Loss, liberation, and agency: Patient experiences of methadone treatment at opioid treatment programs during the COVID-19 pandemic.

BACKGROUND: Despite its safety and effectiveness, methadone treatment for opioid use disorder (OUD) remains highly stigmatized, and stringent opioid treatment program (OTP) attendance requirements create barriers to retention for many patients. The COVID-19 pandemic prompted a shift in federal regulations governing methadone, including a blanket exemption permitting increased take-home doses of methadone. We studied the impact of these changes upon established patients' experiences of OTP care. METHOD: We conducted semi-structured qualitative interviews with 18 OTP patients who met our criteria of having established OTP care (i.e., enrolled at the OTP for at least 12 weeks) and were administered methadone three to six days weekly prior to the March 2020 blanket exemption. Interviews centered on how COVID-19 had affected their experiences of receiving treatment at an OTP. RESULTS: We identified three interconnected themes relevant to transformation of OTP care by the COVID-19 pandemic. Participants described mourning therapeutic OTP relationships and structure (1. loss), yet feeling more satisfaction with fewer in-person OTP visits (2. liberation), and appreciating more opportunities to self-direct their OUD care (3. agency). DISCUSSION: Structural changes made to OTP care early in the COVID-19 pandemic resulted in loss of community and structure. Increasing the availability of take-home methadone also improved patient experience and sense of agency. Our findings join a diverse body of converging evidence in support of policy changes allowing for more flexible dosing and individualized OTP care.

Vaccine Trust Gauge: Mixed methods research to measure and understand vaccine trust.

INTRODUCTION: While trust in vaccination is one factor in the ecosystem that surrounds vaccine decision-making and acceptance, understanding its role may provide insights into effective and tailored approaches to help build individual-level vaccine confidence. The authors developed the Vaccine Trust Gauge (VTG), a scale used to measure trust in vaccines, and conducted mixed methods research to provide an in-depth understanding of the various factors shaping vaccine trust in the United States. MATERIALS AND METHODS: The VTG instrument was developed from previous and scoping research of questionnaires (Larson et al., 2018; Palmedo et al., 2021) and fielded in the US to n = 3026 adults ages ≥18. Based on survey responses, participants were segmented by vaccine trust level (low, medium, or high) through an aggregated scoring system constructed from the VTG. 65 respondents were recruited to participate in in-depth interviews or focus groups conducted by phone or video conference. A conceptual definition of vaccine trust was developed using components of the VTG scale. RESULTS: Multivariate regressions found that higher levels of vaccine trust measured by the VTG are closely associated with trust in healthcare providers and trust in government. College or higher degree, Democrats, and those aged 55+ were more likely to have higher trust in vaccines compared to Black/African Americans, and those experiencing discrimination in the healthcare system. The qualitative analysis allowed the authors to add diverse, contextual elements to the vaccine trust levels summarized here. DISCUSSION: These mixed methods findings suggest future implications for research and practice. Ideas for potential communication, policy, and public health strategies are offered to build vaccine confidence and advance uptake for COVID-19 and other vaccines. CONCLUSIONS: There are diverse underlying factors that influence an individual's trust in vaccines, which means trust categories and demographic characteristics cannot be used as monolithic identifiers. Assessing vaccine trust provides insights into a foundation for engagement to promote individual-level vaccine acceptance. The authors present recommendations for the use of the VTG, future implications for research and practice, and potential strategies to build vaccine confidence.

Supporting US healthcare providers for successful vaccine communication.

