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Comparison of the Effectiveness of Tow Couple-Focused Counseling Methods, Protect and Connect Model (PACT) with the Sexual Health Model on Sexual Health Literacy and Receiving Sexual and Reproductive Health Services in Afghan Immigrants Living in Iran.

Protocol summary

Study aim
Investigating of the Effectiveness of tow Couple-focused Counseling Methods, Protect and Connect model (PACT) with the Sexual Health Model on Sexual Health Literacy and Receiving Sexual and Reproductive Health services Among Afghan Immigrants living in Iran.
Design
Parallel randomized clinical trial with control group, permutation block method and, sample size of 34 couples in each group, without blinding
Settings and conduct
Sampling using the accessible method, eligible couple referring to the health centers of the Yazd Commissariat, people divided into two intervention groups using the permutation block method, with 8 consecutive online counseling sessions
Participants/Inclusion and exclusion criteria
Inclusion criteria included: Afghan citizenship living in Iran, Having a file in the commissariat centers of Yazd , Being married, Being monogamous (self-reported), Speaking the Persian dialect, Women of reproductive age (15 to 49 years) and their spouses, At least one year of marriage, Literacy in reading and writing, Having a smartphone, ability to use the Internet, People with inadequate or not very adequate levels of sexual health literacy (0 to 66 points) Exclution Criteria: Attended sex education classes last year, Drug and alcohol addiction (self-reported or recorded in the file), Experiencing stressful events during the study like family deaths or divorce, Having mental disorders or undergoing psychiatric treatment as indicated by medical records or personal statements.
Intervention groups
The intervention in two intervention groups (PACT) or control (Sexual Health Model) will be conducted in 4 consecutive and weekly sessions, for 90 minutes and online. Men will receive the intervention in 2 consecutive weekly sessions and separately.
Main outcome variables
Sexual health literacy and sexual and reproductive health services

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240720062478N1
Registration date: 2024-08-01, 1403/05/11
Registration timing: prospective

Last update: 2024-08-01, 1403/05/11
Update count: 0
Registration date
2024-08-01, 1403/05/11
Registrant information
Name
Firoozeh Shenvari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3833 7947
Email address
f.shenvari@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Tow Couple-Focused Counseling Methods, Protect and Connect Model (PACT) with the Sexual Health Model on Sexual Health Literacy and Receiving Sexual and Reproductive Health Services in Afghan Immigrants Living in Iran.
Public title
Couple-Focused Counseling, Protect and Connect Model (PACT) with the Sexual Health Model on Sexual Health Literacy and Receiving Sexual and Reproductive Health Services in Afghan Immigrants Living in Iran.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Afghan Citizenship Living in Iran Having a File in the Commissariat Comprehensive Health Center of Yazd Being Married Being Monogamous (Self-Reported) Farsi Dialect At least One Year of Marriage Has Passed Women of Reproductive Age from 15 to 49 Years and their Spouses Literacy for Reading and Writing Having a Smartphone and the Ability to use the Internet People with Inadequate and not very Adequate level of Sexual Health Literacy (0 to 66 points)
Exclusion criteria:
Previous Participation in Sex Education Classes in the past year Drug and Alcohol Addiction (Self-reported) or Recorded in the File Occurrence of Stressful Events while Participating in the Study (such as death of Family members, or Divorce) Suffering from Mental Disorders or Being Treated with Psychiatric Drugs based on Medical Record Information or Individual Statements
Age
From 15 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women referring to the two Health Centers of Kharazmi Commissariat and Ibn Sina Yazd were called based on the criteria of participating in the Study and were Sampled using the Available Method. Then they are assigned to 2 Intervention groups (34 pairs) and Control (34 pairs). The Randomization Sequence is Determined by the permutation Block Method and is Obtained by Considering Blocks of Size 4 after Generating Random Numbers Online using WWW.random.org/sequences, Each Random number is one of the permutations. Random numbers between 1 and 9 (numbers 7-9 are ignored in the order of the above permutations), based on the Output of the Mentioned Software, are used to assign people to Permutation Blocks. Concealment is done in the allocation of Randomization in such a way that neither the researcher nor the subjects know which of the two groups they will be assigned to.
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
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی شهید صدوقی یزد
Street address
یزد، میدان باهنر
City
یزد
Province
Yazd
Postal code
8916189165
Approval date
2024-07-03, 1403/04/13
Ethics committee reference number
IR.SSU.REC.1403.043

Health conditions studied

1

Description of health condition studied
Sexual Health Literacy and use of Reproductive and Sexual Health services
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual Health Literacy
Timepoint
Baseline, completion of the intervention in the fourth week and follow-up at the end of the study in the twelfth week
Method of measurement
Sexual health literacy for adults (SHELA)

Secondary outcomes

1

Description
Receiving Sexual and Reproductive Health services
Timepoint
Baseline, follow-up at the end of the study in the twelfth week
Method of measurement
The number of referrals of people will be extracted through the health system of health centers of the Commissariat.

