This study is a randomized controlled trial. The study population included 80 HIV positive women with access to the study, who are referred to the AIDS Research Center and the Behavioral Advice Center located in Imam Khomeini Hospital in order to receive health care. Without blinding, sampling in each center is done randomly. Intervention in intervention group within 1 month and 4 sessions, weekly one session for 120-190 minutes will be held as group training. Subsequently, a summary questionnaire on the quality of life of HIV positive patients will be completed eight and twelve weeks after the intervention for both intervention and comparison groups.
Settings and conduct
AIDS Research Center and Behavioral Disease Counseling Center located in Imam Khomeini Hospital where participants are randomly selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who are infected with HIV infection ,Iranian nationality, age 15 to 45 years old, knowing how to read and write
Exit criteria: Absence of participant more than two sessions in training classes, getting pregnant during the study.
Intervention groups
En Intervention group: 40 HIV positive women (15-45 years old) who are referred to the AIDS Research Center and Counseling Center for Behavioral Diseases at Imam Khomeini with Written consent, and tendency to participate in the study and receive educational interventions based on the theory of planned behavior.
Control group: 40 HIV positive women (15-45 years old) who are referred to the same center but do not receive any educational intervention.
Main outcome variables
Tutorial based on the TPB model, Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120414009463N58
Registration date:2018-10-20, 1397/07/28
Registration timing:retrospective
Last update:2018-10-20, 1397/07/28
Update count:0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-18, 1396/10/28
Expected recruitment end date
2018-05-18, 1397/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of education based on planned behavior Theory on quality of life in HIV positive women
Public title
Effects of education based on planned behavior Theory on quality of life in HIV positive women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women who are infected with HIV infection
who had been diagnosed in at least 3 months
person who doesn't have any experience of attending in tutorial courses for HIV or HIV counseling sessions
Iranian nationality
age 15 to 45 years old
not being pregnant
knowing how to read and write
not being addicted on drugs
not being addicted on alcohol
not suffering from known chronic diseases, disorders and chronic psychiatric problems and malignant diseases (self-declaration).
Exclusion criteria:
Absence of participant more than two sessions in training classes
getting pregnant during the study.
Age
From 15 years old to 45 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
samples will be selected by simple random sampling using random numbers table will be assigned to two groups of intervention and control, which will be considered after determining how to read the table numbers. odd numbers for the control group and the even numbers for the intervention group.
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
The Ethics Committee of the Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
PO Box 6459,Dr Mirkhani St. (Eastern Nusrat), Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4262
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B20.3
ICD-10 code description
HIV disease resulting in other viral infections
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention; eight weeks and twelve weeks after intervention
Method of measurement
Using standard WHOQOL-Brief questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educational interventions based on the theory of planned behavior in order to improve the quality of life in 40 HIV positive women in the intervention group in 4 sessions, one week in a session for 120-190 minutes, and the quality of life in this group before The intervention will be measured eight to twelve weeks after the intervention.
Category
Other
2
Description
Control group: In the control group, intervention is not performed, and only after completing the study for observance of the ethics of all the teaching aids will be provided to this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Research Center for HIV/AIDS and Voluntary Counselling and Testing (VCT) centre of Imam Khom
Full name of responsible person
Minoo Mohraz
Street address
Iranian Research Center for HIV/AIDS, Imam Hospital.keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Fax
+98 21 6694 7984
Email
ircha@sina.tums.ac.ir
Web page address
http://ircha.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
No23, Valiasr Avenue, Dameshgh Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۷۱
Phone
+98 21 8163 3685
Fax
+98 21 8163 3685
Email
najafif20@gmail.com
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
najafif20@gmail.com
Web page address
http://fnm.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Behboodi Moghadam
Position
Ph.D in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences, East Nosrat Avenue,Towhid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
Behboodi@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Najafi
Position
Master of Midwifery Student Reproductive Health
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan 4,Tehran University of Medical Sciences dormitory, North Karegar Street, Tehran.
City
Tehran
Province
Tehran
Postal code
0098211439957181
Phone
+98 21 8800 2654
Fax
+98 21 8800 3694
Email
najafif20@gmail.com
Web page address
https://eskan.tums.ac.ir/Page/Public/Default.aspx
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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