Addressing Cervical Cancer Screening Disparities: At-Home Self-Collection Among LGBQ+ Populations

Abstract

Background

Over 20 million people in the U.S. are behind on cervical cancer screenings (CCS). Sexual minority populations are 50% less likely to engage in routine screening, putting them at higher risk for cervical dysplasia and cancer due to undetected precancer and delayed diagnosis. Their barriers to speculum exams include access to care, sexual trauma, and provider bias. At-home HPV self-collection (SC) offers a clinically accurate, preferred alternative screening method.

Objective

To assess clinical agreement, usability, and screening experiences and preferences for an FDA-authorized at-home vaginal SC device among participants who identify as lesbian, gay, bisexual, pansexual, queer, or other non-heterosexual identities (LGBQ+).

Methods

SELF-CERV was a prospective, multi-site method-comparison study conducted across 16 U.S. sites. Participants completed SC in a simulated at-home setting and underwent clinician collection with a speculum and cervical brush; paired specimens were tested for primary HPV using the Roche cobas. Surveys assessed barriers to screening, prior screening experiences, usability, and preferences. 609 participants were enrolled; 599 had paired samples, including 74 LGBQ+ participants.

Results

Compared with heterosexual participants, LGBQ+ participants more frequently delayed or avoided screening, had lower preventive care engagement, and described worse prior speculum-based screening experiences, including higher pain, discomfort, and aversion. Clinical agreement between self- and clinician-collected specimens was comparable, with no unanticipated safety concerns. The SC device was rated as easy to use and acceptable across groups; LGBQ+ participants reported greater comfort and empowerment and a stronger preference for at-home self-collection. Qualitative comments emphasized privacy and reduced distress, including trauma- and dysphoria-related concerns.

Conclusion

At-home SC is a clinically valid, usable, and strongly preferred CCS option, particularly among LGBQ+ populations who experience disproportionate barriers to speculum-based CCS. Broader adoption of FDA-authorized at-home SC paired with telehealth will enable future impact assessment to reduce persistent disparities in CCS for LGBQ+ populations.

Plain Language Summary

Cervical cancer can often be prevented through regular screening, but many people in the United States are behind on recommended tests. People who identify as lesbian, gay, bisexual, queer, or another sexual minority are less likely to get screened. Common reasons include discomfort or pain during clinic exams, past trauma, difficulty accessing care, and negative experiences with healthcare providers. This study looked at whether an at-home screening option could help reduce these barriers. Participants used the Teal Wand, a device that allows people to collect their own vaginal sample at home and mail it to a laboratory for HPV testing. The results were compared with samples collected by a healthcare provider during a clinic visit. The study included 609 participants, including 74 people who identified as a sexual minority. The at-home test was just as accurate as samples collected by a clinician. People who identified as a sexual minority were more likely to report pain and discomfort during past clinic exams and were more likely to have delayed or avoided screening in the past. When using the at-home option, sexual minority participants reported feeling more comfortable, more in control, and more empowered than during clinic-based screening. Most found the device easy to use and preferred at-home testing over a traditional exam. Many also said they would be more likely to stay up to date with screening if an at-home option were available. These findings show that at-home cervical cancer screening is a safe, effective, and more comfortable option, especially for people who face barriers to clinic-based care. Expanding access to at-home screening, along with telehealth support, may help reduce long-standing gaps in cervical cancer prevention and improve health outcomes for underserved sexual minority communities.

Keywords

cervical cancer screening HPV primary screening HPV self-collection sexual minority health telehealth trauma-informed care

Introduction

In 2025, it is estimated that 4,320 people will die from cervical cancer in the United States, with around 13,360 new cases being diagnosed.¹ Routine screening, which is recommended for all those with a cervix between the ages of 25 and 65, paired with HPV vaccination, is the most effective way to prevent cervical cancer.² Yet, over 20 million people (approximately 1 in 4) in the U.S. are behind on their routine cervical cancer screening.³ Among those underscreened (defined as behind on their guideline indicated screening), individuals who identify as gay, lesbian, bisexual, pansexual, queer, and other sexual minorities (i.e., non-heterosexual sexual identities) are 50% less likely to engage in routine cervical cancer screening (i.e., in-clinic speculum exams commonly referred to as a Pap smear), with 10% lower prevalence of up-to-date screenings compared to heterosexual counterparts, and significantly less likely to have ever been screened.^4-7 As a result, these populations are at increased risk of undetected HPV-related cervical precancer and delayed diagnosis, with a greater likelihood of presenting later with cervical cancer.^6,8

This lower screening rate and heightened resulting disease risk among sexual minority groups often stems from factors like higher rates of sexual trauma (often correlated with other social stressors such as increased incidence of homelessness and sex work), which can lead to extreme distress with intimate exams and speculum use.^9-12 Other key factors also include systemic implicit bias from healthcare providers, where 87% of LGBTQ+ patients report receiving disrespectful and biased healthcare.¹³ Additionally, among trans men, gender dysphoria related to the speculum exam can be especially challenging, posing a psychoemotional deterrent to screening, and for those who have been using testosterone long-term, it can also be extremely painful as a physical deterrent. One study found that only 56% of trans men were engaged in routine cervical cancer screening compared to 72% of cisgender women; another showed that over 90% of trans male patients preferred self-collecting their cervical/vaginal sample to the speculum exam.^14,15 As a result, patients who identify with sexual or gender minority groups can feel hesitant to seek cervical cancer screenings in clinic settings and miss life-saving preventative care.

