International HIV Antiretroviral Adherence, Resistance and Survival

HIV/AIDS Clinical Trial

— UARTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596322
• Other study ID #: UARTO, R01 MH054907
• Status: Completed
• Phase: N/A
• First received: April 22, 2010
• Last updated: October 29, 2017
• Start date: September 2004
• Est. completion date: September 2015

Study information

• Verified date: October 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Locations

Country	Name	City	State
Uganda	Mbarara ISS Clinic, Mulago HIV Clinic	Mbarara

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	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

Country where clinical trial is conducted

Uganda, 

References & Publications (8)

Altice FL, Friedland GH. The era of adherence to HIV therapy. Ann Intern Med. 1998 Sep 15;129(6):503-5. — View Citation

Friedland GH, Williams A. Attaining higher goals in HIV treatment: the central importance of adherence. AIDS. 1999 Sep;13 Suppl 1:S61-72. Review. — View Citation

Harries AD, Nyangulu DS, Hargreaves NJ, Kaluwa O, Salaniponi FM. Preventing antiretroviral anarchy in sub-Saharan Africa. Lancet. 2001 Aug 4;358(9279):410-4. — View Citation

Popp D, Fisher JD. First, do no harm: a call for emphasizing adherence and HIV prevention interventions in active antiretroviral therapy programs in the developing world. AIDS. 2002 Mar 8;16(4):676-8. — View Citation

Sontag D, Richardson L. Doctors withhold H.I.V. pill regimen from some. N Y Times Web. 1997 Mar 2:1, 35. — View Citation

Tchetgen E, Kaplan EH, Friedland GH. Public health consequences of screening patients for adherence to highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2001 Feb 1;26(2):118-29. — View Citation

UNAIDS. Report on the global HIV/AIDS epidemic. Geneva: UNAIDS, 2002

Wainberg MA, Friedland G. Public health implications of antiretroviral therapy and HIV drug resistance. JAMA. 1998 Jun 24;279(24):1977-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	real time (up to 7 years)
Secondary	Correlates of adherence to antiretroviral therapy	Questionnaires are administered to participants regarding factors such as depression, stigma, food insecurity, reproductive health, and economic status.	every four months
Secondary	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.	every four months and during adherence interruptions
Secondary	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.	every four months