POCTs were restricted to the responses from those who self-reported that they have used such tests. Percentages were calculated after excluding those for whom the question was not applicable and those who did not respond to that particular question.
RESULTS
After exclusions (n=47, Suppl. Figure 1), data from 142 surveys were analyzed and included 44% (n=63) clinicians and 49% (n=69) non-clinicians; the majority were from the U.S. (61%, n=86) or Europe (15%, n=21). Over two-thirds (73%, n=103) reported working in an urban and 20% (n=29) in a rural setting. Of the 98 participants who answered questions related to clinical use of STI POCT in their own clinical settings, 58% (n=57) were clinicians who see patients, 35% (n=34) were non-clinicians, and 5% (n=5) were disease intervention specialists (DIS) (Table 1).
Table 1:
Characteristics of 142 survey participants
| Characteristics | Overall | STI POCT use questions were applicable to their setting or role | STI POCT use questions were not applicable to their setting or role |
|---|---|---|---|
| N(%) (n=142) | N(%) (n=98) | N(%) (n=44) | |
| Profession | |||
| Clinician | 63 (44) | 57 (58) | 6 (14) |
| Not clinician | 69 (49) | 34 (35) | 35 (80) |
| DIS | 8 (6) | 5 (5) | 3 (7) |
| Missing | 2 (1) | 2 (2) | 0 (0) |
| Regions | |||
| U.S. | 86 (61) | 59 (60) | 27 (61) |
| Canada | 6 (4) | 2 (2) | 4 (9) |
| Europe | 21 (15) | 15 (15) | 6 (14) |
| Australia | 7 (5) | 6 (6) | 1 (2) |
| South America | 7 (5) | 6 (6) | 1 (2) |
| Africa | 13 (9) | 9 (9) | 4 (9) |
| Asia | 1 (1) | 1 (1) | 0 (0) |
| Missing | 1 (1) | 0 (0) | 1 (2) |
| Setting | |||
| Urban | 103 (73) | 69 (70) | 34 (77) |
| Rural | 29 (20) | 24 (24) | 5 (11) |
| Missing | 10 (7) | 5 (5) | 5 (11) |
DIS=disease intervention specialist
“Traditional” or “Newer” POCTs for STIs
Among the 98 participants who indicated that STI POCTs were applicable to their practice, 83% (n=81) reported using “traditional” STI POCTs (such as Gram stain) (Table 2A). When asked about their use of “newer” highly accurate rapid STI POCTs (Table 2B), 52% (n=51) reported using any newer STI POCTs. Of these, the highest percentages reported using rapid antibody tests for T. pallidum or CT/NG molecular tests.
Table 2:
Use of Clinical Point of Care Test (POCTs) for Sexually Transmitted Infections for STIs in the Practice/Clinic.
| Type of POCTs | N (%) (n=98) |
|---|---|
| A. “Traditional” POCTs | |
| Yes, having used newer, highly accurate, rapid POCTs available | 81 (83) |
| - Wet Prep Microscopy for Vaginal Secretions | 43 (44) |
| - Urinalysis or Urine Dipstick for Urethritis | 42 (43) |
| - Gram’s Stain for Urethral Secretions | 37 (38) |
| - Gram’s Stain for Cervical Secretions | 29 (30) |
| - STAT RPR | 26 (27) |
| - Darkfield Microscopy for Possible Syphilis Lesions | 22 (22) |
| None | 17 (17) |
| B. Newer, highly accurate, rapid POCTs available in the last 10 years | |
| Yes, having used newer, highly accurate, rapid POCTs available | 51 (52) |
| - Rapid antibody test for T. pallidum | 25 (26) |
| - Molecular test for CT/NG | 25 (26) |
| - Molecular test for TV | 6 (6) |
| - Enzymatic/rapid antigen test for TV | 5 (5) |
| - Other | |
| Rapid HIV and/or HCV test | 8 (8) |
| Lateral flow test | 1 (1) |
| HIV and syphilis test | 1 (1) |
| None | 47 (48) |
44 participants were excluded from the analysis of this particular question since they indicated that questions on use of POCTs for STIs are not applicable to their setting or role
Those utilizing “newer” STI POCTs were asked for which patients these were being used (Suppl. Table 1). Of the 47 respondents, 77% (n=36) reported using these tests for symptomatic patients, 51% (n=24) for asymptomatic contacts to people diagnosed with STIs, 51% (n=24) in people with increased vulnerabilities (defined in Suppl. Table 1 footnote), and 47% (n=22) for asymptomatic patients.
