Increasing Attendance to Cervical Cancer-screening Among Immigrants
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      Although health-related interventions should become increasingly diversity-sensitive, there
      will always be a need of adapting specific interventions to some immigrant populations.
      Adapting selected services to the individual cultural and religious background is necessary
      to reduce health inequalities and provide effective health care and is dependent on the
      active involvement of users. In this proposal the investigators present a community-based
      health intervention trial with two parallel interventions aimed at increasing participation
      of immigrant women to the existing cervical cancer-screening program. Through this study, the
      investigators will provide new practice-based knowledge and a firmer evidence base to improve
      health interventions that can contribute to equal health care and good health for all -
      including the immigrant population.

      Based on identified barriers and factors that influence the interactions between immigrants
      and health care professionals for screening of cervical cancer in Norway, the investigators
      have develop two adapted interventions. One strategy will target immigrant women, and the
      other one will focus on general practitioners. Thus, this proposal will specifically
      contribute to the development of personalized health prevention interventions for the most
      common cancer-screening program in Norway, with a focus on immigrant's personal circumstances
      and health care needs.
    

Detailed description: 
      Goals and objectives of the project The present study is designed to evaluate the
      effectiveness of two different community-based strategies to increase the attendance to the
      cervical cancer screening prevention program. Interventions have been developed together with
      stakeholders and conducted in two different geographical areas in Norway. Each intervention
      group will be compared to a control population in the same county in the first place. The
      main outcome to compare will be the percentage of women in each group attending to the
      screening program. However, the investigators will not only focus on this quantitative
      outcome, but also on the underlying processes determining how communities and individuals
      change their behaviour.

      Secondly, the effect of the interventions measured quantitatively will be compared to each
      other in order to be able to prioritise one of the two strategies if needed, although
      strategies will probably be complementary. A particular interest of the interventions is to
      examine whether and how immigrant women respond to different intervention strategies.

      Methods This study is designed as a community-based health intervention trial. A key feature
      of such trials is the allocation of intact communities or clusters of individuals rather than
      individuals themselves to different intervention groups.

      The study will rely on both quantitative and qualitative evaluation of the interventions. For
      the quantitative part,each of the two interventions will be compared to its control. In
      addition, the effects of the interventions will be compared. Additionally, to know how the
      interventions increased (or not) attendance to the screening program post-intervention focus
      groups among intervention subjects will be conducted.

      Interventions, participants and participating areas Two different intervention strategies
      have developed, one of them meant to increase awareness and attendance among users, and the
      other one targeting health professionals.

        1. User intervention Area and design The developed User intervention will be implemented in
           the counties of Akershus and Buskerud. Women from Somalia and Pakistan were chosen as
           targets for this intervention after previous analyses for register data. Sample size was
           calculated for an increase in cancer screening participation from 0.45 to 0.55 with 80%
           power and 5% significance level. The investigators tried several intra class correlation
           (ICC) levels, and ended dividing the area in 16 clusters that were matched according to
           the calculated number of female immigrants aged 20 to 66 from Somalia and Pakistan.
           After assuring that pairs were not naturally linked by a mosque or other natural known
           gather centre for these populations, clusters were randomly assigned to intervention or
           control groups.

           Participants All women from Somalia and Pakistan living in the intervention clusters
           compose the intervention groups; immigrant women from the same countries of origin
           living in control clusters will be control participants. It is estimated that 625 and
           915 women in screening age from Somalia and Pakistan respectively live in the study area
           (Akershus and Buskerud). Approximately half part of the women from each country will be
           in the intervention clusters.

           Intervention Bilingual key women from the two chosen countries were recruited and
           trained as peer educators for their respective communities to increase awareness
           regarding the importance of cervical cancer prevention and to help peers overcome
           detected barriers and increase attendance to screening. The strategy to achieve these
           goals relied upon meetings with the women organised according to their practical needs,
           using videos and other interactive materials.

        2. Heath professional intervention Area The developed Heath professional intervention will
           be implemented in Bergen. Sample size was calculated for an increase in cancer screening
           participation for non-Western immigrants (all groups together) from 0.45 to 0.55 with
           80% power and 5% significance level. The investigators tried several intra class
           correlation (ICC) levels, and finally divided the area in 20 clusters that were matched
           according to the cluster size and the calculated number of female non-Western immigrants
           aged 20 to 66. The clusters were thereafter randomly assigned to intervention or control
           groups.

           Participants All General practitioners working in the intervention cluster areas were
           assigned to the intervention group; similarly, health professionals working in the other
           clusters will be chosen as controls. Women will for the analyses be linked to their
           general practitioner through the General Practice Database.

           Intervention Based on the existing evidence and on interviews conducted with health
           professionals, an appropriate intervention was developed to increase awareness of the
           health professionals involved in screening working in the chosen areas. Health
           professionals in the intervention areas will be contacted by letter and a personal
           appointment was made to explain the intervention. No change in "screening as usual" will
           be implemented for health professionals working in the control areas.

        3. Post-intervention qualitative studies Among participants included in the intervention
           areas, focus groups/in depth-interviews will be conducted right after the interventions
           are implemented among both users and health professionals to understand whether and how
           each of the interventions worked.

      Measurements The study relies on both quantitative and qualitative evaluation of the
      interventions.

        1. Outcome information on screening attendance for intervention and control groups will be
           obtained from the Norwegian Cytology registry, where all pap smears taken in Norway are
           registered. The leader of the Norwegian Cytology register is part of the Reference group
           for this study, and this register can provide data for the variables Morphology (if the
           test is taken, if it is normal or pathological) and date for test for all women in
           Norway after the necessary permissions are given. This register will be then linked at
           the individual level to the Norwegian National Registry in order to obtain information
           regarding immigrant background, country of origin as explained below, reason for
           migration and length of stay in Norway for all 25 to 69 years old registered in Norway,
           in addition to other socioeconomic variables (age, education, income level, work status,
           cluster area for those in intervention and control areas, geographical centrality, civil
           status, husbands' immigrant background and GP's immigrant background) that will be used
           to adjust our results, and to two variables from the GP database (GP's age and gender)
           to identify the GPs in the intervention and control groups in the Health professional
           strategy. Data will be linked by Statistics Norway before being accessible to the
           researchers. However, since ethnicity is considered sensitive data, and in order to make
           the dataset completely anonymous for the research group, we will only apply for the
           following groups with regard to country of origin (see page 1 for approximate numbers):
           Norway, Western Europe, Eastern Europe, Middle-East, South-East, South Asia, Africa,
           North America, Central and South America, Poland, Sweden, Pakistan and Somalia. As
           explained below, data will be obtained for several years (2012-2018) in order to be able
           to distinguish secular trends in attendance to cervical screening versus the effect due
           to our intervention. Data will be stored in a secure server at the University of Bergen
           (BIOS, Core Facility for Biostatistics and Data Analyses) in an anonymised form.

        2. In addition, the process of how communities and individuals change their behaviour will
           be studied using a qualitative approach to the intervention groups after the
           interventions. These data will do not include any information that can lead to personal
           identification of the women.
    

Intervention name(s): User intervention; Health professional intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): To make participants aware of the lack of participation in screening programs and its consequences, and help to manage obstacles to participation; To provide information on the low attendance of migrants to cervical cancer screening and tools to improve the situation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One intervention targeting women, the other one targeting health professionals.
Masking: None (Open Label)
Primary purpose: Prevention