Determining the effectiveness of telephone behavioral self-regulatory counseling on adherence to treatment in HIV patients
Design
In this research, 40 patients referring to voluntary and counseling center for HIV will be chosen purposefully and a code will be allocated to each one of them. Then, patients randomly will divide into two control and intervention groups. Block randomization and intervention is group counseling
Settings and conduct
It is a randomized controlled clinical trial without blinding.
Setting and conduct: voluntary and counseling testing center of Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Entry requirements
Over 18 years
HIV positive
File formation between 2016 and 2017 in the Behavioral Diseases Counseling Center of Imam Khomeini Hospital
Adherence to treatment less than 95%
Familiarity with using a mobile phone
No entry conditions
Dissatisfaction
Has a psychotic disorder and is receiving psychiatric medication
Intervention groups
The intervention group performs five educational and therapeutic sessions, counseling intervention (one in-person counseling session in person and four telephone counseling sessions in a week in between with a self-regulatory approach) and also measures their adherence in each course. Be.
The control group received the national protocol and measured the level of adherence to treatment in each period.
Main outcome variables
The main messages of our study are the presence or absence of adherence to treatment and the degree of adherence to it.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040037N2
Registration date:2020-10-28, 1399/08/07
Registration timing:prospective
Last update:2020-10-28, 1399/08/07
Update count:0
Registration date
2020-10-28, 1399/08/07
Registrant information
Name
Seyed Ali Dehghan maneshadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 1296
Email address
a_dehghanm@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Behavioral Self-Regulation Counseling on HIV Treatment Adherence Delivered by Phone
Public title
Effect of Behavioral Self-Regulation Counseling on HIV Treatment Adherence Delivered by Phone
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People must be over 18 years old to participate in the project.
Participants must be HIV positive and have a folder and receive medication at the Behavioral Diseases Counseling Center of Imam Khomeini Hospital between 2016 and 2017.
The rate of adherence to drug therapy in participants should be less than 95%.
Participants should be know with how to use a cell phone and send text messages.
Exclusion criteria:
People who are not satisfied with participating in this project.
People who, in addition to HIV, have a psychotic disorder and are taking psychiatric medication.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, because the sample size is 40 people, this amount is less than 100. If people are divided into 2 groups by simple random method. According to the law of tap and line randomization, the number of taps and lines may not be equal in the two groups. Therefore, the Block-Randomization method is used. The sample size calculated in this study is 40 people. Therefore, 10 blocks of 4 people are formed and 5 blocks are randomly assigned to each group. As a result, the balance between the two groups is assigned to one group of 20 people and the other 20 people to the second group. A simple random method is used to assign people to each block. This means that people are placed in one of these blocks based on a table of random numbers.
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
Central Office of Tehran University of Medical Sciences, Corner of Ghods Street, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-07-29, 1399/05/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.149
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Adherence for Treatment
Timepoint
At the beginning of the study (before the intervention) at the end of the study and 2 weeks, 4 weeks and 2 months after the completion of the study.
Method of measurement
Measure adherence to treatment based on self-report and include in the Adherence measurement formula.
Secondary outcomes
1
Description
increase of self-regulation
Timepoint
At the beginning of the study (before the intervention) at the end of the study and 2 weeks, 4 weeks and 2 months after the completion of the study
Method of measurement
Self-Regulation questionnaire, this questionnaire was prepared by Miller & Brown(1999) for measure self-regulating components.
Intervention groups
1
Description
Intervention group:20 HIV-positive participants In the intervention group we hold 5 consultation sessions based on self- regulation.The time of each session is 45 minutes. After being in the intervention group, it tests, which includes two questionnaires: the degree of adherence to treatment and increasing self-regulation skills in the individual, because if you want to do the treatment accurately and treat the person in the field of your skills, it will determine Be. After people have taken their antiretroviral drugs, they are asked to do so for 10 weeks (until their last telephone consultation) each day they buy their drugs to avoid the mobile number they are considering for the plan. Taken, send SMS. The number of unused pills of all participants is measured each week and recorded in the relevant form. After the last telephone counseling session for the intervention group, follow-up to adhere to the treatment for individuals for a period of two weeks - four weeks - and two months later by telephone with each participant. At the end, participants are assessed for their adherence to treatment and self-regulatory skills, and the pre-test and post-test results are compared.
Category
Behavior
2
Description
Control group:20 people who are HIV-positive in the control group they will receive just routine voluntary and counseling protocol for HIV consultation. After placing the people in the control group, the pre-test, which includes two questionnaires, the amount of adherence to treatment and the level of self-regulatory skills in the person, is taken from them to determine the exact score of adherence to treatment and his total score in self-regulatory skills. After people receive their antiretroviral drugs, they are asked to immediately send a text message to the mobile number provided for the plan for 10 weeks each day they take their medication. The number of unused pills of all participants is measured each week and recorded in the relevant form.After the last telephone counseling session for the intervention group, follow-up to adhere to the treatment for individuals for a period of two weeks - four weeks - and two months later by telephone with each participant. At the end, participants are assessed for their adherence to treatment and self-regulatory skills, and the pre-test and post-test results are compared.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Behavioral Disease Counseling Centers
Full name of responsible person
Dr Seyd Ali Dehghan Menshadi
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
a_dehghanm@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Vice Chancellor for Research, Central Campus of the University of Tehran, 16 Azar St., Islamic Revolution Square, Tehran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6697 0178
Fax
+98 21 6648 6500
Email
Research@ut.ac.ir
Grant name
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyd Ali Dehghan Menshadi
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Infectious diseases
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6119 2047
Email
a_dehghanm@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyd Ali Dehghan Menshadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-7331411
Phone
+98 21 6119 2047
Email
a_dehghanm@sinam.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Dehghan Menshadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
a_dehghanm@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD