To determine short- and long-term efficacy of modified directly observed therapy (m-DOT) on antiretroviral adherence.
Randomized controlled trial.
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 ≥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.
From the *Population Council, New Delhi, India; †International Centre for Reproductive Health, Mombasa, Kenya; ‡Population Council, Nairobi, Kenya; §Coast Provincial General Hospital, Mombasa, Kenya; ‖International Centre for Reproductive Health, Ghent University, Ghent, Belgium; and ¶Population Council, New York, NY.
Received for publication September 25, 2007; accepted May 15, 2008.
A.S. and S.L. contributed equally to the paper.
Financial support for this study was provided by President's Emergency Plan for AIDS Relief through the Office of HIV/AIDS, Bureau of Global Health, US Agency for International Development, through the Population Council's Horizons Program cooperative agreement of Award No. HRN-A-00-97-00012-00.
Presented at Implementer's Conference, June 2007, Durban, South Africa (72-week data); IAC, August 2006, Toronto, ON (48-week data); and IAPAC Conference, March 2006, NJ (24-week data).
Correspondence to: Avina Sarna, MBBS, MD, MPH, Population Council, 142 Golf Links, New Delhi 110003, India (e-mail: email@example.com).