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Antiretroviral concentrations in small hair samples as a feasible marker of adherence in rural Kenya.

ABSTRACT: Antiretroviral hair levels objectively quantify drug exposure over time and predict virologic responses. We assessed the acceptability and feasibility of collecting small hair samples in a rural Kenyan cohort. Ninety-five percentage of participants (354/373) donated hair. Although median self-reported adherence was 100% (interquartile range, 96%-100%), a wide range of hair concentrations likely indicates overestimation of self-reported adherence and the advantages of a pharmacologic adherence measure. Higher nevirapine hair concentrations observed in women and older adults require further study to unravel behavioral versus pharmacokinetic contributors. In resource-limited settings, hair antiretroviral levels may serve as a low-cost quantitative biomarker of adherence.

SUBMITTER: Hickey MD

PROVIDER: S-EPMC4146734 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Antiretroviral concentrations in small hair samples as a feasible marker of adherence in rural Kenya.

Hickey Matthew D MD Salmen Charles R CR Tessler Robert A RA Omollo Dan D Bacchetti Peter P Magerenge Richard R Mattah Brian B Salmen Marcus R MR Zoughbie Daniel D Fiorella Kathryn J KJ Geng Elvin E Njoroge Betty B Jin Chengshi C Huang Yong Y Bukusi Elizabeth A EA Cohen Craig R CR Gandhi Monica M

Journal of acquired immune deficiency syndromes (1999) 20140701 3

Antiretroviral hair levels objectively quantify drug exposure over time and predict virologic responses. We assessed the acceptability and feasibility of collecting small hair samples in a rural Kenyan cohort. Ninety-five percentage of participants (354/373) donated hair. Although median self-reported adherence was 100% (interquartile range, 96%-100%), a wide range of hair concentrations likely indicates overestimation of self-reported adherence and the advantages of a pharmacologic adherence me ...[more]

PMID: 24694932

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Project description:Emphasis on adolescent HIV has increased worldwide as antiretroviral treatment has greatly extended life expectancies of HIV-positive children. Few evidence-based guidelines exist on the optimal time to disclose to an adolescent living with HIV (ALHIV); little is known about the medical effects of disclosure. This study looked to determine whether disclosure is associated with improved medical outcomes in ALHIV. Prior work has tended to be qualitative, cross-sectional, and with an emphasis on psychosocial outcomes. This paper addresses the adolescent cohort retrospectively (longitudinally), building upon what is already known about disclosure.Retrospective, longitudinal clinical record reviews of ALHIV seen at Kericho District Hospital between April 2004 and November 2012 were performed. Patient demographics and clinical outcomes were systematically extracted. The student's t-test was used to calculate changes in mean CD4 count, antiretroviral therapy (ART), and cotrimoxazole adherence pre- vs. post-disclosure. Linear regression modelling assessed for trends in those clinical outcomes associated with age of disclosure.Ninety-six ALHIV (54 female, 42 male) were included; most (73%) entered care through the outpatient department. Nearly half were cared for by parents, and 20% experienced a change in their primary caregiver. The mean time in the study was 2.47 years; mean number of visits 10.97 per patient over the mean time in the study. Mean disclosure age was 12.34 years. An increase in mean ART adherence percentage was found with disclosure (0.802 vs. 0.917; p = 0.0015). Younger disclosure age was associated with significantly higher mean CD4 counts over the course of the study (p = 0.001), and a nonsignificant trend toward a higher mean ART adherence percentage (p = 0.055).ART adherence and improved immunologic status are both associated with disclosure of HIV infection to adolescent patients. Disclosure of an HIV diagnosis to an adolescent is an important means to improve HIV care.

Project description:IntroductionHigh levels of adherence to antiretroviral therapy (ART) are central to HIV management. The objective of this study was to compare multiple measures of adherence and investigate factors associated with adherence among HIV-infected children in western Kenya.MethodsWe evaluated ART adherence prospectively for six months among HIV-infected children aged ?14 years attending a large outpatient HIV clinic in Kenya. Adherence was reported using caregiver report, plasma drug concentrations and Medication Event Monitoring Systems (MEMS®). Kappa statistics were used to compare adherence estimates with MEMS®. Logistic regression analyses were performed to assess the association between child, caregiver and household characteristics with dichotomized adherence (MEMS® adherence ?90% vs. <90%) and MEMS® treatment interruptions of ?48 hours. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated.ResultsAmong 191 children, mean age at baseline was 8.2 years and 55% were female. Median adherence by MEMS® was 96.3% and improved over the course of follow-up (p<0.01), although 49.5% of children had at least one MEMS® treatment interruption of ?48 hours. Adherence estimates were highest by caregiver report, and there was poor agreement between MEMS® and other adherence measures (Kappa statistics 0.04-0.37). In multivariable logistic regression, only caregiver-reported missed doses in the past 30 days (OR 1.25, 95% CI 1.14-1.39), late doses in the past seven days (OR 1.14, 95% CI 1.05-1.22) and caregiver-reported problems with getting the child to take ART (OR 1.10, 95% CI 1.01-1.20) were significantly associated with dichotomized MEMS® adherence. The caregivers reporting that ART made the child sick (OR 1.12, 95% CI 1.01-1.25) and reporting difficulties in the community that made giving ART more difficult (e.g. stigma) (OR 1.14, 95% CI 1.02-1.27) were significantly associated with MEMS® treatment interruptions in multivariable logistic regression.ConclusionsNon-adherence in the form of missed and late doses, treatment interruptions of more than 48 hours and sub-therapeutic drug levels were common in this cohort. Adherence varied significantly by adherence measure, suggesting that additional validation of adherence measures is needed. Few factors were consistently associated with non-adherence or treatment interruptions.

Project description:Hair segment analysis is a valuable tool for the assessment of cumulative long-term steroid secretion. Preliminary findings suggest comparable cortisol concentrations in hair collected by instructed laypersons and research staff. However, it remains unclear whether hair sample quality and hair steroids other than cortisol are affected by level of experience (laypersons vs. research staff), home collection circumstances (instructions, familiarity to participant, performance confidence), and characteristics of the layperson (conscientiousness). Sixty participants (23.6 ± 3.9 years; 43 females) provided hair samples twice: first collected by laypersons (HOME) according to provided instructions (written vs. written/video-based instructions) and second by trained research staff (LAB) on the same day or the day after the HOME collection. Hair steroid concentrations (cortisol, cortisone, DHEA, progesterone) were determined using LC-MS/MS. Hair sample quality was evaluated using nine predefined criteria. Laypersons completed questionnaires for the assessment of potential factors of hair outcome measures (hair steroid concentrations, hair sample quality). Hair steroids from HOME and LAB samples were positively correlated (rs between 0.76 and 0.89) and did not significantly differ, with the exception of cortisone. The quality of hair samples was significantly higher for LAB than for HOME samples. Neither HOME collection circumstances nor layperson-related characteristics had an impact on hair outcome measures. However, a low self-reported performance confidence predicted a high absolute difference between HOME and LAB DHEA. In summary, our findings suggest higher quality of hair samples collected by trained research staff compared to instructed laypersons. However, these differences might be negligible, considering the high correlation between HOME and LAB hair steroid concentrations, with the characteristics of the layperson or collection circumstances having a minor impact on hair steroids and hair sample quality. These findings provide further support for the notion that well-instructed laypersons can be enabled to collect hair samples.

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Antiretroviral concentrations in small hair samples as a feasible marker of adherence in rural Kenya.

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Antiretroviral concentrations in small hair samples as a feasible marker of adherence in rural Kenya.

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