Short-and Long-Term Efficacy of Modified Directly Observed Antiretroviral Treatment in Mombasa, Kenya : A Randomized Trial

To determine short- and long-term efficacy of modified directly observed therapy (m-DOT) on antiretroviral adherence. Randomized controlled trial. SETTING AND ANALYTIC APPROACH: From September 2003 to November 2004, 234 HIV-infected adults were assigned m-DOT (24 weeks of twice weekly health center...

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Veröffentlicht in:Journal of acquired immune deficiency syndromes (1999) 2008-08, Vol.48 (5), p.611-619
Hauptverfasser: SARNA, Avina, LUCHTERS, Stanley, GEIBEL, Scott, CHERSICH, Matthew F, MUNYAO, Paul, KAAI, Susan, MANDALIYA, Kishorchandra N, SHIKELY, Khadija S, TEMMERMAN, Marleen, RUTENBERG, Naomi
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container_issue 5
container_start_page 611
container_title Journal of acquired immune deficiency syndromes (1999)
container_volume 48
creator SARNA, Avina
LUCHTERS, Stanley
GEIBEL, Scott
CHERSICH, Matthew F
MUNYAO, Paul
KAAI, Susan
MANDALIYA, Kishorchandra N
SHIKELY, Khadija S
TEMMERMAN, Marleen
RUTENBERG, Naomi
description To determine short- and long-term efficacy of modified directly observed therapy (m-DOT) on antiretroviral adherence. Randomized controlled trial. SETTING AND ANALYTIC APPROACH: From September 2003 to November 2004, 234 HIV-infected adults were assigned m-DOT (24 weeks of twice weekly health center visits for nurse-observed pill ingestion, adherence support, and medication collection) or standard care. Follow-up continued until week 72. Self-reported and pill-count adherence and, secondarily, viral suppression and body mass index measures are reported. Generalized estimating equations adjusted for intraclient clustering and covariates were used. During weeks 1-24, 9.1% (9/99) of m-DOT participants reported missing doses compared with 19.1% (20/105) of controls (P = 0.04) and 96.5% (517/571) of m-DOT pill-count measures were >or=95% compared with 86.1% (445/517) in controls [adjusted odds ratio = 4.4; 95% confidence interval (CI) = 2.6 to 7.5; P < 0.001. Adherence with m-DOT was 4.8 times greater (95% CI = 2.7 to 8.6; P < 0.001) with adjustment for depression and HIV-related hospitalization. In weeks 25-48, adherence with m-DOT (488/589) was similar to controls (507/630). Viral suppression at 48 weeks was 2.0 times (95% CI = 0.8 to 5.2; P = 0.13) as likely in m-DOT participants as controls. M-DOT patients had larger body mass index increases at 24 weeks (2.2 vs 1.4 kg/m3; P = 0.014). Viral suppression was more likely at week 48 (21/25 vs 13/22; P = 0.057) and week 72 (27/30 vs 15/23; P = 0.027) among depressed participants receiving m-DOT. M-DOT increased adherence, most notably among depressed participants.
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Randomized controlled trial. SETTING AND ANALYTIC APPROACH: From September 2003 to November 2004, 234 HIV-infected adults were assigned m-DOT (24 weeks of twice weekly health center visits for nurse-observed pill ingestion, adherence support, and medication collection) or standard care. Follow-up continued until week 72. Self-reported and pill-count adherence and, secondarily, viral suppression and body mass index measures are reported. Generalized estimating equations adjusted for intraclient clustering and covariates were used. During weeks 1-24, 9.1% (9/99) of m-DOT participants reported missing doses compared with 19.1% (20/105) of controls (P = 0.04) and 96.5% (517/571) of m-DOT pill-count measures were &gt;or=95% compared with 86.1% (445/517) in controls [adjusted odds ratio = 4.4; 95% confidence interval (CI) = 2.6 to 7.5; P &lt; 0.001. Adherence with m-DOT was 4.8 times greater (95% CI = 2.7 to 8.6; P &lt; 0.001) with adjustment for depression and HIV-related hospitalization. In weeks 25-48, adherence with m-DOT (488/589) was similar to controls (507/630). Viral suppression at 48 weeks was 2.0 times (95% CI = 0.8 to 5.2; P = 0.13) as likely in m-DOT participants as controls. M-DOT patients had larger body mass index increases at 24 weeks (2.2 vs 1.4 kg/m3; P = 0.014). Viral suppression was more likely at week 48 (21/25 vs 13/22; P = 0.057) and week 72 (27/30 vs 15/23; P = 0.027) among depressed participants receiving m-DOT. 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Randomized controlled trial. SETTING AND ANALYTIC APPROACH: From September 2003 to November 2004, 234 HIV-infected adults were assigned m-DOT (24 weeks of twice weekly health center visits for nurse-observed pill ingestion, adherence support, and medication collection) or standard care. Follow-up continued until week 72. Self-reported and pill-count adherence and, secondarily, viral suppression and body mass index measures are reported. Generalized estimating equations adjusted for intraclient clustering and covariates were used. During weeks 1-24, 9.1% (9/99) of m-DOT participants reported missing doses compared with 19.1% (20/105) of controls (P = 0.04) and 96.5% (517/571) of m-DOT pill-count measures were &gt;or=95% compared with 86.1% (445/517) in controls [adjusted odds ratio = 4.4; 95% confidence interval (CI) = 2.6 to 7.5; P &lt; 0.001. Adherence with m-DOT was 4.8 times greater (95% CI = 2.7 to 8.6; P &lt; 0.001) with adjustment for depression and HIV-related hospitalization. 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subjects Acquired immune deficiency syndrome
Adult
AIDS
AIDS/HIV
Anti-HIV Agents - therapeutic use
Antiretroviral drugs
Antiretroviral Therapy, Highly Active
Biological and medical sciences
CD4 Lymphocyte Count
Clinical trials
Cohort Studies
Depression
Directly Observed Therapy
Female
Fundamental and applied biological sciences. Psychology
HIV
HIV Infections - drug therapy
HIV Infections - immunology
HIV Infections - virology
Human immunodeficiency virus
Human viral diseases
Humans
Infectious diseases
Kenya
Male
Medical sciences
Medical treatment
Mental depression
Microbiology
Miscellaneous
Patient Compliance
Social Class
Surveys and Questionnaires
Treatment Outcome
Viral diseases
Viral Load
Virology
title Short-and Long-Term Efficacy of Modified Directly Observed Antiretroviral Treatment in Mombasa, Kenya : A Randomized Trial
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