There is a paucity of data illuminating the cervical cancer screening experiences of sexual minority groups, where research has typically focused on cisgender, heterosexual women. For instance, a PubMed query for “self-collection and cervical cancer screening” studies since 2018 renders 178 studies related to “women” (without mention of “LGBTQ+”), while showing only 9 results inclusive of LGBTQ+ individuals. Accordingly, this study fills an important need for more scholarship in this area, addressing the perspectives and experiences of sexual minority groups who are disproportionately underscreened and at higher risk for cervical dysplasia and cancer.^6,8

Expanding access to self-collected cervical cancer screening within the home setting is critical to reaching sexual minority populations who are among the underscreened and face a higher disease burden as a result.¹⁶ In 2025, the United States Food and Drug Administration (FDA) approved an at-home self-collection device.¹⁷ This FDA approved device is a prescription-only vaginal self-collection device for testing on the FDA-approved Roche cobas primary HPV assay in the laboratory.¹⁸ Per the American Cancer Society (ACS 2025), primary HPV testing, including using at-home self-collection, is a recommended screening test for those above the age of 25.¹⁹ The United States Preventive Services Task Force (USPSTF) also recommends primary HPV testing for those above 30 and underscores evidence showing the notable impact of at-home self-collection in reaching underscreened populations.^16,20 In a nationwide clinical study, self-collected samples using this at-home SC device showed a 96% clinical sensitivity for the detection of cervical dysplasia (CIN2+ detection, 1.00 relative sensitivity) and 95% positive percent agreement (PPA) for detecting high-risk HPV when comparing self-collected specimens to those collected by a clinician.²¹ This performance is equivalent to that of clinician-collected samples and upholds the quality of screening while offering a collection alternative demonstrated to increase screening.¹⁶

Not only is self-collection an accurate and widely preferred collection method among patients, but allowing patients to collect at home and mail in their samples for testing critically improves screening access.^16,22-30 At-home self-collection removes key barriers to attending in-clinic screening pertinent for sexual minority groups, including emotional and psychological distress, lack of access to LGBTQ+ friendly providers, and physical discomfort.³¹ The SC device studied – a clinically validated, user-friendly, and patient-preferred screening device and corresponding telehealth service that is designed for at-home self-collection – presents a feasible option to accelerate cervical cancer screening engagement among those of diverse sexual identities. This analysis explores clinical outcomes, usability and preferences for the 74 LGBQ+ participants in the SELF-CERV study.

Methods and Study Design

This analysis is based on user experience and preference data collected from participants in the SELF-CERV trial, a prospective, non-randomized method comparison clinical study evaluating the agreement of self-collected to clinician-collected samples for primary HPV testing. In total, there were 609 participants enrolled; 599 with paired samples (self- and clinician-collected) for method comparison.²¹ The data analyzed here focus on those who self-declared their sexual identity (in a demographic survey question) as gay, lesbian, bisexual, pansexual, queer, or questioning (N=74). While we recognize that each of these groups has distinct life experiences, for this analysis, and given that their cervical cancer screening experiences can often be comparable, we refer to this group as ‘LGBQ+’ or ‘non-heterosexual’ to discuss their cervical cancer screening experiences, preferences, and usability as it pertains to at-home self-collection compared to speculum-based in-clinic screenings. The reporting of this study conforms to the STROBE guidelines.³²

The SELF-CERV study compared the agreement between self-collection using a purpose-designed SC device (Teal Wand, Figure 1) in a simulated at-home setting and clinician-collected samples using a speculum and brush for the detection of high-risk HPV genotypes. The trial was conducted across 16 U.S. sites between November 20, 2023 and April 5, 2024. Participants were consecutively recruited from the 16 sites, and those who expressed interest in participation were included if they met the guidelines for cervical cancer screening at the time of enrollment, which included people ages 25-65 with an intact cervix, and no cervical alteration within the prior 5 months. No study procedures were conducted before interested individuals provided written informed consent to participate. Safety evaluations were conducted immediately after device use, and participants were followed for 2 weeks after the study. The trial was approved by a central independent institutional review board and two institutional IRBs: Advarra (Central IRB, Pro00074742, Oct 20, 2023), Johns Hopkins University (IRB00407957, Nov 14, 2023), New York University (i23-01534, Feb 23, 2024), and registered on clinicaltrials.gov (NCT06120205). The study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2024. No patient identifiers are included.

Figure 1.

FDA-authorized vaginal self-collection device for at-home cervical cancer screening (image courtesy of Teal Health, Inc.)

Participants self-collected a vaginal sample with the SC device in a simulated at-home environment (private setting in a clinic) where the unsupervised participant used the SC device using instructions written in 5/6^th grade language (English or Spanish, if requested). This self-collection included unpackaging the device, SC device use, then removal of the collection sponge and placement into the vial for processing. Device usability assessed the user’s understanding and execution of every step required to collect a vaginal sample for testing according to FDA requirements for Human Factors testing.³³ While the clinical site mailed the samples, further usability studies were conducted to assess users’ aptitude to complete all aspects of at home use. For purposes of accurate HPV result comparison, the individual immediately underwent clinician-collection with a speculum and cervical broom for method comparison for HPV detection using the Roche cobas HPV test, which evaluates 14 high-risk HPV genotypes of HPV 16, HPV 18, and a pooled HPV Other for the remaining 12. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for all high-risk HPV was the primary efficacy endpoint. Clinical results from the study have been published elsewhere and supported FDA authorization of the SC device.²¹ Following the collection procedures, participants also completed two surveys: (i) usability, patient experience, and preferences around using the SC device, and (ii) overall screening preferences, attitudes, prior screening experiences, and additional demographic information. The survey instruments were structured and collected primarily quantitative data, with some open-ended questions included to allow respondents to elaborate. Surveys were not validated, but had evolved from a prior pilot study of the SC device.³¹ Not all survey questions required responses, leading to variable respondent totals across questions.

