Determine the effect of group education on the health belief model , on health seeking behavior among women with immunodeficiency virus (HIV) referred voluntary and counseling center of imam Khomeini Hospital
Design
In this research, 80 eligible patients referring to voluntary and counseling center for HIV. will chose purposefully and a code will allocate to each one of them. Then, patients randomly will divide into two control and intervention groups.block randomization and intervention is group counseling
Settings and conduct
It is a randomized controlled clinical trial without blinding. setting and conduct: voluntary and counseling testing Center of Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian HIV-positive women who are pleased to participate in the study
exclusion criteria: addicted who not able for answer the question, In the phase of AIDS that can not participate in the study
Intervention groups
6 section of group counseling for intervention group;
control group: Iranian HIV protocol
Main outcome variables
change in health seeking behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160503027728N10
Registration date:2018-02-21, 1396/12/02
Registration timing:registered_while_recruiting
Last update:2018-02-21, 1396/12/02
Update count:0
Registration date
2018-02-21, 1396/12/02
Registrant information
Name
Zohreh Mahmoodi
Name of organization / entity
Nursing&Midwifery faculty
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
zohrehmahmoodi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-09, 1396/10/19
Expected recruitment end date
2018-07-10, 1397/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of group education on the health belief model , on health seeking behavior among women with immunodeficiency virus
Public title
Effect of group education on the health belief model , on health seeking behavior
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian.
women , infected with HIV Virus according to registered in Voluntary and counseling system
using antiviral virus
more than 18 years
have sex during last 3 month
Reading and writing ability
Written consent
Exclusion criteria:
addicted who not able for answer the question
can not communication in Persian
have psychological problem according to self report
being in AIDS phase
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
First, the sampling will be available and according to the active records in the center. Then they will be divided into two groups based on random blocks. Also for statistical matching, the statistical tests are used to match the underlying variables
The randomization method is done using block randomization so that the sample size of both groups is equal.
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 Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, Shahrake Edari, North Taleghai square, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2017-12-29, 1396/10/08
Ethics committee reference number
Abzums.Rec.1396.145
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
health seeking behavior
Timepoint
Before intervention _ Immediately after the intervention -3 weeks after intervention
Method of measurement
Health seeking behavior questionnaire score
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group of women living with HIV we hold 6 consultation sessions weekly based on model of health belief model .The time of each session is 90 minute.
Category
Behavior
2
Description
Control group: In the control group they will receive just routine voluntary and counseling protocol for HIV consultation
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Imam khomani hospital volantary and counseling center
Full name of responsible person
Dr Zohreh Mahmoodi
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
zohrehmahmoodi2011@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
ِDr moohammad Noori sepehr
Street address
Noor street, Taleghani Square, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3256 3328
Email
zohrehmahmoodi2011@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Zohreh Mahmoodi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Nursing and Midwifery, Alborz University of Medical Science, Golestan1, Eshteraki St., Baghestan, Karaj
City
Karaj
Province
Alborz
Postal code
561-31452
Phone
+98 26 3455 1034
Email
zohrehmahmoodi2011@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zohreh Mahmoodi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Nursing and Midwifery, Alborz University of Medical Sciences, Golestan1, Eshteraki St., Baghestan Blv
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3455 1034
Email
zohrehmahmoodi2011@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zohreh Mahmoodi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Nursing and Midwifery, Alborz University of Medical Sciences, Eshteraki St., Golestan1, Baghestan
City
Karaj
Province
Alborz
Postal code
561-31452
Phone
+98 264551034
Email
zohrehmahmoodi2011@gmail.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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
as an English article we published data .
When the data will become available and for how long
10 month later
To whom data/document is available
Iranian research center for HIV/AIDS , Alborz University of Medical Sciences
Under which criteria data/document could be used
path analysis
From where data/document is obtainable
Iranian research center for HIV/AIDS , Alborz University of nursing and Midwifery
What processes are involved for a request to access data/document