Determining the effect of educational-behavioral interventions on safe sexual behaviors, sexual satisfaction, sexual function and body image
Design
Controlled, randomized trial without blinding is done on 70 participants and randomization is implemented by R statistical software.
Settings and conduct
The researcher receives a list of all transgender women by referring to the Iranian Transgender Support Association. Eligible individuals are divided into control and intervention groups. Standard questionnaires of sexual satisfaction, sexual function, body image satisfaction and safe sexual behaviors are completed before the intervention and 3 months after the educational intervention by both control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: transgender women who have been hormonally or surgically adapted from man to woman and are willing to participate in the study and have a sexual partner and sexual intercourse.
People who stop participating in the study
Exclusion criteria: Unwillingness to participate in the study.
Intervention groups
For the intervention group, there are 4 online training sessions, 2 hours per session and 2 sessions per week. The educational content of the intervention group includes 1- sexually transmitted diseases and AIDS 2- Sexual cycle and sexual problems 3- Mental body image 4- Tests, screening examinations and prevention of high-risk sexual behaviors.
The control group receives the routine training of the association and the usual psychological counseling. The content of the training package are provided to the control group after completing the second stage questionnaires.
Main outcome variables
Safe sexual behaviors, sexual satisfaction, sexual function and body image satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201114049379N1
Registration date:2021-01-13, 1399/10/24
Registration timing:registered_while_recruiting
Last update:2021-01-13, 1399/10/24
Update count:0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Azar Nematollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3633 3128
Email address
nematolah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational-behavioral interventions on the reproductive and sexual health needs of transgender women
Public title
Investigating the effect of educational-behavioral interventions on the reproductive and sexual health needs of transgender women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Transgender women who have been adapted from male to female by hormonal or surgical methods
Transgender women who have sexual partner and sexual intercourse
Transgender women who want to participate in the study
Exclusion criteria:
Reluctance to participation in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The list of eligible transgender women is received from Iranian Transgender Support Center. Considering that the type of treatment for reassignment gender surgery may affect the results of our study, to consider this variability in the sample, first people are divided into two groups according to the type of treatment received (hormone therapy or hormone therapy + surgery). Randomization is done separately in each of these two groups using R software. In each treatment group, the zero codes of the software are assigned to the control group and the codes of one software are assigned to the educational intervention group.
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
School of Nursing and Midwifery, East Nusrat Street, Tohid Square, Tehran
City
Tehran
Province
Fars
Postal code
1419733171
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.TUMS.FNM.REC.1398.052
Health conditions studied
1
Description of health condition studied
Transgender women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of safe sexual behavior in the standard Safe Sex Behaviors Questionnaire (SSBQ)
Timepoint
At the beginning of the study (before the start of the study) and 3 months after the intervention
Method of measurement
Safe Sex Behaviors Questionnaire (SSBQ) (DiIorio, et al., 1993)
2
Description
Sexual Satisfaction Score in The Global Measure of Sexual Satisfaction Questionnaire
Timepoint
At the beginning of the study (before the start of the study) and 3 months after the intervention
Method of measurement
The Global Measure of Sexual Satisfaction Questionnaire(Kelli-an Lawrance)
3
Description
Sexual function in the standard Female Sexual Function Index Questionnaire (FSFI -6)
Timepoint
At the beginning of the study (before the start of the study) and 3 months after the intervention
Method of measurement
Female Sexual Function Index Questionnaire (FSFI -6)
4
Description
Body image satisfaction score in the standard body image satisfaction questionnaire
Timepoint
At the beginning of the study (before the start of the study) and 3 months after the intervention
Method of measurement
Souto and Garcia Standard Satisfaction With Body Image Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, 4 online training sessions are held, each session lasts 2 hours and 2 sessions per week using the lecture method, question answering method and slide show. The educational content of the intervention group includes 1- Wids sexually transmitted diseases 2- Sexual cycle and sexual problems 3- Mental body image 4- Tests and examinations Screening and prevention of high-risk sexual behaviors
Category
Behavior
2
Description
Control group: The control group receives the routine training of the association and the usual psychological counseling. The content of the training package are provided to the control group after completing the second stage questionnaires.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Transgender Support Center
Full name of responsible person
Parisa Khodakhah
Street address
second floor, Toloo Bi-neshanha society center, Shahid Salehi Alley, Before the exit of Imam Ali North, Shahid Mahallati Highway East to West
City
Tehran
Province
Tehran
Postal code
۱۳۵۳۶۶۵۷۹۱
Phone
+98 21 3317 2171
Email
parisakhodakhah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Deputy of Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant number 98-3-100-43201.
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
Shiraz University of Medical Sciences
Full name of responsible person
Azar Nematollahi
Position
Faculty of Midwifery, School of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Namazi Square, School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
0098716474254
Email
azar.nematollahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Farnam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, East Nusrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4124
Fax
Email
f_farnam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azar Nematollahi
Position
Faculty member of midwifery, School of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Namazi Square, School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3633 3128
Fax
Email
azar.nematollahi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available