Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
HIVIND
Study hypothesis
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
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
Study design
Two-centre randomised controlled open trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Can be found at http://ki.se/content/1/c6/03/05/79/HIVIND%20participant%20info%20ISRTCN.pdf
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/09/2009
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
01/09/2009
Recruitment end date
31/12/2012
Locations
Countries of recruitment
India
Trial participating centre
Karolinska Institutet
Stockholm
SE 171 77
Sweden
Sponsor information
Organisation
European Union (EU) (Belgium)
Sponsor details
Directorate - General for Research
Directorate F - Health
CDMA 02/66
Brussels
B 1049
Belgium
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25742320
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24614165
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26525717
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26817634