Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study.

BACKGROUND: People who inject drugs (PWID) are at high risk for opioid overdose and infectious diseases including HIV. We piloted PARTNER UP, a telemedicine-based program to provide PWID with medication for opioid use disorder (MOUD) with buprenorphine/naloxone (bup/nx) and oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine through two syringe services programs (SSP) in North Carolina. We present overall results from this project, including participant retention rates and self-reported medication adherence. METHODS: Study participants met with a provider for an initial in-person visit at the SSP, followed by weekly telemedicine visits in month 1 and then monthly until program end at month 6. Participants were asked to start both MOUD and PrEP at initiation but could choose to discontinue either at any point during the study. Demographics and health history including substance use, sexual behaviors, and prior use of MOUD/PrEP were collected at baseline. Follow-up surveys were conducted at 3- and 6-months to assess attitudes towards MOUD and PrEP, change in opioid use and sexual behaviors, and for self-reported medication adherence. Participant retention was measured by completion of visits; provider notes were used to assess whether the participant reported continuation of medication. RESULTS: Overall, 17 persons were enrolled and started on both bup/nx and PrEP; the majority self-identified as white and male. At 3 months, 13 (76%) remained on study; 10 (77%) reported continuing with both MOUD and PrEP, 2 (15%) with bup/nx only, and 1 (8%) with PrEP only. At 6 months, 12 (71%) remained on study; 8 (67%) reported taking both bup/nx and PrEP, and 4 (33%) bup/nx only. Among survey participants, opioid use and HIV risk behaviors decreased. Nearly all reported taking bup/nx daily; however, self-reported daily adherence to PrEP was lower and declined over time. The most common reason for not continuing PrEP was feeling not at risk for acquiring HIV. CONCLUSIONS: Our study results show that MOUD and PrEP can be successfully administered via telemedicine in SSPs. PrEP appears to be a lower priority for participants with decreased continuation and adherence. Low perception of HIV risk was a reason for not continuing PrEP, possibly mitigated by MOUD use. Future studies including helping identify PWID at highest need for PrEP are needed. TRIAL REGISTRATION: Providing Suboxone and PrEP Using Telemedicine, NCT04521920. Registered 18 August 2020. https://clinicaltrials.gov/study/NCT04521920?term=mehri%20mckellar&rank=2 .

Substance Use Disorders Among US Adult Cancer Survivors.

Importance: Some individuals are predisposed to cancer based on their substance use history, and others may use substances to manage cancer-related symptoms. Yet the intersection of substance use disorder (SUD) and cancer is understudied. Because SUD may affect and be affected by cancer care, it is important to identify cancer populations with a high prevalence of SUD, with the goal of guiding attention and resources toward groups and settings where interventions may be needed. Objective: To describe the cancer type-specific prevalence of SUD among adult cancer survivors. Design, Setting, and Participants: This cross-sectional study used data from the annually administered National Survey on Drug Use and Health (NSDUH) for 2015 through 2020 to identify adults with a history of solid tumor cancer. Substance use disorder was defined as meeting at least 1 of 4 Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria for abuse or at least 3 of 6 criteria for dependence. Main Outcomes and Measures: Per NSDUH guidelines, we made adjustments to analysis weights by dividing weights provided in the pooled NSDUH data sets by the number of years of combined data (eg, 6 for 2015-2020). The weighted prevalence and corresponding SEs (both expressed as percentages) of active SUD (ie, within the past 12 months) were calculated for respondents with any lifetime history of cancer and, in secondary analyses, respondents diagnosed with cancer within 12 months prior to taking the survey. Data were analyzed from July 2022 to June 2023. Results: This study included data from 6101 adult cancer survivors (56.91% were aged 65 years or older and 61.63% were female). Among lifetime cancer survivors, the prevalence of active SUD was 3.83% (SE, 0.32%). Substance use disorder was most prevalent in survivors of head and neck cancer (including mouth, tongue, lip, throat, and pharyngeal cancers; 9.36% [SE, 2.47%]), esophageal and gastric cancer (9.42% [SE, 5.51%]), cervical cancer (6.24% [SE, 1.41%]), and melanoma (6.20% [SE, 1.34%]). Alcohol use disorder was the most common SUD (2.78% [SE, 0.26%]) overall and in survivors of head and neck cancer, cervical cancer, and melanoma. In survivors of esophageal and gastric cancers, cannabis use disorder was the most prevalent SUD (9.42% [SE, 5.51%]). Among respondents diagnosed with cancer in the past 12 months, the overall prevalence of active SUD was similar to that in the lifetime cancer survivor cohort (3.81% [SE, 0.74%]). However, active SUD prevalence was higher in head and neck (18.73% [SE, 10.56%]) and cervical cancer survivors (15.70% [SE, 5.35%]). The distribution of specific SUDs was different compared with that in the lifetime cancer survivor cohort. For example, in recently diagnosed head and neck cancer survivors, sedative use disorder was the most common SUD (9.81% [SE, 9.17%]). Conclusions and Relevance: Findings of this study suggest that SUD prevalence is higher among survivors of certain types of cancer; this information could be used to identify cancer survivors who may benefit from integrated cancer and SUD care. Future efforts to understand and address the needs of adult cancer survivors with comorbid SUD should prioritize cancer populations in which SUD prevalence is high.

