Short- and long-term efficacy of modified directly-observed antiretroviral treatment in Mombasa, Kenya: A randomised trial
OBJECTIVES: To determine short- and long-term efficacy of modified directly observed therapy (m-DOT) on antiretroviral adherence. DESIGN: 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. RESULTS: 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 ≥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/m; 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. CONCLUSIONS: M-DOT increased adherence, most notably among depressed participants.
Sarna, Avina, Stanley Luchters, Scott Geibel, Matthew F. Chersich, Paul Munyao, Susan Kaai, Kishorchandra N. Mandaliya, Khadija Shikely, Marleen Temmerman, and Naomi Rutenberg. 2008. "Short- and long-term efficacy of modified directly-observed antiretroviral treatment in Mombasa, Kenya: A randomised trial," Journal of Acquired Immune Deficiency Syndromes 48(5): 611–619.