BACKGROUND: Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, Home-Based Delivery (HBD) or Adherence Clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard-of-care (SoC).
METHODS: A three-arm cluster-randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35) or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC) or clinic (SoC). Adult HIV+ patients defined as 'stable' on ART, were eligible for inclusion. The primary endpoint was VLS at 12 (+/-3) months, defined as RNA <1000 copies/ml, with a non-inferiority margin of 5%.
RESULTS: Between May-December 2017, 2,489 participants were enrolled (781 SoC, 852 HBD, 856 AC). A higher proportion had VL measurements in the primary outcome window in HBD (60.8%) and AC (56.7%) arms than in the SoC (49.9%) arm (p=0.002). Of 1096 missing observations, 152 were attributable to causes (25 deaths, 37 relocations, 90 LTFU), 690 participants had VL results outside the window period and 254 did not have a VL result after 9 months. The prevalence of VLS was estimated to be 98.3% (95%CI: 96.6%-99.7%) in SoC, 98.7% (95%CI: 97.5%-99.6%) in HBD and 99.2% (95%CI: 98.4%-99.8%) in AC (Figure). This gave an estimated risk difference of 0.34% for HBD compared to SoC (95%CI: -1.46% to +2.37%) and 0.85% for AC compared to SoC (95%CI: -0.76% to +2.77%). There was strong evidence (p<0.001) that both community ART models were non-inferior to SoC.



CONCLUSIONS: Community models of ART delivery were as effective as facility-based care in terms of viral suppression.