BACKGROUND: While many healthcare providers (HCPs) have navigated patients' vaccine concerns and questions prior to the rollout of the COVID-19 vaccines, sentiments surrounding the COVID-19 vaccines have presented new and distinct challenges. OBJECTIVE: To understand the provider experience of counseling patients about COVID-19 vaccinations, aspects of the pandemic environment that impacted vaccine trust, and communication strategies providers found supportive of patient vaccine education. METHODS: 7 focus groups of healthcare providers were conducted and recorded during December 2021 and January 2022, at the height of the Omicron wave in the United States. Recordings were transcribed, and iterative coding and analysis was applied. RESULTS: 44 focus group participants representing 24 US states with the majority (80%) fully vaccinated at the time of data collection. Most participants were doctors (34%) or physician's assistants and nurse practitioners (34%). The negative impact of COVID-19 misinformation on patient-provider communication at both intrapersonal and interpersonal levels as well as barriers and facilitators to patient vaccine uptake are reported. People or sources that play a role in health communication ("messengers") and persuasive messages that impact behavior or attitudes towards vaccination ("messages") are described. Providers expressed frustration in the need to continuously address vaccine misinformation in clinical appointments among patients who remained unvaccinated. Many providers found value in resources that provided up-to-date and evidence-based information as COVID-19 guidelines continued to change. Additionally, providers indicated that patient-facing materials designed to support vaccination education were not frequently available, but they were the most valuable to providers in a changing information environment. CONCLUSIONS: While vaccine decision-making is complex and hinges on diverse factors such as health care access (i.e., convenience, expense) and individual knowledge, providers can play a major role in navigating these factors with their patients. But to strengthen provider vaccine communication and promote vaccine uptake, a comprehensive communication infrastructure must be sustained to support the patient-provider dyad. The findings provide recommendations to maintain an environment that facilitates effective provider-patient communication at the community, organizational and policy levels. There is a need for a unified multisectoral response to reinforce the recommendations in patient settings.

Long-term human papillomavirus vaccination effectiveness and immunity in Rwandan women living with and without HIV: a study protocol.

INTRODUCTION: Prophylactic human papillomavirus (HPV) vaccines have been shown to be highly effective in protecting women against cervical infections, high-grade abnormalities and cancer caused by the targeted HPV types. However, the evidence for their effectiveness in women living with HIV (WLWH) is less clear. METHODS: WLWH and HIV-negative women who likely did (birth cohorts 1996 and later) and WLWH and HIV(-) negative who likely did not (birth cohorts before 1996) receive HPV vaccination (n=3028; 757 participants for each of the four groups). Between groups, we will compare cervicovaginal, anal and oral prevalent and 6-12 month persistent HPV6/11/16/18 infections as measured using a modified AmpFire HPV genotyping assay that tests for 15 high-risk or intermediate-risk HPV genotypes, HPV6 and HPV11. We will also compare the HPV immune response in HPV-vaccinated WLWH to HPV-vaccinated HIV-negative women using an anti-HPV16 and anti-HPV18 ELISA. Vaccination status will be confirmed through national vaccination records. ANALYSIS: We will calculate point prevalence and prevalence of 6-12 month persisting infections by individual HPV-type specific infections and groups of infections for each anatomic site and for each group of women. Results will be stratified by age at vaccination, age at enrolment and the number of doses (3 vs 2) as well as other factors possibly associated with HPV prevalence. Differences in endpoints between groups, overall and between subgroups, will be tested for statistical significance (p<0.05) using Fisher's exact or Pearson χ2 test. Differences in geometric mean titres and seropositivity will be tested for statistical significance using the Mann-Whitney and Fisher's exact tests, respectively. ETHICS AND DISSEMINATION: The study was approved by the Albert Einstein College of Medicine Institutional Review Board and the Rwanda National Ethics Committee. Results will be disseminated through publication in peer-reviewed journals.

Challenges and opportunities associated with cervical cancer screening programs in a low income, high HIV prevalence context.

