NCT03155581

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

2.4 years

First QC Date

May 11, 2017

Last Update Submit

December 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participation in cervical cancer screening

    Registered in national cancer register (yes/no), if the woman has been registered with a Pap-smear or not

    1 year

Secondary Outcomes (1)

  • Process of behavior change

    1 year

Study Arms (2)

User intervention

OTHER

Bilingual key women from Somalia and Pakistan trained as peer educators for their respective communities will meet the women to increase awareness regarding the importance of cervical cancer prevention and to help peers overcome detected barriers and increase attendance to screening during meetings with the women organised according to their practical needs, using videos and interactive material

Behavioral: User intervention

Health professional intervention

OTHER

General practitioners working in the intervention areas are contacted by letter and an appointment is made for a short meeting to increase awareness of the health professionals involved in screening working in the chosen areas. Material is given(posters and reminding objects) to remind practitioners of the intervention and invite women attending to the center to make an appointment with their GP. No change in "screening as usual" will be implemented for health professionals working in the control areas.

Behavioral: Health professional intervention

Interventions

To make participants aware of the lack of participation in screening programs and its consequences, and help to manage obstacles to participation

User intervention

To provide information on the low attendance of migrants to cervical cancer screening and tools to improve the situation

Health professional intervention

Eligibility Criteria

Age25 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFor the women, only females are subject to cervical cancer screening
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For the women: Women from Somalia and Pakistan living in the intervention areas
  • For the health professionals: GPs working in the intervention areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Qureshi SA, Igland J, Moen K, Gele A, Kumar B, Diaz E. Effect of a community-based intervention to increase participation in cervical cancer screening among Pakistani and Somali women in Norway. BMC Public Health. 2021 Jun 30;21(1):1271. doi: 10.1186/s12889-021-11319-1.

  • Moen KA, Kumar B, Igland J, Diaz E. Effect of an Intervention in General Practice to Increase the Participation of Immigrants in Cervical Cancer Screening: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e201903. doi: 10.1001/jamanetworkopen.2020.1903.

  • Qureshi SA, Gele A, Kour P, Moen KA, Kumar B, Diaz E. A community-based intervention to increase participation in cervical cancer screening among immigrants in Norway. BMC Med Res Methodol. 2019 Jul 12;19(1):147. doi: 10.1186/s12874-019-0795-8.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Esperanza Diaz, MD, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Women under are those recruited in the intervention targeting women. In addition, 40 GP centers were recruited
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One intervention targeting women, the other one targeting health professionals.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 16, 2017

Study Start

February 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

No plan