Protocol summary

Summary
This is a quasi-experimental study. The aim of the study is to determine the effect of education on Health Belief Model in prevention of viral hepatitis B in healthy carriers. Carriers with HIV positive, Introduction of healthy carriers diagnosed are included. Carriers with hospital admissions during the study, Unwillingness to continue participating in the study, no participation in training sessions are excluded. The sample size of 120 is required. Before education the questionnaire will be given to the control and experience groups. Education program will be set according to information obtained by questionnaire, direct interview and face to face training by the investigator. Samples come to the clinic after 6 weeks of training and Questionnaire will be given to them again. Comparison of pre- and post-intervention difference between the means of Health Belief Model as the effect of education about preventive behaviors, hepatitis B healthy carriers will be considered in experimental and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062318464N2
Registration date: 2016-01-16, 1394/10/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-16, 1394/10/26
Registrant information
Name
Soghra Nikpour
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2585
Email address
nikpoor.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Of Research Iran University Of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of education based on Health belief Model in prevention of viral hepatitis B in healthy carriers in hospital clinics of Iran university of Medical sciences
Public title
Assessment of the effect of education based on Health belief Model in prevention of viral hepatitis B
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: HIV positive؛ Normal liver enzymes؛ Introduction of healthy carrier’s diagnosed؛ able to respond to the research questions؛ having phone؛ in illiterate healthy carriers having one of the literate family members. Exclusion criteria: hospital admissions Healthy carriers during the study؛ Unwillingness to continue participating in the study؛ no participation in training sessions.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Committee for Ethics in medical research
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran,1449614535,IRAN
City
Tehran
Postal code
1449614535
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
93-01-123-24263-101552

Health conditions studied

1

Description of health condition studied
Viral Hepatitis B
ICD-10 code
B18.0
ICD-10 code description
B18.0Chronic viral hepatitis B with delta-agent

2

Description of health condition studied
Viral Hepatitis B
ICD-10 code
B18.1
ICD-10 code description
Chronic viral hepatitis B without delta-agent

Primary outcomes

1

Description
Catching viral Hepatitis B
Timepoint
Before and 6weeks after education
Method of measurement
Questionnaire

Secondary outcomes

1

Description
prevention of viral hepatitis B
Timepoint
Before and 6weeks after education
Method of measurement
Questionnaire

Intervention groups

1

Description
First the questionnaire will be given to the control and experience groups. Education program will be set according to information obtained by questionnaire, direct interview and face to face training by the investigator. In illiterates questionnaire will be completed by the investigator interview and the answer will be recorded. Carriers at least read the pamphlet 2-3 times a week .In illiterates will be asked of the relatives who come to the clinic to read the pamphlet for the unit of study. Samples come to the clinic after 6 weeks of training and Questionnaire will be given to them again.
Category
Prevention

2

Description
Before the intervention, the control group was given questionnaires .There is no intervention in the control group. After the intervention, 6 weeks later the control group will be given re-questionnaire.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran West Health Center
Full name of responsible person
Dr Haleh Ahmadneia
Street address
Western Dstghyb Street , Moien Blvd, Azadi Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy Of Research Iran University Of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Moosavi
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran,1449614535,IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Of Research Iran University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soghra Nikpour
Position
Assistant professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Rashid-Yasemi St., Valiasr Ave, Tehran, 19964 Iran, Po Box 1939
City
Tehran
Postal code
1449614535
Phone
+86 702503219898
Fax
+98 21 8862 2703
Email
nikiniki_s@yahoo.com , nikpoor.s@iums.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soghra Nikpour
Position
Assistant professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Rashid-Yasemi St., Valiasr Ave, Tehran, 19964 Iran, Po Box 1939
City
Tehran
Postal code
19964
Phone
+98 21 8888 2585
Fax
+98 21 8820 1978
Email
nikiniki_s@yahoo.com وnikpoor.s@iums.ac.ir
Web page address
-

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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