Keywords: HIV, India, adherence, antiretroviral treatment, randomised controlled trial
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.
Tha main aim of the trial is to test the hypothesis that patients in the arm having mobile telephone adherence support (MTS) will have better adherence and hence longer time to treatment failure (the primary outcomes). Adherence will be the secondary outcome. Thus, the aim of is to compare the two arms, with respect to the primary and secondary outcomes, i.e. the time to virological treatment failure and adherence.
The project will also provide estimates of Indian patients failing first-line ART and provide estimates of incidence and manifestations of opportunistic infections, immune reconstitution syndrome and adverse drug events in both arms of the cohort.
The project will validate use of low-cost ELISA-based (ExaVir) viral load tests, a necessity in this setting.. The sensitivity and specificity of ExaVir Load will be evaluated against PCR (gold standard).
The cost-effectiveness of the mobile phone intervention will be assessed.
The study provides evidence with policy implications for India, Asia and other areas of the world.
This study will be one of the largest randomised controlled adherence trials and one of the first to evaluate the role of mobile telephones in promoting adherence and delaying resistance. It will provide important information on the proportion of patients failing first-line ART., It will provide information the incidence and manifestations of opportunistic infections, IRIS and adverse events in an Indian cohort. In addition, the feasibility of employing less expensive tests to monitor viral load will be studied. Thus, the project will be of immediate importance to HIV treatment policies in India which is in the early phase of a governmental antiretroviral treatment roll out. It will provide information on an potentially inexpensive way of influencing adherence and keeping first line ART useful, as well as introduce the possibility of viral load monitoring for patients under the program.
Prof. Vinod K Diwan
|Official Address||Other Information|
|1||N Kumarasamy||YRG Care
|2||Anita Shet||CBCI Society for Medical Education
|3||Per Ashorn||University of Tampere
|4||Mattias Larsson||Hanoi Medical University
|5||Clas Källander||Cavidi AB