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
  Purpose

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


Condition
HIV/AIDS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in Uganda

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 775
Study Start Date: September 2004
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596322

Contacts
Contact: Yap Boum, PHD 011256772721751 yap.boum@epicentre.msf.org
Contact: Annet Kembabazi, BA, MA 011256782027158 akembabazi5@yahoo.com

Locations
Uganda
Mbarara ISS Clinic, Mulago HIV Clinic Recruiting
Mbarara, Uganda
Principal Investigator: Mwebesa Bwana, Mmed, ChB         
Sponsors and Collaborators
Massachusetts General Hospital
University of California, San Francisco
Mbarara University of Science and Technology
University of British Columbia
Dana-Farber Cancer Institute
Investigators
Principal Investigator: David Bangsberg, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: David Bangsberg, MD, Director, MGH Center for Global Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01596322     History of Changes
Other Study ID Numbers: UARTO, R01 MH054907
Study First Received: April 22, 2010
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board
Uganda: National Council for Science and Technology

Keywords provided by Massachusetts General Hospital:
HIV/AIDS in resource limited setting
HIV treatment outcomes in resource limited setting
Adherence to HIV treatment in resource limited setting
ART resistance in resource limited setting

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014