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International HIV Antiretroviral Adherence, Resistance and Survival (UARTO)

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ClinicalTrials.gov Identifier: NCT01596322
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : October 31, 2017
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

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

Condition or disease

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 750 participants.

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Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in Uganda
Actual Study Start Date : September 2004
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

Biospecimen Retention:   Samples With DNA
plasma, buffy coat, saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596322

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Mbarara ISS Clinic, Mulago HIV Clinic
Mbarara, Uganda
Sponsors and Collaborators
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
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Principal Investigator: Jessica Haberer, MD Massachusetts General Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jessica Haberer, MD, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01596322    
Other Study ID Numbers: UARTO, R01 MH054907
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Keywords provided by Jessica Haberer, MD, 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:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases