International HIV Antiretroviral Adherence, Resistance and Survival

Massachusetts General Hospital750 enrolled

Overview

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 750 participants.

Study Type

OBSERVATIONAL

Enrollment

750

Conditions

HIV/AIDS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mbarara ISS Clinic, Mulago HIV Clinic

Mbarara, Uganda

Outcomes

Primary Outcomes

Adherence to antiretroviral therapy

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.

Time frame: real time (up to 7 years)

Secondary Outcomes

Correlates of adherence to antiretroviral therapy

Questionnaires are administered to participants regarding factors such as depression, stigma, food insecurity, reproductive health, and economic status.

Time frame: every four months

Biological consequences of adherence (or incomplete adherence)

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.

Time frame: every four months and during adherence interruptions

Adherence to antiretroviral therapy by self report

Participants report their adherence over the previous 3 and 28 days by doses missed and visual analog scale.

Time frame: every four months

Data from ClinicalTrials.gov

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