A Randomized Trial of Directly Administered Antiretroviral Therapy and Adherence Case Management Intervention

Wohl, Amy Rock; Garland, Wendy H.; Valencia, Rosa; Squires, Kathleen; Witt, Mallory D.; Kovacs, Andrea; Larsen, Robert; Hader, Shannon; Anthony, Monique-Nicole; Weidle, Paul J.
June 2006
Clinical Infectious Diseases;6/1/2006, Vol. 42 Issue 11, p1619
Academic Journal
Background. A randomized, controlled trial was conducted to evaluate the impact of a directly administered antiretroviral therapy program (DAART) and intensive adherence case management (IACM) intervention on virologic and immunologic response to highly active antiretroviral therapy (HAART) among patients at 3 public human immunodeficiency virus clinics in Los Angeles County, California. Methods. Participants included 250 treatment-naive and treatment-experienced persons for whom no more than 1 prior HAART regimen had failed. Five days per week for 6 months, a community worker delivered 1 HAART dose to DAART participants and observed the participant take it. IACM participants met weekly with a case manager to overcome barriers to HAART adherence. A control group (the standard of care [SOC] group) received the usual care. Results. The majority of patients were Latino (64%) or African American (24%); 57% were monolingual Spanish speakers. Seventy-five percent of the patients were male, and 64% reported an annual income of <$10,000. In an intent-to-treat analysis, no statistical differences were observed in the percentage of patients with an undetectable viral load (i.e., <400 copies/mL) at 6 months between the DAART group (54%), IACM group (60%), and SOC group (54%; P>.05 ). An on-treatment analysis determined that there were no statistical differences in the percentage of patients with an undetectable viral load at 6 months between the DAART group (71%), IACM group (80%), and SOC group (74%; P>.)05. Additionally, there were no statistical differences in 6-month changes in the CD4+ cell count or in self-reported adherence to therapy. Conclusions. Among patients with limited prior HAART experience and adherence barriers that had not been assessed before randomization, no differences were found in virologic or immunologic response for DAART or IACM, compared with SOC, at 6 months. DAART and IACM did not improve short-term outcomes when SOC included other means of adherence support that were not controlled for by the study design.


Related Articles

  • Pre-existing Minority Drug-Resistant HIV-1 Variants, Adherence, and Risk of Antiretroviral Treatment Failure. Paredes, Roger; Lalama, Christina M.; Ribaudo, Heather J.; Schackman, Bruce R.; Shikuma, Cecilia; Giguel, Francoise; Meyer III, William A.; Johnson, Victoria A.; Fiscus, Susan A.; D'Aquila, Richard T.; Gulick, Roy M.; Kuritzkes, Daniel R. // Journal of Infectious Diseases;3/1/2010, Vol. 201 Issue 5, p662 

    Background. The clinical relevance of detecting minority drug-resistant human immunodeficiency virus type 1 (HIV-1) variants is uncertain. Methods. To determine the effect of pre-existing minority nonnucleoside reverse-transcriptase inhibitor (NNRTI)-resistant variants on the risk of virologic...

  • Antiretrovirals: HIV, hepatic impairment and HBV/HCV.  // WHO Drug Information;2005, Vol. 19 Issue 3, p214 

    The article presents information on the established the HIV/Hepatitis Co-infection Cohort Collaboration to plan to obtain information on the hepatic safety of highly active antiretroviral treatment in co-infected patients. During 2002, the European Medicines Agency requested the marketing...

  • Valaciclovir versus aciclovir for herpes simplex virus infection in HIV-infected individuals: two randomized trials. Conant, M. A.; Schacker, T. W.; Murphy, R. L.; Gold, J.; Crutchfield, L. T.; Crooks, R. J.; International Valaciclovir HSV Study Group // International Journal of STD & AIDS;Jan2002, Vol. 13 Issue 1, p12 

    Our objective was to evaluate valaciclovir for anogenital herpes in HIV-infected individuals using 2 controlled trials conducted before highly active antiretroviral therapy (HAART) was used. In Study 1, 1062 patients (CD4+ > or = 100 cells/mm(3)) received suppressive valaciclovir or aciclovir...

  • Resistance study to re-evaluate HAART. Kenyon, Georgina // Nature Medicine;May2001, Vol. 7 Issue 5, p515 

    Reports on the international trial to determine the effectiveness of the treatment for AIDS patients for failure of triple therapy on them. Development of HIV resistance to antiretroviral therapy (HAART); Increase in the global management of drug regime; Evaluation of the benefits for the...

  • Superiority of Directly Administered Antiretroviral Therapy over Self-Administered Therapy among HIV-Infected Drug Users: A Prospective, Randomized, Controlled Trial. Altice, Frederick L.; Maru, Duncan Smith-Rohrberg; Bruce, R. Douglas; Springer, Sandra A.; Friedland, Gerald H. // Clinical Infectious Diseases;9/15/2007, Vol. 45 Issue 6, p770 

    Background. Directly administered antiretroviral therapy (DAART) is one approach to improve treatment adherence among human immunodeficiency virus (HIV)-infected drug users. Methods. In this randomized, controlled trial (ClinicalTrials.gov identifier, NCT00367172), the biological outcomes of a...

  • Development and Efficacy of an Intervention to Enhance Readiness for Adherence among Adults Who Had Previously Failed HIV Treatment. Enriquez, Maithe; An-Lin Cheng; McKinsey, David S.; Stanford, James // AIDS Patient Care & STDs;Mar2009, Vol. 23 Issue 3, p177 

    This paper outlines the development and initial testing of the READY intervention that was designed to enhance readiness for adherence among adults with a history of nonadherence to HIV treatment. Participants in this study were adults ( n = 28) who ranged in age from 24 to 57: most were male...

  • Low Rates of Antiretroviral Therapy among HIVInfected Patients with Chronic Kidney Disease. Choi, Andy I.; Rodriguez, Rudolph A.; Bacchetti, Peter; Volberding, Paul A.; Havlir, Diane; Bertenthal, Daniel; Bostrom, Alan; O'Hare, Ann M. // Clinical Infectious Diseases;12/15/2007, Vol. 45 Issue 12, p1633 

    Background. It is unknown whether chronic kidney disease (CKD) influences receipt of highly active antiretroviral therapy (HAART) among patients with the human immunodeficiency virus (HIV) and whether prescription practices contribute to excess mortality. Methods. We conducted a retrospective...

  • Delayed Progression to Death and to AIDS in a Hong Kong Cohort of Patients with Advanced HIV Type 1 Disease During the Era of Highly Active Antiretroviral Therapy. Ka Hing Wong; Kenny Chi Wai Chan; Shui Shan Lee // Clinical Infectious Diseases;9/15/2004, Vol. 39 Issue 6, p853 

    Background. The magnitude of the impact of highly active antiretroviral therapy (HAART) since its introduction in non-Western countries is not entirely clear. We studied disease progression among adult patients with advanced human immunodeficiency virus type 1 (HIV-1) infection in the pre-HAART...

  • Providing antiretroviral treatment in Thailand.  // Report on the Global HIV/AIDS Epidemic: UNAIDS - 2004;1/1/2004, p106 

    The article offers information on the antiretroviral treatment program in Thailand. According to the author, lower drug prices have contributed to a fivefold increase in the number of human immunodeficiency virus (HIV)-positive patients receiving antiretroviral treatment in the country. It was...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics