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International HIV Antiretroviral Adherence, Resistance and Survival (UARTO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Massachusetts General Hospital
Sponsor:
Collaborators:
University of California, San Francisco
Mbarara University of Science and Technology
University of British Columbia
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
David Bangsberg, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01596322
First received: April 22, 2010
Last updated: June 26, 2013
Last verified: June 2013

April 22, 2010
June 26, 2013
September 2004
March 2015   (final data collection date for primary outcome measure)
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.
Adherence to antiretroviral therapy [ Time Frame: real time (up to 3 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.
Complete list of historical versions of study NCT01596322 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
International HIV Antiretroviral Adherence, Resistance and Survival
Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in Uganda

Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

plasma, buffy coat, saliva

Probability Sample

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/AIDS
Not Provided
UARTO

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
775
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who do initiate therapy during the course of the study recruitment
  • Patients who decline or are unable to give consent
Both
18 Years and older
No
Contact: Yap Boum, PHD 011256772721751 yap.boum@epicentre.msf.org
Contact: Annet Kembabazi, BA, MA 011256782027158 akembabazi5@yahoo.com
Uganda
 
NCT01596322
UARTO, R01 MH054907
No
David Bangsberg, MD, Massachusetts General Hospital
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
Principal Investigator: David Bangsberg, MD Massachusetts General Hospital
Massachusetts General Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP