International HIV Antiretroviral Adherence, Resistance and Survival (UARTO)

Mass General Brigham

Status: Completed

Conditions: HIV/AIDS

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01596322

UARTO, R01 MH054907

Details and patient eligibility

About

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

Full 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.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

750 participants in 1 patient group

UARTO