Design, implementation, and evaluation of an intervention based on the social marketing model on the Pap-smear test uptake among women living in Qazvin
Design
A controlled, factorial, unblinded, randomized, phase 3 clinical trial for 90 women.
Settings and conduct
The population of this study consists of women aged 18 to 65 from Qazvin City. From this population, 90 people are randomly selected between two control and intervention groups.
In this study, samples are visited at their doorsteps, and data is collected. Pamphlets and coupons are also delivered to the homes of the intervention group. Then a promotional message is sent to the intervention group. After three months, post-intervention data will be collected.
Participants/Inclusion and exclusion criteria
Female
Age between 18 and 65 years
Married
Not participating in training courses in the field of Pap-smear test
Not doing a Pap-smear test in the last three years
Intervention groups
A four-part intervention based on the 4Ps of social marketing:
1-1- Providing a coupon to cover part of the cost of the test (price: monetary costs)
2-1- Presentation of a pamphlet in the field of reducing anxiety about the test result (price: psychological costs)
3-1- Presentation of a pamphlet stating that the test has no effect on sexual relations to be presented to spouses (price: psychological costs)
2- Providing a schematic map and exact address of comprehensive health service centers in Qazvin city and access ways (place: explain the location of service provision)
3- Presenting an infographic introducing the Pap-smear test and how to perform the test (product: product introduction)
4- Sending SMS containing promotional message (promotion)
Main outcome variables
The percentage of Pap smear test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056609N1
Registration date:2023-04-27, 1402/02/07
Registration timing:prospective
Last update:2023-04-27, 1402/02/07
Update count:0
Registration date
2023-04-27, 1402/02/07
Registrant information
Name
Aisa Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 6749
Email address
a.maleki@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation, and evaluation of an intervention based on the social marketing model on the Pap-smear test uptake
Public title
Evaluation of the intervention based on the social marketing model on the Pap-smear test uptake
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Female
Age between 18 and 65 years
married
Not participating in Pap-smear training courses
Not doing a pap-smear test in the last three years
Exclusion criteria:
Participation in codified training courses related to sexually transmitted diseases
Having a history of screening for human papilloma or genital warts (Co-testing)
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First, the female population of Qazvin is clustered based on urban health community centers. Then based on the share of each cluster in the total population, the number of samples required for both control and intervention groups is selected from each cluster. Randomization of intervention and control group samples is done at the individual level (not at the cluster level). First, the target community is divided into blocks (clusters) based on the comprehensive urban health center. Then, using a random number table, half of the intervention people and half of them are included as controls within each block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee Qazvin University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, 1st Branch, Maudet Alley, Shahid Beheshti Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.QUMS.REC.1402.002
Health conditions studied
1
Description of health condition studied
Encounter for screening for malignant neoplasm of cervix
ICD-10 code
Z12. 4
ICD-10 code description
Primary outcomes
1
Description
Pap-smear test
Timepoint
Measuring the Pap-smear test uptake at the beginning of the study (before the start of the intervention) and three months after the start of the intervention
Method of measurement
A questionnaire including demographic information, cervical cancer history and Pap smear test uptake
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A four-part intervention based on the 4Ps of social marketing: 1-1- Providing a coupon to cover part of the cost of the test (price: monetary costs) 2-1- Presentation of a pamphlet in the field of reducing anxiety about the test result (price: psychological costs) 3-1- Presentation of a pamphlet stating that the test has no effect on sexual relations to be presented to spouses (price: psychological costs) 2- Providing a schematic map and exact address of comprehensive health service centers in Qazvin city and access ways (place: explain the location of service provision) 3- Presenting an infographic introducing the Pap-smear test and how to perform the test (product: product introduction) 4- Sending SMS containing promotional message (promotion)In this study, samples are visited at their doorsteps, and data is collected. Pamphlets and coupons are also delivered to the homes of the intervention group. Then a promotional message is sent to the intervention group. After three months, post-intervention data will be collected.
Category
Prevention
2
Description
Control group: It does not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vice-Chancellor of Health and Health Center of Qazvin province
Full name of responsible person
Aisa Maleki Nadnilooei
Street address
University health department and provincial health center, building number 2 of the university headquarters, Azadegan Blvd.
City
Qazvin
Province
Qazvin
Postal code
3414853135
Phone
+98 922 369 5917
Email
aisamalekii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mehdi Mirhashemi
Street address
Research and Technology Vice-Chancellor, 1st Branch, Maudet Alley, Shahid Beheshti Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3336 8124
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Aisa Maleki Nadnilooei
Position
MSc Student in Health Services Management
Latest degree
Bachelor
Other areas of specialty/work
Health Service Management
Street address
Research and Technology Vice-Chancellor, 1st Branch, Maudet Alley, Shahid Beheshti Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3336 8124
Email
aisamalekii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Omid Khosravizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
Faculty of Health, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
omid.khosravizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Aisa Maleki Nadnilooei
Position
MSc Student in Health Service Management
Latest degree
Bachelor
Other areas of specialty/work
Health Service Management
Street address
Research and Technology Vice-Chancellor, 1st Branch, Maudet Alley, Shahid Beheshti Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3336 8124
Email
aisamalekii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the data is confidential and work for the master thesis will eventually become a training package
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available