Rates of viral suppression in a cohort of people with stable HIV from two community models of ART delivery versus facility-based HIV care in Lusaka, Zambia: a cluster-randomised, non-inferiority trial nested in the HPTN 071 (PopART) trial

Abstract

Background Non-facility-based antiretroviral therapy (ART) delivery for people with stable HIV might increase sustainable ART coverage in low-income and middle-income countries. Within the HPTN 071 (PopART) trial, two interventions, home-based delivery (HBD) and adherence clubs (AC), which included groups of 15-30 participants who met at a communal venue, were compared with standard of care (SoC). In this trial we looked at the effectiveness and feasibility of these alternative models of care. Specifically, this trial aimed to assess whether these models of care had similar virological suppression to that of SoC 12 months after enrolment.Methods This was a three-arm, cluster-randomised, non-inferiority trial, done in two urban communities in Lusaka, Zambia included in the HPTN 071 trial. The two communities were split into zones, which were randomly assigned (1:1:1) to the three treatment strategies: 35 zones to the SoC group, 35 zones to the HBD group, and 34 zones to the AC group. ART and adherence support were delivered once every 3 months at home for the HBD group, in groups of 15-30 people in the AC group, or in the clinic for the SoC group. Adults with HIV who were receiving first-line ART for at least 6 months, virally suppressed using national HIV guidelines in the last 12 months, had no other health conditions requiring the clinicians attention, live in the study catchment area, and provided written informed consent, were eligible for inclusion. The primary endpoint was viral suppression at 12 months (with a 6 month final measurement window [ie, 9-15 months]), defined as less than 1000 HIV RNA copies per mL, with a non-inferiority margin of 5%. FindingsBetween May 5 and Dec 19, 2017, 9900 individuals were screened for inclusion, of whom 2489 (25•1%) participants were enrolled into the trial: 781 (31%) in the SoC group, 852 (34%) in the HBD group, and 856 (34%) in the AC group. A higher proportion of participants had viral load measurements in the primary outcome window in the HBD (581 [61%]of 852 participants) and AC (485 [57%] of 856 participants) groups than in the SoC (390 [50%] of 781 patients) group (p=0•0021). Of the 1096 missing observations, 152 (13•8%) were attributable to either deaths (25 [16%] participants), relocations (37 [24%] participants), or lost to follow-up (90 [59%]); 690 (63•0%) participants had viral load results outside the window period; and 254 (23•2%) did not have a viral load result. The prevalence of viral suppression was estimated to be 98•3% (95% CI 96•6 to 99•7) in the SoC group, 98•7% (97•5 to 99•6) in the HBD group, and 99•2% (98•4 to 99•8) in the AC group. This gave an estimated risk difference of 0•3% (95% CI -1•5 to 2•4) for the HBD group compared with the SoC group and 0•9% (-0•8 to 2•8) for the AC group compared with the SoC group. There was strong evidence (p<0•0001) that both community ART models were non-inferior to the SoC group (p<0•0001). Interpretation Community models of ART delivery were as effective as facility-based care in terms of viral suppression.

Factors that influence the satisfaction of people living with HIV with differentiated antiretroviral therapy delivery models in East Central Uganda: a cross-sectional study

“…Although patient satisfaction with DSDM has not been extensively studied, some studies show similarly high levels of satisfaction (80% or higher) with community-delivery models and facility-based groups in sub-Saharan Africa [ 13 – 15 ]. A recent mixed-methods study suggested that in Uganda, some ART patients may be more satisfied with standard clinic-based care while others appreciate community-based models [ 16 ].…”

Peer-Led Community-Based Support Services and HIV Treatment Outcomes Among People Living With HIV in Wuxi, China: Propensity Score–Matched Analysis of Surveillance Data From 2006 to 2021

“…Retention in care was defined as having received either CD4 or viral load monitoring on at least 1 occasion ≥12 months after ART initiation. People living with HIV who were on ART for at least 6 months and had a documented HIV viral load ≤1000 copies per mL were considered to be virally suppressed [ 25 ].…”

Impact of differentiated service delivery models on retention in HIV care and viral suppression among people living with HIV in sub‐Saharan Africa: A systematic review and meta‐analysis of randomised controlled trials

“…18,19 Disagreement was resolved using arbitration by a third reviewer. A total of 16 RCTs were assessed, of which seven studies had low risk, 11,14,[20][21][22][23][24] seven studies had some concerns, 12,13,[25][26][27][28] and two articles had high risk of bias. 29,30 (Figure 2).…”

“…In total 1596 records were screened for inclusion, of which 16 RCTs met eligibility criteria. 10,11,13,14,[20][21][22][23][24][25][26][27][28][29][30][31] The trials included more than 13,800 PLHIV (Table 1). Most of the trials were conducted in South Africa, [12][13][14]22,23,25,29,31 with most (11 studies) conducted among adult men and women (≥18 years).…”