Cervical Cancer Screening Knowledge, Perceptions, and Behaviors in a Multiracial Cohort of Low-Income, Underscreened Women in North Carolina.

Background: Underscreened, low-income, and uninsured or publicly insured women in the United States bear a greater burden of cervical cancer morbidity and mortality and may face unique barriers that preclude screening adherence. Methods: Participants were 710 My Body My Test-3 clinical trial participants who were publicly insured or uninsured with incomes ≤250% of the U.S. Federal Poverty Level, aged 25-64 years, and not up to date on cervical cancer screening as per national guidelines. Using Health Belief Model constructs, we assessed screening-related knowledge, perceptions, and behaviors-overall and stratified by race and ethnicity-and estimated associations with past-year attempted screening using multivariable regression models. Results: Overall, knowledge was low about the human papillomavirus, purpose of a Pap test, and recommended screening interval. Perceived severity of cervical cancer was high (3.63 on a 4-point scale). Black and Latina/Hispanic women were more likely to perceive screening as lowering their risk of cervical cancer than White women. Black women reported lower perceived risk of cervical cancer compared with White women (p = 0.03), but Black women were more likely to have sought screening in the past year (p = 0.01). Having at least three doctor visits in the past year was associated with a screening attempt. Greater perceived risk of cervical cancer, more positive perceptions of screening, and feeling more nervousness about screening were also associated with a screening attempt (all p < 0.05). Conclusions: Addressing knowledge gaps and misconceptions about cervical cancer screening and leveraging positive perceptions of screening may improve screening uptake and adherence among diverse underscreened U.S. women. Clinical Trial Registration Number: NCT02651883.

Cost-effectiveness of Human Papillomavirus Self-collection Intervention on Cervical Cancer Screening Uptake among Underscreened U.S. Persons with a Cervix.

