An overview of implementing an evidence based program to increase HPV vaccination in HIV community clinics

(2022) 22:1696 Wells et al. BMC Public Health https://doi.org/10.1186/s12889-022-14100-0 Open Access STUDY PROTOCOL An overview of implementing an evidence based program to increase HPV vaccination in HIV community clinics Jessica Wells1* , James L. Klosky2,3, Yuan Liu4,5 and Theresa Wicklin Gillespie5,6 Abstract Background: HPV-related anal cancer occurs in excess rates among people living with HIV (PLWH) and has been increasing in incidence. The HPV vaccine is an effective and safe approach to prevent and reduce the risk of HPVrelated disease. Yet, HPV vaccine programs tailored and implemented in the HIV population are lagging for this highrisk group. Methods: A pre-post intervention study design will be used to tailor, refine, and implement the 4 Pillars™ Practice Transformation Program to increase HPV vaccination among PLWH. Guided by the RE-AIM framework, the CHAMPS study will provide training and motivation to HIV providers and clinic staff to recommend and administer the HPV vaccination within three HIV clinics in Georgia. We plan to enroll 365 HIV participants to receive HPV education, resources, and reminders for HPV vaccination. Sociodemographic, HPV knowledge, and vaccine hesitancy will be assessed as mediators and moderators for HPV vaccination. The primary outcome will be measured as an increase in uptake rate in initiation of the HPV vaccine and vaccine completion (secondary outcome) compared to historical baseline vaccination rate (control). Discussion: The proposed study is a novel approach to address a serious and preventable public health problem by using an efficacious, evidence-based intervention on a new target population. The findings are anticipated to have a significant impact in the field of improving cancer outcomes in a high-risk and aging HIV population. Trial registration: NCT05065840; October 4, 2021. Keywords: HIV, HPV vaccination, Implementation Background HPV-related anal cancer occurs in excess rates among people living with HIV (PLWH) [1], and has been increasing in incidence [1]. Notably, the incidence of anal cancer among men who have sex with men (MSM) is 20- to 40- fold greater relative to non-MSMs [2]. The Human Papillomavirus (HPV) is responsible for 90% of *Correspondence: 1 Nell Hodgson Woodruff School of Nursing, Emory University, 1520 Clifton Road, NE, RM. 230, Atlanta, GA 30324, USA Full list of author information is available at the end of the article anal cancers where oncogenic HPV type 16 is responsible for 90% of anal cancers [3]. It is presumed the increased risk for anal cancer among PLWH is due to an impaired ability to clear HPV infections and increased reactivation of latent HPV infection. Of note, highly active antiretroviral therapy (HAART) has modest to no effect on HPV clearance or persistence; thus, other mechanisms may be involved that result in cellular immune dysfunction [4]. The safety and efficacy of the HPV vaccine has been evaluated in PLWH and is shown to be safe and highly immunogenic against oncogenic HPV types 16 and 18 [5–8]. The HPV vaccine also has been shown to decrease © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Wells et al. BMC Public Health (2022) 22:1696 Page 2 of 8 the risk of HPV-related anal intraepithelial neoplasia in a sample of MSMs [9]. Thus, anal cancer can be potentially a preventable disease through the use of the HPV vaccine [3]. However, very limited research has been conducted on the uptake of HPV vaccination among PLWH. One study found among a sample of young MSM’s who self-reported as HIV-positive, HPV vaccine initiation was 13.4% [10]. Although uptake is low, studies of the acceptability of the HPV vaccine has been found to be high among high risk groups like MSMs [11–13]. The United States’ Advisory Committee on Immunization Practices (ACIP) recommends vaccination up to age 26 years and recently FDA (Food and Drug Association) approved up to age 45 years for women and men [14]. ACIP also advises individuals who are immunocompromised to receive the 3-dose series of the HPV vaccine up to age 26 years of age and with shared clinical decision making for those 26 years and older. The Center for Disease Control and Prevention (CDC) urges catchup vaccination for adults who have not been previously vaccinated and remain vulnerable to develop preventable HPV-related cancers [15]. Yet, there is a dearth of studies that have tailored and implemented evidence-based approaches to promote HPV vaccination among PLWH and eligible for catchup vaccination. Since intervention development is costly, complex, and time consuming, we seek to refine and tailor an existing, evidence-based intervention and integrate in a new population and new setting. The CDC’s 4 Pillars™ Practice Transformation Program (4 Pillars™ Program) is a robust and empirically supported strategic approach that promotes the uptake of adult vaccinations and addresses facilitators and barriers at the patient, provider, and clinic level [16]. The 4 Pillars™ Program incorporates these recommendations via “a menu” of strategies to promote the establishment and maintenance of vaccination into routine practice (Table 1). The 4 Pillars™ Program has shown to improve vaccination rates among high risk adults in primary care practices that successfully implemented strategies across the program [17, 18]. A randomized controlled cluster trial (RCCT) found the 4 Pillars Program significantly increased HPV vaccination among a cohort of 10,861 adolescent patients in primary care practices [19]. The intervention sites increased baseline HPV vaccination by 10.2 percentage points (PP) versus 7.3 PP in the control sites (p < .001) [19]. Furthermore, another large RCCT of adolescents found the 4 Pillars™ Program significantly increased baseline initiation of HPV vaccination by 17.1 PP (p < .001) and increased HPV completion by 14.8 PP (p < .001) [20]. These findings highlight the effectiveness of the 4 Pillars™ (...truncated)