Attitudes of women participating in a clinical trial on point-of-care testing and home testing for STIs

Abstract

Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infections are a public health concern and cost the United States’ healthcare system 16 billion dollars annually. By minimizing barriers to testing, an increased number of infections can be detected and treated. A home-based point-of-care (POC) sexually transmitted infection (STI) test may reduce personal, structural, social and system-level barriers to STI testing. This study assesses patient preferences and acceptance of home-based POC STI testing. We performed a cross-sectional, single-visit study of women aged 18 years and older at a single site. Women completed an anonymous online survey evaluating interest in POC STI testing, comfort in self-collecting vaginal swabs and participant reaction to a positive STI result. 138 participants completed the anonymous online survey. The survey results indicate high acceptability with self-collection of samples and home POC STI testing. A majority of participants were interested or very interested in a home POC STI device-especially amongst women with a past history of a STI. If receiving a positive test result, participants indicated they would want to have someone to discuss their results with, most preferring to speak with their primary care provider. Women on lower incomes were less comfortable and less interested with home testing. Women are likely to be receptive to home POC STI testing. Adapting to home-based testing will require engagement of primary care providers for management and surveillance of STIs.

Keywords

point-of-care testing home testing sexually transmitted infections diagnostic techniques and procedures

Introduction

The Centers for Disease Control and Prevention (CDC) reports 20 million new cases of sexually transmitted infections (STIs) each year and the number of cases continues to increase annually.^1,2 Common STIs—chlamydia (Chlamydia trachomatis, [CT]) and gonorrhea (Neisseria gonorrhoeae, [NG])—often lack symptoms that allow for expeditious detection and treatment. Thus CT infections have increased by 22% and NG infections by 67% in the United States since 2013.³ Both infections can be easily diagnosed through urine or genital polymerase chain reaction-based tests and treated with antibiotics. These are likely underestimations of total CT and NG infections due to barriers to testing, diagnosis and treatment—a large number of infected individuals are asymptomatic and do not get tested. A delay in diagnosis and treatment exponentiates infection spread through asymptomatic carriers. Women are at an additional risk for complications of untreated CT and NG infections due to biological susceptibility.⁴ Early diagnosis and treatment prevents pelvic inflammatory disease. Complications of pelvic inflammatory disease include: chronic pelvic pain, tubo-ovarian abscess, risk of ectopic pregnancy and infertility.^5,6

Despite the availability of testing, the actual screening rates from different healthcare plans in the United States which include commercial HMO, commercial PPO and Medicaid HMO indicate only 47–58% of women get tested annually.⁷ There have been many barriers identified to STI testing: personal (underestimating risk, perception that infection was not serious, fear of invasive procedure, self-consciousness in genital examination and being too busy); structural (cost of testing and clinician attitudes); social (concern for stigma); and system-level (long waiting times, cost and inconvenient clinic hours).^8–10

STI testing via home kits is available through a variety of websites and select Planned Parenthood affiliates. Patients can receive a home testing kit, collect the sample, return the kit and receive results through this method. Patient experience and satisfaction with home testing kits have been positive. Home STI testing kits and the development of point-of-care (POC) STI home tests has the potential to reduce testing barriers related to accessibility, stigma and loss of privacy. When home-based screening with self-collected vaginal swabs was offered to young women in the United States, STI screening rates increased (1.94 versus 1.41 tests annually) and more STI tests were completed in asymptomatic women (1.18 versus 0.75 tests annually).¹¹ Increased STI testing intervals even in the absence of symptoms is especially important in high-risk groups such as women between 15–24 years old. Almost two-thirds of new CT infections and more than half of new NG infections are estimated to occur amongst those between 15–24 years old, and the CDC recommends annual STI screening for women <25 years old.^12–14 Another study found that women were most likely to screen for STIs at home (75.7%) rather than in clinic (16.1%) or with their medical provider (8.2%).¹⁵

Home-based collection has already been studied for STI testing with expedited test results from the laboratory. In a study with 28,451 patients conducted in a sexual health clinic in Birmingham and Solihull England, one-third requested home-based testing kits instead of being tested in clinic. Home-based testing was more popular amongst patients who were aged 16–24 years old, heterosexual female and asymptomatic at the time of testing.¹⁶ Patient characteristics that may have influenced the results include educational, employment and childcare obligations which lead them to seek alternative low-time commitment STI testing services over a traditional face-to-face appointment.