BACKGROUND: We evaluate the cost-effectiveness of human papillomavirus (HPV) self-collection (followed by scheduling assistance for those who were HPV+ or inconclusive) compared with scheduling assistance only and usual care among underscreened persons with a cervix (PWAC). METHODS: A decision tree analysis was used to estimate the incremental cost-effectiveness ratios (ICER), or the cost per additional PWAC screened, from the Medicaid/state and clinic perspectives. A hypothetical cohort represented 90,807 low-income, underscreened individuals. Costs and health outcomes were derived from the MyBodyMyTest-3 randomized trial except the usual care health outcomes were derived from literature. We performed probabilistic sensitivity analyses (PSA) to evaluate model uncertainty. RESULTS: Screening uptake was highest in the self-collection alternative (n = 65,721), followed by the scheduling assistance alternative (n = 34,003) and usual care (n = 18,161). The self-collection alternative costs less and was more effective than the scheduling assistance alternative from the Medicaid/state perspective. Comparing the self-collection alternative with usual care, the ICERs were $284 per additional PWAC screened from the Medicaid/state perspective and $298 per additional PWAC screened from the clinic perspective. PSAs demonstrated that the self-collection alternative was cost-effective compared with usual care at a willingness-to-pay threshold of $300 per additional PWAC screened in 66% of simulations from the Medicaid/state perspective and 58% of simulations from the clinic perspective. CONCLUSIONS: Compared with usual care and scheduling assistance, mailing HPV self-collection kits to underscreened individuals appears to be cost-effective in increasing screening uptake. IMPACT: This is the first analysis to demonstrate the cost-effectiveness of mailed self-collection in the United States.

Patient-Centered Outcomes Associated With a Novel Office-Based Opioid Treatment Program in a District Health Department: Mixed Methods Pilot Study.

BACKGROUND: Granville and Vance counties have some of the highest opioid-related death rates in North Carolina, and have significant unmet needs with regard to opioid treatment. Medication for opioid use disorder (MOUD) is the most effective evidence-based approach to address opioid use disorder. Despite demonstrated efficacy and substantial need, access to MOUD is still insufficient in many parts of the United States. In order to connect patients with needed MOUD services, the district health department, Granville Vance Public Health (GVPH), established an office-based opioid treatment (OBOT) program. OBJECTIVE: In this formative pilot study, we sought to describe patients' goals and outcomes in a program delivered at a rural local health department using an integrated care approach. METHODS: We used a mixed methods concurrent nested research design. The primary method of investigation was one-on-one qualitative interviews with active OBOT patients (n=7) focused on patients' goals and perceived impacts of the program. Trained interviewers followed a semistructured interview guide developed iteratively by the study team. The secondary method was a descriptive quantitative analysis (79 patients; 1478 visits over 2.5 years) of treatment retention and patient-reported outcomes (anxiety and depression). RESULTS: Participants in the OBOT program were 39.6 years of age on average, and 25.3% (20/79) were uninsured. The average retention in the program was 18.4 months. The proportion of individuals in the program with moderate to severe depression (Patient Health Questionnaire-9 scores ≥10) decreased between program initiation (66%, 23/35) and at the most recent assessment (34%, 11/32). In qualitative interviews, participants credited the OBOT program for reducing or stopping the use of opioids and other substances (eg, marijuana, cocaine, and benzodiazepines). Many participants noted how the program helped them manage withdrawal symptoms and cravings, which helped them feel more in control of their use. Participants also attributed improvements in quality of life to the OBOT program, such as improved relationships with loved ones, improved mental and physical health, and improved financial stability. CONCLUSIONS: Initial data show promising patient outcomes for active GVPH OBOT participants, including reduction in opioid use and improvements in quality of life. As a pilot study, a limitation of this study is a lack of a comparison group. However, this formative project demonstrates promising patient-centered outcome improvements for GVPH OBOT participants.

Recruitment strategies and HPV self-collection return rates for under-screened women for cervical cancer prevention.

In the United States, medically underserved women carry a heavier burden of cancer incidence and mortality, yet are largely underrepresented in cancer prevention studies. My Body, My Test is a n observational cohort, multi-phase cervical cancer prevention study in North Carolina that recruited low-income women, aged 30-65 years and who had not undergone Pap testing in ≥ 4 years. Participants were offered home-based self-collection of cervico-vaginal samples for primary HPV testing. Here, we aimed to describe the recruitment strategies utilized by study staff, and the resulting recruitment and self-collection kit return rates for each specific recruitment strategy. Participants were recruited through different approaches: either direct (active, staff-effort intensive) or indirect (passive on the part of study staff). Of a total of 1,475 individuals screened for eligibility, 695 were eligible (47.1%) and 487 (70% of eligible) participants returned their self-collection kit. Small media recruitment resulted in the highest number of individuals found to be study eligible, with a relatively high self-collection kit return of 70%. In-clinic in-reach resulted in a lower number of study-eligible women, yet had the highest kit return rate (90%) among those sent kits. In contrast, 211 recruitment which resulted in the lowest kit return of 54%. Small media, word of mouth, and face-to-face outreach resulted in self-collection kit return rates ranging from 72 to 79%. The recruitment strategies undertaken by study staff support the continued study of reaching under-screened populations into cervical cancer prevention studies.

