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Completed

NCT Number: NCT01596322

International HIV Antiretroviral Adherence, Resistance and Survival

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

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mbarara ISS Clinic, Mulago HIV Clinic

Mbarara, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Department of Health and Human Services
  • Mbarara University of Science and Technology
  • University of British Columbia
  • University of California, San Francisco

Registry information

Official study title

Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in Uganda

Acronym: UARTO

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
May 11, 2012
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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