The aim of this study is to assess the acceptability and effectiveness of a mobile-health intervention to improve adherence to treatment and medication for people living with HIV. The intervention will use text-messaging to provide support and counselling to patients. Adherence to anti-retroviral therapy will be measured through self report and clinical outcomes.
Design
This is a single-blinded (investigator blinded) Randomised Controlled Trial, with two parallel groups.
Settings and conduct
This trial will be based in the HIV/AIDS clinic in Iran. The investigators will be blinded to allocation of participants, however due to the nature of the intervention the participants cannot be blinded to the receiving of the intervention.
Participants/Inclusion and exclusion criteria
Patients will be eligible it they are 1) already receiving ART treatment, 2) aged 18 years or above, 3) own or have sufficient access to a mobile phone (shared access is allowed if access is daily and the phone owner agrees to participate), 4) 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).
Intervention groups
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 via self report, and confirmed through CD4-cell count and viral load tests.
Main outcome variables
Adherence to HIV treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100601004076N23
Registration date:2019-03-09, 1397/12/18
Registration timing:prospective
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The acceptability and effectiveness of a mobile-health intervention to improve adherence to treatment and medication for people living with HIV
Public title
MHealth for Antiretroviral adherence
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
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)
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Tehran University of Medical Sciences
Street address
Central building of TUMS, Ghods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
0123456789
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.TUMS.VCR.REC.1397.558
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Adherence to HIV treatment
Timepoint
Every week
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Vira Load
Timepoint
At the end of intervention
Method of measurement
Lab Test
2
Description
CD4 Cell Count
Timepoint
At the end of the intervention
Method of measurement
Lab test
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Research Centre for HIV / AIDS
Full name of responsible person
Dr. Minoo Mohraz
Street address
The Department of Infectious and Tropical Diseases, Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
minoomohraz@ams.ac.ir
Web page address
http://ircha.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Minoo Mohraz
Street address
Iranian Research Center for HIV/AIDS,Imam Khomeini Hospital,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
0123456789
Phone
+98 21 6641 9661
Email
minoomohraz@ams.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
Minoo Mohraz
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Iranian Research Center for HIV/AIDS (IRCHA), Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1956865432
Phone
+98 21 6694 7984
Email
ircha@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vira Ameli
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1123565479
Phone
+98 21 6658 1583
Email
vira.ameli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vira Ameli
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
Iranian research center for HIV/AIDS, Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1123565479
Phone
+98 21 6658 1583
Email
vira.ameli@gmail.com
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
Due to the possibility of unauthorized copying and duplication of the shared data, it is not possible to publish the data set