Acceptability in microbicide and PrEP trials: current status and a reconceptualization

Mensch, Barbara S.a; van der Straten, Arianeb; Katzen, Lauren L.a

doi: 10.1097/COH.0b013e3283590632
PRE-EXPOSURE PROPHYLAXIS: Edited by Kenneth H Mayer

Purpose of review: Assessment of acceptability is a central component of most oral PrEP and microbicide trials. In this paper we review current definitions and frameworks employed in acceptability research, discuss findings from recent studies of product acceptability and summarize trends in acceptability research. We conclude by offering a new framework for investigating product acceptability within clinical trials, one which considers product acceptability to be conceptually distinct from adherence.

Recent findings: Although numerous studies have investigated product acceptability, a consensus is lacking regarding the definition and operationalization of the concept. In addition fewer than half of the studies reviewed investigated actual candidate products. To the extent that an overall measure of acceptability is considered, the consensus is that most participants find the products acceptable. However, it is the rare study that investigates whether product adherence is associated with acceptability.

Summary: Given that adherence is critical to the success of clinical trials, it is important to identify the extent to which acceptability is a factor in product usage and to ascertain which dimensions of acceptability – product attributes, dosing regimen, delivery mechanism, use attributes, partner's attitudes, effect of product on the sexual encounter, product-related norms – if any, affect adherence.

aPopulation Council USA, New York

bWomen's Global Health Imperative, RTI International, San Francisco, USA

Correspondence to Barbara S. Mensch, Senior Associate, Population Council USA, One Dag Hammarskjold Plaza, New York, NY 10017, USA. Tel: +1 212 339 0640; e-mail: bmensch@popcouncil.org

© 2012 Lippincott Williams & Wilkins, Inc.