Primary Care and Community-Based Partnerships to Enhance HPV Vaccine Delivery.

INTRODUCTION/OBJECTIVES: With growing vaccination misinformation and mistrust, strategies to improve vaccination communication across community-based settings are needed. METHODS: The Rural Adolescent Vaccine Enterprise (RAVE), a 5-year (2018-2022) stepped-wedge cluster randomized study, tested a clinic-based practice facilitation intervention designed to improve HPV vaccination. An exploratory aim sought to explore the use of partnerships between primary care clinics and a community partner of their choosing, to implement a social marketing campaign related to HPV immunization. We assessed perceptions about the value and success of the partnership, and barriers and facilitators to its implementation using a 29-item community partner survey, key informant interviews, and field notes from practice facilitators. RESULTS: Of the initial 45 clinics participating in RAVE, 9 were unable to either start or complete the study, and 36 participants (80.0%) were actively engaged. Of these, 16/36 clinics (44.4%) reported establishing successful partnerships, 10 reported attempting to develop partnerships (27.8%), and another 10 reported not developing a partnership (27.8%), which were often caused by the COVID-19 pandemic. The most common partnership was with public health departments at 27.3%. Other partnerships involved libraries, school districts, and local businesses. More than half (63.7%) reported that creating messages regarding getting HPV vaccination was moderately to very challenging. Just under half reported (45.5%) that messaging was hard because of a lack of understanding about the seriousness of diseases caused by HPV, parents being against vaccines because of safety concerns, and religious values that result in a lack of openness to HPV vaccines. Community partners' health priorities changed as a result of RAVE, with 80% prioritizing childhood immunizations as a result of the RAVE partnership. CONCLUSIONS: Community groups want to partner with primary care organizations to serve their patients and populations. More research is needed on how best to bring these groups together.

Challenges in Use of Practice-based Research Networks for a Medical Device Trial to Detect SARS-CoV-2.

INTRODUCTION/OBJECTIVES: Primary care practice-based research networks (PBRNs) participated in a point of care (POC) device study funded by by the National Institutes of Health and led by the University of Massachusetts Chan Medical School (UMass) to speed the development, validation, and commercialization of POC tests to detect SARS-CoV-2. The purposes of this study were to describe the characteristics of participating PBRNs and their respective collaborators in this device trial and describe complications challenging its execution. METHODS: Semi-structured interviews were conducted with lead personnel from participating PBRNs and UMass. RESULTS: Four PBRNs and UMass were invited to participate and 3 PBRNs and UMass participated. This device trial recruited 321 subjects in 6 months; 65 subjects from PBRNs. Each PBRN and the academic medical center site enrolled and recruited subjects differently. Main challenges identified were having adequate clinic personnel to enroll and aid in consent and questionnaire completion, frequently changing inclusion/exclusion criteria, use of the digital electronic data collection platform, and having access to a -80°C freezer to store supplies. DISCUSSION: This trial involved numerous researchers, primary care clinic leaders and staff, and academic center sponsored program staff and attorneys resulting in a resource-intensive endeavor to enroll 65 subjects in the real-world clinical setting of primary care PBRNs with the academic medical center enrolling the rest. Multiple obstacles to standing up the study were encountered by the PBRNS. CONCLUSIONS: Primary care PBRNs rely largely on the goodwill established between academic health centers and participating practices. For future investigations involving device studies, collaborating PBRN leaders should assess whether recruitment criteria may change, obtain detailed lists of equipment needed, and/or know if the study is likely to be halted suddenly to appropriately prepare their member practices.

Human Papillomavirus Immunization in Rural Primary Care.

INTRODUCTION: Despite the safety and efficacy of the human papillomavirus vaccine, thousands are impacted by human papillomavirus and its related cancers. Rural regions have disproportionately low rates of human papillomavirus vaccination. Primary care clinics play an important role in delivering the human papillomavirus vaccine. A positive deviance approach is used to identify workflows, organizational factors, and communication strategies in rural clinics with higher human papillomavirus vaccine up-to-date rates. Positive deviance is a process by which exceptional behaviors and strategies are identified to understand factors that enable success. METHODS: Rural primary care clinics were rank ordered by human papillomavirus vaccine up-to-date rates using 2018 Oregon Immunization Program data, then recruited via purposive sampling of clinics in the top and bottom quartiles. Two study team members conducted previsit interviews, intake surveys, and 2-day observation visits with 12 clinics and prepared detailed field notes. Data were collected October-December 2018 and analyzed using a thematic approach January-April 2019. RESULTS: Four themes distinguished rural clinics with higher human papillomavirus vaccine up-to-date rates from those with lower rates. First, they implemented standardized workflows to identify patients due for the vaccine and had vaccine administration protocols. Second, they designated and supported a vaccine champion. Third, clinical staff in higher performing sites were comfortable providing immunizations regardless of visit type. Finally, they used clear, persuasive language to recommend or educate parents and patients about the vaccine's importance. CONCLUSIONS: Positive deviance identified characteristics associated with higher human papillomavirus vaccine up-to-date rates in rural primary care clinics. These findings provide guidance for rural clinics to inform human papillomavirus vaccination quality improvement interventions.