Participant perceptions on the acceptability and feasibility of a telemedicine-based HIV PrEP and buprenorphine/naloxone program embedded within syringe services programs: a qualitative descriptive evaluation.

BACKGROUND: People who inject drugs (PWID) are at risk for HIV and opioid overdose. We piloted PARTNER UP, a telemedicine-based program to provide PWID with access to both oral pre-exposure prophylaxis (PrEP) for HIV prevention and medication for opioid use disorder (MOUD) through two syringe services programs (SSPs) in North Carolina. We conducted a qualitative evaluation to assess the acceptability and feasibility of PARTNER UP from the participant perspective. METHODS: PARTNER UP participants met with a provider for an initial in-person visit at the SSP, followed by weekly telemedicine visits in month 1 and then monthly telemedicine visits until program end at month 6. Using a qualitative descriptive study design, we conducted in-depth interviews with a subsample of PARTNER UP participants at 1 month and 4 months. Informed by the technology acceptance model, we assessed participant perceptions of the usefulness and ease of use of PARTNER UP, as well as their intent to continue to use the program's components. We audio-recorded all interviews with participants' permission and used applied thematic analysis to analyze the verbatim transcripts. RESULTS: We interviewed 11 of 17 people who participated in PARTNER UP-10 in the month 1 interview and 8 in the month 4 interview. Nearly all participants were motivated to join for consistent and easy access to buprenorphine/naloxone (i.e., MOUD); only a few joined to access PrEP. Most were comfortable accessing healthcare at the SSP because of their relationship with and trust toward SSP staff, and accessing services at the SSP was preferred compared with other healthcare centers. Some participants described that telemedicine allowed them to be honest and share more information because the visits were not in-person and they chose the location, although the initial in-person meeting was helpful to build provider trust and rapport. Most participants found the visit schedule to be feasible, although half described needing to reschedule at least once. Nearly all participants who were interviewed intended to continue with MOUD after the program ended, whereas none were interested in continuing with PrEP. CONCLUSIONS: Participant narratives suggest that the PARTNER UP telemedicine program was acceptable and feasible. Future studies should continue to explore the benefits of embedding both PrEP and MOUD into SSPs with larger numbers of participants. Trial registration Clinicaltrials.gov Identifier: NCT04521920.

Patient perspectives on cervical cancer screening interventions among underscreened women.

BACKGROUND: Cervical cancer is highly preventable with regular screening, yet over 4,000 women die from it annually in the United States. Over half of new cervical cancer cases in the U.S. are attributable to insufficient screening. METHODS: Participants were 23 low-income, uninsured or Medicaid-insured women in North Carolina who were overdue for cervical cancer screening according to national guidelines. Semi-structured interviews examined perspectives on barriers to cervical cancer screening and on interventions to reduce these barriers. We also elicited feedback on three proposed evidence-based interventions: one-on-one education, coupons to reduce out-of-pocket costs, and self-collection of samples for detection of high-risk human papillomavirus (HPV) infection, the primary cause of cervical cancer. RESULTS: Reported barriers included high cost, inconvenient clinic hours, lack of provider recommendation, poor transportation, difficulty finding a provider, fear of pain, and low perceived need. Participants suggested interventions including reducing cost, improving convenience through community-based screening or extended clinic hours, strengthening provider recommendations, and providing one-on-one counseling and education outreach. HPV self-collection was most frequently selected as the "most helpful" of 3 proposed interventions (n = 11), followed by reducing out-of-pocket costs (n = 7) and one-on-one education (n = 5). CONCLUSION: Cost was the most reported barrier to cervical cancer screening, although women experience multiple simultaneous barriers. Novel interventions such as HPV self-collection promise to reduce some, but not all, barriers to primary screening. Interventions that work on reducing multiple barriers, including obstacles to receiving follow-up care, may be most effective to prevent cervical cancer among these high-risk women.

