Trial looks at community-based multi-month dispensing of ARVS

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Dispensing antiretroviral drugs to people with suppressed viral load every six months is just as effective as dispensing medication every three months, a study in Lesotho has found. People who picked up their medication every six months from a community dispensing point were no more likely to be lost from care than people who attended an adherence club or clinic every three months to pick up medication.

The study findings were presented by Betty Tukei of Right to Care, Lesotho, to the 2020 virtual Conference on Retroviruses and Opportunistic Infections. (All CROI presentations are taking place online this year due to coronavirus.)

Reducing the frequency of clinic visits to collect medication could help people who are stable on HIV treatment to stay engaged in care and maintain adherence. Missed clinic visits due to conflicting demands on their time or unaffordable transport costs can leave people without medication and eventually lead to disengagement from care.

To investigate the effect of six-monthly medication dispensing, researchers from Right to Care and Kheth’Impilo in South Africa carried out a cluster-randomised trial in Lesotho. The trial compared the impact of three methods for dispensing medication on retention in HIV care and HIV suppression.

Once randomised to a dispensing strategy, participants stuck with it. Twelve months after randomisation, 94% of participants were still receiving medication in the same way as they had been assigned at the beginning of the trial.

Viral load testing had only been carried out in around two-thirds of participants by the time that 12-month study outcomes were assessed – 93% of those tested had an undetectable viral load. Again, there was no difference in outcome when three-month or six-month dispensing were compared to clinic-based dispensing.

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

Betty B Tukei, Geoffrey Fatti, Appolinaire Tiam, Vincent Tukei, Thapelo Maotoe, Ian Sanne, Thembisile Xulu, Nicky Mabhena, Francis Akpan, Ian Memb

Full Aidsmap report

CROI 2020 abstract

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