This study will be conducted on AIDS patients who are referred to the Behavioral Disease Counseling Center of Qom who receive antiretroviral drugs. In this study, the criteria for entry are patients who do not follow appropriate treatments. These patients include people who receive less than 95% of their prescribed medication. Then they are randomly divided into two groups of control and intervention. Each group consists of 36 people.A researcher-made questionnaire whose validity and reliability were confirmed by the Panel of Experts and Will be available to both groups. The initial and main consequence of this study is to increase treatment compliance in patients with AIDS, and its secondary implications include increased sensitivity and perceived severity, increased awareness of the barriers and benefits of treatment, and the impact of social protection in adherence to treatment, which ultimately leads to Patients' self-efficacy is the regular use of medications. Attendance criteria for patients receiving at least 2 years of AIDS treatment and exit criteria include the death of a patient or the imprisonment or migration of patients under study. For the intervention group, 3 educational sessions will be based on the structures of the developed Health Belief Model on AIDS and its treatment, and finally, the pre-test and post-test will be analyzed.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017020432386N1
Registration date:2017-10-20, 1396/07/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-20, 1396/07/28
Registrant information
Name
Javad Yadegari
Name of organization / entity
Qom Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 25 3230 3387
Email address
jyadegari@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-02-09, 1395/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Education Interventional base on Extended Health Belief Model to Antiretroviral adherence in HIV/AIDS patients
Public title
Effectiveness of Education Interventional base on Extended Health Belief Model to Antiretroviral adherence in HIV/AIDS patients
Purpose
Prevention
Inclusion/Exclusion criteria
Entry criteria The drug recceived less than 23 time in the last 2 years; Willingness to participate in this research project; No prison record in the past two years; Treatment began more than two years
Exit criteria any reason that a person is not able to cooperate during the study and conviction to prison during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The randomization in this study is based on names blocking from the Drug Availability Office at the Behavioral Disease Advice Center. The number of names of the patients receiving the drug was 217, which divided into 72 blocks of 3, respectively. From 1 to 3, one number was randomly selected and was selected with 3 other names, so that 72 patients were selected in this study. .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom Univercity of Medical Sciences
Street address
Saheli Avenue
City
Qom
Postal code
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
IR.MUQ.REC.1395.33
Health conditions studied
1
Description of health condition studied
Aids
ICD-10 code
B23
ICD-10 code description
Acute HIV infection syndrome
Primary outcomes
1
Description
Adherece to Antiretroviral Treatment
Timepoint
One month befor intervention and 3 month after
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Social Suport
Timepoint
One month befor intervention and 3 month after
Method of measurement
Questionnaire
2
Description
Perceived Susceptibility
Timepoint
One month befor intervention and 3 month after
Method of measurement
Questionnaire
3
Description
Perceived Severity
Timepoint
One month befor intervention and 3 month after
Method of measurement
Questionnaire
4
Description
Perceived Barriers
Timepoint
One month befor intervention and 3 month after
Method of measurement
Questionnaire
5
Description
Perceived Benefites
Timepoint
One month befor intervention and 3 month after
Method of measurement
Questionnaire
6
Description
Perceived Self efficacy
Timepoint
One month befor intervention and 3 month after
Method of measurement
Questionnaire
Intervention groups
1
Description
In the intervention group, 3 training sessions were held. The first session was for an hour and about the immune system's function. The second session was for an hour and about the general AIDS. The third session was for one hour for antiretroviral drugs and their complications. All of these sessions were based on the health belief model.
Category
Other
2
Description
no intervention in control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Behavioral Disease Counseling Center
Full name of responsible person
Javad Yadegari
Street address
Nirougah, Nabovat sq, Qom
City
University of Medical Science
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom Univercity of Medical Sciences
Full name of responsible person
Gharlipour Zabiholah
Street address
Saheli avenue
City
Qom
Grant name
ندارد
Grant code / Reference number
Does not have
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom Univercity 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
Qom University of Medical Science
Full name of responsible person
Javad Yadegari
Position
Master Student
Other areas of specialty/work
Street address
School of Public Health
City
Qom
Postal code
Phone
+98 25332303387
Fax
+98 25332625456
Email
jyadegari@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Science
Full name of responsible person
Javad Yadegari
Position
Master Student
Other areas of specialty/work
Street address
School of Public Health
City
Qom
Postal code
Phone
+98 25332303387
Fax
+98 253625456
Email
jyadegari@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Science
Full name of responsible person
Javad Yadegari
Position
Master Student
Other areas of specialty/work
Street address
School of Public Hhealth
City
Qom
Postal code
Phone
+98 25 3230 3387
Fax
+98 25 3262 5456
Email
jyadegari@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)