BACKGROUND: Cervical cancer is a leading cause of death among Cameroon women. The burden of cervical cancer is in part traceable to the inadequate understanding of socio-contextual determinants of access to screening and prevention opportunities. We explored multilevel individual, community and structural factors that facilitate or inhibit cervical cancer prevention in women at risk in a low-income, high HIV prevalence context. METHODS: We utilized an exploratory qualitative approach to obtain data through focus group discussions and in-depth interviews from May to August, 2018. A two-stage purposive sampling strategy was used to select 80 women and 20 men who participated in 8 focus group discussions and 8 in-depth interviews. The socio-ecological model guided data analyses to identify micro-, meso-, and macro-level determinants of cervical cancer screening. RESULTS: Micro-level factors including lack of awareness and knowledge about cervical cancer, lack of access to information, excessive cost of cervical cancer screening, low risk perceptions, and poor health seeking behaviors were major barriers for women seeking cervical cancer screening. Meso-level factors, such as social networks, socio-cultural norms, perceptions of the role of men and HIV-related stigma when screening is integrated into HIV care, also engender negative attitudes and behaviors. Macro-level barriers to cervical cancer screening included poorly equipped health facilities and a lack of national cancer prevention policies and programs. CONCLUSION: In the context of the call for elimination of cervical cancer as a public health problem, our findings highlight challenges and opportunities that should be considered when implementing interventions to increase uptake of cervical cancer screening in low-middle income settings.

A Pilot Study of Human Papillomavirus Detection in Urine Using a Novel Nucleic Acid Amplification Test.

INTRODUCTION: Human papillomavirus (HPV) testing is the standard-of-care for cervical cancer screening globally. Urine is a promising alternative to collecting a cervical specimen during a pelvic exam for HPV testing. There are no studies to date of HPV testing of urine using the Xpert HPV test. METHODS: We conducted a pilot study of 40 women; 30 women undergoing colposcopy because of a previous abnormality and 10 undergoing routine screening, to evaluate HPV detection in urine by the Xpert HPV test on the GeneXpert platform. Xpert HPV testing of urine was done according to the manufacturer's instructions for testing cervical specimens. These results were compared to a reference of combined results of 2 research HPV genotyping tests conducted on cervical specimens and to repeat Xpert HPV testing of urine. RESULTS: Analytic sensitivity and specificity of Xpert testing of urine for any high-risk HPV versus the cervical sample, categorized as HPV positive if at least 1 test was positive, were 64.3% (95% confidence interval [95%CI] = 42.1-76.1%) and 100% (97.5%CI = 71.5-100%), respectively. Analytic sensitivity and specificity of Xpert testing of urine for any high-risk HPV versus the cervical sample, categorized as positive if both tests were positive, were 66.7% (95%CI = 44.7-84.4%) and 86.7% (95%CI = 59.5-98.3%), respectively. Kappa values for first vs. second and first vs. third testing of urine by Xpert were 0.89 (95%CI = 0.79-1.00) and 0.90 (95%CI = 0.81-1.00), respectively. DISCUSSION: Given the call for global elimination of cervical cancer and widespread availability of GeneXpert, optimizing Xpert HPV testing of urine may be warranted.

A comparison of screening tests for detection of high-grade cervical abnormalities in women living with HIV from Cameroon.