Analysis

This cohort analysis explored the experiences of participants identifying as LGBQ+ in the larger study, including clinical performance, usability, and preferences. The study was not powered specifically to determine differences between these cohorts; analysis is presented using descriptive statistics. In evaluating usability of the SC device in this group, the FDA’s guidance on Human Factors testing (e.g., usability) recommends a minimum of 15 users to identify 90% of usability problems.³³ As such, with the LGBQ+ sample size (N=74) substantially larger than this minimum recommendation, we are able to detect 97-99% of possible use errors and concerns relating to device usability. The sample size is also relatively large compared to other preferences, attitudes, and experiences studies about sexual minority groups and cervical cancer screening. Survey data were analyzed between heterosexual and non-heterosexual participants using Fisher’s exact test for categorical variables, and the Mann-Whitney U test for continuous and ordinal variables. P-values ≤ 0.05 were deemed statistically significant. All percentages presented are ‘valid percentages,’ using a variable denominator depending on how many respondents answered the particular question. No missing data were replaced or imputed in any analysis.

Results

Demographic Overview

Among all participants, 13% (74/588) self-identified as LGBQ+ (Table 1). Their responses represent gay, lesbian, bisexual, pansexual, queer, questioning, and not listed/other sexual identities (identities other than “heterosexual/straight”). Overall, the SELF-CERV study enrolled a diverse patient population from across the US. The population largely represented the U.S. population in terms of race and ethnicity per the 2022 Census and captured wide diversity across demographic categories such as annual household income, highest level of education, geographic location/residence, and screening eligible age groups.³⁴ This diversity is consistent when considering demographic breakdowns per sexual orientation (heterosexual vs. non-heterosexual). Further, the sample size appears to be reflective of the U.S. population in terms of sexual identification; a 2025 Gallup survey reports that 10% of U.S. women self-identify as LGBTQ+, reflecting the sample of sexual minority participants in this study (N=74, 13%) (Table 2).³⁵

Table 1.

SELF CERV Participants by Sexual Orientation

Sexual orientation	Percent
Heterosexual/Straight	86% (515/599)
Gay/Lesbian	2% (10/599)
Bisexual	7% (42/599)
Pansexual/Queer/Questioning	4% (21/599)
Not listed (Other)	0.2% (1/599)
Prefer not to reply	1% (7/599)
Unknown/no response	0.5% (3/599)
Total	100% (599)

Table 2.

Participant Demographics

		Non-heterosexual, percent (n/N)	Heterosexual, percent (n/N)
Race	White/Caucasian	58% (42/73)	62% (304/493)
	Black or African American	19% (14/73)	27% (133/493)
	Asian	8% (6/73)	3% (17/493)
	Multi-Racial	8% (6/73)	3% (14/473)
	Native Hawaiian/Pacific Islander	1% (1/73)	0% (2/473)
	American Indian or Alaskan Native	0% (0/73)	1% (4/473)
	Other	5% (4/73)	4% (19/473)
Ethnicity	Non-Hispanic/Latinx	78% (57/73)	81% (409/504)
Ethnicity	Hispanic/Latinx	22% (16/73)	19% (95/504)
Highest level of education completed	No formal schooling completed	0% (0/74)	1% (3/513)
	Up to middle school (Grade 8)	3% (2/74)	2% (11/513)
	High School or equivalent (GED)	27% (20/74)	26% (134/513)
	Associate’s Degree (2-year degree)	8% (6/74)	19% (96/513)
	Vocational or Technical School	4% (3/74)	7% (37/513)
	Bachelor’s Degree (4-year degree)	38% (28/74)	31% (158/513)
	Master’s Degree or higher (professional degree or PhD)	20% (15/74)	14% (74/513)
Annual household income	Less than $9,999	18% (13/71)	11% (53/466)
	$10,000 to $19,999	4% (3/71)	6% (30/466)
	$20,000 to $49,999	35% (25/71)	23% (109/466)
	$50,000 to $99,999	28% (20/71)	32% (151/466)
	$100,000 to $149,999	7% (5/71)	13% (61/466)
	More than $150,000	7% (5/71)	13% (62/466)
Employment status	Employed full-time	58% (42/73)	69% (344/502)
	Employed part-time	14% (10/73)	12% (58/502)
	Unemployed	29% (21/73)	20% (100/502)
Health insurance	Private insurance	68% (50/74)	64% (328/513)
	Government	18% (13/74)	24% (124/513)
	No insurance (self-pay)	12% (9/74)	8% (42/513)
	Other	3% (2/74)	4% (19/513)

Demographics were self-reported. As such, not all questions were answered by all those who completed surveys. The Total numbers in each category represent the number of responses to each categorial question.

