International HIV Antiretroviral Adherence, Resistance and Survival

NCT01596322 | Completed

• 1 other identifier: UARTO, R01 MH054907
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV/AIDS

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlates of adherence to antiretroviral therapy

  every four months

• Biological consequences of adherence (or incomplete adherence)

  every four months and during adherence interruptions

• Adherence to antiretroviral therapy by self report

  every four months

Study Arms (1)

UARTO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV positive adults 18 years and older, who are ART naive and initiating ART at either Mbarara HIV clinic or Mulago HIV clinic in Uganda

You may qualify if:

• 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

You may not qualify if:

• Patients who do initiate therapy during the course of the study recruitment
• Patients who decline or are unable to give consent

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of California, San Francisco: collaborator
• Department of Health and Human Services: collaborator
• Mbarara University of Science and Technology: collaborator
• University of British Columbia: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Mbarara ISS Clinic, Mulago HIV Clinic

Mbarara, Uganda

Location

Related Publications (9)

• Altice FL, Friedland GH. The era of adherence to HIV therapy. Ann Intern Med. 1998 Sep 15;129(6):503-5. doi: 10.7326/0003-4819-129-6-199809150-00015. No abstract available.

  PMID: 9735090 RESULT

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

  PMID: 10546786 RESULT

• Sontag D, Richardson L. Doctors withhold H.I.V. pill regimen from some. N Y Times Web. 1997 Mar 2:1, 35. No abstract available.

  PMID: 11647150 RESULT

• 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. doi: 10.1097/00042560-200102010-00003.

  PMID: 11242178 RESULT

• Wainberg MA, Friedland G. Public health implications of antiretroviral therapy and HIV drug resistance. JAMA. 1998 Jun 24;279(24):1977-83. doi: 10.1001/jama.279.24.1977.

  PMID: 9643862 RESULT

• 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. doi: 10.1016/s0140-6736(01)05551-9.

  PMID: 11502341 RESULT

• 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. doi: 10.1097/00002030-200203080-00025. No abstract available.

  PMID: 11873017 RESULT

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

  RESULT

• Chang JL, Tsai AC, Musinguzi N, Haberer JE, Boum Y, Muzoora C, Bwana M, Martin JN, Hunt PW, Bangsberg DR, Siedner MJ. Depression and Suicidal Ideation Among HIV-Infected Adults Receiving Efavirenz Versus Nevirapine in Uganda: A Prospective Cohort Study. Ann Intern Med. 2018 Aug 7;169(3):146-155. doi: 10.7326/M17-2252. Epub 2018 Jun 26.

  PMID: 29946683 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, buffy coat, saliva

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jessica Haberer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: May 11, 2012
• Study Start: September 1, 2004
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

UG (1)