Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.
J Int AIDS Soc
; 19(1): 20642, 2016.
Article
en En
| MEDLINE
| ID: mdl-26850270
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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Infecciones por VIH
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Fármacos Anti-VIH
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Cumplimiento de la Medicación
/
Profilaxis Pre-Exposición
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Tenofovir
Tipo de estudio:
Clinical_trials
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Prognostic_studies
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Qualitative_research
Límite:
Adult
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Female
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Humans
Idioma:
En
Revista:
J Int AIDS Soc
Asunto de la revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Año:
2016
Tipo del documento:
Article
País de afiliación:
Estados Unidos