Background:  ART services are rapidly expanding in Sub-Saharan Africa. Evaluation of national ART programs, while logistically challenging, is essential to ensure quality. Rwanda, with about 3% of adults and 200,000 persons estimated to be HIV⁺, established a national ART program in 2004. By December 2005, 19,058 persons, including 1443 (7.6%) children, had initiated ART at 83 sites. Nationally representative clinical and immunologic outcome data, however, had not been evaluated.

Methods:   We conducted a retrospective cohort study to assess key 6- and 12-month treatment outcomes among a nationally representative stratified (by ART clinic size) random sample of patients who initiated ART from January 1, 2004 to December 31, 2005. Medical records abstraction was completed for 3523 patients at 30 sites. Data available for 3196 adults and 288 pediatric (<15 years) patients were included in this analysis.

Results:  The median age of adults at ART initiation was 37 years and 65% were female. Of children, 8 (3%) were <2 years, 75 (26%) were 2 to 5 years, and 202 (70%) were 6 to 14 years of age; 3 (1%) had no recorded age at ART initiation; 50% were female. First-line ART regimens included stavudine, lamivudine, and either nevirapine or efavirenz for 79% of adults and 84% of children. At ART initiation, the median adult CD4⁺ cell count was 141/µL. Of adults, 92% and 86%, and of children, 93% and 89% remained on ART at their original site at 6- and 12-months, respectively. For adult patients with follow-up data, median CD4⁺ cell counts increased by 98/µL at 6 months (n = 1445) and 119/µL at 12 months (n = 957). In multivariate analysis, adults at large- (OR 0.56; p = 0.013) and medium-sized (OR 0.73; p = 0.017) clinics were less likely to have a CD4⁺ cell count increase of ≥120/µL by 12 months on ART than were patients at small clinics (clinic size defined as >1500, 75 to 1500, and <75 patients, respectively). For children, older age at ART start was associated with lower mortality at 6 (OR 0.60/year; p = 0.006) and 12 months on treatment (OR 0.56/year; p = 0.005).

Conclusions:  Rwanda’s national ART program achieved excellent 6- and 12-month retention and immunologic outcomes during the first 2 years of rapid scale-up. However, data completeness was limited. Nationally representative sampling of routinely collected data can provide important information about program quality and may be useful in resource-limited settings.