Clinical Outcomes

Positive percent agreement (PPA) for all high-risk HPV was the key endpoint of this clinical study, a benchmark that was established as acceptable to the FDA when developing the clinical trial, given the vast international data substantiating the clinical sensitivity of self-collected samples tested with highly sensitive molecular HPV tests.³⁶ When analyzing the clinical performance of the SC device by sexual identity, we find that PPA of paired, valid samples is strong and comparable for both groups (95.6% heterosexual vs. 93.9% non-heterosexual) (Table 3). The marginal difference in performance is not statistically significant. The agreement threshold for equivalence was 87% and agreement for both cohorts exceeded that threshold. There were no unanticipated safety concerns or adverse events.

Table 3.

Method Comparison of Clinical Outcomes by Sexual Orientation

All high-riskHPV	Non-heterosexual			Heterosexual			p-value
All high-riskHPV	Frequency	Percent	Invalid	Frequency	Percent	Invalid	p-value
Positive Percent Agreement (PPA)	31/33	94% (95% CI:80.4-98.3)	4%	239/250	96% (95% CI:92.3-97.5)	2%	0.654
Negative Percent Agreement (NPA)	36/37	97% (95% CI:86.2-99.5)	4%	221/249	89% (95% CI:84.2-92.1)	2%	0.146

The PPA and NPA for all high-risk HPV were not different between cohorts. The invalid rates were also not different (p=0.255). Genotype reporting is found for the overall study in a prior report.²¹ There were 6 cases of HPV16/HPV18 (5, 1 respectively) in the non-heterosexual cohort, all of which had 100% PPA.

Usability

The study found that the SC device and its accompanying instructions were easy to use and engendered high confidence in both heterosexual and non-heterosexual groups (Table 4). Among non-heterosexual participants, 97% used only the provided instructions and agreed that these instructions had clear directions on key elements of the self-collection procedure. Further, 93% did not feel that they required any help to complete their collection using the SC device, and 84% completed their self-collection (which includes reading instructions, self-collecting, and removing the sponge with their sample) in under 5 minutes. All LGBQ+ participants were able to successfully detach the collection sponge atop the SC device, which is a critical step in being able to package the sample (collected on the sponge) for mailing to the laboratory, where it was tested on the FDA-approved Roche cobas primary HPV assay. The majority (71%) of LGBQ+ participants felt confident that they completed their collection correctly (note, almost all samples were collected correctly, with no difference in invalid sample rates). In total, 95% of non-heterosexual participants found self-collection with the SC device to be easy, with the remaining 5% reporting it was neither easy nor difficult.

Table 4.

Usability of the Self-Collection Device

Question	Non-Heterosexual,Percent (n/N)	Heterosexual,Percent (n/N)
Used only the instructions provided with the Self-Collection Wand	97.3% (72/74)	99.0% (509/514)
Did not feel they needed any help while collecting your sample	93.2% (69/74)	93.0% (478/514)
Agree that instructions were clear for how to find a comfortable position before inserting the Wand	97.3% (72/74)	98.2% (505/514)
Agree that instructions were clear for how to hold the Wand and position it to guide it into vagina	97.3% (72/74)	98.6% (506/513)
Agree that instructions were clear for how to place the Wand into vagina and toward cervix until slight pressure or resistance	97.3% (72/74)	97.1% (499/514)
Was able to detach the sponge	100% (74/74)	98.6% (506/513)
On a scale from 1 (not confident) to 5 (very confident), do you feel that you followed the instructions to successfully collect a sample?
5 - I feel very confident that I collected the sample properly	24.3% (18/74)	43.8% (225/514)
4 - I feel confident that I collected the sample properly	47.3% (35/74)	35.2% (181/514)
3 - I feel like there is a 50/50 chance I collected the sample properly	16.2% (12/74)	11.9% (61/514)
2 - I am not certain about whether I collected the sample properly	6.8% (5/74)	5.6% (29/514)
1 - I do not have any confidence that I collected the sample properly	5.4% (4/74)	3.5% (18/514)
On a scale from 1 (Very difficult) to 5 (Very easy), overall, how clear were the instructions for using the Self-Collection Wand?
5 - Very Easy	44.6% (33/74)	51.2% (263/514)
4 - Easy	50% (37/74)	40.9% (210/514)
3 - Neither difficult nor easy	5.4% (4/74)	7.4% (38/514)
2 - Difficult	0.0% (0/74)	0.6% (3/514)
1 - Very difficult	0.0% (0/74)	0.0% (0/514)
How long did it take you to complete the self-collection procedure, start to finish?
Less than 1 minute	4.1% (3/74)	5.8% (30/513)
Between 1 and 2 minutes	36.5% (27/74)	33.3% (171/513)
Between 3 and 5 minutes	43.2% (32/74)	53% (272/513)
More than 5 minutes	16.2% (12/74)	7.8% (40/513)

Qualitative comments from LGBQ+ participants further highlight the ease, usability, and comfort experienced when using the SC device. A sample of these comments is presented below for illustrative purposes:

“Simple, quick, painless process, not hard [at] all.”

“Amazing, for those who can't physically come to the office, is practical, or even if a patient needs privacy. Loved it!”

“Much more comfortable than a traditional screening w/ speculum. Those always hurt, but the Teal test didn’t.”

“Really easy. I didn't have the same discomfort that I usually have w/ a clinician pap smear [...].”

