]>
IRCT20180610040037N2 IRCT 2020-10-28 Tehran University of Medical Sciences Effect of Behavioral Self-Regulation Counseling on HIV Treatment Adherence Delivered by Phone Effect of Behavioral Self-Regulation Counseling on HIV Treatment Adherence Delivered by Phone 2020-11-21 anticipated 80 Complete https://irct.ir/trial/50054 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Human immunodeficiency virus. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is No information available.
public Dr Seyd Ali Dehghan Menshadi
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 14-19-733141 +98 21 6119 2047 a_dehghanm@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr Seyd Ali Dehghan Menshadi
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 14-19-7331411 +98 21 6119 2047 a_dehghanm@sinam.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both 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. B20 Human immunodeficiency virus [HIV] disease Behavior Behavior 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. 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. 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. 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. Tehran University of Medical Sciences Approved 2020-07-29 Ethics Committee of Tehran University of Medical Sciences Central Office of Tehran University of Medical Sciences, Corner of Ghods Street, Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)