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

18 Years
Open (Enrolling)

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Trial Information

Novel Approaches to Monitoring and Utilizing Adherence to HIV Therapy in 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 775 participants.

Inclusion Criteria:

- HIV positive patients over 18 years

- ART naive and initiating therapy at the Mbarara Immune Suppression Syndrome (ISS)

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Adherence to antiretroviral therapy

Outcome Description:

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.

Outcome Time Frame:

real time (up to 7 years)

Safety Issue:


Principal Investigator

David Bangsberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:

UARTO, R01 MH054907



Start Date:

September 2004

Completion Date:

March 2015

Related Keywords:

  • 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
  • Acquired Immunodeficiency Syndrome