Intervention groups

1

Description
Intervention group: The intervention in the first group will be carried out online in the sky room for 4 consecutive sessions, once a week for 90 minutes, after obtaining written consent . Men will also receive the intervention in 2 consecutive weekly sessions. Men's and women's meetings will be held separately and online. Training for installing and using the Skyroom program will be done. The intervention will be conducted by the first researcher, who has completed the couple therapy course and obtained the necessary certificate under the supervision of a clinical psychologist and reproductive health specialist and a reproductive health specialist consultant. The intervention in two groups of men will be provided by a male colleague with a health care expert degree who has the task of counseling and providing reproductive health services to men in comprehensive health centers and has received the necessary training to perform the intervention. Intervention group meetings (PACT Model) will be held with a focus on the goals of each meeting. The objectives of the meetings include: the importance of reproductive health and its related issues, common sexually transmitted diseases and methods of prevention and treatment, the importance of the role of people in establishing a safe relationship, getting to know the services available in the field of reproductive and sexual health, assessing risks and strengthening self-efficacy, discussion It is about sexual coercion and targeting to increase protective behaviors and reduce risky behaviors. Online counseling will be in the form of PowerPoint presentations, educational videos, questions and answers, group discussions and assignments. At the beginning of each session, a summary of the materials related to the previous sessions is reviewed and the assignments related to the previous session are reviewed by the first and second researcher to measure the sexual health literacy status of the people in each session. Women are asked to participate in online counseling discussions and ask questions. The researcher will also ask questions about the topics of the meeting for the participation of more people. At the end of each meeting, a summary of the important topics mentioned is presented and the questions of the people are answered, and the couples are asked to do their homework until the next meeting.
Category
Behavior

2

Description
Control group: The intervention in the second group (active control) will be carried out in the form of 4 consecutive sessions, once a week for 90 minutes, online in the sky room. Men will also receive the intervention in 2 consecutive weekly sessions. The conditions of the training, the way it will be held, the lecturer and the presentation of materials will be the same as the intervention group. The goals of the control group sessions (Sexual Health Model) include: definition of sexual health and familiarity with anatomy and sexual function, determination of factors affecting sexual relationship, familiarity with the concepts of mental health in sexual relationship and discussion about intimate relationship. The presentation method will be similar to the intervention group and will be taught in the form of PowerPoint and questions and answers. At the beginning of each session, a summary of the materials related to the previous sessions is reviewed, and the assignments related to the previous session are reviewed by the first and second researchers in order to measure the sexual health literacy status of the people in each session. To improve the advancement of the objectives of the question and answer sessions And the discussion about the content of each session will take place. At the end of each session, a summary of the important topics mentioned is presented, and the questions of the individuals are answered, and the couple is requested to do their homework until the next session.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kharazmi Health Center
Full name of responsible person
Tahmineh Farajkhoda
Street address
Khavidak Road, Yazd
City
Yazd
Province
Yazd
Postal code
8913783343
Phone
+98 35 3836 8511
Email
farajkhoda_t@yahoo.com

2

Recruitment center
Name of recruitment center
Ibn Sina Health Center
Full name of responsible person
Tahmineh Farajkhoda
Street address
Daneshkadeh Ave, Imam Reza Blvd
City
Yazd
Province
Yazd
Postal code
8913783343
Phone
+98 35 3625 5882
Email
farajkhoda_t@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Bahnar Square, Central Organization of Shahid Sadougi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3733 3726
Fax
+98 35 3732 3726
Email
abargouei@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Psychology
Street address
Bo Ali St., Faculty of Nursing and Midwifery
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
farajkhoda_t@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Psychology
Street address
Bo Ali St., Faculty of Nursing and Midwifery
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
farajkhoda_t@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Psychology
Street address
Bo Ali St., Faculty of Nursing and Midwifery
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
farajkhoda_t@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All Individual data of study participants can be shared after de-identification.
When the data will become available and for how long
After publishing the results
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them.
Under which criteria data/document could be used
Scientific application
From where data/document is obtainable
Email of corresponding author Dr. Tahmineh Farajkhoda as Principle investigator
What processes are involved for a request to access data/document
From email during two weeks
Comments
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