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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4744323 | PMC |
| http://dx.doi.org/10.7448/IAS.19.1.20642 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Probing the Self-Aggregation of l-Tryptophan into Spherical Microstructures and Their Selective Interactions with Bilirubin.
ACS Appl Bio Mater
January 2025
Department of Chemistry, Indian Institute of Technology Palakkad, Palakkad, Kerala 678 623, India.
The aggregation of proteins, peptides and amino acids has been a keen subject of interest owing to their implications in metabolic disorders. In this work, we investigated the self-aggregation of the unmodified aromatic amino acid l-tryptophan (Trp) into unusual spherical microstructures. Using fluorescence spectroscopy and field emission scanning electron microscopy (FE-SEM), we detail the time-dependent transformation of monomeric tryptophan into spherical aggregates with distinct fluorescence characteristics (λ = 345 nm, λ = 430 nm) compared to the monomer.
View Article and Find Full Text PDFMedicaid Spending in Coordination-Only Dual-Eligible Special Needs Plans.
JAMA Netw Open
January 2025
Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.
Importance: More than 4 million Medicare beneficiaries have enrolled in dual-eligible Special Needs Plans (D-SNPs), and coordination-only D-SNPs are common. Little is known about the impact of coordination-only D-SNPs on Medicaid-covered services and spending, including long-term services and supports, which are financed primarily by Medicaid.
Objective: To evaluate changes in Medicaid fee-for-service (FFS) spending before and after new enrollment in coordination-only D-SNPs vs new enrollment in non-D-SNP Medicare Advantage (MA) plans among community-living beneficiaries enrolled in both Medicare and North Carolina Medicaid.
Cerebral Microbleeds and Amyloid Pathology Estimates From the Amyloid Biomarker Study.
JAMA Netw Open
January 2025
Alzheimer Center Limburg, Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, the Netherlands.
Importance: Baseline cerebral microbleeds (CMBs) and APOE ε4 allele copy number are important risk factors for amyloid-related imaging abnormalities in patients with Alzheimer disease (AD) receiving therapies to lower amyloid-β plaque levels.
Objective: To provide prevalence estimates of any, no more than 4, or fewer than 2 CMBs in association with amyloid status, APOE ε4 copy number, and age.
Design, Setting, And Participants: This cross-sectional study used data included in the Amyloid Biomarker Study data pooling initiative (January 1, 2012, to the present [data collection is ongoing]).
Psychiatric, Neurological, and Somatic Comorbidities in Intermittent Explosive Disorder.
JAMA Psychiatry
January 2025
Department of Psychiatry and Behavioral Sciences, Norton College of Medicine, SUNY Upstate Medical University, Syracuse, New York.
Importance: Intermittent explosive disorder (IED) is an understudied psychiatric condition marked by impulsive aggression and poorly regulated emotional control, often resulting in interpersonal and societal consequences. Better understanding of comorbidities can improve screening, diagnosis, and treatment.
Objective: To investigate the prevalence of IED and its associations with psychiatric, neurological, and somatic disorders.
Oral vs Intravenous Antibiotics for Fracture-Related Infections: The POvIV Randomized Clinical Trial.
JAMA Surg
January 2025
Vanderbilt University Medical Center, Nashville, Tennessee.
Importance: Fracture-related infection (FRI) is a serious complication following fracture fixation surgery. Current treatment of FRIs entails debridement and 6 weeks of intravenous (IV) antibiotics. Lab data and retrospective clinical studies support use of oral antibiotics, which are less expensive and may have fewer complications than IV antibiotics.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!