Determination of the effect of peer education on HIV related high risk behaviors, risk taking and HIV screening test in male to female transgenders
Design
In this study 80 male to female transgenders who have inclusion criteria such as having a smartphone
Settings and conduct
The app will install on smartphones in school of behavioral sciences, Iran University of Medical Sciences. The data will collect by a smart phone app.
Participants/Inclusion and exclusion criteria
Male to Female transgenders who have smartphone and internet and HIV negative
Intervention groups
The intervention group will receive information about high risk behaviors, prevention skills and screening from their peers. The control group would not receive such information.
Main outcome variables
HIV related high risk behaviors
Risk taking behaviors
Screening test taking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100911004728N2
Registration date:2018-01-16, 1396/10/26
Registration timing:prospective
Last update:2018-01-16, 1396/10/26
Update count:0
Registration date
2018-01-16, 1396/10/26
Registrant information
Name
Hadi Ranjbar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 6862
Email address
ranjbar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of peer education on high-risk behavior, risk taking and participation in HIV screening test in transgenders
Public title
Effect of peer education on HIV related Behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being a transgender
Having Smart phone
Age above 18
Male
Exclusion criteria:
HIV positive
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Peer educators are randomly allocate into one of two groups by throwing coins. Elected transgender subjects will be grouped into two groups by random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data will be collected by a mobile app and the data analyzer do not have information about allocation process
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran Province, Tehran, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-09-18, 1396/06/27
Ethics committee reference number
IR.IUMS.REC 1396.96-01-121-29335
Health conditions studied
1
Description of health condition studied
HIV related high risk behaviors and test screening
ICD-10 code
Z11.4
ICD-10 code description
Encounter for screening for human immunodeficiency virus [HIV]
Primary outcomes
1
Description
HIV related risk behaviors
Timepoint
3 month after intervention
Method of measurement
Mobile App Questionnaire
2
Description
HIV Screening Test
Timepoint
3 month after intervention
Method of measurement
Mobile App Questionnaire
3
Description
HIV related behavioral risk taking
Timepoint
3 month after intervention
Method of measurement
Mobile App Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Peer education of information about HIV related high risk behaviors and screening test
Category
Behavior
2
Description
Control group: Only Follow up by mobile App
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Behavioral Sciences & mental health - Iran Institute of Psychiatry
Full name of responsible person
Hadi Ranjbar
Street address
No 1, Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue,
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6650 6862
Email
hadiranjbar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Tehran, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1021
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hadi Ranjbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
hadiranjbar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hadi Ranjbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
hadiranjbar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hadi Ranjbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
hadiranjbar@yahoo.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of the individual participant data collected during the trial, after deidentification
When the data will become available and for how long
Immediately following publication. No end date.
To whom data/document is available
Anyone who wishes to access the data.
Under which criteria data/document could be used
To gain access, data requestors will need to sign a data access agreement. The data is available for any purpose.
From where data/document is obtainable
All applications should be sent to hadiranjbar@yahoo.com
What processes are involved for a request to access data/document
All requests will be answered within a maximum of one month by email.