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International HIV Antiretroviral Adherence, Resistance and Survival

NCT ID: NCT01596322

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2015-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV/AIDS

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UARTO

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Department of Health and Human Services

FED

Sponsor Role collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jessica Haberer, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Haberer, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Mbarara ISS Clinic, Mulago HIV Clinic

Mbarara, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type RESULT
PMID: 9735090 (View on PubMed)

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

Reference Type RESULT
PMID: 10546786 (View on PubMed)

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.

Reference Type RESULT
PMID: 11647150 (View on PubMed)

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.

Reference Type RESULT
PMID: 11242178 (View on PubMed)

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.

Reference Type RESULT
PMID: 9643862 (View on PubMed)

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.

Reference Type RESULT
PMID: 11502341 (View on PubMed)

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.

Reference Type RESULT
PMID: 11873017 (View on PubMed)

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

Reference Type 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.

Reference Type DERIVED
PMID: 29946683 (View on PubMed)

Other Identifiers

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UARTO, R01 MH054907

Identifier Type: -

Identifier Source: org_study_id