Designing and evaluating a theory-based educational intervention using mobile app for promoting preventive behaviors of sexually transmitted infections in women.
The effect of mobile-based educational intervention on the improvement of preventive behaviors of sexually transmitted infections in women of reproductive age in Tehran
Design
This study was a randomized controlled trial (RCT) with a parallel control group.
Settings and conduct
According to the inclusion criteria, the target group is women aged at reproductive (18-35 yrs. ), which will be announced through an internet call on several common social networks for participation in the study.
Participants/Inclusion and exclusion criteria
The inclusion criteria
being married (at least one experience);
being residence in Tehran;
at least 18 years old,
having at least one sexual relationship experience;
having a smartphone and the ability to use it.
The exclusion criteria
Lack of interest in the subject of the curriculum
Having a mobile phone under IOS
Accommodation outside Tehran
Being single and having no sexual experience
Intervention groups
Individuals receive the HESTIA intervention program
The control group does not receive anything during the study.
Main outcome variables
Preventive behaviors of sexually transmitted infections including:
The intention for safe sex (using condom)
The intention for doing a screening test (pap-test, genital examination)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181205041861N1
Registration date:2019-03-20, 1397/12/29
Registration timing:registered_while_recruiting
Last update:2019-03-20, 1397/12/29
Update count:0
Registration date
2019-03-20, 1397/12/29
Registrant information
Name
Sara Kazemi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8882 4546
Email address
sara.kazemi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluating a theory-based educational intervention using mobile app for promoting preventive behaviors of sexually transmitted infections in women.
Public title
Mobile Phone Applications Education In STIs
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women (once married)
living in Tehran
At least 18 years old
Having a smartphone and the ability to use it
Exclusion criteria:
Unwillingness to continue to participate in the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method was used to randomize the samples.
Envelopes will be ready, printed and embedded in the envelope by a member of the research team and random numbers on the Randomaize.com site. The envelopes will be closed and its contents will not be visible.
Then the researcher explains the purpose of the study by phone for people who were eligible to enter the study. If the person is willing to participate in the study, she will be required to submit the informed consent form by the email or the contact number registered on one of the social networks, such as Telegram and WhatsApp.
Then the applicant is allowed to the researcher to open an envelope on his behalf. The researcher then unpacks the envelope and, based on the contents of the envelope, the applicant will be categorized for the intervention or control group.
Blinding (investigator's opinion)
Single 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 Tarbiat Modares University of Medical Sciences
Street address
Tehran , Jalal Ale Ahmad , Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2018-11-18, 1397/08/27
Ethics committee reference number
IR.MODARES.REC.1397.154
Health conditions studied
1
Description of health condition studied
Promoting preventive behaviors of sexually transmitted infections (STIs)
ICD-10 code
A50-A64
ICD-10 code description
Infections with a predominantly sexual mode of transmission
Primary outcomes
1
Description
Preventive behaviors of sexually transmitted diseases
Timepoint
Measurement of behavior before intervention,Immediately after intervention, and 3 months after intervention
Method of measurement
Use of preventive behaviors questionnaire for sexually transmitted diseases
Secondary outcomes
empty
Intervention groups
1
Description
First, after receiving the ethics code from the Ethics Committee of the Vice-Chancellor of Research in Tarbiat Modares University, an online call for participating to a mobile based educational program designed and requited women at reproductive aged which had eligibility for the study. After initial phone re-checking the inclusion criteria the main researcher had simple randomized allocation for categorizing the participants in two separate intervention and control groups. Moreover, the researcher explained about the study goal and asked them for a contact way such as email or phone number for sending the consonant form and the pre-test questionnaire for both intervention and control groups as the same time. After receiving the completed pre-test questionnaire from both groups, the intervention group was announced for receiving an application download link via e-mail or a registered number on one of the online social networks. After receiving and installing the application (HESTIA), they can use the educational contents about preventive behavior of STIs one month. The educational content of this app was in various appearances, including games, flashcards, and animated short films, quiz questions, and texts. Theoretically, the content has been developed based on the principles of protected motivation theory. Furthermore, the educational content was based on the latest national and international (CDC) guidelines for the prevention of sexually transmitted diseases. After one month of the first download, HESTIA will be deactivated automatically and users will not have access to educational content through the app. The first post-test immediately after the end of the intervention will start by sending the online questionnaire, then the second post-test one month after the zero tests. The last but third post-test will be done three months after the end of the intervention. The measurement and evaluation tool is the same at all stages before and after the intervention.
Category
Behavior
2
Description
Control group: The control group will not receive intervention and at the end of the study to follow the ethics, a training booklet will be placed in the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Street address
Tehran ,Jalal Ale Ahmad ,Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Dr Yaghoub Fathollahi
Street address
Tehran ,Jalal Ale Ahmad ,Nasr,
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medical Sciences, Tarbiat Modares University
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
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Ms student of health education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran ,Jalal Ale Ahmad ,Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fateme Zarei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran, Jalal Ale Ahmad ,Nasr.Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran ,Jalal Ale Ahmad ,Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411731116
Phone
+98 21 8288 4546
Fax
Email
f.zarei@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Demographic information is confidential, but information about the outcome of the people's knowledge, attitude and behavior is shareable.
When the data will become available and for how long
A week after receiving the request via email to the corresponding researcher
To whom data/document is available
Researchers in academic institutions
Under which criteria data/document could be used
Deputies of health in Medical Universities
From where data/document is obtainable
Contact with Dr.Fatemeh Zarei as the corresponding researcher via email: f.zarei@modares.ac.ir
What processes are involved for a request to access data/document
A week after receiving the request via email the corresponding researcher