Condition category
Infections and Infestations
Date applied
18/05/2009
Date assigned
24/07/2009
Last edited
07/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hivind.eu/

Contact information

Type

Scientific

Primary contact

Dr Ayesha Mariette De Costa

ORCID ID

Contact details

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

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

http://cordis.europa.eu/fp7/

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

Belgium

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

Publication citations

Additional files

Editorial Notes

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