Protocol summary

Summary
The aim of study is to assess the effectiveness of peer education on self-esteem, perceived vulnerability and performance towards prevention of HIV and hepatitis B in women with substance use disorder. This study design is cluster randomized controlled intervention trial without blinding and randomization are in the centers to five intervention and five control centers. The study population are 100 women with substance use disorder referring to Drop-in Centers, Harm reduction centers and camps who are over 18 years old, When filling out the questionnaire and participate in the class have the ability to answer and dialogue, Having at least degree of knowledge, substance use at least for 3 months, sexually active and lack of HIV infection. In this study intervention will be based on peer education by someone whit a history of substance use and provide information, including interpersonal skills, decision making skills and self-esteem, problem solving, the definition of hepatitis B and HIV and transmission of, techniques for the prevention of HIV, hepatitis b, dialogue and assertiveness techniques with the partner. Primary outcome are self-esteem, perceived vulnerability and performance toward HIV and hepatitis B that measuring with Rosenberg Self-Esteem questionnaire, Demographic, Sexual function questionnaire and Vulnerability to HIV and hepatitis B. Information will collecting before, immediately, one months and three months after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201612113034N17
Registration date: 2017-05-31, 1396/03/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Mansoureh Jamshidimanesh
Name of organization / entity
Iran University Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1811
Email address
delshad2@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy School of Nursing and Midwifery, Iran University of Medical Sciences
Expected recruitment start date
2017-05-10, 1396/02/20
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of peer-based education on self-esteem , perceived vulnerability and performance towards prevention of HIV and hepatitis B in women with substance use disorder
Public title
The effectiveness of peer education on preventive behaviors of HIV and hepatitis B
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Age over 18 years;When filling out the questionnaire and participate in the class have the ability to answer and dialogue;Having at least degree of knowledge;substance use at least for 3 months; sexually active;lack of HIV infection.exclusion criteria: do not participate in training class for more than one session;Happening unexpected events
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Iran University of Medical Science
Street address
Iran University of Medical Science, Next to the Milad Tower, Shahid Hemat Highway, Tehran, Iran
City
Teran
Postal code
19964
Approval date
2017-04-05, 1396/01/16
Ethics committee reference number
IR.IUMS.REC 1395.9311373001

Health conditions studied

1

Description of health condition studied
HIV
ICD-10 code
B20-B24
ICD-10 code description
Human immunodeficiency virus [HIV] disease

2

Description of health condition studied
Hepatitis B
ICD-10 code
B16
ICD-10 code description
Acute hepatitis B

Primary outcomes

1

Description
Self-esteem
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Rosenberg Self-esteem Questionnaire

2

Description
Perceived Vulnerability to HIV
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Vulnerability to HIV Questionnaire

3

Description
Perceived Vulnerability to Hepatits b
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Vulnerability to Hepatitis B Questionnaire

4

Description
Performance
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Demographic, Sexual function questionnaire

Secondary outcomes

1

Description
Condom use
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Demographic, Sexual function questionnaire

2

Description
HIV test
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Demographic, Sexual function questionnaire

3

Description
HBV TEST
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Demographic, Sexual function questionnaire

4

Description
Type of sex
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Demographic, Sexual function questionnaire

5

Description
Number of partner
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Demographic, Sexual function questionnaire

6

Description
Number of save sex
Timepoint
Before intervention, immedately, 4 weeks and 12 weeks after intervention
Method of measurement
Demographic, Sexual function questionnaire

Intervention groups

1

Description
Control: To control group, a training session based on the protocol Ministry of Health to prevent HIV infection in the mother and child will be held after filling out the questionnaire.
Category
Prevention

2

Description
In this intervention peers education is the most important part of education. Researcher make a test, based on check list of intervention session and each peer who be able to get satisfaction score will select as a peer educator. Researcher will educate peers educators in 30 hours and education of intervention group will be in 6 session two days a week and each session is about 45 to 60 minutes. Educational content includes HIV and Hepatitis B disease definition and ways of prevention of them,save sexual behavior, use of condom, do HIV and Hepatitis B test, dialogue and assertiveness techniques with the partner and problem solving. For control grope one session will hold according to the Ministry of Health protocol based on the prevention of HIV in mother and child after filling out questionnaire.It should be noted, researcher will monitor all stages of the intervention process.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mikhak center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

2

Recruitment center
Name of recruitment center
Kaj center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

3

Recruitment center
Name of recruitment center
Mehr Protetive Center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

4

Recruitment center
Name of recruitment center
Mojeze Aria Pak center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

5

Recruitment center
Name of recruitment center
Llavizan Residency
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

6

Recruitment center
Name of recruitment center
Payamavaran Hamyari Center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

7

Recruitment center
Name of recruitment center
Navid Hamrazi Iranian center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

8

Recruitment center
Name of recruitment center
khane Mian Rah center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

9

Recruitment center
Name of recruitment center
Simaye Sabze Rahaei Center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

10

Recruitment center
Name of recruitment center
Shahid Emami Center
Full name of responsible person
Soheila Ahmadi
Street address
Tehran, Valiasr st, Rashidyasemi, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy school of Nursing and Midwifery of Iran University of Medical Sciences
Full name of responsible person
DR Rafiei Forough, DR Mousavi Alijavad
Street address
Tehran, Shahid Hemmat Highway, Iran University of Medical Sciences, 1449614535
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy school of Nursing and Midwifery of Iran 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 & Midwifery Iran University of Medical Sciences
Full name of responsible person
Soheila Ahmadi
Position
Master of Midwifery student
Other areas of specialty/work
Street address
Tehran, Valiasr st, Rashidyasemi st, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran
Postal code
1996713883
Phone
+98 218888288586
Fax
Email
soheila_ahmadi124@yahoo.com; catherine515124@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing & Midwifery Iran University of Medical Sciences
Full name of responsible person
Jamshidimanesh Mansoureh
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Tehran, Valiasr st, Rashid Yasemi St, School of Nursing & Midwifery Iran University of Medical Sciences
City
Tehran
Postal code
1996713883
Phone
+98 218888288586
Fax
Email
jamshidimanesh@yahoo.com; mjamshidimanesh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing & Midwifery Iran University of Medical Sciences
Full name of responsible person
Soheila Ahmadi
Position
Master of Midwifery student
Other areas of specialty/work
Street address
Tehran, Valiasr st, Rashidyasemi st, School of Nursing & Midwifery Iran University ofMedical Sciences
City
Tehran
Postal code
1996713883
Phone
+98 218888288586
Fax
Email
soheila_ahmadi124@yahoo.com; catherine515124@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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