"Easy women get it": pre-existing stigma associated with HPV and cervical cancer in a low-resource setting prior to implementation of an HPV screen-and-treat program.

BACKGROUND: Cervical cancer is preventable with vaccination and early detection and treatment programs. However, for these programs to work as intended, stigma related to HPV and cervical cancer must be understood and addressed. We explored pre-existing stigma associated with HPV and cervical cancer in the public healthcare system and community of a low-resource setting prior to implementation of an HPV screen-and-treat program. METHODS: This study conducted thematic analysis of data collected during implementation of a novel HPV screen-and-treat system for cervical cancer early detection and treatment in Iquitos, Peru. We included 35 semi-structured interviews (19 health professionals, 16 women with cervical precancer or cancer), eight focus groups (70 community women), one workshop (14 health professionals), 210 counseling observations (with 20 nurse-midwives), and a document review. We used the Socio-Ecological Model to organize the analysis. RESULTS: We identified three main themes: 1. the implication that women are to blame for their HPV infection through characterizations of being easy or promiscuous, 2. the implication that men are to blame for women's HPV infections through being considered careless or unfaithful, 3. HPV is shameful, embarrassing, and something that should be hidden from others. Consequently, in some cases, women refrained from getting screened for HPV. These themes were seen at the individual level among women, relationship level among women, men, and family members, community level among healthcare staff, and societal level within components of cervical cancer guidelines and male chauvinism. CONCLUSIONS: Cervical cancer early detection and treatment programs in limited resource settings must address stigma entrenched throughout the entire healthcare system and community in order to sustainably and successfully implement and scale-up new programs. Interventions to tackle this stigma can incorporate messages about HPV infections and latency to lessen the focus on the influence of sexual behavior on HPV acquisition, and instead, promote screening and treatment as paramount preventative measures.

"Easy women get it": Pre-existing stigma associated with HPV and cervical cancer in a low-resource setting prior to implementation of an HPV screen-and-treat program.

Background: Cervical cancer is preventable with vaccination and early detection and treatment programs. However, in order for these programs to work as intended, stigma related to HPV and cervical cancer must be understood and addressed. We explored pre-existing stigma associated with HPV and cervical cancer in the public healthcare system of a low-resource setting prior to implementation of an HPV screen-and-treat program. Methods: This study conducted thematic analysis of data collected during implementation of a novel HPV screen-and-treat system for cervical cancer early detection and treatment in Iquitos, Peru. We included 35 semi-structured interviews (19 health professionals, 16 women with cervical precancer or cancer), eight focus groups (70 community women), one workshop (14 health professionals), 210 counseling observations (with 20 nurse-midwives), and a document review. We used the Socio-Ecological Model to organize the analysis. Results: We identified three main themes: 1. the implication that women are to blame for their HPV infection through characterizations of being easy or promiscuous, 2. the implication that men are to blame for women's HPV infections through being considered careless or unfaithful, 3. HPV is shameful, embarrassing, and something that should be hidden from others. Consequently, in some cases, women refrained from getting screened for HPV. These themes were seen at the individual level among women, relationship level among women, men, and family members, community level among healthcare staff, and societal level within components of cervical cancer guidelines and male chauvinism. Conclusions: Cervical cancer early detection and treatment programs in limited resource settings must address stigma entrenched throughout the entire healthcare system in order to sustainably and successfully implement and scale-up new programs. Interventions to tackle this stigma can incorporate messages about HPV infections and latency to lessen the focus on the influence of sexual behavior on HPV acquisition, and instead, promote screening and treatment as paramount preventative measures.

"Day or night, no matter what, I will go": Women's perspectives on challenges with follow-up care after cervical cancer screening in Iquitos, Peru: a qualitative study.

BACKGROUND: The study's objective was to explore the factors associated with loss to follow-up among women with abnormal cervical cancer screening results in Iquitos, Peru from women's perspectives. METHODS: In-depth interviews were conducted with 20 screen-positive women who were referred for follow-up care but for whom evidence of follow-up was not found. Interview transcripts were thematically analyzed inductively, and the codes were then categorized using the Health Care Access Barriers Model for presentation of results. RESULTS: All interviewed women were highly motivated to complete the continuum of care but faced numerous barriers along the way, including cognitive barriers such as a lack of knowledge about cervical cancer and poor communication from health professionals regarding the process, structural barriers such as challenges with scheduling appointments and unavailability of providers, and financial barriers including out-of-pocket payments and costs related to travel or missing days of work. With no information system tracking the continuum of care, we found fragmentation between primary and hospital-level care, and often, registration of women's follow-up care was missing altogether, preventing women from being able to receive proper care and providers from ensuring that women receive care and treatment as needed. CONCLUSIONS: The challenges elucidated demonstrate the complexity of implementing a successful cervical cancer prevention program and indicate a need for any such program to consider the perspectives of women to improve follow-up after a positive screening test.

Design and management considerations for control groups in hybrid effectiveness-implementation trials: Narrative review & case studies.

