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

Abstract

Antiretroviral therapy for the treatment of HIV infection requires high levels of adherence to both maintain plasma HIV RNA at undetectable levels and prevent the emergence of drug resistance. As adherence to treatment is a major criterion for the evaluation of therapeutic outcomes, randomized clinical trials (RCTs) conducted among HIV-infected patients commonly include an assessment of adherence. However, there is still no gold-standard tool for assessing adherence behaviors in HIV RCTs. The methods currently used to collect and analyze adherence data are varied, which makes the comparison of results between studies difficult. The scope of this article is to review and discuss the range of adherence measures currently used in RCTs conducted among HIV-infected adults.

Keywords::

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

Acknowledgement

The authors wish to thank Jude Sweeney for the English revision and editing of this manuscript.

Financial & competing interests disclosure

The authors are French researchers in the area of social sciences in health, with a focus on psychosocial issues associated with HIV infection. Their work is mainly devoted to encouraging the integration of patient-reported outcomes in HIV research, as an essential complement to clinical end points. They are involved in the design and analysis of cohort studies and clinical trials conducted both in high- and low-income settings, mostly funded by the French National Agency for Research on AIDS and Viral Hepatitis (ANRS). Since 2007, B Spire has been the National President of AIDES, the main nongovernmental HIV organization in France. As President, he is involved in major advocacy fields, including the rights of minorities, gay men, injecting drug users and migrants, in order to guarantee an equal access to care. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.