Racial and ethnic differences in cervical cancer screening barriers and intentions: The My Body My Test-3 HPV self-collection trial among under-screened, low-income women.

Under-screened women are more likely to be diagnosed with invasive cervical cancer at later stages and have worse survival outcomes. Under- or un-insured women, low-income women, and minoritized groups face barriers to screening. Intention to screen is an indicator of future screening behavior, yet is understudied among low-income, under-screened women. Participants were 710 low-income, uninsured or publicly insured women ages 25-64 years in North Carolina who were not up to date on cervical cancer screening according to national guidelines. Participants were asked about barriers to screening and intention to screen. We estimated reported barriers to cervical cancer screening stratified by race and ethnicity (categorized as White, Black, and Hispanic) and assessed predictors of intention to screen. Sixty-one percent of all participants reported 5 or more barriers to screening. The most commonly reported reasons for not getting screened were lack of insurance (White: 71%, Black: 62%, Hispanic/Latina: 63%) and cost (White: 55%, Black: 44%, Hispanic/Latina: 61%). Women were more likely to have an intention to screen if they reported "it was not hard to get screening" (OR: 1.47 (1.00, 2.15)). Older women reported being less likely to intend to screen. Black women reported being more likely to intend to screen than White women. Lack of health insurance and cost were frequently reported barriers to cervical cancer screening. Increasing knowledge of affordable clinics and expanding access to Medicaid may reduce barriers and increase cervical cancer screening uptake.

Perceived Financial Barriers to Cervical Cancer Screening and Associated Cost Burden Among Low-Income, Under-Screened Women.

Background: Despite screening's effectiveness in reducing cervical cancer incidence and mortality, disparities in cervical cancer screening uptake remain, with lower rates documented among uninsured and low-income individuals. We examined perceived financial barriers to, and the perceived cost burden of, cervical cancer screening. Materials and Methods: We surveyed 702 low-income, uninsured or publicly insured women ages 25-64 years in North Carolina, U.S., who were not up to date on cervical cancer screening according to national guidelines. Participants were asked about perceived financial barriers to screening and how much they perceived screening would cost. We used multivariable logistic regression to assess the sociodemographic predictors of perceived financial barriers. Results: Seventy-two percent of participants perceived financial barriers to screening. Screening appointment costs (71%) and follow-up/future treatment costs (44%) were most commonly reported, followed by lost pay due to time missed from work (6%) and transportation costs (5%). In multivariable analysis, being uninsured (vs. publicly insured), younger (25-34 vs. 50-64 years), White (vs. Black), and not reporting income data were associated with perceiving screening costs and future treatment costs as barriers to screening. Participants reported wide-ranging estimates of the perceived out-of-pocket cost of screening ($0-$1300), with a median expected cost of $245. Conclusions: The majority of our sample of low-income women perceived substantial financial barriers to screening, particularly related to screening appointment costs and potential follow-up/future treatment costs. Providing greater cost transparency and access to financial assistance may reduce perceived financial barriers to screening, potentially increasing screening uptake among this underserved population. Clinicaltrials.gov registration number NCT02651883.

Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial.