The World Health Organization (WHO) STI health sector reaffirms the need for: early diagnosis, inclusive screening for asymptomatic carriers and rapid linkage to treatment as a priority intervention.¹⁷ The WHO asserts “a major barrier to STI control and prevention is the unavailability of reliable, low-cost [point-of-care testing] which allow diagnosis and treatment in a single visit.”¹⁸ Nucleic acid amplification tests (NAATs) have become the gold standard for sensitivity, specificity and rapidity.¹⁹ POC NAAT testing in the clinic has already been achieved but not widely implemented with devices such as the desktop binx io that has high performance for sensitivity and specificity for CT and NG.²⁰ This device is a recently FDA-approved rapid test for diagnosis of CT and NG that could be used in the clinic setting. The next step would be a completely patient-operatable home POC STI test that fulfills the WHO ASSURED criteria: affordable, sensitive, specific, user-friendly, rapid, equipment-free and deliverable to the end user.²¹ Ideally a patient would collect the specimen, operate the device and obtain results at home. This would provide a real-time lab-quality diagnostic result within minutes rather than hours or days. In this study, we asked women participating in a clinical trial how receptive they would be to home testing with immediate results to anticipate the evolution of STI testing technology advances—especially now that this is an achievable and forthcoming advancement.

Methods

The UC San Diego AntiViral Research Center enrolled 186 participants in a clinical trial of a new POC STI device for use in clinic as part of a multisite clinical study. The objective of the device study was to evaluate the performance of this investigational device using self-collected swabs tested on the device compared to provider-collected FDA-approved STI swabs. We obtained Investigational Review Board approval from UC San Diego and online informed consent prior to administration and completion of an anonymous online survey. The survey objective was to assess acceptability of self-collection and the potential of home STI testing if this device ever became available. For the main device study, participants were recruited through multiple methods: by provider referral from investigators on the study, via the website ResearchMatch, via advertising from StudyKik, referrals from previous participants and through IRB-approved flyers distributed amongst UC San Diego campuses. The eligibility criteria included being: female at birth, 18 years or older, able to read and understand study procedures, able to give voluntary written informed consent and able to refrain from using vaginal products (e.g. deodorants, feminine washes, lubricants, or douches) within 48 hours of enrollment.

This online survey was administered between September 2019 and November 2019 amongst the English-speaking participants in San Diego. Participants were first recruited via phone or text message and then emailed the survey link if interested in participation. Survey data were collected and managed using REDCap electronic data capture tools hosted at UCSD.²² The survey instrument comprised of 15 items that collected: demographics (age, race/ethnicity, income and education), previous STI history, interest or preferences in POC STI testing, confidence in self-collecting vaginal swabs and reaction to a positive STI result. Survey questions were composed to evaluate opinion of study participants on self-collection and testing for STIs using a POC test. Responses utilized a four- to five-point Likert scale (e.g. strongly disagree to strongly agree). Quality of questions were reviewed by study team members prior to publishing final instrument.

To determine interest in POC STI testing, the survey asked the participant to use a five-point Likert scale to answer: “would you be interested in a POC test for STIs where the result is available in 20–30 minutes?” To determine ease of use and comfort level, the survey asked the participant to use a five-point Likert scale to answer: “how comfortable would you be/are you in using a POC test at home by yourself?” To assess participant adequacy in obtaining treatment with a positive STI result, the survey asked “if you use a STI point of care test at home what would you do if you were positive?” To evaluate participant reaction to obtaining a positive STI result, the survey asked participants to rank the following statements using a four-point Likert scale: I would feel overwhelmed, I would need a phone help line with someone knowledgeable to talk to and I would want to speak to my primary care provider (PCP). Survey data did not include any patient identification and participants could decline to answer certain questions.

