Heterogeneity in practitioner-reported barriers to use,cost considerations and priorities for point of care sexually transmitted infection tests on surveys across seven years

Abstract

Background

Point of care diagnostic tests (POCTs) for sexually transmitted infections (STIs) have the potential to improve STI care worldwide. However, barriers to adoption, cost considerations and practitioner priorities may not be uniform globally and over time. We conducted two surveys, 7 years apart, among members of the International Union Against Sexually Transmitted Infections (IUSTI), and compare results here.

Methods

Surveys were given to members attending two IUSTI conferences in 2012 (Australia) and 2019 (Estonia). Descriptive analyses were performed and chi-square or Fisher’s exact tests conducted.

Results

Amongst N = 190 participants in 2012 and N = 166 in 2019, 61% in 2012 and 77% in 2019 were from high-income countries (HICs). In 2012, 84% of respondents from low- and middle-income countries (LMICs) and 70% from HICs thought cost of test was more important than amount of reimbursement. Trends were similar in 2019. In 2012, unreliability was considered the most important barrier to POCT use by all groups, followed by being laboratory-driven and complexity. In 2019, time frame was considered most important, followed by unreliability and being laboratory-driven. In 2012, the top priority for POCT development among LMIC respondents was early HIV seroconversion (31%), versus chlamydia (57%) for HICs. In 2019, chlamydia remained top priority for HICs (40%), followed by early HIV seroconversion (19%) and gonorrhea (17%); top priorities for LMICs were chlamydia (26%), HPV (24%), and early HIV seroconversion (21%).

Conclusions

Practitioner priorities for STI POCTs may be shifting. Cost may be critical to adoption in all settings. Larger studies are needed to verify findings.

Keywords

Point of care sexually transmitted infection testing

Introduction

Point of care (POC) diagnostic tests for sexually transmitted infections (STIs) have the potential to substantially improve patient care by decreasing loss to follow-up, time to accurate therapy and both over- and under-treatment.^1–3 The need for POC tests for STIs (STI POCTs) is not new, but perhaps more pressing now given limitations on in-person evaluations and decreased clinic capacity during the SARS-COV2 pandemic. Although the World Health Organization (WHO) has been stressing this need for decades, getting POC tests through the pipeline from development to market has historically been difficult. Encouragingly, several new highly accurate POC tests have recently been approved or are in late-stage development.^2,4 Yet, more tests are needed, and adoption of available tests has been slow.⁵ Provider’s perceived needs for STI POCTs, as well as perceived barriers to adoption and use may be shifting over time, both in high-income countries (HICS) as well as low- and middle-income countries (LMICS).⁶ Understanding these shifting concerns across geography and time will be critical to inform ongoing efforts to develop and adopt STI POCTS.

Previous surveys have examined provider preferences for STI POCTs cross sectionally in HIC and LMIC^5–10 respondents, but there are few data comparing the two longitudinally. In order to determine if opinions and use of STI POCTs differed between HICs and LMICs and over time, we conducted two separate but similar surveys among members of the International Union Against Sexually Transmitted Infections (IUSTI) 7 years apart and compare results here.

Methods

Two similar surveys which queried members of the International Union Against Sexually Transmitted Infection (IUSTI) (including clinicians, academic researchers, health workers and laboratory professionals) regarding their wishes and needs for STI POCTs were administered. The surveys were designed based on a large-scale in-depth focus discussion study among STI experts and professionals^8–10 and were given in person to IUSTI members attending two international conferences in 2012 (Melbourne, Australia) and 2019 (Tallinn, Estonia).

Key comparisons included economic factors that participants felt were most important regarding decisions for use of POCTs, barriers (all barriers and the most important one) to using POCTs in practice, and the top two STIs that participants felt were highest priority for development of a POCT. The International Monetary Fund (IMF) (see www.imf.org) during this period defined countries as “developed” or “developing”, however this language may be outdated. We therefore grouped participants’ reported residence countries according to these definitions, but in this paper refer to “developed” countries as “high income countries (HICs)” and “developing countries” as “low- and middle-income countries (LMICs)”. Participant’s self-reported professions were categorized to 6 groups, including medical doctor (MD), non-MD professional, health worker, laboratory professional, academic, and other. Type of practice was categorized to public or private practice. Descriptive analyses were performed first to summarize data using frequencies and percentages as appropriate. Then, chi-square tests or Fisher’s exact tests were used in order to compare geographic region, profession, and type of practice between conference attendees in 2012 and 2019. The same analytical approaches were employed to compare the responses between participants from the LMICs and HICs within 2012 and 2019 IUSTI conference attendees, respectively, as well as the responses between 2012 and 2019 IUSTI conference attendees by LMICs or HICs.

