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IRCT20100601004076N23 IRCT 2019-03-09 Tehran University of Medical Sciences MHealth for Antiretroviral adherence The acceptability and effectiveness of a mobile-health intervention to improve adherence to treatment and medication for people living with HIV 2019-04-04 anticipated 50 Complete https://irct.ir/trial/30699 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization procedure will follow CONSORT guidelines and occur after study enrollment and baseline data collection. The study will use a free web-based program for randomizing (e.g. SealedEnvelopeTM www.sealedenvelope.com/freerandomiser/v1/). This will reduce the potential for allocation bias through correct sequence generation and allocation concealment. Researchers will notify participants about their allocation individually. Allocation of other participants will not be disclosed in order to reduce contamination bias, Blinding description: Data collectors will be blinded to the participant allocation. However, due to the nature of this study, double blinding will not be possible as participants will know their allocation to the intervention group. 3 HIV. Intervention 1: Intervention group: Mobile messages will be sent to the intervention group to provide personalized support through counseling and reminders to improve adherence to medication. Adherence will be measured through self-report, and confirmed through CD4 and viral load tests. Intervention 2: Control group: Adherence to the medication among the control group will be measured through self-report, and confirmed through viral load and CD4 cell tests. However, the control group will not receive the intervention through mobile messaging. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the possibility of unauthorized copying and duplication of the shared data, it is not possible to publish the data set
public Minoo Mohraz
Iranian Research Center for HIV/AIDS (IRCHA), Imam Khomeini Hospital
Tehran Iran (Islamic Republic of) 1956865432 +98 21 6694 7984 ircha@tums.ac.ir Tehran University of Medical Sciences scientific Vira Ameli
Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital
Tehran Iran (Islamic Republic of) 1123565479 +98 21 6658 1583 vira.ameli@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) All PLHIV will be eligible to participate if they are receiving ART aged 18 years or above own or have sufficient access to a mobile phone are able to sufficiently operate a cell phone to communicate using mobile-messaging (help by a partner is sufficient for patients with reading and/or writing difficulties) 18 years no limit Both B20 Human immunodeficiency virus [HIV] disease Behavior Treatment - Devices Intervention group: Mobile messages will be sent to the intervention group to provide personalized support through counseling and reminders to improve adherence to medication. Adherence will be measured through self-report, and confirmed through CD4 and viral load tests. Control group: Adherence to the medication among the control group will be measured through self-report, and confirmed through viral load and CD4 cell tests. However, the control group will not receive the intervention through mobile messaging. Adherence to HIV treatment. Timepoint: Every week. Method of measurement: Questionnaire. Vira Load. Timepoint: At the end of intervention. Method of measurement: Lab Test. CD4 Cell Count. Timepoint: At the end of the intervention. Method of measurement: Lab test. Tehran University of Medical Sciences Approved 2018-11-10 Ethical committee of Tehran University of Medical Sciences Central building of TUMS, Ghods St, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)