Background: SEARCH (NCT:01864683) is a community-cluster randomized study in rural Uganda and Kenya evaluating whether a multi-disease, streamlined-care approach to HIV “test and treat” reduces HIV incidence and improves community health, compared to a national guideline approach augmented with baseline HIV and NCD (hypertension and diabetes) testing.
Methods: We randomized (2013-2014) 32 pair-matched communities in 3 regions (Uganda- West, Uganda-East, Kenya) to an active control with baseline HIV/NCD testing and ART/NCD care by national guidelines or an intervention with additional annual population HIV/NCD testing, rapid-start ART for all HIV+, and patient-centered, streamlined ART/NCD care. In all communities, population-level testing was delivered through multi-disease health fairs; non- participants were tested at home/in community. In the control arm, ART eligibility expanded during the study from CD4+< 350 to CD4+< 500 to all HIV+. Three-year HIV cumulative incidence, HIV viral suppression, mortality, HIV-TB, and hypertension control were compared between arms using targeted maximum likelihood estimation.
Results: At baseline, 335,005 persons (150,395 adults ≥15 years) were enrolled; 90.1% of adults were HIV-tested. HIV prevalence was 6.6%, 3.5%, and 19.3%, and HIV viral suppression was 47.5%, 43.0%, and 52.8% in Uganda-West, Uganda-East, and Kenya, respectively. Population-level viral suppression increased to 73.0% by year 1 in the intervention arm; at year 3, suppression was higher in intervention (79.7%) vs. control (68.4%) (RR:1.17; 95%CI:1.11,1.22; P< 0.001). At year 3, the intervention arm had 21% lower mortality among HIV+ (RR:0.79; 95%CI:0.65,0.96; P=0.02), 59% lower annual TB incidence among HIV+ (RR:0.41; 95%CI:0.19,0.86; P= 0.02), and 16% less uncontrolled hypertension (RR:0.84; 95%CI:0.79,0.90; p< 0.001) compared to control. Annual HIV incidence in the intervention arm decreased from year 1 to year 3 by 30% (RR:0.70; 95%CI:0.57,0.86; P< 0.001); incidence decreased by 45% in Kenya (RR:0.55; 95%CI:0.40,0.76; P< 0.001). Three-year cumulative HIV incidence did not differ between intervention (0.77%) and control (0.81%) (RR:0.95; 95%CI:0.77,1.17; P=0.60).
Conclusions: A multi-disease disease approach using streamlined care rapidly achieved UNAIDS 90-90-90 targets, improving community health (HIV mortality, HIV-TB, hypertension control). Annual HIV incidence decreased by 30% during the study; however, three-year cumulative HIV incidence did not differ between arms.
Continued investment and innovation in HIV treatment and prevention are needed for HIV elimination.