Finally, responses from 2019 conference attendees on the preferred POCT in 3 questions that compared a pair of POCTs which had different attributes in positive and negative probability and cost (see Suppl. Material for questions) were analyzed by developing country status. All analyses were performed by using SAS version 9.04 (SAS Institute Inc., Cary, NC). All p values were 2-sided, with p < .05 considered to be significant.

IRB approval for these surveys was obtained from the Johns Hopkins Institutional Review Board (IRB# NA-00012998).

Results

A total of 356 participants, (N = 190 for 2012 and N = 166 for 2019), completed the surveys. Two participants in 2019 did not respond to the survey question regarding their country of residence and were excluded from subsequent analysis relating to LMIC versus HIC status. As expected due to the locations of the conferences (2012 in Australia, 2019 in Europe), a higher proportion of respondents were from Oceania in the earlier survey, with a higher proportion from Europe in the later survey. The majority of respondents (61% in 2012 and 77% in 2019 (p =< .01) were from HICS. The largest proportion of respondents were medical doctors, and most were employed in public practices (See Table 1).

Table 1.

Respondent characteristics.

	2012 responses (N = 190) (%)	2019 responses (N = 166) (%)	p-values
Geographic region^a			<0.001
Europe	27	52
Oceania	26	7
Americas	22	28
Africa	11	6
Asia	11	6
LMICs	39	23	0.001
Profession			0.048
Medical doctor (MD)	61	55
Non-MD professional	11	11
Academic	14	13
Health worker	4	2
Lab professional	7	6
Other	3	12
Type of practice^b			0.052
Public	74	83
Private	26	17

Statistically significant p values are bolded.

^a2 did not respond to question regarding residence of country in 2019.

^b26 did not respond to question regarding type of practice in 2012.

Participants were asked to choose whether they felt that “the cost of the test from the manufacturer or distributor” versus “the amount of reimbursement received for performing the test” was more important as an economic factor for a health care provider using a POCT. The majority of respondents from both HICs and LMICs reported that the cost of the test from the manufacturer was more important than the amount of reimbursement received. However, in 2012, a higher percentage (84%) of respondents from LMICs than from HICs (70%, p = .03) thought cost of the test was more important. Trends were similar in 2019 (86% vs 72%), though the difference was no longer statistically significant (Table 2).

Table 2.

Economic factor that participants reported as more important to a health care provider using point-of-care tests by survey time and country type (HICs/LMICs).^a

	2012 survey responses			2019 survey responses			2012 vs 2019
	% from HICs (N = 116)	% from LMICs (N = 74)	p value	% from HICs (N = 122)	% from LMICs (N = 35)	p value	HICs p value*	LMICs p value**
The cost of the test from the manufacturer or distributor	70%	84%	0.030	72%	86%	0.101	0.695	0.795
The amount of reimbursement received for performing the test	30%	16%		28%	14%

Statistically significant p values are bolded.

^a7 participants in 2019 did not respond to this question.

*p value comparing proportions for those from HICs between 2012 and 2019.

**p value comparing proportions for those from LMICs between 2012 and 2019.

Barriers to using POCT in the participant’s practice were reported by similar proportions of respondents in both HICs and LMICs. However, a larger proportion of those from HICs reported “time frame” (63%) and “interruption of work flow” (37%) as a concern in 2019 as compared to those from LMICs (43% and 19%, respectively, p < .05). Nonetheless, the highest proportion of respondents cited “time frame” in both HICs and LMICs in 2019; concerns for “time frame” increased within HICs respondents from 38% in 2012 to 63% reporting concerns in 2019, with similar trends in LMICs. A larger proportion of those from HICs reported “Unreliability” (40% vs 24% in LMICs) and a smaller proportion reported “Invasiveness” (3% vs 11% in LMICs) as a barrier in 2012 but differences were not statistically significant in 2019. Overall, the lowest proportion of respondents in both 2012 and 2019 and in HICs as well as LMICs reported “Invasiveness” and “Difficulty in reading results” as concerns (See Table 3).

Table 3.