Analysis predictors were defined as: young age (18–25); race/ethnicity divided into four groups (White, Asian, Latina and other); past STI history (CT, NG, HIV, HPV, herpes or trichomonas); vaginitis (yeast or bacterial); low income (yearly income less than $50,000); and education (dichotomized for those with bachelor’s degree or higher). For outcomes not already dichotomized: overwhelmed was defined as “agree” or “strongly agree” that they would feel overwhelmed; phone help was defined as “agree” or “strongly agree” with need for someone to talk to; comfort with self-collection as highest Likert level of “comfortable”; and comfort with home POC as highest Likert level of “comfortable.” All analyses were conducted using SAS v9 statistical software package.²³ The Fisher exact test was used for determining relationships between categorical variables. Significance was determined as a two-sided p < .05. Logistic regressions were performed without elimination for significant findings to adjust for young age, race/ethnicity (ordinal variable with Non-Hispanic White, Non-Hispanic Asian, Latina and other), low income and higher education.

Results

138 out of the 184 (74.2%) eligible English-speaking clinical trial participants completed the survey. More than half of participants were aged 18–30 and almost all participants had attended some college or higher education (Table 1). Participants self-reported a history of a genital tract infection: 22% reported chlamydia, 34% reported bacterial vaginosis, and 50% reported yeast vaginitis in the past (Table 1).

Table 1.

Demographics and reported history of STIs.

	Frequency (n = 138)	Percent(%)
Age range (years)
18–25	53	38.4
25–30	21	15.2
30–50	44	31.9
>50	20	14.5
Race
Asian	38	27.5
Hispanic or Latino	20	14.5
White	58	42.0
Other	22	15.9
Highest education level
Bachelor’s degree	56	40.6
High school diploma or GED	5	3.6
Less than high school diploma	1	0.7
Some college or technical training	46	33.3
Advanced degree (master’s, PhD, MD)	30	21.7
Income (annual)
$49,999 or less	72	52.2
$50,000 to $99,999	33	23.9
$100,000 or more	22	15.9
Do not wish to report	11	8.0
Reported history of STIs
Chlamydia	31	22.5
Gonorrhea	5	3.6
Trichomonas	10	7.2
HIV	<5	<3.6
HPV	20	14.5
Herpes	12	8.7
Bacterial vaginosis	47	34.1
Yeast vaginitis	69	50.0

There was high interest in the idea of a POC STI diagnostic with: 92 (67%) that were very interested, 18 (13%) interested, 16 (12%) neutral and only 12 (8%) not interested “in a POC test for STIs where the result is available within 20–30 minutes.” 120 participants (88%) indicated a high level of comfort with a self-collected vaginal swab and 119 participants (88%) indicated a high level of comfort with performing a home POC test; the remaining 16 participants (12%) were neutral or uncomfortable with home testing and self-collection. 63 participants (46%) preferred to do self-collected specimens over a healthcare provider (e.g. physician, nurse, etc), 61 participants (44%) did not have a preference and the remaining 14 participants (10%) preferred a healthcare provider-collected swab (Table 2). When asked the preferred location (home, lab or at a provider’s office) to self-collect their specimen: 58 participants (42%) selected home, 45 participants (32%) did not have a location preference, 19 participants (14%) selected lab and only 16 (12%) selected healthcare provider’s office (Table 2).

Table 2.

Attitudes and preferences towards POC STI testing.

	Frequency (n = 138)	Percent (%)
Who would you prefer to collect the test sample?
Self-collected	63	45.7
Physician-collected	9	6.5
Nurse-collected	5	3.6
No preference	61	44.2
Where would it be appropriate for self-collected POC STI testing?
Self-collect at lab and lab does the test	19	13.8
Self-collect at home and do test on your own	58	42.0
Self-collect at provider appointment and provider does test	16	11.6
No preference	45	32.6
Where would you like to purchase a POC STI test from?
Pharmacy	106	76.8
Clinic	28	14.5
Other	4	2.9
If you used a POC STI test at home, what would you do if you were positive?
Go to local STI clinic	16	11.6
Call/go to primary care provider	81	58.7
Go to urgent care	6	4.4
Go to emergency room	1	0.7
Go to Planned Parenthood	31	22.5
Other	3	2.2

106 participants (77%) would be interested in purchasing a POC STI test from the pharmacy. However, if the test were positive for STIs, 96 participants (70%) indicated they agree or strongly agree that they would feel ‘overwhelmed’ (Table 3). Most women, 86 participants (62%), agreed or strongly agreed that they would want someone available by phone that was knowledgeable to answer questions. A majority, 116 participants (82%), would like to be able to speak to their PCP about the results. 81 participants (59%) reported they would seek treatment from their PCP and the remaining participants reported they would seek treatment at Planned Parenthood (22%), community/public health clinic (12%), urgent care (4%) or the emergency room ( < 1%) (Table 2).

