Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.

ABSTRACT:

Introduction

In the Microbicide Trial Network MTN-003 (VOICE) study, a Phase IIB pre-exposure prophylaxis trial of daily oral or vaginal tenofovir (TFV), product adherence was poor based on pharmacokinetic (PK) drug detection in a random subsample. Here, we sought to compare behavioural and PK measures of adherence and examined correlates of adherence misreporting.

Methods

We included participants with PK and behavioural data from VOICE random subsample. Behavioural assessments included face-to-face interviews (FTFI), audio computer-assisted self-interviewing (ACASI) and pharmacy-returned product counts (PC). TFV concentrations < 0.31 ng/mL in plasma (oral group) and < 8.5 ng/swab in vaginal group were defined as "PK non-adherent." Logistic regression models were fit to calc

SUBMITTER: van der Straten A 

PROVIDER: S-EPMC4744323 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature