Protocol summary

Summary
The present study is a randomized control trial, parallel, not blinded, designed With assessment of the effect cognitive-behavioral consultant in reproductive health of women with HIV. Researchers after obtaining permission from the authorities feeder every days of the week to visit to Imam Khomeini Consultation Center for Clients with Risky Behaviors, and after explaining the purpose of the study and the consent of the participants has started sampling has available,In this study126 patients with the HIV virus are into two groups, Intervention (get consultation) and control group (receiving routine care). Inclusion criteria can be noted from the women in the age range between 15-45 years, The ability to read and write and having sex. Exclusion criteria include failure to attend counseling sessions over three sitting and severe addiction and severe psychiatric disorder who are not able to answer questions. Number eight 50-minute sessions of cognitive-behavioral counseling for the intervention group will be held. The implications of this study include the quantity of physical and acceptance of HIV disease, increase compliance with the disease, increase responsible behavior towards illness, Reduce instability in life, increase self-awareness, enhance the quality of reproductive health and reducing anxiety and depression.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101920719N3
Registration date: 2017-04-19, 1396/01/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-19, 1396/01/30
Registrant information
Name
Sara Esmaelzadeh Saeieh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
s-esmaelzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research chancellor of Alborz University of Medical Sciences
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of the effect cognitive-behavioral consultant in reproductive health of women with HIV referred to Imam Khomeini Consultation Center for Clients with Risky Behaviors in Tehran city in 1395
Public title
The effect consultant in reproductive health of women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria consisted of women in the age range between 15-45 years, The ability to read and write, lack of severe addiction to substances that do not have the ability to respond to questions, No history of severe psychological disorders, Lack of advanced stages of disease, Having sex. Exclusion criteria included Lack of consultation sessions over 3 sitting, disinterest To participate in research, having severe addiction to substances that do not have the ability to respond to questions and Severe psychiatric disease.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
N/A
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
Research chancellor of Alborz University of Medical Sciences
Street address
Taleghani Square Taleghani Blvd North - the administrative settlement - alborz University of Medical Sciences
City
Karaj
Postal code
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
Abzums.Rec.1395.150

Health conditions studied

1

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

Primary outcomes

1

Description
Reproductive health
Timepoint
Beforen and A month after the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Anxiety
Timepoint
Before and a month after consultation
Method of measurement
Questionnaire

2

Description
Depression
Timepoint
Before and a month after consultation
Method of measurement
Questionnaire

3

Description
Stress
Timepoint
Before and a month after consultation
Method of measurement
Questionnaire

Intervention groups

1

Description
In the intervention grope: 8 sessions of cognitive-behavioral counseling for two days a weak(Sunday and Wednesday) for 50 minutes to be held which including reproductive health, sexuality, responsible behavior, fertility, coping with illness, psychological problems, health problems related to pregnancy and social problems.
Category
Behavior

2

Description
Control group: In this group, except for routine care, there is no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Consultation Center for Clients with Risky Behaviors
Full name of responsible person
Sara Esmaelzadeh
Street address
Imam Khomeini hospital, Keshavarz Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research chancellor of Alborz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Noori Sepehr
Street address
Azimieh Sq.,Research chancellor of Alborz University of Medical Sciences,Karaj,Alborz.
City
karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research chancellor of Alborz 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
Research chancellor of Alborz University of Medical Sciences
Full name of responsible person
Katayoon Salehi
Position
A graduate student in consultation on midwifery
Other areas of specialty/work
Street address
Azimieh Sq.,Research chancellor of Alborz University of Medical Sciences,Karaj,Alborz.
City
Karaj
Postal code
Phone
+98 26 3452 9133
Fax
Email
salehi.katayoun@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh
Position
PHD in Reproductive Health/Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery,First Baghestan,Gholshahr.
City
Karaj
Postal code
Phone
+98 26 3433 6008
Fax
Email
esmaelzadeh1360@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh
Position
PHD in Reproductive Health/Faculty member
Other areas of specialty/work
Street address
Alborz School of Nursing and Midwifery,First Baghestan,Gholshahr.
City
Karaj
Postal code
Phone
+98 26 3433 6008
Fax
Email
esmaelzadeh1360@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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