Cervical Cancer Screening Experiences and Preferences

There are notable differences when comparing the prior experiences and barriers to cervical cancer screening between heterosexual and non-heterosexual groups (Table 5). We find that 51% of LGBQ+ participants report having delayed or avoided getting a cervical cancer screening in the past, compared to 29% of heterosexual participants. This difference is statistically significant (p<0.001). When asked about the barriers that lead them to delay or avoid cervical cancer screenings, we see key statistically significant differences between heterosexual and non-heterosexual groups. The non-heterosexual group reports more discomfort with the exam (19% vs. 9%, p=0.017), transportation limitations (6% vs. 1%, p=0.034), clinic-related challenges such as not being sure where to go or not being able to get an appointment (12% vs. 4%, p=0.003), and financial constraints (21% vs. 8%, p=0.002).

Table 5.

Cervical Cancer Screening Background

	Non-heterosexual, Percent (n/N)	Heterosexual, Percent (n/N)	p-value^§
Before today, have you previously had a Pap smear?
Yes	95% (70/74)	98% (506/514)	0.052
No	5% (4/74)	2% (8/514)	0.052
When you have previously had a Pap smear, did you know that it was for a cervical cancer screening?
Yes	79% (55/70)	84% (421/503)	0.307
No	21% (15/70)	16% (82/503)	0.307
Have you ever delayed or avoided getting a Pap smear?
Yes	51% (36/70)	29% (147/506)	<0.001
No	49% (34/70)	71% (359/506)	<0.001
Reasons for delaying Pap smear (check all that apply)
Uncomfortable with the exam
Yes	19% (13/70)	9% (44/506)	0.017
No	81% (57/70)	91% (462/506)	0.017
Clinic-related issues
Yes	13% (9/70)	4% (18/506)	0.003
No	87% (61/70)	96% (488/506)	0.003
Transportation limitations
Yes	6% (4/70)	1% (7/506)	0.034
No	94% (66/70)	99% (499/506)	0.034
Lack of time
Yes	11% (8/70)	10% (51/506)	0.677
No	89% (62/70)	90% (455/506)	0.677
Not aware of the medical reasons
Yes	4% (3/70)	2% (12/506)	0.410
No	96% (67/70)	98% (494/506)	0.410
Afraid of results
Yes	9% (6/70)	5% (24/506)	0.243
No	91% (64/70)	95% (482/506)	0.243
Financial constraints
Yes	21% (15/70)	8% (42/506)	0.002
No	79% (55/70)	92% (464/506)	0.002
COVID-19 reasons
Yes	9% (6/70)	4% (20/506)	0.114
No	91% (64/70)	96% (486/506)	0.114
Preventive healthcare engagement
Attends 2 visits annually with PCP and OBGYN	27% (20/74)	42% (215/513)	0.048
Attends 1 visit annually with PCP	20% (15/74)	18% (94/513)
Attends 1 visit annually with OBGYN	18% (13/74)	18% (92/513)
Sometimes attends visit with PCP	4% (3/74)	5% (27/513)
Sometimes attends visit with OBGYN	11% (8/74)	4% (23/513)
Does not go to doctor regularly	15% (11/74)	8% (40/513)
Other	5% (4/74)	4% (22/513)

§ Calculated using 2-sided Fisher’s exact test.

Respondents also had the opportunity to write qualitative comments about their barriers to screening and reasons for delaying or avoiding screening in the past. A sample of these comments from non-heterosexual individuals is presented below for illustrative purposes. Of note, multiple comments refer to discomfort with the speculum and trauma around this screening:

“Don't like speculums.”

“Not being able to get the time off work.”

“PTSD”

“Sexual trauma”

“Unclear/changing recommendations regarding frequency.”

These patterns are consistent when looking at preventive healthcare engagement as a whole, too. The non-heterosexual group reports attending preventive healthcare appointments significantly less frequently than those who identify as heterosexual: 27% of LGBQ+ report going to 2 visits annually with a primary care provider (PCP) and obstetrician-gynecologist (OBGYN), compared to 42% of heterosexual individuals, while 15% report not going to the doctor regularly, compared to 8% of heterosexual individuals (p=0.048).

Significantly more non-heterosexual participants reported feeling pain (36% vs. 20%, p=0.005) and discomfort (77% vs. 60%, p=0.006) than heterosexual individuals during standard speculum-based cervical cancer screenings (Table 6). Comments from LGBQ+ respondents about speculum-based cervical cancer screenings included: “Dehumanization,” “trauma response,” “discomfort (with) male provider,” and “it’s not something any woman looks forward to.”

Table 6.

Experiences With Clinician-Collection Using Speculum and Self-Collection

In the past, when you had a Pap smear performed by a healthcare provider, did you feel: (Check all that apply)	Non-heterosexual, Percent (n/N)	Heterosexual, Percent (n/N)	p-value^§
Pain
Yes	36% (25/70)	20% (99/505)	0.005
No	64% (45/70)	80% (406/505)	0.005
Discomfort
Yes	77% (54/70)	60% (301/505)	0.006
No	23% (16/70)	40% (204/505)	0.006
Embarrassment
Yes	19% (13/70)	13% (65/505)	0.194
No	81% (57/70)	87% (440/505)	0.194
Nervous
Yes	51% (36/70)	43% (217/505)	0.200
No	49% (34/70)	57% (288/505)	0.200
Ease
Yes	10% (7/70)	12% (61/505)	0.698
No	90% (63/70)	88% (444/505)	0.698
In control
Yes	7% (5/70)	5% (26/505)	0.568
No	93% (65/70)	95% (479/505)	0.568
Neutral
Yes	31% (22/70)	21% (105/505)	0.064
No	69% (48/70)	79% (400/505)	0.064

§ Calculated using 2-sided Fisher’s exact test.

