Lesotho adopted the test and start strategy for HIV services in June 2016 with anticipated increase in patient load. Our study evaluated community-based differentiated models of multi-month dispensing (MMD) of ART among stable HIV-infected adults in Lesotho. We report 12 month outcomes of the study.
The cluster-randomised trial was conducted in 30 selected clusters, stratified into rural and urban geo-locations. The clusters were randomised to three differentiated model of care arms: (i) 3 monthly ART supply at facilities (3MF) as control, (ii) 3 monthly ART supply through community ART groups (3MC) as intervention; (iii) 6 monthly ART supply through community ART distribution points (6MCD) as intervention. The primary outcome was retention in care with virologic suppression as secondary outcome. Outcome analysis were by intention-to-treat. We compared risk differences between arms with binomial population and used Cox’s proportional hazards regression to compare arms, controlling for potential imbalances between arms and specifying for clustering.
A total of 5336 participants were enrolled, 3MF (1898), 3MC (1558) and 6MCD (1880) arms. Retention in ART care was not different across the arms and achieved the noninferiority limit (-3.25%) with 3MC vs. 3MF 6MCD vs. 3MF (control) and 6MCD vs. 3MC, adjusted RD= -0.1% (95% CI: -1.6% to 1.5%), adjusted RD= -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD= -1.2% (95% CI: -2.9% to 0.5%), respectively. Retention in the intervention arms for both 3MC and 6MCD arms did not differ vs. 3MF, adjusted RD=1.1% (95% CI: -0.6% to 2.8%) and adjusted RD= -0.6% (95% CI: -2.4% to 1.1%), respectively. However, there was a slight reduction in 6MCD vs 3MC, adjusted RD= -1.9% (95% CI: -3.6% to -0.2%). Amongst 1503, 1126 and 1285 participants with available viral load results after 12 months, 1482 (98.6%), 1104 (98.1%) and 1263 (98.3%) were virally suppressed in arms 3MF, 3MC and 6MCD, respectively. There were no differences in viral suppression between 3MC, or 6MCD vs. control, risk ratio (RR)=1.00 (95% CI: 0.98-1.01) and RR=1.00 (95% CI: 0.98-1.01), respectively.
There is no difference in retention in care or viral load suppression for stable patients receiving 3 or 6 month dispensing of ART within community-based differentiated models of care when compared to the standard 3 month facility dispensing model