Hybrid effectiveness-implementation studies allow researchers to combine study of a clinical intervention's effectiveness with study of its implementation with the aim of accelerating the translation of evidence into practice. However, there currently exists limited guidance on how to design and manage such hybrid studies. This is particularly true for studies that include a comparison/control arm that, by design, receives less implementation support than the intervention arm. Lack of such guidance can present a challenge for researchers both in setting up but also in effectively managing participating sites in such trials. This paper uses a narrative review of the literature (Phase 1 of the research) and comparative case study of three studies (Phase 2 of the research) to identify common themes related to study design and management. Based on these, we comment and reflect on: (1) the balance that needs to be struck between fidelity to the study design and tailoring to emerging requests from participating sites as part of the research process, and (2) the modifications to the implementation strategies being evaluated. Hybrid trial teams should carefully consider the impact of design selection, trial management decisions, and any modifications to implementation processes and/or support on the delivery of a controlled evaluation. The rationale for these choices should be systematically reported to fill the gap in the literature.

OASI2: a cluster randomised hybrid evaluation of strategies for sustainable implementation of the Obstetric Anal Sphincter Injury Care Bundle in maternity units in Great Britain.

BACKGROUND: The Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle's effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle. METHODS: OASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by 'buddy' units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle's sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians' adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis. DISCUSSION: OASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle's clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable 'implementation blueprint' will be produced to inform development of future guidelines to prevent perineal trauma. TRIAL REGISTRATION: ISRCTN26523605.

The OASI care bundle quality improvement project: lessons learned and future direction.

Rising rates of obstetric anal sphincter injury (OASI) led to a collaborative effort by the Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Midwives (RCM) to develop and evaluate the OASI Care Bundle (OASI-CB). The OASI-CB comprises four practices (antenatal discussion about OASI, manual perineal protection, mediolateral episiotomy at 60° from the midline, and systematic examination of the perineum, vagina and ano-rectum after vaginal birth) and was initially implemented as part of a quality improvement (QI) project-"OASI1"-in 16 maternity units across Great Britain. Evaluation of the OASI1 project found that the care bundle reduced OASI rates and identified several barriers and enablers to implementation. This paper summarises the key findings, including strengths, limitations and lessons learned from the OASI1 QI project, and provides rationale for further evaluation of the OASI-CB.

Integrative Systems Praxis for Implementation Research (INSPIRE): An Implementation Methodology to Facilitate the Global Elimination of Cervical Cancer.

BACKGROUND: The World Health Organization (WHO) has called for a systems thinking approach to health systems strengthening to increase adoption of evidence-based interventions (EBI). The Integrative Systems Praxis for Implementation Research (INSPIRE) methodology operationalizes the WHO systems thinking framework to meet cervical cancer elimination-early detection and treatment (CC-EDT) goals. METHODS: Using a systems thinking approach and grounded in the consolidated framework for implementation research, INSPIRE integrates multiple research methodologies and evaluation frameworks into a multilevel implementation strategy. RESULTS: In phase I (creating a shared understanding), soft systems methodology and pathway analysis are used to create a shared visual understanding of the CC-EDT system, incorporating diverse stakeholder perspectives of the "what, how, and why" of system behavior. Phase II (finding leverage) facilitates active stakeholder engagement in knowledge transfer and decision-making using deliberative dialogues and multiple scenario analyses. Phase III (acting strategically) represents stakeholder-engaged implementation planning, using well-defined implementation strategies of education, training, and infrastructure development. In phase IV (learning and adapting), evaluation of key performance indicators via a reach, effectiveness, adoption, implementation, and maintenance framework is reviewed by stakeholder teams, who continuously adapt implementation plans to improve system effectiveness. CONCLUSIONS: The INSPIRE methodology is a generalizable approach to context-adapted implementation of EBIs. IMPACT: Replacing static dissemination of implementation "roadmaps" with learning health systems through the integration of systems thinking and participatory action research, INSPIRE facilitates the development of scalable and sustainable implementation strategies adapted to local contexts.

Evaluation of new approaches to the access of official monitoring results for live bivalves molluscs.

BACKGROUND: Live bivalve molluscs, echinoderms, tunicates and marine gastropod are referred in EU food laws, and require member states to implement official controls in classified production areas, with the monitoring and classification of those areas. If, due to contaminant tests results, a production area is closed, any product from there is prohibited to be commercialized. Mobile applications optical character recognition (OCR) functionalities could ease the access to contaminant levels and production area classifications. This study verifies what information is available in live bivalves' labels, describes an OCR algorithm for those labels and evaluates it. METHODS: 86 labels were selected from four sale points in Lisbon, and photographed using smartphones. Each label was evaluated by a human to determine what data was available (either required or not). An OCR algorithm was developed and applied on the collected labels and validated against the data extracted by the human analysis. RESULTS: The analysis shows that all the labels included the required information, and 63% of the labels included the identifier for the production zone. The label-reading algorithm performs with an accuracy of 79.85% for the individual values. CONCLUSION: High accuracy of the developed label-reading algorithm shows potential for providing instant automatic access to the date and production area, but is affected by the variability on the label structure. Although not required by food laws, the majority of the sampled labels included complementary information (classified production area) that will allow access to more precise information about the existing biotoxin tests and analysis results.