However, turning to self-collection with the SC device, significantly more non-heterosexual participants agreed that this mode of sample collection made them feel empowered and in control (92% vs. 80%, p=0.010) (Table 7). Similarly, significantly more non-heterosexual participants felt more comfortable self-collecting their own sample using the SC device, rather than having their sample collected by a clinician using a speculum; 71% of LGBQ+ participants found the SC device to be ‘a lot more’ or ‘somewhat more’ comfortable than clinician-collection, compared to 57% among the heterosexual group (p=0.014). Here, we also find that significantly more LGBQ+ respondents prefer to self-collect using the SC device, rather than clinician-collection, as compared to heterosexual respondents (79% vs. 63% self-collection preference, p=0.008). Similarly, significantly more LGBQ+ respondents also prefer telehealth visits, when possible, rather than going in-person to the clinic, compared to heterosexual respondents (59% vs. 44% telehealth preference, p=0.017).

Table 7.

Experiences With Self-Collection

	Non-heterosexual, Percent (n/N)	Heterosexual, Percent (n/N)	p-value^§*
True or False, performing my own cervical cancer screening test makes me feel empowered or in more control of my experience?
True	92% (67/73)	80% (405/509)	0.010
False	8% (6/73)	20% (104/509)	0.010
Compared to your prior experiences with a healthcare provider, how comfortable was your experience with the Self-Collection Wand?
A lot more comfortable than with a healthcare provider	41% (29/70)	31% (157/506)	0.014*
Somewhat more comfortable than with a healthcare provider	30% (21/70)	26% (132/506)
About the same as with a healthcare provider	24% (17/70)	32% (160/506)
Somewhat less comfortable than with a healthcare provider	4% (3/70)	9% (46/506)
A lot less comfortable than with a healthcare provider	0% (0/70)	2% (11/506)
If an at-home self-collecting option was available, would you be more likely to stay up-to-date with routine cervical cancer screening?
Yes	89% (66/74)	85% (437/512)	0.476
No	11% (8/74)	15% (75/512)	0.476
If you could choose from the following screening options, which one would you prefer?
Self-collection home or in clinic	79% (58/73)	63% (325/513)	0.008
Speculum by health care provider at clinic	21% (15/73)	37% (188/513)	0.008
For cervical cancer screening, if you could get the same trusted results with a self-collection that you could from a Pap smear with a healthcare provider, would you feel confident using self-collection for your screening?
Yes	97% (71/73)	94% (475/508)	0.294
No	3% (2/73)	6% (33/508)	0.294
Preference for video versus in-person doctor visit, when in-person tests are not required (e.g., self-collection option available)
Video visit	59% (43/73)	44% (222/509)	0.017
In-person clinic visit	41% (30/73)	56% (287/509)	0.017

§ Calculated using 2-sided Fisher’s exact test, except * Mann-Whitney U was used to test differences for continuous and ordinal variables.

It is also worth noting that both groups expressed high confidence using the SC device if they knew they would get trusted, accurate results, which the clinical validation data has since established, with no differences between heterosexual and LGBQ+ study participants.²¹ Similarly, both groups reported high likelihoods of staying up to date with their cervical cancer screening with an at-home self-collection option: 85% heterosexual and 89% non-heterosexual (no significant difference).

Some LGBQ+ participants also included comments about their self-collection experience using the SC device, including:

“Could be very helpful for women with PTSD/sexual trauma that gets triggered during these exams.”

“I like that I can take my time with the self-collection because pain from Paps has been a concern I have had. With self-collection I can better manage the pain by working slowly.”

“The privacy aspect is a big deal for me, and I have several friends who have expressed discomfort at having to be spread-eagle with their feet in stirrups.”

“I know a lot of people who are uncomfortable with pelvic exams because of dysphoria. They would be a lot more likely to do a self-test.”

“It was really good to be about to do the test without having to undress fully and let another person (or 3) look at my cervix. I liked the privacy and how I didn’t have to have a full speculum inserted.”

Discussion

Consistent with other reports, non-heterosexual persons report more barriers to cervical cancer screening, including having more negative experiences during prior screenings.^15,37 This study’s findings show that pain and discomfort are among the key reasons sexual minority groups delay or avoid their in-clinic cervical cancer screenings, citing discomfort with speculum-based exams as a reason for delaying or avoiding routine screenings (p=0.017), pain (p=0.005) and discomfort (p=0.006) compared to heterosexual participants. Numerous qualitative comments describing prior cervical cancer screening experiences describe post-traumatic stress disorder, sexual trauma, and feeling their privacy violated. Higher rates of sexual trauma among this community, as well as experiences of systemic healthcare biases, can lead to distress around in-person healthcare interactions and particularly intimate exams such as cervical cancer screening.^9-13 Other barriers, which had a significantly larger impact on LGBQ+ participants include transportation limitations (p=0.034), clinic-related challenges such as not being sure where to go or not being able to get an appointment (p=0.003), and financial constraints (p=0.002). Subsequently, significantly higher rates (p<0.001) of having delayed or avoided getting cervical cancer screenings and significantly lower overall attendance to preventive healthcare appointments with a PCP and/or OBGYN were reported when compared to heterosexual participants (p=0.048), findings that align with established research.^4,5,38,39 These data illuminate the magnified challenges that sexual minority groups face with regard to cervical cancer screening, and the consequent disproportionately lower rates of screening and broader preventive healthcare engagement among this population.^4-7,38 Taken together, research shows this leads to broader health disparities pertaining to cervical dysplasia and cervical cancer within this community.^6,8

