Assessing adherence to antiretroviral therapy in randomized HIV clinical trials: a review of currently used methods

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From: Expert Review of Anti-infective Therapy(Vol. 11, Issue 3)
Publisher: Expert Reviews Ltd.
Document Type: Clinical report
Length: 8,758 words
Lexile Measure: 1500L

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Author(s): Fabienne Marcellin [*] 4 , Bruno Spire 1 , Maria Patrizia Carrieri 1 , Perrine Roux 1



adherence; antiretroviral therapy; ART; clinical trial; HAART; HIV

Adherence to antiretroviral therapy (ART) is a major determinant of virological response, immune restoration [1] and clinical progression [2] among HIV-infected individuals. Although the relationships between adherence and resistance are complex and depend notably on the type of antiretroviral drugs considered [3] , suboptimal adherence is known to increase the risk of hospitalization and death [1] and to foster the development of drug resistance [4] . Therefore, the assessment of adherence to ART has long been included in the design of randomized clinical trials (RCTs) conducted among HIV-infected patients and is a key component of a successful evaluation of therapeutic outcomes [5] . However, there is still no consensus on the single best method to use for assessing adherence behaviors [6] . This is true in terms of both research context and clinical practice. In 2000, Miller et al . drew up a list of adherence measures commonly used in HIV clinical trials, along with their merits and shortcomings, but to our knowledge, no study has since provided an updated description of the adherence toolbox that can be used in HIV RCTs [7] . The purpose of this review is to describe and discuss the range of adherence measures currently used in RCTs conducted among HIV-infected adults, focusing on publications during the past 5 years.

Criteria & methods used for the review of published literature

A systematic primary search of the MEDLINE database (Pubmed) was conducted among articles published between the years 2007 and 2012, using the following Medical Subject Headings terms: HIV, adherence, antiretroviral therapy and clinical trial. The following two criteria were then used to select from the search results: RCTs conducted among HIV-infected adults (over 18 years old) and primary or secondary end points including assessment of adherence to ART.

Main characteristics of the studies reviewed

The primary search provided 213 references. Among these, only 50 met the selection criteria. The design of the corresponding 50 studies is described in Table 1. Most of the associated trials were conducted in the USA [8-31] . The others took place in Africa [32-44] , Asia [45,46] or in Europe [47-51] . Six trials were intercontinental [52-57] . Twenty one studies included only ART-naive patients [24,26,28,29,32,34,35,37-44,50,52-54,[56,57] , 17 included only ART-experienced patients [11-14,18,20,25,27,30,31,33,46-49,51,55] and the remaining 12 had no restrictions with regard to participant exposure to ART [8-10,15-17,19,21-23,36,45] . Some studies were conducted in specific subpopulations, including drug users [9,11,16,19,21,46] , women [12,13,32] , patients with low socioeconomic status [22,23] , and finally, patients with HIV-associated Kaposi sarcoma [38] . Twenty-six studies assessed interventions aimed at improving adherence to ART, 20 compared therapeutic strategies, three compared adherence measures and one evaluated the efficacy of a therapeutic strategy for the prevention of mother-to-child transmission. Finally, adherence to ART was one of the primary outcomes for half of the studies (n = 25), while it was among the secondary outcomes for the other half.

Adherence to ART: which levels are considered optimal?

Very high levels of...

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Gale Document Number: GALE|A321012722