Protocol summary

Summary
The purpose of this study is determine the effect of education on health promotion model of adherence to treatment in HIV-positive patients treated in behavioral disorders Counseling Center in Bushehr.Inclusion criteria: Age over 18 years؛ The indications for Antiretroviral therapy؛ literacy؛ Mental health. Exclusion criteria:No consent for participation in the study. This study is a clinical trial,Performed On least 60 patients the antiretroviral treatment in Counseling Center behavioral disorders in Bushehr. Because of the limited number of patients, samples taken from all patients who randomly divided into two groups, education and Without education. Intervention group, is performed face to face training for 30 patients treated during two training session spaced two weeks. At the first session, in addition to providing education booklet, will speak in relation to AIDS, transmission and prevention of disease and the benefits of drug and treatment and then in the second session will be provided on the barriers drug, social support family and friends Along with the invitation one of the family and Feeling to treatment and strategies to increase adherence patients to treatment . Participants in the control group, received the routine education and at the end will be presented of the education booklet to them. Patients in both groups will respond at baseline, two weeks and three months after the start of training to all questions in the questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015022821262N1
Registration date: 2015-08-04, 1394/05/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-04, 1394/05/13
Registrant information
Name
Faredeh Esmaeili
Name of organization / entity
Bushehr University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0089
Email address
fa.esmaeili@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University Of Medical Sciences
Expected recruitment start date
2015-04-16, 1394/01/27
Expected recruitment end date
2015-07-18, 1394/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on health promotion model on adherence to treatment in HIV-positive patients in Bushehr
Public title
The Impact of education on adherence to treatment in HIV-positive patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; The indications for Antiretroviral therapy; literacy; Mental health. Exclusion criteria: No willingness to participation in the study.
Age
From 18 years old
Gender
Both
Phase
N/A
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
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences campus, Salman Farsii Street, Bushehr
City
Bushehr
Postal code
7514633341
Approval date
2014-02-16, 1392/11/27
Ethics committee reference number
B-93-16-15

Health conditions studied

1

Description of health condition studied
HIV
ICD-10 code
B20, B21,
ICD-10 code description
Human immunodeficiency virus [HIV] disease

Primary outcomes

1

Description
Perceived Benefits
Timepoint
Before the intervention, two weeks after the beginning of the study, three months after the intervention.
Method of measurement
5 questions chosen from the astandard questionnaire attitude to drug

2

Description
Perceived Barriers
Timepoint
Before the intervention, two weeks after the beginning of the study, three months after the intervention.
Method of measurement
Barriers to Medication Adherence Questionnaire (PMAQ)

3

Description
Perceived Self-Efficacy
Timepoint
Before the intervention, two weeks after the beginning of the study, three months after the intervention.
Method of measurement
Adherence Self-Efficacy Questionnaire

4

Description
Social Protection
Timepoint
Before the intervention, two weeks after the beginning of the study, three months after the intervention.
Method of measurement
Social Support Questionnaire Shrburn and Stewart

5

Description
Feelings Related to Behavior
Timepoint
Before the intervention, two weeks after the beginning of the study, three months after the intervention.
Method of measurement
Believe about Medication Questionnaires (BMQ)

6

Description
Adherence to Medication
Timepoint
Before the intervention, two weeks after the beginning of the study, three months after the intervention.
Method of measurement
Self-Report

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group, will be provided face to face training for 30 patients treated during two sessions spaced two weeks, and the booklet in the first session and drug boxes to reduce the forgotten drug the second session. Cooperation and support family the second session is formed with the help of a family member.
Category
Other

2

Description
Control group during the study period to will receive care routine center.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr Counseling Center of Behavioral Diseases
Full name of responsible person
Dr. Katayon Vahdat
Street address
Building Emergency 115,Third Floor Central Laboratory , Imam Khomeini Street
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bushehr University of Medical Sciences Research Center
Full name of responsible person
Dr. Afshin Ostovar
Street address
Bahmaney,Salman Farsi Street, Pardis site, Bushehr University of Medical Sciences
City
Bushehre
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr University of Medical Sciences Research Center
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
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Azita Noroozi
Position
PhD Health Education and Health Promotion
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Pardis site, Salman Farsi Street, Bahmaney
City
Bushehr
Postal code
Phone
+98 77 3455 0089
Fax
Email
azitanoroozi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Azita Noroozi
Position
PhD Health Education and Health Promotion
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Pardis site, Salman Farsi Street, Bahmaney
City
Bushehr
Postal code
Phone
+98 77 3455 0089
Fax
Email
azitanoroozi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Faredeh Esmaeili
Position
Graduate student Health Education
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Pardis site, Salman Farsi Street, Bahmaney
City
Bushehr
Postal code
Phone
+98 77 3345 0646
Fax
Email
faredeh53@yahoo.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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