Protocol summary

Study aim
The effect of web-based education based on health belief model on voluntary HIV testing in couples, referring to the pre-marriage counseling center
Design
Clinical trial with control group, with parallel groups, without blinding randomized, 152 couples referring to counseling center.
Settings and conduct
Providing web-based education to couples referring to the pre-marriage counseling center and assessment with a questionnaire.
Participants/Inclusion and exclusion criteria
Entry requirements: inclination to participate in research.Internet access. Access to a computer or smartphone. At least literacy at reading and writing levels.There is no medical and paramedical education.The HIV test has not been done before. Non-arrival conditions: the collaborator will review the collaboration with the researcher during the study and refrain from continuing the collaboration.
Intervention groups
Intervention group: they will see the educational program based on health belief model patterns for a week on the website. Additionally, from the interval between the completion of the training program and the next two weeks, reminder messages will be sent by SMS to encourage learners to view the educational content uploaded to the website.The assessment will be done by the questionnaire two weeks after the intervention before the intervention.In the control group, patients will receive routine training.The assessment will be done by the questionnaire two weeks after the intervention before the intervention.
Main outcome variables
Awareness; perceived sensitivity; perceived severity; perceived barriers; perceived benefits; self-efficacy in overcoming barriers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190712044183N1
Registration date: 2019-10-12, 1398/07/20
Registration timing: retrospective

Last update: 2019-10-12, 1398/07/20
Update count: 0
Registration date
2019-10-12, 1398/07/20
Registrant information
Name
Ali Khaledi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0084
Email address
ali.khaledi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of web-based education based on health belief model on voluntary HIV testing in couples, referring to the pre-marriage counseling center
Public title
The effect of web-based education on voluntary HIV testing in couples, referring to the pre-marriage counseling center.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The person willing to participate in research The person has internet access The person has access to a computer or smartphone The person has at least a literacy level of reading and writing Do not have any medical or paramedical education The person has not tested HIV before
Exclusion criteria:
The participator will review the participation with the researcher during the study and refrain from continuing the participation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
Randomization (investigator's opinion)
Randomized
Randomization description
Couples in random allocation by ( block method with permutation) placed in two groups of intervention and control.
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 Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences-Salman Farsi St.-Bahmani
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.BPUMS.REC.1398.100

Health conditions studied

1

Description of health condition studied
Acquired Immunodeficiency Syndrome (AIDS)
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease

Primary outcomes

1

Description
Awareness
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
Awareness questionnaire (researcher made)

2

Description
Perceived sensitivity
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
Perceived susceptibility questionnaire (researcher made)

3

Description
Perceived severity
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
Perceived severity questionnaire (researcher made)

4

Description
Perceived barriers
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
Perceived barriers questionnaire (researcher made)

5

Description
Perceived benefits
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
Perceived benefits questionnaire (researcher made)

6

Description
Self-efficacy in overcoming obstacles
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
Self-efficacy in overcoming obstacles questionnaire (researcher made)

7

Description
Behaviors doing HIV testing
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
Behaviors doing HIV testing questionnaire (researcher made)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the intervention group will receive the educational content in addition to the routine education. To do this, they will first be presented with a card containing the username and password to view the content. These people will watch a multimedia-based curriculum based on Health Belief Model constructs for a week on a health education website. In addition, reminder messages will be sent once a week via text message to encourage learners to view the educational content uploaded to the website within two weeks of completing the education program. this group will be evaluated by a questionnaire before and two weeks after the intervention.
Category
Lifestyle

2

Description
Control group: the control group receive routine education. Evaluation will be done through questionnaire before the intervention and two weeks after the end of the intervention. After the final measurement, participants in the control group will receive a card containing username and password to view educational content.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center for Nabi Akram
Full name of responsible person
Hossein Zarei
Street address
Commercial., AlleyMotahari St
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3355 4684
Email
ali.khaledi@bpums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Khamisipour
Street address
University of Medical Sciences، Salman Farsi St., ,
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
ali.khaledi@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Mahnoush Reisi
Position
Ph.D. Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University of Medical Sciences, Salman Farsi St., Bahmani
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0084
Email
reisi_mr@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mahnoush Reisi
Position
Ph.D. Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University of Medical Sciences , Salman Farsi St.,
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0084
Email
reisi_mr@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Ali Khalidi
Position
Graduate student of health education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
University of Medical , Salman Farsi St.,
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0084
Email
alikhaledi1404@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The protocol of study includes the content of education, the questionnaire and the methodology. Although statistical analysis and the results will be shared in public, no decision is made yet about the sharing of file of participants
When the data will become available and for how long
After announcing the results in 2019
To whom data/document is available
All researchers and students in the public and private sectors
Under which criteria data/document could be used
For use in research and education at universities
From where data/document is obtainable
Dr mahnoush -Bushehr University of Medical Sciences-Bahmani-Salman Farsi St.alikhaledi1404@gmail.com.reisi_mr@yahoo.com
What processes are involved for a request to access data/document
Request by using an official email is enough.
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