A randomized clinical trial comparing the efficacy of psychosocioal and behavioral interventions on reducing HIV/AIDS related high risk behaviors among secondary school students
Objective: The purpose of this study is to determine the impact of a psycho-social and behavioral interventions on controlling and preventing risky sexual and addictive behaviors related to HIV transmission . The main inclusion and exclusion criteria: Secondary school students with age range 13-16 years with a history of using at least one substance drug or one friendly relationship with opposite sex during previous 6 month. Study participants and sample size: First all secondary school students studying in Shorghoon area will be screened using standard youth high risk behavior questionnaire to identify high risk students. Then, 200 students ( 100 girls & 100 boys) with high risk behaviors will be selected and categorized in two intervention groups randomly. Two hundred students with random allocation will put into control groups. Design: Proposed intervention will be randomized control trial with random allocation into control and intervention groups. Interventions: A brief psycho social and behavioral interventions (6 months) will be used. The study will be conducted at two stages including baseline and intervention. Primary outcome measure: Two groups in two genders will be compared regarding the effectiveness of intervention program on reducing HIV related high risk behaviors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051521684N3
Registration date:2016-05-30, 1395/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-30, 1395/03/10
Registrant information
Name
Mahmood AminiLari
Name of organization / entity
Shiraz HIV/AIDS Research Center, Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3738 6272
Email address
aminlari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial comparing the efficacy of psychosocioal and behavioral interventions on reducing HIV/AIDS related high risk behaviors among secondary school students
Public title
Psychosociol and behavariol interventions among Secondary school students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Being secondary school student ; age range between 13-16 years; having a history of using at least 1 substance drug or one friendly relationship with opposite sex over the past sex month; completing inform consent.
Exclusion criteria: Having severe mental and personality disorders.
Age
From 13 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The intervention and control groups were divided using table of random numbers.
Secondary Ids
1
Registry name
NA
Secondary trial Id
NA
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
7th Floor, Central Building, Shiraz University of Medical Sciences, Zand Ave, Shiraz, Iran Shiraz
City
Shiraz
Postal code
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
IR.SUMS.REC.1394.S45
Health conditions studied
1
Description of health condition studied
High Risk Behaviors
ICD-10 code
Z20.6
ICD-10 code description
Mental and behavioural F19:disorders due to psychoactive substance use
Primary outcomes
1
Description
Addictive High Risk Behavior
Timepoint
Before intervention and immediately after intervention
Method of measurement
Youth High Risk Behaviors Questionnaire
2
Description
Sexual High Risk Behavior
Timepoint
Before intervention and immediately after intervention
Method of measurement
Youth High Risk Behaviors Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Educational interventions contain 3 sessions (1.5 H) including "Understanding of the new drugs and substance abuse"," The methods of preventing substance abuse" and " The method of preventing sexual and addictive high risk behaviors". Psychological interventions include individual counseling (5 sessions, 45 min) and Life skills training (24 hours). Social supports will be providing required facilities and introducing students to the art and sport centers.
Category
Behavior
2
Description
Control group will receive no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Three secondary school in marginalized Shorghoon area
Full name of responsible person
Mr.Aghaei
Street address
Dabaghmanesh School, Vazir Abad
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Poostfroosh
Street address
7th Floor, Central Building, Shiraz University of Medical Sciences, Zand Ave, Shiraz, Iran Shiraz
City
Shiraz
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, Shiraz 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
Shiraz HIV/ AIDS Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Mahmood AminiLari
Position
Executive Director
Other areas of specialty/work
Street address
2nd floor, Voluntary Counseling and Testing Center, Lavan Ave, Delavaran-e Basij Blvd, Khatoun Sq, Shiraz, Iran Shiraz
City
Shiraz
Postal code
Phone
+98 71 3738 6272
Fax
Email
maminil@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahmood AminiLari
Position
MA
Other areas of specialty/work
Street address
2nd floor, Voluntary Counseling and Testing Center, Lavan Ave, Delavaran-e Basij Blvd, Khatoun Sq, Shiraz, Iran Shiraz
City
Shiraz
Postal code
Phone
+98 71 3738 6272
Fax
Email
maminil@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AminiLari
Full name of responsible person
Mahmood
Position
MA
Other areas of specialty/work
Street address
2nd floor, Voluntary Counseling and Testing Center, Lavan Ave, Delavaran-e Basij Blvd, Khatoun Sq, Shiraz, Iran Shiraz
City
Shiraz
Postal code
Phone
+98 71 3738 6272
Fax
Email
maminil@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)