Enhancing HIV treatment adherence in South India: The Chetana study

Investigator: Maria Ekstrand, PhD
Sponsor: NIH National Institute of Mental Health

Location(s): India


The global scale up of antiretroviral treatment has resulted in decreased mortality rates and improved quality of life in both resource rich and resource-limited settings. However, the long-term success of these programs depends on excellent medication adherence in order to maximize the durability of available regimens and reduce the development of drug resistance. The proposed study was designed to meet this need by testing a novel and sustainable adherence-enhancing intervention that addresses, in a comprehensive manner, the needs of People Living with HIV in India and, if found effective, would have implications for adherence research both in other resource-limited settings and in the US.

Enhancing HIV treatment adherence in South India: The Chetana Study Excellent adherence to antiretroviral therapy is essential to achieve HIV suppression and long term treatment success, especially in settings where antiretroviral treatment options may be limited. To accomplish this, it is vitally important that we develop and test culturally appropriate adherence interventions that target local adherence patterns and barriers and that can be quickly scaled up and sustained by local groups. There is also a need for reliable and valid objective adherence monitoring strategies to supplement self-report, which tends to overestimate true adherence rates. The recently developed "Wisepill", which will be used in this study, has the potential to accomplish this. It uses mobile and wireless technology to monitor adherence in real-time and appears to overcome many of the limitations of other objective measures, such as MEMS caps, pharmacy refill records or unannounced pill counts, which are not always feasible in Resource-Limited Settings (RLS). There are few adherence interventions developed for RLS and none have been shown effective in India. This application addresses this gap, building directly on findings from our ongoing collaborative research program examining ART adherence in Bengaluru, India (R01MH067513). To date, we have identified local patterns of non-adherence that predict both treatment failure and the development of drug resistance. We have also documented barriers to optimal adherence in this setting, including the role of AIDS stigma. Based on this work, we developed and pilot-tested "Chetana", a promising, culturally relevant adherence-enhancing intervention that addresses, in a comprehensive manner, the needs of People Living with HIV/AIDS (PLHA). This proposed innovative program is grounded in Social Cognitive Theory (SCT), with specific content based on our previous descriptive research and extensive pilot testing. In response to participant feedback, it targets not only medication adherence, but also includes other culturally-relevant topics designed to enhance physical and mental health among PLHA, including yoga/meditation, nutrition, legal services, and assistance accessing local resources. It is administered in both group and individual format, is designed to provide peer support for those who do not have sufficient support from family and friends, is flexible enough to be tailored to individual needs, and, if found to be efficacious, could easily be scaled up and sustained with the help of local NGOs. Preliminary research demonstrates the feasibility and acceptability of this intervention among sub-optimally adherent PLHA and pilot data suggest that it can help participants reduce adherence barriers, improve adherence and reduce treatment interruptions. We now propose to evaluate the effects of this promising intervention in a Randomized Controlled Trial among 500 sub-optimally adherent patients, comparing it to a time-matched active control condition, consisting of only the non-adherence specific components of the intervention and standard clinic counseling.