International HIV Antiretroviral Adherence, Resistance and Survival (UARTO)
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ClinicalTrials.gov Identifier: NCT01596322
Recruitment Status :
First Posted : May 11, 2012
Last Update Posted : October 31, 2017
Massachusetts General Hospital
University of California, San Francisco
Department of Health and Human Services
Mbarara University of Science and Technology
University of British Columbia
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Jessica Haberer, MD, Massachusetts General Hospital
Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.
Condition or disease
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 750 participants.
Adherence to antiretroviral therapy [ Time Frame: real time (up to 7 years) ]
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.
Secondary Outcome Measures :
Correlates of adherence to antiretroviral therapy [ Time Frame: every four months ]
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 ]
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 ]
Participants report their adherence over the previous 3 and 28 days by doses missed and visual analog scale.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
HIV positive adults 18 years and older, who are ART naive and initiating ART at either Mbarara HIV clinic or Mulago HIV clinic in Uganda
HIV positive patients over 18 years
ART naive and initiating therapy at the Mbarara Immune Suppression Syndrome (ISS) Clinic
Live within 60 kilometers of the clinic
Women who have received a single dose of nevirapine for prevention of mother to child transmission, but have not received other ART, will be included
Patients who do initiate therapy during the course of the study recruitment
Patients who decline or are unable to give consent