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IRCT20181112041616N1 IRCT 2018-12-12 Yazd University of Medical Sciences Impact of an Information, Motivation and Behavioral Skills (IMB) Model on Adherence to Treatment Regimen 0 Planning, Implementing and Evaluating the Impact of an Empowerment Program Based on Information, Motivation and Behavioral Skills (IMB) Model on Adherence to Treatment Regimen Patients with positive HIV in the Behavioral Disease Counseling Center 2017-10-23 anticipated 122 Complete https://irct.ir/trial/35200 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The researcher used a simple randomized method. The random unit is HIV positive patients. The instrument is through allocating two groups of A and B In the random sequence, first we use the convenience sampling method. The questionnaire is completed for all people referring to the Behavioral Disease Counseling Center on different days of the week until the sample size is reached. Codes of 1 to 122 are considered for each questionnaire. In the next step, we will consider two groups of A and B, then we put the even numbers in group A and the odd numbers in group B, and finally we will consider the intervention and control groups. Hiding random allocation: In this method, without knowing the names of the two groups, after the individuals are assigned to both groups, a group is called the intervention and the other is called control group, Blinding description: The researcher does not inform the participants of the number of individuals, individual characteristics and intervention in each group, which makes all those involved in the study think that all participants receive intervention, although some do not receive it. In our study, only the researcher knows the allocation of the two groups, but the participants, evaluators and the data monitoring committee are not aware of the type of assigned intervention. Another useful way is that the evaluator is selected from outside the treatment team. Given that the researcher is aware of the type of intervention devoted to the participants in the study, this awareness cannot affect the data analysis. N/A Condition 1: HIV. Condition 2: Adherence to Nutrition. Condition 3: HIV. Condition 4: Adherence to Physical Activity. Intervention 1: Intervention group: "The intervention is based on at least 20 training sessions (60 minutes per session according to the participants' viewpoints) within 16 weeks for treatment adherence behavior using information, motivation and behavioral skills model. Due to stigma and shame, sessions will be held separately for men and women for more participation of people. Considering that drug adherence, nutrition and exercise are intended, according to the opinion of male participants, two sessions were held in parks and forests to do a variety of exercises and walking as well as the use of equipment inside parks and create a sense of pleasure in people and the third session is conducted inside the counselling center until reaching 20 sessions. In the women's group, 10 sessions of the aerobics class will be held at the club (according to women’s opinion) and 4 sessions will be held inside the women's park and 8 sessions of nutrition and medication classes will be held at the Behvarzi institute while holding aerobic classes. The 8 training sessions are as follows: The first and second sessions will be held to increase knowledge and information for 2 weeks. The third and fourth sessions will be held to increase motivation for two weeks using group discussion and lectures, posters, pamphlets, and PowerPoint: Motivation construct consists of three parts. Individual motivation, social motivation and perceived sensitivity (perception of risk). 1-Individual motivation: Using brainstorming and projection in all possible outcomes in a training session and evaluating outcomes (group discussions on all possible outcomes). SMS or MMS are used to send messages at appropriate times (message timing control) for creation of individual motivation. Social motivation: holding sessions in the parks, doing exercises, and involving all people will bring more people together and approval of friends and family. The 5th, 6th and 7th sessions are used to increase behavioral skills within 3 weeks. Behavioral skills consist of two parts: 1. Increasing self-efficacy, which is a powerful strategy for behavioral development. 2. Performing objective skills for correct behavior in 2 or 3 sessions. Role playing of people and encouraging them with rewards (in cash and non-cash) give them the opportunity to get self-confidence and learn skills. The eighth session is held one month after the seventh session for the purpose of follow up and review of presented materials. Intervention 2: "Control group:" routine care. No - There is not a plan to make this available Justification or reason for not sharing IPD is HIV patients were reluctant to share data
public Ehsan Movahed
Shohaday Gomnam Blvd., Yazd Town., near Azad University
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9138 e.movahed@ssu.ac.ir Yazd University of Medical Sciences scientific Ehsan Movahed
Shohaday Gomnam Blvd., Yazd Town., near Azad University
Yazd Iran (Islamic Republic of) 8915173160 +98 34 3213 3151 e.movahed@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) People over the age of 18 HIV positive Antiviral drugs used for 6 months Willingness to participate in the study 18 years no limit Both They have severe motor disabilities They don’t have reading and writing skills D89.9 D51.9 D82.9 Z89.9 Disorder involving the immune mechanism, unspecified Vitamin B12 deficiency anaemia, unspecified Immunodeficiency associated with major defect, unspecified Acquired absence of limb, unspecified Behavior Other Intervention group: "The intervention is based on at least 20 training sessions (60 minutes per session according to the participants' viewpoints) within 16 weeks for treatment adherence behavior using information, motivation and behavioral skills model. Due to stigma and shame, sessions will be held separately for men and women for more participation of people. Considering that drug adherence, nutrition and exercise are intended, according to the opinion of male participants, two sessions were held in parks and forests to do a variety of exercises and walking as well as the use of equipment inside parks and create a sense of pleasure in people and the third session is conducted inside the counselling center until reaching 20 sessions. In the women's group, 10 sessions of the aerobics class will be held at the club (according to women’s opinion) and 4 sessions will be held inside the women's park and 8 sessions of nutrition and medication classes will be held at the Behvarzi institute while holding aerobic classes. The 8 training sessions are as follows: The first and second sessions will be held to increase knowledge and information for 2 weeks. The third and fourth sessions will be held to increase motivation for two weeks using group discussion and lectures, posters, pamphlets, and PowerPoint: Motivation construct consists of three parts. Individual motivation, social motivation and perceived sensitivity (perception of risk). 1-Individual motivation: Using brainstorming and projection in all possible outcomes in a training session and evaluating outcomes (group discussions on all possible outcomes). SMS or MMS are used to send messages at appropriate times (message timing control) for creation of individual motivation. Social motivation: holding sessions in the parks, doing exercises, and involving all people will bring more people together and approval of friends and family. The 5th, 6th and 7th sessions are used to increase behavioral skills within 3 weeks. Behavioral skills consist of two parts: 1. Increasing self-efficacy, which is a powerful strategy for behavioral development. 2. Performing objective skills for correct behavior in 2 or 3 sessions. Role playing of people and encouraging them with rewards (in cash and non-cash) give them the opportunity to get self-confidence and learn skills. The eighth session is held one month after the seventh session for the purpose of follow up and review of presented materials. "Control group:" routine care Adherence to drug regimen. Timepoint: Adherence to drug regimen before and 3 months after the intervention. Method of measurement: Adherence to the drug regimen based on the AACG drug compliance questionnaire and the self made information, motivation and behavioral skills questionnaire. Adherence to nutrition regimen. Timepoint: Adherence to nutrition regimen before and 3 months after the intervention. Method of measurement: Adherence to the diet based on a nutrition questionnaire and a researcher-made questionnaire of information, motivation and behavioral skills. Adherence to physical activity regimen. Timepoint: Adherence to physical activity regimen before and 3 months after the intervention. Method of measurement: Adherence to the physical activity program based on Beck questionnaire and self made information, motivation and behavioral skills questionnaire. Yazd University of Medical Sciences Approved 2017-07-30 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd ُShohaday Gomnam Blvd.,Faculty of Health., Yazd Town Kerman Kerman Iran (Islamic Republic of)