BACKGROUND: Screening substantially reduces cervical cancer incidence and mortality. More than half of invasive cervical cancers are attributable to infrequent screening or not screening at all. The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening. METHODS/DESIGN: The study will enroll at least 510 US women aged 25-64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years. We will randomize participants to an intervention or control arm. The intervention arm will receive kits to self-collect a sample at home and mail it for HPV testing. In both the intervention and control arms, participants will receive assistance in scheduling an appointment for screening in clinic. Study staff will deliver HPV self-collection results by phone and assist in scheduling participants for screening in clinic. The primary outcome is completion of cervical cancer screening. Specifically, completion of screening will be defined as screening in clinic or receipt of negative HPV self-collection results. Women with HPV-negative self-collection results will be considered screening-complete. All other participants will be considered screening-complete if they obtain co-testing or Pap test screening at a study-affiliated institution or other clinic. We will assess whether the self-collection intervention influences participants' perceived risk of cervical cancer and whether perceived risk mediates the relationship between HPV self-collection results and subsequent screening in clinic. We also will estimate the incremental cost per woman screened of offering at-home HPV self-collection kits with scheduling assistance as compared to offering scheduling assistance alone. DISCUSSION: If mailed self-collection of samples for HPV testing is an effective strategy for increasing cervical cancer screening among women overdue for screening, this method has the potential to reduce cervical cancer incidence and mortality in medically underserved women at higher risk of developing cervical cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT02651883, Registered on 11 January 2016.

Use of Short Messaging Service to Improve Follow-Up for Abnormal Pap Test Results in Minority and Medically Underserved Women in North Carolina: Questionnaire on Attitudes and Acceptability.

BACKGROUND: An estimated one in eight cervical cancer cases are due to a lack of follow-up care for abnormal Pap test results. Low rates of completion of follow-up care particularly affect low-income minority women. The burden of cervical cancer could be reduced through interventions that improve timely colposcopy follow-up and treatment of abnormal screening results. Mobile communications via text messaging present a low-cost opportunity to increase rates of clinic return among women referred to follow-up after obtaining abnormal screening results. OBJECTIVE: Our aims were to determine the acceptability and feasibility of using text messaging to increase completion of follow-up care following abnormal cervical cancer screening (Pap test) results and to examine factors that may affect the acceptability and use of text messaging to increase communications between health care providers (HCP) and low-income minority women. METHODS: The study participants were 15 low-income women who had undergone a Pap test within the preceding 12 months. Semistructured interviews, including open- and closed-ended questions from a validated questionnaire, were conducted by phone or in person. Responses to closed-ended survey items were tabulated, and descriptive statistics were generated using Microsoft Excel. Responses to the open-ended questions were coded and analyzed using NVivo 11 qualitative analysis software. RESULTS: Nearly all participants (14/15, 93%) were comfortable receiving a text message from an HCP stating that their Pap test results were available (<40 years: 100%; ≥40 years: 86%). Over half (8/15; 53%) of the participants were comfortable receiving a text message stating that their Pap test results were abnormal, although many preferred to receive such information via a phone call (6/15; 40%). Most participants (9/15; 60%) believed that receiving a text reminder would make them more likely to attend their appointment. The preferred method for receiving a reminder appeared to vary by age, with older women preferring telephone reminders over text messaging reminders. Analysis of open-ended questions suggested that text messaging appeals to some women due to its wide use and convenience for communicating with HCPs. However, women cited concerns about the confidentiality of messages and barriers to understanding the messages, including the physical capacity to read and accurately interpret the content of the messaging. CONCLUSIONS: Most participants indicated a willingness to receive text messages from their HCPs about cervical cancer screening results and believed that text messages were the best way to remind them of appointments for follow-up care. Potential concerns could be addressed by excluding explicit references to the nature of the appointment in the text message in order to avoid disclosure of sensitive health information to unauthorized individuals. Although text messaging seems promising to improve adherence to timely follow-up, personal preferences should be considered by allowing patients to opt-out of text communications.

Predictors of Cervical Cancer Screening Among Infrequently Screened Women Completing Human Papillomavirus Self-Collection: My Body My Test-1.