Barriers that make it difficult to use Point-Of-Care tests in participant’s practice by survey time and country type (HICs/LMICs).^a

	2012 survey responses			2019 survey responses			2012 vs 2019
	% from HICs (N = 105)	% from LMICs (N = 71)	p value	% from HICs (N = 125)	% from LMICs (N = 37)	p value	HICs*	LMICs**
Complexity (multiple steps)	30%	30%	0.994	34%	27%	0.452	0.508	0.781
Time frame	38%	25%	0.078	63%	43%	0.030	<0.001	0.057
Laboratory driven	28%	35%	0.284	32%	38%	0.508	0.470	0.787
Difficulty in reading results	10%	16%	0.324	14%	14%	0.989	0.471	0.784
Interruption of work flow	27%	25%	0.846	37%	19%	0.042	0.101	0.452
Unreliability	40%	24%	0.027	38%	35%	0.719	0.804	0.218
Invasiveness	3%	11%	0.030	2%	5%	0.321	1.000	0.319
Patient’s perceived wait time	34%	28%	0.393	37%	24%	0.159	0.692	0.669
Other	23%	28%	0.425	23%	22%	0.841	0.951	0.461

Statistically significant p values are bolded.

^a14 participants in 2012 did not respond to this question; 2 participants in 2019 did not respond to the question.

*p value comparing proportions for those from HICs between 2012 and 2019.

**p value comparing proportions for those from LMICs between 2012 and 2019.

When asked to identify the single most important barrier to STI POCT use, in 2012, unreliability was reported by the largest proportion of all groups in both HICs and LMICs (21% overall), followed by being laboratory driven (i.e., having to be conducted in a laboratory (even if not a core laboratory) rather than at being able to be conducted in a setting without laboratory capabilities-for example a test that needed to be conducted in an on-site “stat” laboratory rather than being able to be used in any setting, even those completely without laboratory capabilities) (13%) and complexity (13%). However, in 2019, time frame (23%) was considered most significant, followed by unreliability (19%) and being laboratory driven (17%). There were no significant differences between HICs and LMICs in either 2012 or 2019 though there were some shifts within HICs and LMICs between the two times. For example, a larger proportion of both HIC and LMIC participants reported time frame as the most important barrier in 2019 (See Suppl. Table 1).

In 2012, the top priority for POCT test development among LMICs respondents was early HIV seroconversion (which could be an HIV viral load or antigen test) (31%), versus chlamydia (57%) for HICs respondents, though in 2012, 25% of LMICs respondents did report chlamydia as the highest priority test for development. In 2019, while the largest proportion of participants from HICs still reported chlamydia (40%) as the highest priority, an increased percentage also reported gonorrhea as the highest priority (17% vs 5%); there was a similar trend in LMICs (13% vs 7%). In 2019, the largest percentage of LMICs respondents (26%) chose chlamydia as the highest priority test while 24% reported HPV and 21% reported early HIV seroconversion as the highest priority. There was no statistically significant change in reported first choice POCT for development amongst LMICs respondents from 2012 to 2019 (See Suppl. Table 2). When asked about their second choices for test development, chlamydia, gonorrhea, early HIV seroconversion, syphilis and HSV were prioritized in 2019 (See Suppl. Table 3).

In 2019, participants identified the attributes of a POCT that were most important to them using 3 forced-response questions (See Suppl. Table 4 and Suppl. Material for exact questions). When tests were set at the same level of negative probability at 95%, higher positive probability was preferred over the lowest cost (questions 1 and 2 from question set A). This applied to both participants from the developing and developed countries. When the positive probability was high (90-99%), (questions 3 and 4 from question set B) participants from LMICs and those from HICs had a different preference. Approximately half of participants from the LMICs preferred the lowest cost of the test rather than highest negative probability with moderate cost, as compared with 80% from HICs who preferred the highest negative probability with moderate cost. However, under the same level of positive probability, the majority of participants from both developing and developed countries preferred the test with moderate cost and moderate level of negative probability over one with high negative probability but high cost (questions 5 and 6 from question set C).

Discussion

Our study revealed both similarities and differences in economic and other factors influencing practitioners’ STI POCT use, perceived barriers to test adoption, priorities for test development, and desired test characteristics longitudinally and between participants from HICs versus LMICs. This study extends results from a similar clinician survey conducted by our group in 2009, in which >89% of participants were from the US, Canada or Europe^9,11 and adds to the limited literature on practitioner preferences for STI POCT⁷ by enabling comparisons between HICs and LMICs over time.