BACKGROUND: Women living with human immunodeficiency virus (WLWH), especially those living in low- and middle-income countries (LMIC), are at increased risk of cervical cancer. The optimal cervical-cancer screening strategy for WLWH has not been determined. We therefore conducted a pilot study of screening methods in WLWH living in Limbe, Cameroon. METHODS: Five-hundred sixty-six WLWH, aged 25-59 years, were enrolled. After self-collecting a cervicovaginal specimen, they underwent a pelvic exam, during which a provider also collected a cervical specimen and visual inspection after acetic acid (VIA) was performed. Both self- and provider-collected specimens were tested for high-risk HPV by the Xpert HPV Test (Cepheid, Sunnyvale, CA, USA), with the residual of the latter used for liquid-based cytology. Women testing HPV positive on either specimen and/or VIA positive were referred to colposcopy and biopsies. However, because of poor attendence for follow-up colposcopy for the screen positives due to civil strife and technical issues with biopsies, high-grade cytology and/or clinical diagnosis of cancer was used as the primary high-grade cervical abnormality endpoint. Clinical performances for high-grade cervical abnormality of HPV testing and VIA for screening WLWH, and the most carcinogenic HPV genotypes and/or VIA to triage high-risk HPV-positive WLWH, were evaluated. RESULTS: Four-hundred eighty-seven (86.0%) WLWH had results for HPV testing on both specimen, VIA, and cytology and were included in the analysis. Forty-nine (10.1%) had a high-grade cervical abnormality. HPV testing on provider- and self-collected specimens was more sensitive than VIA (95.9 and 91.8% vs. 43.8%, respectively, p < 0.01 for both comparisons) for identifying women with high-grade cervical abnormalities. HPV testing on provider- and self-collected specimens was less specific than VIA (57.5 and 51.6% vs. 89.7%, respectively, p < 0.01 for both comparisons) for identifying women with high-grade cervical abnormalities; HPV testing on provider-collected specimens was more specific than on self-collected specimens (p < 0.01). Among HPV-positive women, HPV16/18/45 detection or VIA positivity had a sensitivity and positive predictive value of 73.5 and 29.0%, respectively, for provider-collected specimens and 68.8 and 22.9%, respectively, for self-collected specimens for high-grade cervical abnormalities. CONCLUSIONS: HPV testing was more sensitive but less specific than VIA for detection of high-grade cervical abnormality in WLWH. Improved triage methods for HPV-positive WLWH are needed. TRIAL REGISTRATION: NCT04401670 (clinicaltrials.gov); retrospectively registered on May 26, 2020.

A scoping review: Facilitators and barriers of cervical cancer screening and early diagnosis of breast cancer in Sub-Saharan African health settings.

To address gaps in access to cervical cancer screening and early diagnosis of breast cancer services in Sub-Saharan African (SSA), this scoping review was conducted to explore facilitators and barriers that exist on the patient-, provider-, and system-level. An extensive literature search was conducted in accordance with scoping review methodology and the Cochrane guidelines. Our search criteria were limited to original research studies conducted in community or clinical settings in SSA within the last 10 years (2010-2020). Themes found from this review included patient knowledge and provider education, access to screening services, trust, health-related behaviors, attitudes, values, and practices, community and social values, health infrastructure, resource allocation, and political will. Identified barriers included lack of knowledge about cervical and breast cancer among patients, gaps in education and training among providers, and lack of resources and health infrastructure at the facility level and within the overall health system. Facilitators included perceived risk of cancer, support and encouragement of the provider, and utilization of novel approaches in low-resource settings by health systems. To better address individual-, provider-, and health system and facility-based facilitators and barriers to care, there is a need for political and financial investment and further research on the health service delivery in specific national health systems, especially in the context of the global campaign to eliminate cervical cancer as a public health problem.

A Pooled Analysis to Compare the Clinical Characteristics of Human Papillomavirus-positive and -Negative Cervical Precancers.

Given that high-risk human papillomavirus (HPV) is the necessary cause of virtually all cervical cancer, the clinical meaning of HPV-negative cervical precancer is unknown. We, therefore, conducted a literature search in Ovid MEDLINE, PubMed Central, and Google Scholar to identify English-language studies in which (i) HPV-negative and -positive, histologically confirmed cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+) were detected and (ii) summarized statistics or deidentified individual data were available to summarize proportions of biomarkers indicating risk of cancer. Nineteen studies including 3,089 (91.0%) HPV-positive and 307 (9.0%) HPV-negative CIN2+ were analyzed. HPV-positive CIN2+ (vs. HPV-negative CIN2+) was more likely to test positive for biomarkers linked to cancer risk: a study diagnosis of CIN3+ (vs. CIN2; 18 studies; 0.56 vs. 0.24; P < 0.001) preceding high-grade squamous intraepithelial lesion cytology (15 studies; 0.54 vs. 0.10; P < 0.001); and high-grade colposcopic impression (13 studies; 0.30 vs. 0.18; P = 0.03). HPV-negative CIN2+ was more likely to test positive for low-risk HPV genotypes than HPV-positive CIN2+ (P < 0.001). HPV-negative CIN2+ appears to have lower cancer risk than HPV-positive CIN2+. Clinical studies of human high-risk HPV testing for screening to prevent cervical cancer may refer samples of HPV test-negative women for disease ascertainment to correct verification bias in the estimates of clinical performance. However, verification bias adjustment of the clinical performance of HPV testing may overcorrect/underestimate its clinical performance to detect truly precancerous abnormalities.