Background: Approximately one-half of cervical cancer cases in the United States occur in underscreened or never-screened women. We examined predictors to completing Papanicolaou (Pap) testing and whether a positive human papillomavirus (HPV) self-collection result affects Pap testing adherence among underscreened women. Materials and Methods: Low-income women aged 30-65 years who reported no Pap testing in ≥4 years were recruited in North Carolina. Knowledge, attitudes, and barriers regarding cervical cancer and Pap testing were assessed by telephone questionnaires. We mailed self-collection kits for HPV testing and provided information regarding where to obtain affordable Pap testing. Participants received $45 for completing all activities. We used multivariable logistic regression to assess the predictors of longer reported time since last Pap (≥10 vs. 4-9 years) and of completion of Pap testing following study enrollment (follow-up Pap). Results: Participants (n = 230) were primarily black (55%), uninsured (64%), and with ≤high school education (59%). Cost and finding an affordable clinic were the most commonly reported barriers to screening. White women and those with ≤high school education reported longer intervals since last Pap test. Half of the participants reported completing a follow-up Pap test (55%). Women with a positive HPV self-collection were five times more likely to report completing a follow-up Pap test than those with negative self-collection (odds ratio = 5.1, 95% confidence interval 1.4-25.7). Conclusions: Improving awareness of resources for affordable screening could increase cervical cancer screening in underserved women. Home-based HPV self-collection represents an opportunity to re-engage infrequently screened women into preventive screening services.

Home Self-Collection by Mail to Test for Human Papillomavirus and Sexually Transmitted Infections.

OBJECTIVE: To evaluate the validity and acceptability of at-home self-collection to test for high-risk human papillomavirus (HPV) and sexually transmitted infections among women overdue for cervical cancer screening by national guidelines. METHODS: Low-income, infrequently screened women were recruited from the general population in North Carolina to participate in an observational study. Participants provided two self-collected cervicovaginal samples (one at home and one in the clinic) and a clinician-collected cervical sample. Samples were tested for high-risk HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Cervical samples were also tested by liquid-based cytology. RESULTS: Overall, 193 women had conclusive high-risk HPV results for all three samples and cytology results. Prevalence of high-risk HPV within self-home samples (12.4%) was not different from that within clinician samples (11.4%; P=.79) and from that within self clinic samples (15.5%; P=.21). Positivity for high-risk HPV in all sample types increased with increasing grades of cervical abnormality (P<.001). Self-home samples detected high-risk HPV in all identified cases of high-grade squamous intraepithelial lesions and of cervical intraepithelial neoplasia 2 or worse. Detection was comparable across sample types for T vaginalis (range 10.2-10.8%), M genitalium (3.3-5.5%), C trachomatis (1.1-2.1%), and N gonorrhoeae (0-0.5%). Kappa values between sample types ranged from 0.56 to 0.66 for high-risk HPV, 0.86-0.91 for T vaginalis, and 0.65-0.83 for M genitalium. Most participants reported no difficulty understanding self-collection instructions (93.6%) and were willing to use self-collection in the future (96.3%). CONCLUSION: Mail-based, at-home self-collection for high-risk HPV and sexually transmitted infection detection was valid and well accepted among infrequently screened women in our study. These findings support the future use of high-risk HPV self-collection to increase cervical cancer screening rates among higher risk women in the United States.

Preference for Human Papillomavirus Self-Collection and Papanicolaou: Survey of Underscreened Women in North Carolina.