Notably, ‘cost of test’ questions converged over time as being more important to the majority of respondents from both HICs and LMICs than the amount of reimbursement received for performing the test. This suggests that this is a main factor that should be prioritized in contemporary test development not only for LMICs, as might be expected, but also for HICs. This is in line with previous literature on the topic. In our survey (Hsieh et al., 2011) conducted primarily in US, Canadian and European respondents, 78% felt the cost of the test was vital versus only 22% identifying the amount of reimbursement as a barrier.⁹ In another study (Ferreyra et al., 2020) which conducted qualitative interviews with 15 experts from LMIC regarding a hypothetical NG/CT POC and an NG antimicrobial resistance marker POC, test price was the most frequently mentioned factor driving adoption of a new test.⁷

The most important recently identified barriers to STI POCT were similar between LMICs and HICs and were identified as time frame, unreliability, and being laboratory-driven. Again, this is supported by previous literature: Hsieh et al. reported that time frame required (40%) was felt by the largest proportion of respondents to be the most important barrier.⁹ We asked separately about “patient’s perceived wait time” as a barrier and 37% from HICs and 24% from LMICs identified this as a concern (Suppl. Table 3). There is likely some overlap in these concerns as “time frame” of the test being perceived as a barrier may relate at least in part to provider concerns over patient’s willingness to wait for test results. Our finding also aligns with literature on patients’ needs, which suggests that at least in the US, willingness to wait after the initial clinical encounter for STI POCT results decreases after 20 min.^12,13 Willingness to wait may differ in other settings; in one study amongst women attending STI clinics conducted in China, 99.1% of patients were willing to wait up to 2 h for a rapid chlamydia test result.¹⁴

In 2019, chlamydia was important for the largest proportion of both HICs and LMICs as a priority for STI POCT. Early seroconversion HIV was reported by a large proportion of both groups as well, suggesting that chlamydia and early HIV seroconversion should remain priorities for test development. Of note, in our study, while priorities for STI test development did not change statistically significantly over time in HIC respondents, a higher proportion did report that gonorrhea was their highest priority in 2019 as compared with 2012. A trend towards the same result in LMICs suggests that perhaps gonorrhea should be increasingly prioritized for test development. Some of the enhanced interest in POCT for gonorrhea may relate to increasing concerns regarding (and the WHO’s focus on) the threat of antimicrobial resistance in this organism.¹⁵ Our results are similar to previous literature from HICs—providers in our previous 2009 survey (62%) also identified chlamydia as the top priority for new POC.⁹ Relatively little previous data exists on practitioner reported preference for STI POCT development in LMICS, though in a previous study conducted in Uganda in 2016 the top priority was HIV seroconversion, followed by hepatitis, syphilis, HPV and gonorrhea—chlamydia was not reported to be a priority.⁶

In our study, in 2019, test sensitivity was paramount (and more important than cost) for both HICs and LMICs respondents. Both were willing to compromise on specificity for lower cost but this occurred at a higher price point for HICs than LMICs respondents, suggesting that ideal test characteristics might differ between the two groups. Though the results are not directly comparable, this is somewhat different from our previous (HIC-based) 2009 survey in which participants were more willing to compromise on sensitivity for lower cost.⁹ This is interesting in light of a recent U.S. calibrated modelling study (Ronn et al.¹) which suggested even a slightly less sensitive POCT chlamydia test could impact chlamydia burden if screening frequency could be improved, as discussed by Van Der Pol.¹⁶ The potential value of a less sensitive POCT was also previously highlighted by Gift et al.¹⁷

There are significant limitations to this study. Most importantly, the participants were a select group of individuals attending two international STI conferences and not all participants at the conferences participated. Moreover, the majority worked in public rather than private settings. Our sample size was fairly small, and a larger proportion of individuals were from developed countries. Therefore, the results may not be broadly generalizable to all practitioners. Additionally, there were some shifts in geographic region between 2012 and 2019 (as to be expected given the different geographic locations of the two conferences) which could have affected results, though our approach in stratifying analysis based on developing country versus developed country status rather than geographic location should have helped to mitigate this issue. Not all questions could be analyzed as some were quite differently worded in the surveys in the 2012 as compared with the 2019 conferences. We were not able to capture responses from patients and therefore the perspectives here are limited to those of practitioners. Finally, our study was conducted prior to the SARS-COV2 pandemic. While many aspects of healthcare may currently be returning to pre-pandemic operations, others may have been irrevocably altered, and may continue to shift.

Rapid, affordable POCTs with good performance are needed to increase access to STI diagnostic certainty and targeted treatment. Yet, our results suggest that, even pre-pandemic, practitioner priorities for STI POCTs may have been shifting over time in HICs and LMICs. We also found that low cost should remain a strong consideration during assay development and may be critical to adoption and access in all settings. However, our study was small and had significant limitations. It is important that these factors are repeatedly assessed and carefully considered in future larger, more systematic studies in order to best guide STI POCT development in a post-pandemic world.

Declaration of conflicting interests: 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. YCM has received research grant support to Johns Hopkins University from Hologic, Cepheid, Roche, ChemBio, Becton Dickinson, miDiagnostics, and has provided consultative support to Abbott. AR receives royalities from UpToDate. CG has received research grants from Binx Health and Visby Health.

