Evaluating Multimonth Dispensing Models for ART

Reducing barriers to care is paramount for people living with HIV and one such barrier in some countries, such as Zimbabwe, is high treatment loads that affect health system efficiency. To combat this, investigators are exploring differentiated service delivery models for antiretroviral therapy (ART).

A poster presented at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2020) examined the effects of multimonth dispensing (MMD) of ART in a cluster-randomized trial that compared 3- and 6-monthly MMD among community-based ART refill groups (CARGs) versus standard-of-care clinic-based ART in Zimbabwe.

“We felt that we needed to look at different ways of supporting adherence or differentiated models of adherence support for stable patients,” Ashraf Grimwood, MBChB, MPH, CEO of Kheth’Impilo AIDS Free Living in South Africa, and a co-author on the study, told Contagion^®.

The research team carried out the 3-arm, unblinded, pragmatic cluster-randomized noninferiority trial across 30 health care facilities. CARGs in these clusters were assigned to either: 1) ART collected 3-monthly at facility (3MF, control), 2) ART provided 3-monthly in CARGs (3MC), 3) ART provided 6-monthly in CARGs (6MC).

To be eligible for enrollment, adult participants had to be stable and receiving ART ≥6 months with baseline viral load (VL) <1000 copies/ml w><1000 copies/mL. The primary end point was retention in ART care, with a secondary outcome of viral suppression 12 months after enrollment.

The study enrolled a total of 4800 participants (1919 in 3MF, 1335 in 3MC, and 1546 in 6MC). Across the 3 arms, retention was similarly high (93.0%, 94.8%, 95.5%, respectively).

“The pre-specified noninferiority limit (-3.25%, risk difference [RD]) was met for comparisons between all arms; 3MC vs. 3MF, adjusted RD=1.1% (95% CI: -0.5% to 2.8%); 6MC vs. 3MF: aRD=1.2% (CI: -1.0% to 3.6%); and 6MC vs. 3MC: aRD=0.1% (CI: -2.4% to 2.6%),” investigators reported. “[Viral load] completion at 12 months was 49%, 45% and 8% in 3MF, 3MC, and 6MC, respectively. [Viral suppression] in 3MC (99.7%) was high and not different to 3MF (99.1%), relative risk=1.0 (CI: 1.0-1.0). VS was marginally reduced in 6MC (92.9%) vs. 3MF, relative risk=0.9 (CI: 0.9-1.0).”

Overall, investigators determined that retention in CARGs that received 3- and 6-monthly MMD was noninferior to standard-of-care, clinic-based ART for stable patients in Zimbabwe. However, further studies are needed to evaluate the effect on viral suppression.

“There are methods to decongest the clinics and for stable patients to be able to move out of the clinics and receive their ART in the community so that they don't need to go to the clinic on a regular basis,” Geoffrey Fatti, MBChB, MPH, Kheth'Impilo AIDS Free Living, and presenting author of the study, said. “Also, from the patient's perspective, it saves them time and money in terms of regular traveling to the clinic.”

The late-breaking poster, “3- vs 6-Monthly Dispensing of ART in Community ART Groups: A Cluster-Randomized Trial,” was virtually presented Monday, March 9, 2020, at CROI 2020.