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.
Several strategies have been piloted to reduce the frequency of clinic visits including adherence clubs, where people with HIV meet on a regular basis to pick up medication and support each other, or simply reducing the frequency of clinic visits and medication pick-ups.
Both strategies have shown no drop-off in retention in care, but a question remains. If people can receive three months of medication without a higher rate of loss from care, what is the effect of giving six months of medication? Is this interval too long, will people begin to lose their sense of connection to care or suffer from a lack of support?
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. Communities were randomised to one of three methods:
- HIV medication dispensed every three months at a health facility (the control arm) (1898 participants)
- HIV medication dispensed every three months at an adherence club (1558 participants)
- HIV medication dispensed every six months at a community dispensing point (1880 participants).
"Reducing the frequency of clinic visits could help people who are stable on HIV treatment to stay engaged in care."
People were eligible to join the study if they had been on antiretroviral treatment for at least six months and had at least one viral load measurement below 1000 copies per ml in the previous year. The study excluded people on second-line treatment or anyone who needed to attend a health facility more frequently, such as pregnant or breastfeeding women.
The study population was predominantly female, ranging from 61% in the control arm to 71% in the three-month arm and 67% in the six-month arm. The median CD4 cell count ranged from 515 cells/mm3 in the control arm to 535 cells in the six-month arm and 560 in the three-month arm.
The primary outcome of the study was retention in antiretroviral care after 12 months. Retention was high in all three study arms, averaging 96%, and did not differ significantly between arms, showing that both the three-month and six-month dispensing strategies were non-inferior to the standard of care.
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. Ninety-eight per cent 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.
Full image credit: 'Developing Infrastructure to Promote Quality Health Care'. Baylor College of Medicine Children's Foundation–Malawi / Robbie Flick. USAID images. Available at www.flickr.com/photos/usaid_images/14742507309/in/photolist-osKcNv under a Creative Commons licence CC BY-NC-ND 2.0. Image is for illustrative purposes only.
Tukei B et al. Community-based multimonth dispensing of ART: a cluster randomised trial in Lesotho. Conference on Retroviruses and Opportunistic Infections, abstract 43, March 2020.
Update: Following the conference presentation, this study was published in a peer-reviewed journal:
Tukei B et al. Twelve-Month Outcomes of Community-Based Differentiated Models of Multimonth Dispensing of ART Among Stable HIV-Infected Adults in Lesotho: A Cluster-Randomized Noninferiority Trial. Journal of Acquired Immune Deficiency Syndrome, 85: 280-291, November 2020.