Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules

dc.contributor.authorle Roux, Stanzien_ZA
dc.contributor.authorCotton, Marken_ZA
dc.contributor.authorGolub, Jonathanen_ZA
dc.contributor.authorle Roux, Daviden_ZA
dc.contributor.authorWorkman, Lesleyen_ZA
dc.contributor.authorZar, Heatheren_ZA
dc.date.accessioned2015-10-30T09:35:19Z
dc.date.available2015-10-30T09:35:19Z
dc.date.issued2009en_ZA
dc.description.abstractBACKGROUND:Tuberculosis contributes significantly to morbidity and mortality among HIV-infected children in sub-Saharan Africa. Isoniazid prophylaxis can reduce tuberculosis incidence in this population. However, for the treatment to be effective, adherence to the medication must be optimized. We investigated adherence to isoniazid prophylaxis administered daily, compared to three times a week, and predictors of adherence amongst HIV-infected children. METHODS: We investigated adherence to study medication in a two centre, randomized trial comparing daily to three times a week dosing of isoniazid. The study was conducted at two tertiary paediatric care centres in Cape Town, South Africa. Over a 5 year period, we followed 324 HIV-infected children aged [greater than or equal to] 8 weeks. Adherence information based on pill counts was available for 276 children. Percentage adherence was calculated by counting the number of pills returned. Adherence [greater than or equal to] 90% was considered to be optimal. Analysis was done using summary and repeated measures, comparing adherence to the two dosing schedules. Mean percentage adherence (per child during follow-up time) was used to compare the mean of each group as well as the proportion of children achieving an adherence of [greater than or equal to] 90% in each group. For repeated measures, percentage adherence (per child per visit) was dichotomized at 90%. A logistic regression model with generalized estimating equations, to account for within-individual correlation, was used to evaluate the impact of the dosing schedule. Adjustments were made for potential confounders and we assessed potential baseline and time-varying adherence determinants. RESULTS: The overall adherence to isoniazid was excellent, with a mean adherence of 94.7% (95% confidence interval [CI] 93.5-95.9); similar mean adherence was achieved by the group taking daily medication (93.8%; 95% CI 92.1-95.6) and by the three times a week group (95.5%; 95% CI 93.8-97.2). Two-hundred and seventeen (78.6%) children achieved a mean adherence of [greater than or equal to] 90%. Adherence was similar for daily and three times a week dosing schedules in univariate (odds ratio [OR] 0.88; 95% CI 0.66-1.17; P = 0.38) and multivariate (adjusted OR 0.85; 95% CI 0.64-1.11; P = 0.23) models. Children from overcrowded homes were less adherent (adjusted OR 0.71; 95% CI 0.54-0.95; P = 0.02). Age at study visit was predictive of adherence, with better adherence achieved in children older than 4 years (adjusted OR 1.96; 95% CI 1.16-3.32; P = 0.01). CONCLUSION: Adherence to isoniazid was excellent regardless of the dosing schedule used. Intermittent dosing of isoniazid prophylaxis can be considered as an alternative to daily dosing, without compromising adherence or efficacy.TRIAL REGISTRATION:Clinical Trials NCT00330304en_ZA
dc.identifier.apacitationle Roux, S., Cotton, M., Golub, J., le Roux, D., Workman, L., & Zar, H. (2009). Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules. <i>BMC Medicine</i>, http://hdl.handle.net/11427/14532en_ZA
dc.identifier.chicagocitationle Roux, Stanzi, Mark Cotton, Jonathan Golub, David le Roux, Lesley Workman, and Heather Zar "Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules." <i>BMC Medicine</i> (2009) http://hdl.handle.net/11427/14532en_ZA
dc.identifier.citationle Roux, S. M., Cotton, M. F., Golub, J. E., le Roux, D. M., Workman, L., & Zar, H. J. (2009). Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules. BMC medicine, 7(1), 67.en_ZA
dc.identifier.ris TY - Journal Article AU - le Roux, Stanzi AU - Cotton, Mark AU - Golub, Jonathan AU - le Roux, David AU - Workman, Lesley AU - Zar, Heather AB - BACKGROUND:Tuberculosis contributes significantly to morbidity and mortality among HIV-infected children in sub-Saharan Africa. Isoniazid prophylaxis can reduce tuberculosis incidence in this population. However, for the treatment to be effective, adherence to the medication must be optimized. We investigated adherence to isoniazid prophylaxis administered daily, compared to three times a week, and predictors of adherence amongst HIV-infected children. METHODS: We investigated adherence to study medication in a two centre, randomized trial comparing daily to three times a week dosing of isoniazid. The study was conducted at two tertiary paediatric care centres in Cape Town, South Africa. Over a 5 year period, we followed 324 HIV-infected children aged [greater than or equal to] 8 weeks. Adherence information based on pill counts was available for 276 children. Percentage adherence was calculated by counting the number of pills returned. Adherence [greater than or equal to] 90% was considered to be optimal. Analysis was done using summary and repeated measures, comparing adherence to the two dosing schedules. Mean percentage adherence (per child during follow-up time) was used to compare the mean of each group as well as the proportion of children achieving an adherence of [greater than or equal to] 90% in each group. For repeated measures, percentage adherence (per child per visit) was dichotomized at 90%. A logistic regression model with generalized estimating equations, to account for within-individual correlation, was used to evaluate the impact of the dosing schedule. Adjustments were made for potential confounders and we assessed potential baseline and time-varying adherence determinants. RESULTS: The overall adherence to isoniazid was excellent, with a mean adherence of 94.7% (95% confidence interval [CI] 93.5-95.9); similar mean adherence was achieved by the group taking daily medication (93.8%; 95% CI 92.1-95.6) and by the three times a week group (95.5%; 95% CI 93.8-97.2). Two-hundred and seventeen (78.6%) children achieved a mean adherence of [greater than or equal to] 90%. Adherence was similar for daily and three times a week dosing schedules in univariate (odds ratio [OR] 0.88; 95% CI 0.66-1.17; P = 0.38) and multivariate (adjusted OR 0.85; 95% CI 0.64-1.11; P = 0.23) models. Children from overcrowded homes were less adherent (adjusted OR 0.71; 95% CI 0.54-0.95; P = 0.02). Age at study visit was predictive of adherence, with better adherence achieved in children older than 4 years (adjusted OR 1.96; 95% CI 1.16-3.32; P = 0.01). CONCLUSION: Adherence to isoniazid was excellent regardless of the dosing schedule used. Intermittent dosing of isoniazid prophylaxis can be considered as an alternative to daily dosing, without compromising adherence or efficacy.TRIAL REGISTRATION:Clinical Trials NCT00330304 DA - 2009 DB - OpenUCT DO - 10.1186/1741-7015-7-67 DP - University of Cape Town J1 - BMC Medicine LK - https://open.uct.ac.za PB - University of Cape Town PY - 2009 T1 - Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules TI - Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules UR - http://hdl.handle.net/11427/14532 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14532
dc.identifier.urihttp://dx.doi.org/10.1186/1741-7015-7-67
dc.identifier.vancouvercitationle Roux S, Cotton M, Golub J, le Roux D, Workman L, Zar H. Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules. BMC Medicine. 2009; http://hdl.handle.net/11427/14532.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDepartment of Paediatrics and Child Healthen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2009 le Roux et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceBMC Medicineen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcmed/en_ZA
dc.subject.otherTuberculosisen_ZA
dc.subject.otherAntitubercular Agentsen_ZA
dc.subject.otherHIV Infectionsen_ZA
dc.subject.otherMedication Adherenceen_ZA
dc.titleAdherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedulesen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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