HIVIND is a European Union (EU) funded FP7 project, coordinated by the Division of Global Health at Karolinska Institutet, Stockholm, Sweden, with the main objective of improving adherence to first line antiretrovirals among HIV patients in South India using locally relevant innovative means.

Specifically, this study is a randomized controlled trial of an approach using a contextually relevant intervention (mobile telephones) to influence ART adherence in 600 ART naïve, HIV+ Indian patients eligible for ART, in Karnataka and Tamil Nadu in India. 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.

Below you will find information on Project Partners, Objectives, Work Packages and Potential Impact.

PROJECT PARTNERS

Karolinska Institutet, Dept of Public Health, Division of Global Health, Stockholm, Sweden (Coordinator)

CBCI Society for Medical Education (St. John’s National Academy of Health Sciences), Bangalore, Karnataka, India

YR Gaitonde Medical Education and Research Foundation, Chennai, Tamil Nadu, India

Hanoi Medical University, Hanoi, Vietnam

University of Tampere, Tampere, Finland

Cavidi AB, Uppsala, Sweden

OBJECTIVES OF THE PROJECT

Overall Aim

This project aims to study a contextually relevant intervention to promote adherence in ART naïve, HIV+ Indian patients, in a randomized controlled trial design. The intervention, called hereafter the Mobile phone treatment support design (MTS) 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. Further, new, simpler and inexpensive ELISA based techniques to assess viral load and resistance will be evaluated in these contexts.

Specific Objectives

1. To create a platform and follow up a study population 600 ART naive, HIV+ Indian patients who are eligible to be initiated on ART. The study population will be randomized into two different arms, MTS and CT. Follow up will include clinical examinations, assessments of adherence, viral load and CD4+ counts at predetermined points in time for a minimum of 24 months or till the development of resistance whichever is earlier.

2. To compare the two arms in terms of proportion of patients and timing (since initiation of ART) of failing treatment (virological failure).

3. To type the resistance (mutations) detected in the cohort.

4. To compare the influence of MTS intervention on adherence to first line ART and to compare then the influence of adherence on virological failure in this setting.

5.To study contextual predictors of failure – socioeconomic, demographic and nutritional

6. To correlate different adherence measures used in the study (3d recall, VAS and mobile telephone based)

7. Further to study quantitatively the association of other factors (socio economic, gender, system related, therapy related, and patient factors) with ART adherence.

8. To explore qualitatively barriers to adherence and the experience of having treatment support via the mobile telephone intervention.

9. To evaluate the ELISA based load tests (ExaVir Load) among Indian patient cohorts. This test will be evaluated against the gold standard (polymerase chain reaction). The sensitivity, specificity and predictive value of ExaVir Load in these setting will be studied.

10. To describe the incidence and manifestations of opportunistic infections (OI). A nested case–control within the cohort will used to assess factors (socio economic, demographic, nutritional and disease related parameters associated with defined common OIs

11. To describe the incidence and manifestations of immune reconstitution syndrome (IRIS). A nested case–control within the cohort will used to assess factors (socio economic, demographic, and disease related parameters associated with IRIS

12. To describe the incidence and manifestations of adverse events in a cohort of 600 patients

13. To describe the use of antibiotic medication (other than first line ART) in the cohort and compare this in the two arms.

14. To assess the cost effectiveness of two strategies in relation to the outcomes. The entire cost effectiveness analysis will be done principally from a societal perspective.

WORK PACKAGES (WP)

The project will be executed through a series of work packages. Each work package is led by one of the partners. The work pacakges and their titles are listed here. For more details, please contact vinod.diwan(a)ki.se

WP1 – Creation of clinical platform

WP2 – Comparison of adherence in the two areas

WP3 – Load and resistance using context appropriate viral load and resistance tests

WP4 – Study and describe the detection of OIs, IRIS, adverse drug reactions in the patient cohorts

WP5 – Cost effectiveness of two strategies in relation to the outcomes

WP6 – Dissemination and linkages

WP7 – Project Management

WP8 – Ensuring ethical sensitivity in the project

POTENTIAL IMPACT OF THE PROJECT

As scale up of treatment is planned, adherence is a key issue that needs to be addressed. High adherence to antiretroviral treatment (ART) for HIV is a key determinant of the degree and durability of viral suppression and is associated with a lower rate of disease progression, hospitalization and mortality. Given the potential for rapid development of drug resistant viral strains, poor adherence has serious consequences for individual and public health due to treatment failure, increased morbidity/mortality and the risk of transmission from non-adherent patients with poor virological control. From an economic perspective, poor adherence and resistance development can be devastating, particularly in a resource constrained setting, due to the prohibitive costs of second line antiretroviral treatment (ART).

Mobile phones in India: Stepping up telecommunications technology in resource limited healthcare settings has been included as a World Health Organization/UNAIDS priority. The existence of a so-called “digital divide” along socio-economic gradients is far less with mobile phones than with other communication technologies such as the Internet. This non requirement of massive infrastructure has led to an increasing access to cell phones even in remote areas.

As of March 2009, India had a total of 391 million cell phone subscribers (as against 40 million fixed lines). In the last year, there have been on average between 10 and 12 million new mobile phone subscriptions every month in the country.

The use of telecommunications technology in resource constrained settings is a potentially important innovation for enhancing adherence, but is considerably underdeveloped. Given the widespread growth of mobile phone use in the country and the increasing number of patients on HIV treatment, its use in adherence promotion is timely and appropriate in this setting. This will be tested in a randomized trial design under the HIVIND project.

The project will also provide important information on the proportion of patients failing first line ART, adherence levels and factors influencing them, a possible adherence influencing strategy, the feasibility of employing less expensive tests to monitor viral load (which has consequences for individual patients and public health), the incidence and manifestations of OIs, IRIS and AEs in an Indian cohort.