Table 3.

If you found out that you were positive for STIs (e.g. chlamydia, gonorrhea) from a home test that you did yourself.

	1 (Strongly disagree)	2 (Disagree)	3 (Agree)	4 (Strongly agree)
I would feel overwhelmed	12 (9%)	30 (22%)	49 (36%)	47 (34%)
I would need a phone help line with someone knowledgeable to talk to	18 (13%)	34 (25%)	46 (33%)	40 (29%)
I would want to speak to my primary care provider	6 (4%)	16 (12%)	31 (22%)	85 (62%)

STI history and income level influenced participants’ survey responses. 57 participants self reported a history of a STI—defined as a previous CT, NG, HSV, HPV, or trichomonas infection(s). Of the 57 participants with a history of a STI, 45 participants (79%) were highly interested in a POC STI test compared to the 47 participants (58%) that have never had a STI (p < .05) (Table 4). In multivariate logistic regression, past STI history remained significant for an association with interest in POC testing with odds ratio (OR) of 3.2 (95% confidence interval [Cl] 1.3–7.7). Those with a past history of a STI diagnosis were also less likely to be overwhelmed by a positive result from a home test. 33 participants (58%) with a history of STI reported they would be overwhelmed with a positive home test result versus 63 participants (78%) without a history of a STI (p < .05) (Table 4). However, in multivariate logistic regression past STI history became insignificant for an association with being overwhelmed (OR 0.5 95% Cl 0.2–1.2) while those who were Asian (OR 4.4 95% Cl 1.2–16.5) or White (OR 6.1 95% Cl 1.9–20.2) were more likely to be overwhelmed compared to those of other race.

Table 4.

Fisher exact test comparing interest and comfort of home POC testing with past STI history and annual income.

	Past STI history		P-value	Annual income		P-value
	Yes (n = 57)	No (n = 81)		High (n = 55)	Low (n = 72)
Interest in home POC testing	45 (79.0%)	47 (58.0%)	P < .05	33 (60.0%)	51 (70.8%)	P < .05
Comfort with self-collection	44 (77.2%)	56 (69.1%)	0.34	46 (83.6%)	45 (62.5%)	P < .05
Comfort with home POC testing	25 (43.9%)	33 (40.7%)	0.73	30 (54.6%)	23 (31.9%)	P < .05
Interest in buying test at a pharmacy	46 (80.7%)	60 (74.1%)	0.42	49 (89.1%)	48 (66.7%)	P < .01
Being overwhelmed with a positive result	33 (57.9%)	63 (77.8%)	P < .05	36 (65.5%)	51 (70.8%)	0.57

Note: Statistically significant values are shown in bold.

Participants with a lower income, defined as an annual income less than $50,000 were less likely to be very confident in obtaining a self-collected swab compared to participants with annual incomes greater than $50,000: 45 lower income participants (63%) versus 46 higher income participants (84%) (p < .01) (Table 4). This finding remained significant in multivariate logistic regression (OR 0.4 95% Cl 0.1–0.9) along with Whites compared to other race (OR 4.5 95% Cl 1.3–15.7).

Lower income participants were less likely to have comfort in performing a home test when compared to higher income participants (p < .05): 23 lower income participants (32%) versus 30 higher income participants (55%) (Table 4). This result remained significant with multivariate logistic regression (OR 0.3 95% CI 0.1–0.8). Asians were also less likely to be comfortable with running a home test than other race (OR 0.2 95% CI 0.1–0.8). Lower income participants were less likely to be interested in buying a home test at a pharmacy: 67% lower income participants versus 89% higher income participants (p < .01) (Table 4). This remained significant with multivariate logistic regression for low income (OR 0.2 95% CI 0.1–0.7). Those between 18–25 years old (OR 4.0 95% CI 1.2–13.1) and Whites (OR 5.6 95% CI 1.3–24.8) were also more likely to want to buy a POC test at the pharmacy. Participants with lower incomes reported they would seek care at community/public health clinic (17%) and Planned Parenthood (25%) as the most common choices.

