Background
Universal testing and treatment (UTT) is a potential strategy to reduce HIV incidence,
yet prior trial results are inconsistent. We report results from HPTN 071 (PopART), the
largest HIV prevention trial to date.
Methods
In this community-randomized trial (2013-18), 21 communities in Zambia and South Africa
were randomized to Arm A (PopART intervention, universal antiretroviral therapy [ART]),
Arm B (PopART intervention, ART per local guidelines), and Arm C (standard-of-care). The
PopART intervention included home-based HIV-testing delivered by community workers who
supported linkage-to-care, ART adherence, and other services. The primary outcome, HIV
incidence between months 12-36, was measured in a Population Cohort (PC) of ~2,000
randomly-sampled adults/community aged 18-44y. Viral suppression (VS, <400 copies
HIV RNA/ml) was measured in all HIV-positive PC participants at 24m.
Results
The PC included 48,301 participants. Baseline HIV prevalence was similar across study
arms (21%-22%). Between months 12-36, 553 incident HIV infections were observed over
39,702 person-years (py; 1.4/100py; women: 1.7/100py; men: 0.8/100py). Adjusted
rate-ratios were A vs. C: 0.93 (95%CI: 0.74-1.18, p=0.51); B vs. C: 0.70 (95%CI:
0.55-0.88, p=0.006). At 24m, VS was 71.9% in Arm A; 67.5% in Arm B; and 60.2% in Arm C.
ART coverage after 36m was 81% in Arm A and 80% in Arm B.
Conclusions
The PopART intervention with ART per local guidelines reduced HIV incidence by 30%. The
lack of effect with universal ART was surprising and inconsistent with VS data. This
study provides evidence that UTT can reduce HIV incidence at population level.
Trial registration
ClinicalTrials.gov NCT01900977