Cervical human papillomavirus DNA detection in women living with HIV and HIV-uninfected women living in Limbe, Cameroon.

BACKGROUND: There are limited data on cervical HPV prevalence in Cameroon and none from its Anglophone region. We investigated cervical HPV prevalence in HIV-uninfected (HIV[-]) and HIV-infected (WLWH) women living in the region. METHODS: A convenience sample of consecutively recruited HIV[-] women (n = 295) and women living with HIV (WLWH) (n = 560) attending the Limbé Regional Hospital were enrolled into a cervical screening study. Women underwent screening that included HPV testing of self-collected and provider-collected specimens. We calculated the HPV prevalence by HIV status, overall and stratified by age, and among WLWH, stratified by CD4 counts. We compared the concordance for the detection of HPV between self- and provider-collected specimens. RESULTS: Crude HPV prevalence was 21.69 % (95 % confidence interval [95 %CI] = 17.21-26.48 %) for HIV[-] women and 46.43 % (95 %CI = 42.24-50.66 %) for WLWH (p < 0.001). Among WLWH, older age (ptrend = 0.01) and higher CD4 counts (ptrend = 0.007) were associated with lower HPV prevalence. There was a good-to-excellent agreement for HPV detection between specimens, and self-collected were more likely than provider-collected specimens to test HPV positive, for all women and stratified by HIV status. CONCLUSIONS: HIV-related immunosuppression was a risk factor for HPV prevalence in this population. HPV testing of self-collected specimens appeared to be less specific than HPV testing of provider-collected specimens.

Acceptability of Self-Sampling for Cervical Cancer Screening Among Women Living With HIV and HIV-Negative Women in Limbé, Cameroon.

Introduction: Like many countries in Sub-Saharan Africa, Cameroon has a high burden of cervical cancer and low availability and uptake of screening. Self-collection has the potential to increase the uptake of cervical cancer screening among Cameroon women. This paper explores patient and community insights surrounding self-collection among women living with HIV and HIV[-] women as well as the barriers and facilitators to obtaining and utilizing self-collected specimens in cervical cancer screening programs. Materials and methods: We utilized an exploratory qualitative approach to obtain data through focus group discussions and in-depth interviews during data collection that took place from May to August 2018. A two-stage sampling strategy was used to select 80 women who participated in six focus group discussions and eight in-depth interviews. We utilized the socio-ecological framework to guide data analysis. Results: All participants indicated that self-sampling was an acceptable method of specimen collection and should be offered as an option for cervical cancer screening in Cameroon. Whereas, most women, regardless of HIV status, preferred the option for self-collection, barriers were identified, such as lack of education about self-collection procedure, being uncomfortable, embarrassed or in pain from the procedure, fear of consequences, perceived competence about ability to self-collect and privacy and confidentiality. We also found that HIV-related stigma was a major concern for HIV[-] women that could prevent them from accessing cervical cancer screening integrated within HIV treatment settings. Conclusions: To promote self-collection for cervical cancer screening, educational interventions with both patients and providers are necessary to increase knowledge of and overall willingness to utilize self-collection. Further research is recommended to examine the role of stigma for HIV[-] women in screening locations associated with HIV treatment.

Participation in Cervical Screening by Self-collection, Pap, or a Choice of Either in Brazil.

