Community Research and Development Information Service - CORDIS

Periodic Report Summary 3 - COHEAHR (Comparing health services interventions for the prevention of HPV-related cancer)

Project Context and Objectives:
CoheaHr stands for "comparing health services interventions for the prevention of HPV-related cancer" and is an European Commission-funded multidisciplinary consortium of key researchers in the field of HPV screening and vaccination. CoheaHr aims to provide a strong evidence base which will enable policy makers and other stakeholders to make informed decisions on HPV prevention strategies, thereby contributing to strengthening health systems and health services interventions in Europe. HPV-related cancers include cancers of the anogenital tract and the oropharynx. The consortium focuses explicitly on cervical cancer – for which both primary prevention (HPV vaccination) and secondary prevention methods (screening) are available.

The project is organised in 7 different work packages (WP). The CoheaHr consortium is conducting a number of studies in organised screening settings to determine i) the efficacy and feasibility of self-collection of specimens for HPV testing as an alternative to physician-based sampling (WP2), ii) the safety and quality of life of less frequent screening in women vaccinated at young age (WP3a), and iii) the effectiveness of HPV screening in vaccinated women (WP3b). In addition, a multi-country study is ongoing to assess the acceptability and feasibility of HPV vaccination in screen-eligible women (WP4). In WP5 transmission and Markov models are being (further) developed, validated and used to provide long-term projections of vaccination and screening on cancer incidence and mortality. The trials will provide (some of) the input parameters for these models. Finally the data will feed a previously established standardised joint European data warehouse and pooled analyses and meta-analyses will be performed (WP6).

Project Results:
Since its initiation in November 2013, two randomized controlled clinical trials (RCT, WP2 and WP3a) and the feasibility study (WP4) have started enrolment. The methodology of the third RCT (WP3b) has undergone some changes (amendment under review) because in the current framework of the health care services and infrastructure a randomized comparative effectiveness trial was no longer feasible. A summary of the progress in the different work packages is provided here below.

The first trial (WP2; IMPROVE) is an RCT comparing hrHPV self-sampling as first screening test versus physician-collected sample. The trial was conducted in the Netherlands and coordinated by the VU University Medical Center. A total of 187,473 women were invited to participate in the study and 13,925 women provided informed consent and participated in the study. The HPV prevalence was 7.4% in the self-collected and 7.2% in the clinician-collected samples. Cross-test results of over 90% positive women were available in both groups. The histological outcomes of this study have been analysed and will be soon available.

The second trial (WP3a) is an RCT evaluating different screening policies in vaccinated women and is conducted in Finland (University of Tampere). HPV-vaccinated women (birth cohorts 1992-1995) are randomized to three different arms to receive PAP smear at the age of 22, 25 and 30; at age 25 and 30; or at age 30 only. Arm 1 and 3 will include at least 7,000 women each. The enrolment of the 1992-1994 birth cohorts have been completed and the 1995 birth cohort will be enrolled in 2018. In WP3b a registry-based study will be conducted to evaluate the influence of vaccination on the performance of cervical cancer screening.

The fourth study (WP4) aims to assess the acceptability and feasibility of HPV vaccination in screen-eligible 25 to 45-year-old women in eight countries. Seven countries have completed enrolment, in Sweden recruitment has started in March 2018 and is still open. The UK performed a questionnaire-only survey investigating the hypothetical acceptability of HPV vaccination among older women.

The modelling work (WP5) focused on simulation of the effects of vaccination on screening in different populations. Alternative vaccination strategies targeting different age and gender specific groups were simulated. It was shown for example, that within the Dutch setting, sex-neutral vaccination is a cost-effective alternative to girls’ only vaccination and also more resilient against a sudden decline in vaccine uptake than girls’ only vaccination. Modelling was also used to replicate observed herd effects and quantify the contribution of herd effects to the control and elimination of different HPV types. The HPV progression/screening model was used to elucidate the biological mechanism underlying the performances of cytology-based screening programs as observed in the major EU screening trials. The model is currently used to assess the impact and resource requirement of selected HPV-based screening strategies.

In WP6 – Pooled analyses have been done on the data of the European randomised controlled trials using the updated data warehouse. Models are being used to explore observed patterns in the data.
A statistical procedure was developed to perform diagnostic network meta-analysis. Multiple meta-analyses have been conducted and published in the field of HPV testing, complications after treatment of CIN23, and efficacy and safety of HPV vaccines. An extensive review of over 100 European HPV vaccine tender procedures revealed important information on the tender price development of the bivalent, quadrivalent, and nonavalent vaccine.

The contents of an e-learning course on cervical cancer prevention have been developed in WP7. The course has been translated to several languages and the virtualization of the course has been done.

Potential Impact:
HPV research and development has delivered to the promise by introducing proprietary technologies and methods such as new HPV vaccines and HPV DNA screening to clinical practice. CoheaHr is taking the next crucial step in optimising the delivery of health services by providing a comprehensive evidence base regarding the comparative effectiveness and cost-effectiveness of nation-wide screening and vaccination programmes for HPV related disease. Results of CoheaHr have been disseminated at international conferences and a special session on CoheaHr has been held at Eurogin 2015 (Seville, Spain), Eurogin 2016 (Salzburg, Austria) and Eurogin 2017 (Amsterdam, the Netherlands). A complete list of publications from the CoheaHr consortium, as well as additional information on the project and the consortium partners, can be found at: www.coheahr.eu. The results of CoheaHr will support policy makers and other decision makers at National and EU level, thereby improving public health interventions in relation to HPV prevention and adding to the health of European Citizens.
List of Websites:
www.coheahr.eu

Reported by

STICHTING VUMC
Netherlands

Subjects

Life Sciences
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