International HIV Antiretroviral Adherence, Resistance and Survival (UARTO)
Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in Uganda|
- Adherence to antiretroviral therapy [ Time Frame: real time (up to 7 years) ] [ Designated as safety issue: No ]Adherence is assessed through a medication event monitoring system which records every time the device is opened (e.g. for pill taking). Before June 2012, this data was stored on the device and downloaded monthly. After June 2012, this data is transmitted through cellular networks to a central server in real time.
- Correlates of adherence to antiretroviral therapy [ Time Frame: every four months ] [ Designated as safety issue: No ]Questionnaires are administered to participants regarding factors such as depression, stigma, food insecurity, reproductive health, and economic status.
- Biological consequences of adherence (or incomplete adherence) [ Time Frame: every four months and during adherence interruptions ] [ Designated as safety issue: No ]Specimens are collected for immunologic and genetic testing at baseline and every four months, as well as during interruptions in adherence as detected by the real time adherence monitoring system.
- Adherence to antiretroviral therapy by self report [ Time Frame: every four months ] [ Designated as safety issue: No ]Participants report their adherence over the previous 3 and 28 days by doses missed and visual analog scale.
Biospecimen Retention: Samples With DNA
plasma, buffy coat, saliva
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
The investigators will study use a novel method of real-time wireless adherence monitoring in one of the best established multi-disciplinary HIV antiretroviral treatment cohorts in rural Africa. The investigators will advance our theoretical understanding of HIV antiretroviral adherence behavior, HIV pathogenesis, and to address the monitoring and prevention of HIV antiretroviral treatment failure. Based on a successful pilot study in rural Uganda and favorable cost-effective estimates, the investigators will deploy the Wisepill real-time wireless adherence monitoring system to objectively monitor adherence in real time. The investigators will determine to what extent social capital mitigates economic barriers to long-term adherence and determine if the pervasive impact of stigma on adherence operates through social capital (Aim 1). The investigators will determine the relationship between missed doses, low-level viremia (between 1 and 50 copies RNA/mL), inflammation, bacterial translocation, suboptimal CD4 response, and mortality (Aim 2). Finally, The investigators will examine the relationship between complex adherence patterns and viral failure to both inform selective viral load monitoring and to lay the foundation for the first-of-kind intervention to prevent viral failure after missed doses, but before viral rebound (Aim 3). The investigators will secure behavioral and biologic data over nine years of potential treatment by recruiting 500 additional people to our existing cohort in Mbarara, Uganda for a total of 775 participants.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596322
|Contact: Yap Boum, PHDfirstname.lastname@example.org|
|Contact: Annet Kembabazi, BA, MAemail@example.com|
|Mbarara ISS Clinic, Mulago HIV Clinic||Recruiting|
|Principal Investigator: Mwebesa Bwana, Mmed, ChB|
|Principal Investigator:||David Bangsberg, MD||Massachusetts General Hospital|