Effect of Universal Testing and Treatment on HIV Incidence — HPTN 071 (PopART)

Abstract

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

Maximizing the impact of HIV prevention technologies in sub‐Saharan Africa

“…The targets were based on modelling which estimated the coverage needed to achieve these reductions, namely meeting 90‐90‐90 treatment targets, 90% coverage of key populations with combination prevention programmes, 90% reported condom use rates with non‐regular partners and 90% male circumcision . However, investment in prevention has been lower than required to achieve this coverage , and results from trials of intensive population “test and treat” approaches show a lower impact than hoped for, with up to 30% reduction in incidence, but with lower engagement and coverage of younger people .…”

Dapivirine vaginal ring for HIV prevention: modelling health outcomes, drug resistance and cost‐effectiveness

“…Our base‐case analyses optimistically assume timely and precise attainment of the ambitious treatment and treatment‐mediated prevention targets for 2020 and 2030 . However, attainment of these treatment targets may be insufficient for population‐level HIV control , whereas the attainment itself is jeopardized by suboptimal retention between HIV diagnosis and treatment in South Africa ; underscoring the need for additional investment in HIV prevention. Thus, a less than optimal Fast‐Track realization will bolster PrEP's epidemiological and economic efficiency (Table ).…”

Determination of HIV status and identification of incident HIV infections in a large, community‐randomized trial: HPTN 071 (PopART)

“…The primary study endpoint was HIV incidence after the first intervention year. HIV incidence was reduced by 30% in communities where ART was provided according to the local guidelines (Arm B vs. C), but was not significantly reduced in communities with UTT (Arm A vs. C) .…”

“…Universal testing and treatment (UTT) for HIV prevention is an important component of HIV prevention programmes . The HIV Prevention Trials Network (HPTN) 071 (PopART) trial, the largest HIV prevention trial performed to date, investigated whether UTT and other known effective prevention strategies could reduce HIV incidence on a population level . HPTN 071 (PopART) was conducted in 21 urban and peri‐urban communities in South Africa and Zambia.…”