OBJECTIVES: Self-collection of samples for human papillomavirus (HPV) testing (self-collection) has the potential to increase cervical cancer screening among underscreened women. We assessed attitudes toward at-home HPV self-collection compared with clinic-based Pap testing in this higher-risk population. MATERIALS AND METHODS: Participants were low-income women in North Carolina overdue for cervical cancer screening. Women self-collected samples at home, returned samples by mail for HPV testing, and completed phone questionnaires about at-home HPV self-collection. Participants were referred to clinic-based Pap testing and invited to complete a second questionnaire about Pap testing. A cross-sectional questionnaire compared attitudes, experiences, and preferences for self-collection versus Pap testing and assessed predictors of preference for HPV self-collection. RESULTS: Half (51%) of 221 women reported a preference for HPV self-collection, 19% preferred Pap testing, and 27% reported no preference. More women reported difficulty finding time to do the Pap test (31%) than the self-test (13%, p = .003) and being afraid of the self-test results (50%) than the Pap test results (36%, p = .02). There were relatively fewer reports of physical discomfort and pain from self-collection than Pap testing (discomfort: 18% self; 48% Pap; pain: 8% self; 30% Pap, p = .001). No differences were found in positive versus negative thoughts about the tests, trust in the tests' safety and accuracy, or willingness to do tests again. CONCLUSIONS: Overall positive attitudes toward HPV self-collection compared with Pap testing among underscreened women suggest that self-collection is a promising option to increase cervical cancer screening in this high-risk population.

Acceptability and ease of use of mailed HPV self-collection among infrequently screened women in North Carolina.

OBJECTIVES: Self-collection of cervico-vaginal samples for human papillomavirus (HPV) testing has the potential to make cervical cancer screening more accessible to underscreened women. We evaluated the acceptability and ease of use of home-based HPV self-collection within a diverse population of low-income, infrequently screened women. METHODS: Participants were low-income women from North Carolina who had not received Pap testing in 4 or more years. Eligible women received a self-collection kit containing instructions and a brush for home-based sample collection. A total of 227 women returned a self-collected sample by mail and completed a questionnaire to assess their experiences with HPV self-collection. We described acceptability measures and used logistic regression to identify predictors of overall positive thoughts about the self-collection experience. RESULTS: Nearly all women were willing to perform HPV self-collection again (98%) and were comfortable receiving the self-collection kit in the mail (99%). Overall, 81% of participants reported positive thoughts about home-based self-collection. Women with at least some college education and those who were divorced, separated or widowed were more likely to report overall positive thoughts. Aspects of self-collection that participants most commonly reported liking included convenience (53%), ease of use (32%) and privacy (23%). The most frequently reported difficulties included uncertainty that the self-collection was done correctly (16%) and difficulty inserting the self-collection brush (16%). CONCLUSIONS: Home-based self-collection for HPV was a highly acceptable screening method among low-income, underscreened women and holds the promise to increase access to cervical cancer screening in this high-risk population.

Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States.

BACKGROUND: Testing for high-risk human papillomavirus (HPV) infection using mailed, self-collected samples is a promising approach to increase screening in women who do not attend clinic screening at recommended intervals. METHODS: To assess this intervention among high-risk women in the United States, 429 women without a Papanicolaou (Pap) test in 4 or more years (overdue by US guidelines) were recruited from the general population. Participants aged 30 to 65 years were mailed a kit to self-collect a cervicovaginal sample at home, return the sample by mail, and receive HPV results by telephone, with referral to follow-up cytological Pap testing at a local clinic. Cervicovaginal self-samples were collected with a Viba brush, stored in Scope mouthwash, and tested by Hybrid Capture 2. Data were collected in 2010 to 2011 and analyzed in 2017. RESULTS: Two-thirds (64%) of participants returned a self-collected sample, of whom 15% tested HPV DNA positive. Human papillomavirus self-test-positive women reported higher rates of follow-up Pap tests (82%) than did those with self-test negative results (51%). No demographic differences were found in self-test return rate or HPV positivity. High acceptability was reported in participant surveys: most women (81%) had "mostly positive" overall thoughts about the self-test, and most reported being comfortable receiving the kit in the mail (99%), returning their self-collected sample by mail (82%), and receiving their test results by telephone (97%). CONCLUSIONS: Conducting HPV self-testing through population-based recruitment, mailed kit delivery and return by mail, and results delivery by telephone has the potential to reach a broad segment of US underscreened women.