A randomised controlled trial of mobile phones to influence adherence to first line antiretroviral treatment among human immunodeficiency virus (HIV) infected patients in South India

ISRCTN	ISRCTN79261738
DOI	https://doi.org/10.1186/ISRCTN79261738
Secondary identifying numbers	N/A

Submission date: 18/05/2009
Registration date: 24/07/2009
Last edited: 07/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Ayesha Mariette De Costa
Scientific

Dept. Of Public Health Sciences
Karolinska Institutet
Stockholm
SE 171 77
Sweden

Study information

Study design	Two-centre randomised controlled open trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Can be found at http://ki.se/content/1/c6/03/05/79/HIVIND%20participant%20info%20ISRTCN.pdf
Scientific title	The antiretroviral roll out for human immunodeficiency virus (HIV) in India (HIVIND) - strengthening capacity to promote adherence and patient follow-up in the context: a two-centre, randomised, controlled, open trial in South India to study an innovative approach using mobile phones delivery to promote adherence in antiretroviral naive, HIV+ Indian patients
Study acronym	HIVIND
Study objectives	Antiretroviral treatment (ART) naive patients started on ART, followed up for 24 months after ART initiation, and receiving reminders on their mobile telephones will have better adherence and hence, a longer time to resistance development than patients who do not receive such reminders over the same period.
Ethics approval(s)	1. Sweden: Karolinska Institutet, Stockholm, 18/03/2009, ref: 2009/303 - 31/2 2. Finland: University of Tampere, 21/04/2009, ref: R09064 3. India: St. John's National Academy of Health, Bangalore, 20/03/2009, ref: IERB/1/172/09 4. India: YRG Care, Chennai, 18/04/2009 5. Vietnam: Hanoi Medical University, 02/02/2009, ref: 66/HMURB
Health condition(s) or problem(s) studied	Human immunodeficiency virus (HIV)
Intervention	Both arms will receive mobile telephones. However in the control arm, there will be no further interaction via the mobile phone. In the intervention arm, the mobile phone intervention will be as described below: 1. Each of the 300 patients in the intervention arm will receive a cell phone (handset) with free incoming calls, and a set amount of talk time per month which will be prepaid by the project (approximately Rs 200 per phone per month). The talk time is included to allow functionality of the phone, and expiry of the talk time will not disallow any of the project related communications (this has been discussed with the mobile network company). 2.1. Automated voice calls (IVR) reminding patients to take their medication will go out once a week at a specified time to each of the 150 patients in the intervention arm at each site. This will be in Kannada, Telugu or Tamil, depending on the language the patient speaks. If the patient for any reason does not receive this call, then a repeat call is sent within the next hour. 2.2. A second weekly 'adherence reminder contact' will be made by hospital counsellors, from a number based at the hospital and dedicated to this purpose, to remind the patients about his medication (a standard script for this part of the conversation), enquire about the patients' wellbeing, follow up on any pending issues. (These calls will be scheduled on the 4th day after the IVR has been sent out). 3. Patients will report back once a day to record that they have taken their medication. A simple functionality for this has been developed involving two clicks of the phone. In the event of non-receipt of such a message or a negative response, an automatic reminder will be sent to the patient 24 hours later.
Intervention type	Other
Primary outcome measure	Time to occurrence of virological failure (defined as having greater than 400 copies/ml on two consecutive measures at least one month apart. Date of failure is documented as the date of initial reading of the value greater than 400 copies/ml.
Secondary outcome measures	Self-reported adherence expressed as a percentage
Overall study start date	01/09/2009
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	600
Key inclusion criteria	1. Human immunodeficiency virus (HIV) seropositive 2. Aged between 18 - 60 years, either sex 3. Meet criteria to start ART (in India, ART is indicated for symptomatic patients with a World Health Organization [WHO] Clinical Stage 4 condition regardless of CD4 counts and plasma viral load; WHO Stage 3 condition with CD4 less than 350/mm^3 and in asymptomatic patients, with CD4 count less than 200/mm^3) 4. ART naive (i.e. no prior antiretroviral therapy or ART for less than 7 days) 5. Residence in the Southern Indian States with the ability to visit clinic regularly for follow-up visits
Key exclusion criteria	1. Severely ill (Karnofsky score less than 70) at the time of recruitment 2. Impaired renal function (creatinine greater than 2 times upper limit of normal) 3. Study participant already recruited in the same household 4. Non-availability of mobile telephone network
Date of first enrolment	01/09/2009
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

India
Sweden

Study participating centre

Karolinska Institutet

Stockholm
SE 171 77
Sweden

Sponsor information

European Union (EU) (Belgium)
Government

Directorate - General for Research
Directorate F - Health
CDMA 02/66
Brussels
B 1049
Belgium

Website	http://cordis.europa.eu/fp7/
"ROR"	https://ror.org/019w4f821

Funders

Funder type

Government

Seventh Framework Programme
Government organisation / National government

Alternative name(s): EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	10/03/2014	Yes	No
Results article	results	24/10/2014	Yes	No
Results article	results	02/11/2015	Yes	No
Results article	results	27/01/2016	Yes	No

Editorial Notes

07/10/2016: Publication reference added.
01/04/2016: Publication reference added.