Effect of group counselling versus no counselling on quality of life, knowledge and attitude toward HIV/AIDS among HIV-positive women: a randomized clinical trial
Objectives: To assess the effect of group counselling versus no counselling on quality of life, knowledge and attitude toward HIV/AIDS among HIV-positive women.
Design: A randomized clinical trial.
Setting and conduct: The eligible HIV-positive women who will refer to Shohada Health Center during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; HIV-positive women.
Exclusion criteria: Advanced AIDS; Sever mental disorders.
Intervention group: Routine care plus group counselling once a week for 60 minutes in four successive weeks.
Control group: Just routine care.
Primary outcome: (a) assessing quality of life using standard WHOQOL-Brief questionnaire before intervention and 4 weeks after that; (b) assessing knowledge toward HIV/AIDS using standard questionnaire before intervention and 4 weeks after that; (c) assessing attitude toward HIV/AIDS using standard questionnaire before intervention and 4 weeks after that.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201711199014N202
Registration date:2017-11-20, 1396/08/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group counselling versus no counselling on quality of life, knowledge and attitude toward HIV/AIDS among HIV-positive women: a randomized clinical trial
Public title
Effect of group counselling versus no counselling on quality of life, knowledge and attitude toward HIV/AIDS among HIV-positive women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; HIV-positive women.
Exclusion criteria: Advanced AIDS; Sever mental disorders.
Age
From 18 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-10-28, 1396/08/06
Ethics committee reference number
IR.UMSHA.REC.1396.500
Health conditions studied
1
Description of health condition studied
HIV-positive
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Assessing quality of life
Timepoint
Before intervention and 4 weeks after that
Method of measurement
Using standard WHOQOL-Brief questionnaire
2
Description
Assessing knowledge toward HIV/AIDS
Timepoint
Before intervention and 4 weeks after that
Method of measurement
Using standard questionnaire
3
Description
Assessing attitude toward HIV/AIDS
Timepoint
Before intervention and 4 weeks after that
Method of measurement
Using standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus group counselling once a week for 60 minutes in four successive weeks.
Category
Other
2
Description
Control group: Just routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Health Center
Full name of responsible person
Akram Mohammadi Gheisar
Street address
Takhti Ave. Shohada Health Center
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Akram Mohammadi Gheisar
Position
Midwifery Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
nedamohammadi85@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Batoul Khodakarami
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
zahrabatul2006@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)