At home self-collection is a preferred and usable alternative for cervical cancer screening in this LGBQ+ cohort, reporting more empowerment (p=0.010) and greater comfort with self-collecting their sample in an at-home setting (p=0.014). Extensive qualitative specifically refers to resolved feelings around trauma, dysphoria, shame, and anxiety that are triggered during the speculum exam. LGBQ+ participants felt confident that they correctly completed their self-collection, with clinical agreement that was equivalent to clinician collection, and 95% stated the collection was easy resulting in a strong preference for SC (79%), high user confidence (97%) and greater likelihood to stay up-to-date with screenings (89%). While preference for self-collection was strong across both groups, this preference was significantly higher among non-heterosexual participants (p=0.008), reflecting the heightened barriers and negative experiences with in-clinic speculum-based cervical cancer screening.^21,31

As part of the preferences survey, experiences with telehealth were evaluated. Significantly more LGBQ+ participants in this study preferred telehealth visits when possible (p=0.017).^16,19 Telehealth presents opportunities to close gaps in screening education, institute high-touch care reminder mechanisms, and provide dedicated, convenient and patient-centered access to providers where securing in-person appointments, particularly with affirming providers, can often be a healthcare barrier. At-home telehealth enabled screening options can encourage higher screening engagement among patients as well as provide consistent support for patients requiring follow-up triage care.⁴ We found that 16% of heterosexual participants and 21% of non-heterosexual participants were not aware that their prior Pap smears were intended for cervical cancer screening, and research shows low and declining rates of HPV awareness among the U.S. population.^40-42 Telehealth platforms can offer patients accurate educational resources, avoiding the vagaries of unsupported online resources and other misinformation from non-clinical sources, as well as facilitating informative interactions with providers to help close these informational gaps and further increase confidence in one’s ability to self-collect a sample for HPV testing.⁴

At-home self-collection paired with a patient-centered, high-touch telehealth platform and consistent provider access has been implemented in the United States using this FDA-authorized device since July 2025. As of December 2025, over 1,500 U.S. patients completed their at-home screening, while receiving ongoing provider support, referrals to local in-person follow-up care (i.e., in-clinic cytology or colposcopy), and patient navigation around all aspects of the cervical cancer screening continuum. While not required to report sexual orientation as a part of their demographic information when registering for at-home screening, of those 382 who reported, 17.5% (67/382) identified as non-heterosexual (internal company data). Considering a 2025 Gallup survey reports 10% of U.S. women identify as LGBTQ+, 17.5% indicates that at-home self-collection is serving this underscreened population, and the SELF-CERV study results are translating into real-world utilization.³⁵

FDA approval of, and medical guideline inclusion of self-collection by the USPSTF (United States Preventive Services Task Force), ACS (American Cancer Society), ASCCP (American Society for Colposcopy and Cervical Pathology) and advocacy by HRSA (Health Resources Services Administration) as an acceptable screening option also underscores the clinical validity of this option.^16,19,43,44 The ACS 2025 guidelines specifically note the SC device reported in this study as a clinically validated, FDA-authorized option for on-guideline at-home self-collection.¹⁹ Here, we also underscore the importance of at-home screening devices and models that are FDA-reviewed and authorized, and thus bolster trust and confidence in self-collection overall. In the SELF CERV study, both heterosexual (94%) and non-heterosexual (97%) participants reported high confidence using this SC device if they could be reassured of accurate results; samples collected produce results clinically equivalent to those of clinician-collected samples, which is also reflected in updated clinical guidelines.^19,21

For clinically validated at-home self-collection approaches to have their optimal impact on closing screening gaps among underscreened and minority populations, there needs to be increased awareness and endorsement of these options among provider communities and knowledge of the updated guidelines. Providers must be able to provide patients with unbiased and accurate information about various cervical cancer screening options, and enable patients to select the approach that best suits their needs and experiences, toward the goal of increasing screening rates.⁴ Relatedly, insurance plans must cover all aspects of implementing FDA-authorized at-home cervical cancer screenings as a standard benefit, recognizing that this is a Grade A preventive screening per the United States Preventive Services Task Force.²⁰ Updates to HRSA Women’s Preventive Services Guidelines (January 2026) work to overcome insurance coverage barriers for screening and diagnostic follow up starting in January 2027, essential to expanding patient access to care in the home setting.^44,45 Given the potential that at-home self-collection holds and early uptake among sexual minorities, it is critical to have systemic cooperation that enables successful implementation.^16,27,29