Supplemental Material

Supplemental Material - Heterogeneity in practitioner-reported barriers to use, cost considerations and priorities for point of care sexually transmitted infection tests on surveys across seven years

Supplemental Material for Heterogeneity in practitioner-reported barriers to use, cost considerations and priorities for point of care sexually transmitted infection tests on surveys across seven years by Susan Tuddenham, Yu-Hsiang Hsieh, Yukari C Manabe, Charlotte Ann Gaydos and Anne Rompalo in International Journal of STD & AIDS

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health (U54EB007958), and the National Institute of Allergy and Infectious Diseases, National Institutes of Health (U01AI068613).

Contributorship

AR, YH, and CG designed the surveys. AR and CG administered the surveys. YH conducted the statistical analysis. ST wrote the first draft of the publication. AR, YH, CG, YM and ST all contributed significantly to interpretation of data and manuscript drafting.

ORCID iD

Susan Tuddenham

Supplemental Material

Supplemental material for this article is available online.

References

Ronn

Menzies

Gift

, et al. Potential for point-of-care tests to reduce chlamydia-associated burden in the United States: a mathematical modeling analysis. Clin Infect Dis 2020; 70: 1816–1823.

Hsieh

Melendez

Gaydos

, et al. Bridging the gap between development of point-of-care nucleic acid testing and patient care for sexually transmitted infections. Lab Chip 2022; 22: 476–511.

Dawkins

Bishop

Walker

, et al. Clinical integration of a highly accurate polymerase chain reaction point-of-care test can inform immediate treatment decisions for chlamydia, gonorrhea, and trichomonas. Sex Transm Dis 2022; 49: 262–267.

Gaydos

Manabe

Melendez

. A narrative review of where we are with point-of-care sexually transmitted infection testing in the United States. Sex Transm Dis 2021; 48: S71–S77.

Korte

Rompalo

Manabe

, et al. Overcoming challenges with the adoption of point-of-care testing: from technology push and clinical needs to value propositions. Point Care 2020; 19: 77–83.

Parkes-Ratanshi

Kikonyogo

Hsieh

, et al. Point-of-care diagnostics: needs of African health care workers and their role combating global antimicrobial resistance. Int J STD AIDS 2019; 30: 404–410.

Ferreyra

Redard-Jacot

, et al. Barriers to access to new gonorrhea point-of-care diagnostic tests in low- and middle-income countries and potential solutions: a qualitative interview-based study. Sex Transm Dis 2020; 47: 698–704.

Hsieh

Gaydos

Hogan

, et al. Perceptions on point-of-care tests for sexually transmitted infections - comparison between frontline clinicians and professionals in industry. Point Care 2012; 11: 126–129.

Hsieh

Gaydos

Hogan

, et al.

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

PLoS One 2011; 6: e19263.

10.

Hsieh

Hogan

Barnes

, et al. Perceptions of an ideal point-of-care test for sexually transmitted infections--a qualitative study of focus group discussions with medical providers. PLoS One 2010; 5: e14144.

11.

Adhikari

Bhattarai

Basnet

, et al. Prevalence and associated risk factors for tuberculosis among people living with HIV in Nepal. PLoS One 2022; 17: e0262720.

12.

Widdice

Hsieh

Silver

, et al. Performance of the Atlas genetics rapid test for chlamydia trachomatis and women’s attitudes toward point-of-care testing. Sex Transm Dis 2018; 45: 723–727.

13.

Gettinger

Van Wagoner

Daniels

, et al. Patients are willing to wait for rapid sexually transmitted infection results in a university student health clinic. Sex Transm Dis 2020; 47: 67–69.

14.

Yin

Peeling

Chen

, et al. Clinic-based evaluation of clearview chlamydia MF for detection of chlamydia trachomatis in vaginal and cervical specimens from women at high risk in China. Sex Transm Infect 2006; 82(Suppl 5): v33–v37.

15.

World Health Organization (WHO) . https://www.who.int/news/item/22-11-2021-gonorrhoea-antimicrobial-resistance-results-and-guidance-vaccine-development and https://www.who.int/publications/i/item/9789240021341

16.

Van Der Pol

. Making the most of point-of-care testing for sexually transmitted diseases. Clin Infect Dis 2020; 70: 1824–1825.

17.

Gift

Pate

Hook

3rd , et al. The rapid test paradox: when fewer cases detected lead to more cases treated: a decision analysis of tests for Chlamydia trachomatis. Sex Transm Dis 1999; 26: 232–240.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.48 MB