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The Effect of Education Based on Health Belief Model on the Intention of Injection of HPV Vaccine in vulnerable women in Isfahan in 2018

Protocol summary

Study aim
The Effect of Education Based on Health Belief Model on the Intention of Injection of HPV Vaccine in vulnerable women in Isfahan in 2018
Design
The clinical trial has 1 intervention group (in two centers) and 1 control group, each group based on the lottery and randomly selected from 3 vulnerable women's counseling centers under welfare coverage. The sample size for each group was 36,but Considering the Chance of sample Loos, Sample Size was Increased to 72.
Settings and conduct
The research environment in this study is three vulnerable women's counseling centers under Supervision of Welfare Organization of Isfahan city, two of which will be randomly selected as an intervention group and one center will be selected as the control group. Firstly, by visiting these centers, a list of vulnerable women aged 15-45 and their telephone numbers will be extracted and invited by telephone to participate in the research. Group training sessions are organized in four sessions of an hour and a half with a one-hour interval in a room in these centers.
Participants/Inclusion and exclusion criteria
Vulnerable women, aged 15-45 years old, non-pregnant, women whose spouses have one of the following characteristics: drug users, current imprisonment or current imprisonment. Pregnancy During the study, prisoners should be imprisoned during the study, not completing the questionnaire, misdiagnosis (completeness without accuracy), abstaining from attending educational sessions more than once
Intervention groups
Intervention group: Group discussions and lectures and presentation of pamphlets will be held in four sessions, one and a half hours, which will take place approximately one week. Control group: no additional work
Main outcome variables
The Intention of Injection of HPV Vaccine

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110529006624N2
Registration date: 2019-02-27, 1397/12/08
Registration timing: registered_while_recruiting

Last update: 2019-02-27, 1397/12/08
Update count: 0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
zahra boroomandfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 1726
Email address
boroumandfar@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-18, 1397/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Education Based on Health Belief Model on the Intention of Injection of HPV Vaccine in vulnerable women in Isfahan in 2018
Public title
The Effect of Education Based on Health Belief Model on the Intention of Injection of HPV Vaccine in vulnerable women in Isfahan in 2018
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Vulnerable women Aged 15-45 years old Non-pregnant Women whose spouses have one of the following characteristics: drug users, current imprisonment or current imprisonment.
Exclusion criteria:
Pregnancy During the study Prisoners should be imprisoned during the study Not completing the questionnaire Misdiagnosis (completeness without accuracy) Abstaining from attending educational sessions more than once
Age
From 15 years old to 26 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
3 The Special Women's Advice Center for vulnerable women under the Welfare Organization will be allocated to intervention teams based on the Health Belief Model (grouped by lecture, pamphlet, etc.) and the control group (2 centers of intervention and 1 control center) .Samples will be selected based on convenience sampling in centers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences,Hezar Jarib Street,Azadi Square
City
Isfahan, Iran
Province
Isfehan
Postal code
8174673461
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.224

Health conditions studied

1

Description of health condition studied
The Intention of Injection of HPV Vaccine in vulnerable women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The Intention of Injection of HPV Vaccine
Timepoint
Before the intervention, immediately and 6 weeks after the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group discussions and lectures and presentation of pamphlets will be held in four sessions, one and a half hours, which will take place approximately one week.
Category
Other

2

Description
Control group: no additional work( No intervention)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Social Services Base HASEH
Full name of responsible person
Zahra Arjmandi
Street address
Hasseh. First Street of Imam Khomeini
City
Isfahan, Iran
Province
Isfehan
Postal code
816637316
Phone
+98 31 3558 3593
Email
Z.arjmandi53@gmail.com

2

Recruitment center
Name of recruitment center
Arsenan Social Services Base
Full name of responsible person
Safiyan
Street address
Zainabeeh Street
City
Isfahan, Iran
Province
Isfehan
Postal code
816637316
Phone
+98 31 3551 7897
Email
ll_abab@yahoo.com

3

Recruitment center
Name of recruitment center
Women's Damage Center
Full name of responsible person
Leila Heidary
Street address
Robat St
City
Isfahan, Iran
Province
Isfehan
Postal code
816637316
Phone
+98 31 3337 8923
Email
leilaheidary.2012@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjouy Javanmard
Street address
Research &Technology Dept, Isfahan University of Medical Sciences. hezar Jareib St, Azadi Square
City
Isfahan, Iran
Province
Isfehan
Postal code
319-81745
Phone
+98 31 3668 8138
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Boroumandfar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and midwifery , Isfahan University of Medical Sciences.Hezar Jareyb St. Azadi Square,
City
Isfahan, Iran
Province
Isfehan
Postal code
8174673461
Phone
+98 37927536
Email
boroumandfar@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Boroumanfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and midwifery .Isfahan University of Medical Sciences, hezar Jarib St, Azadi Square
City
Isfahan, Iran
Province
Isfehan
Postal code
8174673461
Phone
+98 37927536
Email
boroumandfar@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Abab
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and midwifery .Isfahan University of Medical Sciences, hezar Jarib St, Azadi Square
City
Isfahan, Iran
Province
Isfehan
Postal code
8174673461
Phone
+98 37927536
Email
ll_abab@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of the clinical study will be published as article
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Email:boroumandfar@nm.mui.ac.ir
What processes are involved for a request to access data/document
Maximum one week after the communication by email
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