This study represents one of the larger samples (N=74) examining the experiences, barriers, and references around cervical cancer screening for sexual minority groups, a population that has typically received less attention in existing scholarship. It provides comprehensive data and analysis on critical aspects of at-home self-collection usability and preferences among non-heterosexual populations and illuminates how an at-home screening approach can be feasibly implemented toward increased screening engagement and health disparity reduction for this group. The report and analysis have some limitations. First, patients were recruited from clinics and had known screening history, so they do not represent people with a cervix entirely unengaged in cervical cancer screening. However, 32% of all the SELF-CERV participants reported having delayed screening beyond guideline recommendations,²¹ a value higher for non-heterosexuals (51%). Additional limitations include that survey instruments were not validated, but they had evolved from a prior study of over 200 patients.³¹ Not all participants responded to each survey question, reducing the available data in some analyses. The study was not powered to detect differences between these cohorts. As such some observed differences may not reach significance due to limited power rather than absence of a true effect. Respondents in this study completed their self-collection within a simulated at-home environment (rather than within their homes) to meet the study design requirements for clinical analysis; however, extensive supplemental usability an human factors research⁴⁶ was conducted as part of FDA review and commercial use since July 2025 shows that the simulated experience translates to real-world use. With clinically validated at-home self-collection now implemented in the U.S. using this SC device and telehealth, forthcoming data will encompass the entirety of a self-collection experience within participants’ homes, including kit delivery and sample mailing procedures.

Conclusion

The findings from the SELF CERV study demonstrate that a purpose-designed at-home vaginal self-collection device is clinically accurate, usable and a widely preferred option among sexual minority study participants. Compared with speculum-based in-clinic screening, at-home SC offers a significantly more comfortable and acceptable experience that addresses the systemic barriers this population faces, including trauma histories, gender dysphoria, and healthcare bias, which limit access to care. At-home self-collection for cervical cancer screening is FDA-authorized for this SC device only, which is paired with a telehealth platform, enabling consistent provider-patient communication and referrals for in-person follow-up care. To fully realize the population-level benefits of self-collection options for LGBQ+ patients, broader institutional integration from healthcare systems is essential, particularly to ensure access for those historically left behind by traditional in-clinic screening modalities.

Supplemental Material

Supplemental Material - Addressing Cervical Cancer Screening Disparities: At-Home Self-Collection Among LGBQ+ Populations

Supplemental material for Addressing Cervical Cancer Screening Disparities: At-Home Self-Collection Among LGBQ+ Populations by Colleen McNicholas, Lisa Memmel, Clair Kaplan, Youri Hwang, LaShonda Crane, Ronald Orso, Kimberly Harshberger, R. Lamar Parker, Ann Collins, Christine Conageski, Sangini Sheth, Lindsay Kuroki, Jenell Coleman, Elizabeth Sutton, Ashley Jennings, Emeline Aviki, Megan Fitzpatrick, Karl Hibler, Alexandra Ripkin and Meghna Mukherjee in Cancer Control.

Supplemental Material

Supplemental Material - Addressing Cervical Cancer Screening Disparities: At-Home Self-Collection Among LGBQ+ Populations

Footnotes

Acknowledgements

We thank each of the study sites, their clinical teams, and staff who supported data collection to evaluate the study device. We are also grateful to each study participant who generously shared their perspectives. We thank Karl Hibler, MS, statistician who analyzed these data, Paddington T Mundagowa, MPH, who represented these data at the 2024 APHA meeting, and the many people who supported the SELF-CERV study, including: the entire Teal Health team and the research team (Trena Depel, MS, Courtney Parsons Anderson, MS, Megan Fitzpatrick, MD, Meghna Mukherjee, PhD), Global Bioclinical Consulting (Jen Maas, MS, Neil Mucci, BS, Sharon Tapia, BA), Vantage Clinical Advisors (Jessica Sturm, RN, MPH, Mary DeVoe, RN, MS), Slope Clinical (Maleeha Arshad, MPH), Bioreference Health Laboratories (Linda Cilindrello, BA and Kristin Kolano, BS), Catherine Behrens, MD, PhD, and David Hawkes, PhD of VCS/ACPCC. Artificial Intelligence (AI) was not used in any aspect of this manuscript preparation or editing.

ORCID iDs

Youri Hwang

Christine Conageski

Lindsay Kuroki

Jenell Coleman

Elizabeth Sutton

Emeline Aviki

Megan Fitzpatrick

Alexandra Ripkin

Meghna Mukherjee

Ethical Considerations

Advarra (Central IRB, Pro00074742, Oct 20, 2023), Johns Hopkins University (IRB00407957, Nov 14, 2023), New York University (i23-01534, Feb 23, 2024). No study procedures were conducted before interested individuals provided written informed consent to participate.

Author Contributions

All authors had access to the study data and contributed to the review of the manuscript, ensuring transparency and adherence to rigorous methodological standards. MM led manuscript writing and data analysis in close collaboration with KH. All co-authors provided review and substantive inputs in the analysis and write-up of the results.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was financially supported by Teal Health, Inc., and the National Institutes of Health (Small Business Innovation Research Grant No. R44CA291336).

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: At the time of the study and/or manuscript creation, Megan Fitzpatrick, MD, Alexandra Ripkin, MPH, MSW, and Meghna Mukherjee, PhD, were employees at Teal Health, Inc., which funded this clinical study. Teal Health employees were not involved in study participant recruitment or data collection, which was conducted solely by study sites. Teal Health employees supported data analysis and manuscript preparation. No other relationships or activities have influenced the submitted work.

Data Availability Statement

De-identified data can be made available upon request for researchers whose proposed use of the data has been approved. Data are part of a confidential regulatory submission and therefore not public. Requests will be reviewed on a case-by-case basis after approval of a proposal, with a signed data access agreement.*

Disclaimer

The findings and conclusions in this paper are those of the authors and do not necessarily reflect the views of Planned Parenthood Federation of America, Inc.

Supplemental Material

Supplemental material for this article is available online.

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Supplementary Material

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