The purpose of this randomized clinical trial is to examine the effect of counseling based on PLISSIT model on sexual function of women with HIV. The statistical population of this research includes all the Married women who go to Imam Khomeini Hospital of Tehran to receive routine care for HIV. This study will be on 60 Married women who are positive HIV, and who are qualified to participate for this research. The main inclusion criteria involves: HIV-positive married women and having an intact marriage; HIV-negative husband; Passing at least 3 months of HIV diagnosis in person; Do not use alcohol and drugs; No addiction; lack of mental and chronic physical illness; and the main exclusion criteria involves: If a woman does not want to continue take parting in this study or becomes pregnant. After taking a written testimonial, the researcher asked the qualified women to fill the questionnaires of demographic information, FSFI and Beck Depression questionnaires. Randomly the participants are assigned to two groups of intervention and control. In the intervention group, participants will be counseling based on PLISSIT model on sexual function of women. The control group will receive routine care for HIV . Training session will be held once a week. Data will be collected from participants at three points: before consultation, 1 months and 3 months after consultation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211179463N10
Registration date:2016-06-13, 1395/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-13, 1395/03/24
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of PLISSIT Model Counselling On Sexual Function Of Married Women With HIV
Public title
The Effect Of PLISSIT Model Counselling On Sexual Function Of Married Women With HIV
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Married women HIV And is stable life with wife; HIV-negative wife; Passing at least 3 months of HIV diagnosis in person; With at least read and write; No history of participating in training classes or consulting with a focus on sexual function; Do not use alcohol and drugs; The lack of chronic disease (self-reported); The lack of; known mental illness (self-reported); Do not use medications that affect sexual function; Not pregnant.
Exclusion criteria: Wife's death during the study; Not wanting to continue cooperation; Pregnancy during the study; Mental disease during the study.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Tehran University of Medical Sciences
Street address
The 6th floor of The central organization of Tehran University of Medical Sciences, at the corner of Qods Street , Keshavarz street.
City
Tehran
Postal code
Approval date
2016-01-20, 1394/10/30
Ethics committee reference number
IR.TUMS.REC.1394.1705
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B20.3
ICD-10 code description
HIV disease resulting in other viral infections
Primary outcomes
1
Description
Sexual Function
Timepoint
Before the intervention; one monthes and three monthes after intervention
Method of measurement
Female Sexual Function Index questionnare
Secondary outcomes
empty
Intervention groups
1
Description
intervention group, at first the FSFI questionnaire and Beck Depression in order to assess the sexual function completed with intervention group. Then participate with Sexual dysfunction without depression in counseling sessions. For individual counseling are using PLISSIT model. Finally, 1 months and 3 months after the last counseling session sexual function of subjects are assessed and compared.
Category
Other
2
Description
just Routine care is done in control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Voluntary Counselling and Testing (VCT) centre of Imam Khomeini hospital
Full name of responsible person
Minoo Mohraz
Street address
Iranian Research Center for HIV/AIDS, Imam Hospital.keshavarz Blvd
City
Tehran
2
Recruitment center
Name of recruitment center
Zamzam behavioral health center
Full name of responsible person
Dr.Seyed aham Seyed Alinaghi
Street address
Iranian Research Center for HIV/AIDS, Triangular clinic for sexual and behavioral disease.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
No23, Valiasr Avenue, Dameshgh Street
City
Tehran
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, Tehran 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
Nursing and Midwifery Faculty, Tehran University of Medical Sciences
Full name of responsible person
Leila Asadi
Position
MS student in Midwifery Education
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 17 3243 1578
Fax
Email
Asadi.midwife@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghaddam
Position
PhD in Reproductive Health, Faculty member of TUMS
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences, East Nosrat Avenue,Towhid square
City
Tehran
Postal code
Phone
+98 21 8826 7483
Fax
Email
Behboodi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of medical Sciences
Full name of responsible person
Leila Asadi
Position
M.Sc student in Midwifery Education
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
Fax
Email
Asadi.midwife@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)