Abstract:
Background: We tested the hypothesis that patient-centered, streamlined human
immunodeficiency virus (HIV) care would achieve lower mortality than the standard treatment
model for persons with HIV and CD4 ≤ 350/uL in the setting of population-wide HIV testing.
Methods: In the SEARCH (Sustainable East Africa Research in Community Health) Study
(NCT01864603), 32 communities in rural Uganda and Kenya were randomized to country-guided
antiretroviral therapy (ART) versus streamlined ART care that included rapid ART start, visit
spacing, flexible clinic hours, and welcoming environment. We assessed persons with HIV and
CD4 ≤ 350/uL, ART eligible in both arms, and estimated the effect of streamlined care on ART
initiation and mortality at 3 years. Comparisons between study arms used a cluster-level analysis
with survival estimates from Kaplan-Meier; estimates of ART start among ART-naive persons
treated death as a competing risk.
Results: Among 13 266 adults with HIV, 2973 (22.4%) had CD4 ≤ 350/uL. Of these, 33% were
new diagnoses, and 10% were diagnosed but ART-naive. Men with HIV were almost twice as
likely as women with HIV to have CD4 ≤ 350/uL and be untreated (15% vs 8%, respectively).
Streamlined care reduced mortality by 28% versus control (risk ratio [RR] = 0.72; 95% confidence
interval [CI]: .56, .93; P = .02). Despite eligibility in both arms, persons with CD4 ≤ 350/uL started
ART faster under streamlined care versus control (76% vs 43% by 12 months, respectively; P <
.001). Mortality was reduced substantially more among men (RR = 0.61; 95% CI: .43, .86; P =
.01) than among women (RR = 0.90; 95% CI: .62, 1.32; P = .58).
Conclusions: After population-based HIV testing, streamlined care reduced population-level
mortality among persons with HIV and CD4 ≤ 350/uL, particularly among men. Streamlined HIV
care models may play a key role in global efforts to reduce AIDS deaths.