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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 calculate the combined predictive ability of the behavioural measures as summarized by area under the curve (AUC). Baseline characteristics associated with over-reporting daily product use relative to PK measures was assessed using a Generalized Linear Mixed Model. RESULTS:In this random adherence cohort of VOICE participants assigned to active products, (N = 472), PK non-adherence was 69% in the oral group (N = 314) and 65% in the vaginal group (N = 158). Behaviourally, ≤ 10% of the cohort reported low/none use with any behavioural measure and accuracy was low (≤ 43%). None of the regression models had an AUC > 0.65 for any single or combined behavioural measures. Significant (p < 0.05) correlates of over-reporting included being very worried about getting HIV and being unmarried for the oral group; whereas for the vaginal group, being somewhat worried about HIV was associated with lower risk of over-reporting. CONCLUSIONS:PK measures indicated similarly low adherence for the oral and vaginal groups. No behavioural measure accurately predicted PK non-adherence. Accurate real-time measures to monitor product adherence are urgently needed. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT00705679.

journal_name

J Int AIDS Soc

journal_title

Journal of the International AIDS Society

authors

van der Straten A,Brown ER,Marrazzo JM,Chirenje MZ,Liu K,Gomez K,Marzinke MA,Piper JM,Hendrix CW,MTN-003 VOICE Protocol Team for Microbicide Trials Network.

doi

10.7448/IAS.19.1.20642

subject

Has Abstract

pub_date

2016-02-04 00:00:00

pages

20642

issue

issn

1758-2652

pii

20642

journal_volume

pub_type

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