Clinical Samples for “newer” STI POCTs
Participants were asked when samples were collected during a clinical encounter and by whom, a clinician or the patient through self-collection for newer STI POCTs. Of the 48 participants who answered, 81% (n=39) reported that the patient’s sample was obtained during/after clinician interactions versus prior [19%, (n=9)]. The majority (54%, n=26) reported clinician-collected samples, followed by either clinician or patient self-collection (29%, n=14), and patient self-collection (17%, n=8). Of the 49 participants who responded to questions on delivery of test results, 71% (n=35) replied it was during the clinic visit, 10% (n=5) contact patients by phone/SMS/email the same day, 10% (n=5) contact patients by phone/SMS/email the next day; 4% (n=2) patients returned for the results on the same day, 2% (n=1) patients returned for the result next day.
Obstacles to use of newer STI POCTs
Of the 83 participants who responded regarding obstacles to using newer STI POCTs, 65% (n=54) indicated “cost of the test to the clinical practice or health care system” (Suppl. Table 2). When asked about the most important obstacles to using such tests, the “cost of the test to the clinical practice or healthcare system” was the most cited (43%, n=26), and “requires changing clinic work flows or establishing new workflows” was the second most cited (23%, n=14), followed by increased wait time (25%, n=30) (Suppl. Table 3 and 4).
POC self-tests for STIs
Of the 98 participants who responded to questions regarding patient self-tests for STIs, 51% (n=50) were clinicians who see patients, 44% (n=43) non-clinicians, 3% (n=3) DIS, and 2% (n=2) of unknown profession. Among these, 58% (n=57) were in favor of POC STI self-tests, 29% (n=28) indicated “maybe”, 11% (n=11) said “no” they would not be in favor, and 2% (n=2) indicated “don’t know”. When asked about their concerns regarding POC self-tests for STIs, 77% (n=75) chose “lack of follow-up to ensure counseling/appropriate treatment for patients and their partners”, 66% (n=65) chose “inaccurate reporting to public health systems for tracking STI rates”, and 49% (n=48) chose “lack of follow-up to ensure HIV PrEP (pre-exposure prophylaxis) initiations would be discussed” (Table 3). The most important concern regarding patient self-tests was the lack of follow-up to ensure counselling/appropriate treatment for the patient and their partner (45% and 30% respectively) (Suppl. Tables 5 and 6).
Table 3:
Concerns with over the counter, patient self-tests (i.e. the patient conducts and interprets the result without input from a health care provider) POCTs for STIs?
| Responses | N (%) (n=98) |
|---|---|
| Cost to health care system | 8 (8) |
| Cost to patient | 22 (22) |
| Test will be too complicated for the patient to perform | 16 (16) |
| The patient will not be able to interpret the test result | 33 (34) |
| The test will not give a reliable and accurate result | 31 (32) |
| Lack of follow-up to ensure counseling/appropriate tx for pt/partner | 75 (77) |
| Lack of follow-up to ensure HIV PrEP initiations are discussed | 48 (49) |
| Inaccurate reporting to public health epi system for tracking STI rates | 65 (66) |
| Other | 8 (8) |
| No concerns | 2 (2) |
98 participants responded to the question regarding whether they have a favorable view on future over the counter at-home self-collected, at home-resulted POCTs for STIs. They included (1) 41 of 51 participants who indicated that questions on current clinical use of STI POCT were applicable to their setting or role and reported using newer, highly accurate STI POCT; (2) 33 of 47 participants who indicated that questions on current clinical use of STI POCT were applicable to their setting or role and reported not using newer, highly accurate STI POCT; and (3) 24 of 44 participants who indicated that questions on current clinical use of STI POCT were not applicable to their setting or role (See Supp. Figure)
tx=treatment, pt=patient
Missing response analysis
When analyzing missing responses, the most notable pattern was a significant decrease in the number of participants answering the two questions that required a “drag and drop” ranking of top obstacles or concerns. For example, N=83 participants answered the question regarding “what are the obstacles to use of newer…POCTs for STIs”(see Suppl. Table 2) which only required picking all they felt were applicable, whereas only N=60 answered the next question which required them to drag and drop the top 3 obstacles (see Supp. Tables 3 and 4 for top 2 results). A similar pattern was seen with the last questions of the survey where the initial question that required only clicking any relevant concerns about patient self-tests (Table 3) had N=98 respondents whereas the drag and drop following question (see Suppl. Table 5 and 6) which asked participants to rank their top 3 concerns had only N=80 respondents.
DISCUSSION
In this study, we found about half of clinicians surveyed were using “newer” POCTs for STIs in clinical practice. In line with several other studies, cost (primarily to the clinic or healthcare system, followed by cost to the patient) was identified as the most important obstacle (9, 10). This is critically important for all stakeholders (industry, policymakers, healthcare administrators, clinicians and policymakers) to understand, as it indicates a tremendous need for STI POCT to be priced affordably to ensure adoption(11).
The next most commonly cited barriers were requirements to change clinic workflows or wait time for test results. Changing clinic workflows may in fact be key to negotiating the wait time for test results—self-collected samples (12, 13) or deploying a “sample first” approach (14) in which certain patients give or collect samples on arrival, the test run is initiated prior to the clinical interaction, and the results are available while the patient is still with the clinician. This use of newer STI POCTs can facilitate timely results and minimise excess empirical therapy. In our study, many endorsed using clinician-collected tests, after the clinician interaction, suggesting that there may be room for clinician and patient education or altering workflows to optimise use. Toolkits or guides to setting up optimised workflows in different clinical settings could be useful to improve uptake, timeliness, and usefulness of STI POCTs.
Interestingly, the most frequent reported use of these “newer” tests was for symptomatic patients. As new STI POCTs become available, it is possible that given cost, workflow, and waiting time considerations, these tests could be most useful for a subset of patients; e.g. those who are symptomatic or those who are contacts to STI cases. The use case for each POCT needs to be established and will depend on the characteristics of the population in which it is intended to be used, rather than anticipating that STI POCTs would be used in every clinical scenario.
Lastly, patient STI self-tests are beginning to become available (6). Despite some early evidence suggesting these may be acceptable to patients (15–17), there are few data on attitudes of clinic staff, researchers and clinicians towards such tests. While most survey respondents in our study were in favor of such tests, the major concerns were first and foremost around lack of linkage-to-care for the treatment of patients and their partners, followed by lack of surveillance reporting. These are major concerns that policy makers, test manufacturers and public health officials need to address now, before such tests become more widespread.
There are limitations to this study. It was a survey of interested participants at an STI research-focused conference, mainly from the U.S., which may not reflect the attitudes of clinicians, staff, public health practitioners or researchers more broadly. Our sample size was relatively small, allowing a descriptive study rather than statistical analyses. Considerable missing responses for some questions may limit generalizability. In particular due to lower response rates, possibly due to questionnaire design, we hypothesize that participants may have had difficulty with the “drag and drop” questions and either were not able to complete them or became frustrated with those questions, which could have led to bias. Future surveys should probably avoid the “drag and drop” option.
Our study points to the need for more research to understand the attitudes towards, barriers to, and use of existing STI POCTs among larger groups of clinicians and other stakeholders in specific clinical settings—e.g., STI clinics, emergency departments or urgent care centers, and primary care or obstetrics/gynecology practices, both in the United States and globally. This is important if we want meaningful adoption to address patient and public health. It is important for developers of POCTs to consider affordability of such assays. It also highlights the importance of additional studies to better understand attitudes towards and concerns regarding specific types of POC STI self-tests amongst key stakeholders, including public health officials, clinicians and the patients themselves in a rapidly changing testing environment.
Supplementary Material
Declaration of funding:
This research was supported by the NIH (U54EB007958, PI: Tuddenham). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Conflicts of Interest:
YM, CAG receive funds from Binx, Health. MH has received speaker fees and donation of research kits to Johns Hopkins University from Cepheid and Roche Diagnostics and receives royalties from UpToDate. ST has been a consultant for Biofire Diagnostics, Roche Molecular Diagnostics and Luca Biologics, receives royalties from UpToDate and has received speaker honoraria from Roche Molecular Diagnostics and Medscape/WebMD. She participates in research supported by in-kind donation of test kits from Hologic. Y-HH, HS, GY, and AR do not have any conflicts of interest to report.
Data Availability Statement:
The data that support this study will be shared upon reasonable request to the corresponding author.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The data that support this study will be shared upon reasonable request to the corresponding author.