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HIVIND


The antiretroviral roll out for HIV in India - generating evidence to promote adherence and patient follow-up in the context.
 
 
Framework programme:
 7
Contract/Grant agreement number:
222946
EC contribution:
2,900,000 €
Duration:
48 months
Funding scheme:
Collaborative Project (SICA)
Starting date:
01/11/2008
Project Web site:
http://hivind.eu/
 
 

Keywords: HIV, India, adherence, antiretroviral treatment, randomised controlled trial

Background

As a scale-up of HIV treatment is planned in India, adherence is a key issue. High adherence to antiretroviral treatment (ART) for HIV is a key determinant of viral suppression and is associated with a lower rate of disease progression. Given the potential for rapid development of drug-resistant viral strains, poor adherence has serious consequences for public health.

HIVIND is conducting a randomised control trial of two approaches to influencing ART adherence in 600 ART-naive HIV-infected Indian patients eligible for ART in two high-prevalence Indian provinces. The conventional existing approach (as in the national guidelines) will be compared with an intervention in which the patient is provided adherence support using a mobile telephone interface. Besides assessing the effect of intervention on adherence, the project will provide estimates of Indian patients failing first-line ART. It will present factors which promote and obstruct adherence and provide estimates of incidence and manifestations of opportunistic infections, immune reconstitution syndrome and adverse drug events in both arms of the cohort.

The two ART delivery strategies include the mobile treatment support (MTS) design which will be evaluated against the existing conventional (CT) treatment to assess if failure, adherence and other outcomes are influenced. The CT arm will serve as the control arm.

While studies of interventions to improve adherence have been published, most have been underpowered or have not used a randomised controlled trial (RCT) design, except for a few studies conducted mainly in the US and Europe. More recent reviews have advocated the need for more rigour in the conduct of the intervention trials. No RCT has been so far conducted on an Asian population to assess the effect of adherence improving interventions among patients in this context. Besides no trials have been reported on the use of the mobile phone, ubiquitous, inexpensively and contextually appropriate means of supporting adherence in many low income settings. India particularly has experienced a massive growth in mobile phone use, the country has 471 million mobile phone connections, with one of the lowest rates of telephony in the world.

New, simpler and inexpensive ELISA-based techniques (i.e. based on enzyme-linked immunosorbent assay) to assess viral load and resistance will be evaluated in these contexts.

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