Most cervical cancers occur in women who do not participate in cervical-cancer screening. We therefore evaluated adherence to screening for clinic-based Pap testing, self-collected sampling for HPV testing, and choice of the 2 among 483 unscreened/underscreened women in Brazil. Three public Basic Health Units (BHU) were each randomly assigned to three arms: (i) Pap testing at the BHU (N = 160), (ii) "Self&HPV" (self-collection for HPV testing) (N = 161), and (iii) "Choice" between self-collection and HPV testing and Pap test at the local BHU (N = 162). The theory-based (PEN-3 and Health Belief Model) intervention in all three arms was implemented by trained Community Health Workers (CHW) at participants' home. With the first invitation, 60.0% in the Pap arm, 95.1% [154 of 161 (95.7%) who selected Self&HPV and 0 of 1 (0.0%) who selected Pap] in the Choice arm, and 100% in the Self&HPV arm completed screening. By the second invitation to choose a method of screening in the Choice arm, 100% completed screening. After three invitations, 75.0% of women in the Pap arm completed screening. Adherence to screening differed by study arm (P < 0.001). In conclusion, Self&HPV testing is a promising strategy for unscreened/underscreened women who are recalcitrant or unable to undergo clinic-based cervical screening to complement the screening modality used in the general population. In Brazil, where Pap testing is recommended for routine cervical screening, training CHWs in behavior change strategies and offering Self&HPV or Choice could greatly improve screening population coverage by reaching the unscreened/underscreened populations.

(At Least) Once in Her Lifetime: Global Cervical Cancer Prevention.

Cervical cancer disproportionately burdens lower-resourced settings, in which nearly 90% of cervical cancer and cervical cancer-related deaths occur. Targeting human papillomavirus (HPV) by prophylactic HPV vaccination in young adolescent girls and HPV-based screening in mid-adult women offers the most cost-effective strategy to reduce cervical cancer burden worldwide and mitigate the health disparities in cervical cancer burden between low-resourced and high-resourced settings. Political and social will, along with the necessary financial investments, will be necessary to realize the opportunity for significant global reductions in the cervical cancer burden. Perfect cervical cancer prevention (total eradication) is practically and financially unrealistic.

A systematic review and meta-analysis on the attribution of human papillomavirus (HPV) in neuroendocrine cancers of the cervix.

BACKGROUND: There remains uncertainty about the role of human papillomavirus (HPV) infection in causing small-cell neuroendocrine carcinoma (SCNC) and large-cell neuroendocrine carcinoma (LCNC) of the cervix. To clarify the role of HPV in the development of SCNC and LCNC, we conducted a systematic review and meta-analyses. METHODS: PubMed and Embase were searched to initially identify 143 articles published on or before June 1, 2017. Studies were limited to methods that tested for HPV in the cancer tissue directly to minimize misattribution. Thirty-two studies with 403 SCNC and 9 studies of 45 LCNC were included in the analysis. RESULTS: For SCNC, 85% (95% confidence interval [95%CI]=71%-94%) were HPV positive, 78% (95%CI=64%-90%) were HPV16 and/or HPV18 positive, 51% (95%CI=39%-64%) were singly HPV18 positive, and 10% (95%CI=4%-19%) were singly HPV16 positive. In a subset of 5 SCNC studies (75 cases), 93% were positive for p16INK4a by immunohistochemistry and 100% were HPV positive. For LCNC, 88% (95%CI=72%-99%) were HPV positive, 86% (95%CI=70%-98%) were positive for HPV16 or HPV18, 30% were singly HPV18 positive (95%CI=4%-60%), and 29% (95%CI=2%-64%) were singly HPV16 positive. CONCLUSIONS: In conclusion, most SCNC and LCNC are caused by HPV, primarily HPV18 and HPV16. Therefore, most if not all SCNC and LCNC will be prevented by currently available prophylactic HPV vaccines.