َAssessing the effectiveness of an educational intervention with the help of peers on awareness, attitude and performance towards sexually transmitted diseases, attitude towards HIV testing and self-efficacy of condom use in female sex workers.
Assessing the effectiveness of an educational intervention on sexual health outcomes among female sex workers in Arak
Design
This clinical trial has control and intervention groups selected from two cities to prevent contamination. In each group, 35 people from the centre's clients will be randomly entered into the study, and blinding and randomization won't be used in this study.
Settings and conduct
Place of study: Special HIV center in Arak city. Study population: sex workers referring to the special HIV clinic. Blinding: Blinding will not be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Experience of sex work in the past year; Age above 18 years; Staying for more than three months in the city of study. Exclusion criteria: HIV patient; transgenders
Intervention groups
Intervention group: The group to whom the educational package is presented, designed to measure the effectiveness of the sexual health educational package, trained peer forces present the educational package to the test group in the form of one-hour sessions.
Control group: The group that receives only the center's routine services.
Main outcome variables
Knowledge, attitude, and performance of female sex workers towards sexually transmitted diseases; attitude towards HIV testing; self-efficacy of condom use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240220061054N1
Registration date:2024-03-24, 1403/01/05
Registration timing:prospective
Last update:2024-03-24, 1403/01/05
Update count:0
Registration date
2024-03-24, 1403/01/05
Registrant information
Name
Iman Navidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3314 6266
Email address
navidi58@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
َAssessing the effectiveness of an educational intervention with the help of peers on awareness, attitude and performance towards sexually transmitted diseases, attitude towards HIV testing and self-efficacy of condom use in female sex workers.
Public title
Assessing the effectiveness of an educational intervention with the help of peers on awareness, attitude and performance towards sexually transmitted diseases, attitude towards HIV testing and self-efficacy of condom use in female sex workers.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Experience of sex work in the past year
Age above 18 years
Staying for more than three months in the city of study
Exclusion criteria:
Transgenders
HIV patients
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Not 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
Ethics committee of Tehran University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology, 6th floor, Headquarters of Tehran University of Medical Sciences, at the corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
IR.TUMS.SPH.REC.1402.281
Health conditions studied
1
Description of health condition studied
Sexual Health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Knowledge, attitude and performance of female sex workers towards sexually transmitted diseases
Timepoint
At the beginning of the study and 3 months after the end of the intervention (educational package)
Method of measurement
The questionnaire of knowledge, attitude and practice of sexually transmitted diseases in vulnerable women which has been validated by Broumandfar et al. (2016) in Iran.
2
Description
Attitudes towards HIV testing
Timepoint
At the beginning of the study and 3 months after the end of the intervention (educational package)
Method of measurement
Questionnaire of attitudes towards HIV testing
3
Description
Condom use self-efficacy
Timepoint
At the beginning of the study and 3 months after the end of the intervention (educational package)
Method of measurement
Questionnaire of Condom use self-efficacy
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group receives the sexual health education package from peer forces through one-hour training sessions once a week at the center. Five female sex workers referred to the center as peer forces will be trained in training sessions by the project implementers and explained how to present the training package to the target group. Each peer works as a facilitator and is responsible for training people in the intervention group; the training content is designed and evaluated based on the components of Robinson's sexual health model and a qualitative study on the sexual health training needs of the target group.
Category
Other
2
Description
Control group: The control group, which has been selected from a similar center in Tehran to prevent sample contamination, do not receive educational intervention from peers and will only be provided with the center's routine services.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak special HIV center
Full name of responsible person
Parvaneh Safikhani
Street address
Qaim Maqam street
City
Arak
Province
Markazi
Postal code
3177838189
Phone
+98 86 3313 9035
Email
navidi58@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbari Sari
Street address
Vice-Chancellor for Research and Technology, 6th floor, Headquarters of Tehran University of Medical Sciences, at the corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@sina.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
Iman Navidi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Unit 1, No. 46, Taha Complex, Nastern Alley, Jahan Panah Blvd, Arak
City
Arak
Province
Markazi
Postal code
3819734391
Phone
+98 86 3314 6266
Email
navidi58@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Iman Navidi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Unit 1, No. 46, Taha Complex, Nastern Alley, Jahan Panah Blvd, Arak
City
Arak
Province
Markazi
Postal code
3819734391
Phone
+98 86 3314 6266
Email
navidi58@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Iman Navidi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Unit 1, No. 46, Taha Complex, Nastern Alley, Jahan Panah Blvd, Arak
City
Arak
Province
Markazi
Postal code
3819734391
Phone
+98 86 3314 6266
Email
navidi58@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
Yes - There is a plan to make this available
Title and more details about the data/document
The data related to the main outcomes of the study including knowledge, attitude and performance of sexually transmitted diseases, attitude towards HIV testing and self-efficacy of condom use will be published after the study is completed.
When the data will become available and for how long
The data is accessible six months after the announcement of the final results.
To whom data/document is available
This data is only accessible to health policymakers and related academic researchers.
Under which criteria data/document could be used
The use of this data is only allowed for use in similar and complementary research in order to identify the existing knowledge gap and help provide practical solutions to help the target group, as well as the formulation of guidelines related to the health of these people by the policymakers of the Ministry of Health.
From where data/document is obtainable
Applicants can submit their requests through the program administrator's email, Navidi58@gmail.com.
What processes are involved for a request to access data/document
After receiving the official request for information by e-mail, the project manager obtains the necessary permission and provides the information to the applicant.