International HIV Antiretroviral Adherence, Resistance and Survival

Completed

• Conditions: HIV/AIDS

• Registration Number: NCT01596322
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-11
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to antiretroviral therapy	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

Name	Time	Method
Adherence to antiretroviral therapy by self report	every four months	Participants report their adherence over the previous 3 and 28 days by doses missed and visual analog scale.
Correlates of adherence to antiretroviral therapy	every four months	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)	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.

Trial Locations

Locations (1)

Mbarara ISS Clinic, Mulago HIV Clinic; 🇺🇬 Mbarara, Uganda