Abstract
IntroductionProduct adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials.DiscussionThe interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings) and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1) adherence support – sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2) self-reported psychometric measures – creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3) more objective measurement of adherence – real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion. Coordinating research along these three pathways will result in a comprehensive approach to product adherence within clinical trials.ConclusionsBetter measurement of adherence will not, by itself, ensure that future effectiveness trials will be able to address the most basic question: if the product is used per instructions, will it prevent HIV transmission? The challenges to adherence measurement must be addressed as one component of a more integrated system that has as its central focus adherence as a behaviour emerging from the social context of the user.
Highlights
Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies
The interdisciplinary framework highlights the dual use of adherence measurement and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour
Better measurement of adherence will not, by itself, ensure that future effectiveness trials will be able to address the most basic question: if the product is used per instructions, will it prevent HIV transmission? The challenges to adherence measurement must be addressed as one component of a more integrated system that has as its central focus adherence as a behaviour emerging from the social context of the user
Summary
In July 2010, the CAPRISA 004 clinical trial of tenofovir 1% gel demonstrated that an ARV-based vaginal gel could prevent acquisition of HIV [1]. Self-reported adherence has been shown to over-estimate product use to varying degrees in ARV-based HIV prevention trials, collecting information on reasons for non-adherence and participants’ experiences with product use more generally is essential to providing effective counselling and support for proper use of all such products, including vaginal rings. In the case of vaginal rings, the wide intra-individual variability in drug blood levels during use creates challenges for accurately assessing how long an ARV-based ring has been inserted or if it has been removed or expelled and reinserted [22]. Empirical data on the fidelity of research teams to adherence support guidelines is limited, further undermining efforts to understand the effectiveness of a given adherence support approach Biometric measures such as drug levels have undergone continual refinement in the context of the very trials where those measures have been used to evaluate adherence. Innovative approaches sometimes have difficulty getting traction in clinical trials, due to concerns about their impact on trial implementation in the absence of pilot data
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