title: An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings.
abstract: BACKGROUND
  Product 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Social and Behavioral Health Sciences, FHI 360, Durham, NC, USA; kmacqueen@fhi360.org.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: MacQueen
authors.affiliation: Social and Behavioral Health Sciences, FHI 360, Durham, NC, USA.
authors.forename: Elizabeth E
authors.initials: EE
authors.lastname: Tolley
authors.affiliation: Contraceptive Technology Institute, FHI 360, Durham, NC, USA.
authors.forename: Derek H
authors.initials: DH
authors.lastname: Owen
authors.affiliation: Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, USA.
authors.forename: K Rivet
authors.initials: KR
authors.lastname: Amico
authors.affiliation: Centers for Behavioral & Preventive Medicine, The Miriam Hospital, Providence, RI, USA; Department of Psychiatry & Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Morrow
authors.affiliation: Reprotect Inc, Baltimore, MD, USA; The Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Moench
authors.affiliation: Product Development, CONRAD, Arlington, VA, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Friend
authors.affiliation: Population Council, New York, NY, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Friedland
mesh_terms: D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D018890:Chemoprevention / Q000379:methods*; D003274:Contraceptive Devices, Female; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D055118:Medication Adherence; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D016032:Randomized Controlled Trials as Topic
chemical_list: D044966:Anti-Retroviral Agents
keywords: HIV prevention; acceptability; adherence; clinical trial research; measurement; vaginal ring