Public perception of predictive cancer genetic testing and research in Oregon.

The potential for using widespread genetic testing to inform health care has become a viable option, particularly for heritable cancers. Yet, little is known about how to effectively communicate the benefits and risks of both personal genetic testing and participation in biorepositories that aid scientific advancements. Nationwide efforts are engaging communities in large genetic studies to better estimate the population-wide prevalence of heritable cancers but have been met with hesitance or declination to participate in some communities. To successfully engage an Oregon population in longitudinal research that includes predictive genetic testing for pathogenic or likely pathogenic variants associated with an increased risk for cancer, researchers conducted 35 focus groups (two of which were held in Spanish) in 24 of Oregon's 36 counties to better understand knowledge and attitudes related to genetic testing and willingness to participate in longitudinal genetic research. A total of 203 adults (mean = 45.6 years; range 18-88), representing a range of education levels and prior knowledge of genetic research, participated in the focus groups. The majority (85%) of participants reported personal or family diagnoses of cancer (e.g., self, family, friends). A majority (87%) also reported a strong interest in cancer genetic testing and receiving genetic information about themselves. Nearly all focus groups (94%, 33 of 35 sites) included participant discussion citing their families (e.g., children, close relatives, and extended family members) as key motivators for participation in genetic research. For example, participants reported interest in increasing personal knowledge about their own and their families' cancer risks in order to respond proactively, if a pathogenic variant was found. While most focus groups (94%, 33 of 35 sites) included participant discussion describing barriers to predictive genetic, testing such as concerns about outcomes, the desire to learn about health risks in oneself mitigated or outweighed those fears for many participants. Other commonly reported concerns were related to potential mistrust of insurance companies, researchers, or institutions, or lack of knowledge about genetics, genetic testing, or genetic research. Participants, particularly in rural areas, highlighted critical factors for research recruitment, such as trust, personal interaction, public education about genetic research, and clear communication about study goals and processes. Our statewide findings reflect that public interest in predictive cancer genetic testing and cancer genetic research can surpass lack of knowledge of the complex topics, particularly when benefits for self and family are emphasized and when study considerations are well articulated.

κ Agonists as a novel therapy for menopausal hot flashes.

OBJECTIVE: The etiology of postmenopausal hot flashes is poorly understood, making it difficult to develop and target ideal therapies. A network of hypothalamic estrogen-sensitive neurons producing kisspeptin, neurokinin B and dynorphin-called KNDy neurons-are located adjacent to the thermoregulatory center. KNDy neurons regulate pulsatile secretion of gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH). Dynorphin may inhibit this system by binding κ opioid receptors within the vicinity of KNDy neurons. We hypothesize that hot flashes are reduced by KNDy neuron manipulation. METHODS: A double-blind, cross-over, placebo-controlled pilot study evaluated the effects of a κ agonist. Hot flash frequency was the primary outcome. Twelve healthy postmenopausal women with moderate to severe hot flashes (aged 48-60 y) were randomized. Eight women with sufficient baseline hot flashes for statistical analysis completed all three interventions: placebo, standard-dose pentazocine/naloxone (50/0.5 mg), or low-dose pentazocine/naloxone (25/0.25 mg). In an inpatient research setting, each participant received the three interventions, in randomized order, on three separate days. On each day, an intravenous catheter was inserted for LH blood sampling, and skin conductance and Holter monitors were placed. Subjective hot flash frequency and severity were recorded. RESULTS: The mean (SEM) hot flash frequency 2 to 7 hours after therapy initiation was lower than that for placebo (standard-dose κ agonist, 4.75 [0.67] hot flashes per 5 h; low-dose κ agonist, 4.50 [0.57] hot flashes per 5 h; placebo, 5.94 [0.78] hot flashes per 5 h; P = 0.025). Hot flash intensity did not vary between interventions. LH pulsatility mirrored objective hot flashes in some--but not all--women. CONCLUSIONS: This pilot study suggests that κ agonists may affect menopausal vasomotor symptoms.