Discussion

Current STI literature on POC home testing is very limited and only shows data for home testing with laboratory services. This study aims to address the attitudes and acceptability of self-collected swabs with the participant conducting the test and receiving the results at home. Women who participated in a STI diagnostic device study indicated high acceptability of self-collecting vaginal specimens and high acceptance of POC testing. A majority of survey respondents felt competent to perform a home POC STI test. However, participants would like resources such as their PCP for counseling and treatment for a positive home test. These findings have implications for future development of home POC STI tests and preferences for how patients will want to be managed. With previous studies that involved participants sending back self-collected swabs to the laboratory, the clinic providing the home tests was ultimately responsible for follow-up care, referral or treatment (if there were any).¹¹ There currently is no unanimous protocol with home POC STI testing. Pre-test counseling from a PCP or virtual counselor could reduce the possibility of participants feeling overwhelmed: participants would feel more comfortable if they were educated with treatment options prior to a positive result. Regardless, there needs to be a clear and easy-to-follow resource sheet that provides guidance on where to obtain treatment to eliminate potential gaps in providing care and subsequent infection spread.

Survey responses indicate participants are confident in self-collecting vaginal swabs and prefer this method to healthcare provider collection. Most college women also preferred to self-collect vaginal swabs over other testing methods and indicated that they would be tested more often if a self-collected vaginal swab was available.²⁴ Another study found that self-collected vaginal swabs were actually more sensitive for detection of CT and NG than clinician-collected endocervical swabs and first-catch urine—endocervical swabs and first-catch urine can miss up to 10% of diagnoses.²⁵ Therefore, self-collected POC testing would align with patient preferences to increase STI testing and identification amongst women. As the infected individuals and their partners are identified and treated, a lower incidence of STIs would be expected in the community. Even when comparing retesting rates amongst populations, the majority overwhelmingly preferred to collect a specimen at home and showed higher retesting rates in the home arm versus clinic arm (64% versus 39%).²⁶

There are potential challenges with home POC STI testing such as: patient distress with testing positive for STIs, not having access to healthcare for timely treatment, reluctance to notify sexual partners, healthcare provider unfamiliarity with home STI POC testing and delay or lack of reporting to Public Health Departments. Healthcare providers would need to be educated on availability, performance and expectations of their role around home POC STI testing. This may be accomplished via engaging local/national professional organizations; providing continuing education programs; and endorsement by public health organizations.

It is a challenge to gather complete surveillance of STI incidence due to underreporting, unreliability and limited geographic scopes. This will be even more so exacerbated as home POC STI testing will bypass the lab-based reporting mechanism. Surveillance practices would need to maintain the four components of STI surveillance as indicated by the WHO: clinical case reporting, infection prevalence surveys, assessment of STI syndromes and monitoring of antimicrobial resistance.²⁷ In particular, clinical case reporting (e.g. confidential morbidity reports) by providers may be more necessary than before to capture treatment of STIs without a lab-based result. Since rapid tests do provide a result that confirms an organism, improved diagnostic coding for prescribing should be emphasized and monitored. Healthcare providers would need to enter diagnostic codes of the specific organism rather than just general codes such as “sexually transmitted infection” for clarity and improved surveillance. Prevalence studies may also be more necessary to monitor population-level disease rates.

Limitations of this study include the relatively small sample size derived from only one geographic location (San Diego) with the majority of participants (132; 96%) having completed at least some college. The participants were previous participants in a STI device study which could have a bias towards interest and acceptability of home STI testing. Survey participants self-reported a high rate of prior STI diagnoses which may further bias towards an interest in home STI testing. Next steps would be to increase the sample size to see if similar responses are obtained by repeating the study in a larger cohort. An assessment of healthcare providers’ opinions on home POC STI testing should also be performed. This can be achieved by developing and distributing a survey to healthcare providers to address how they might support patients’ ability to collect samples; administer home POC STI testing; manage home POC STI testing results; provide expedited partner treatment; and enhance reporting results to the Public Health department.

In conclusion, this survey-based study found the majority of participants were interested or very interested in a home POC STI device. Although there are issues that still need to be addressed, a home POC STI device could increase testing frequencies in women and therefore be a possible new avenue to lower the STI rates, reduce preventable adverse health outcomes and lower the 16 billion dollars spent annually on treatment of STIs and subsequent health issues in the United States.²

Footnotes

Declaration of conflicting interests

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

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.

ORCID iD

Karen Chow

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