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. 2021 Dec 15;88(5):477-486.
doi: 10.1097/QAI.0000000000002797.

Out-of-Facility Multimonth Dispensing of Antiretroviral Treatment: A Pooled Analysis Using Individual Patient Data From Cluster-Randomized Trials in Southern Africa

John Lopes  1 , Ashraf Grimwood  2 , Nicoletta Ngorima-Mabhena  2 , Appolinaire Tiam  3 , Betty Bawuba Tukei  4 , Tonderai Kasu  5 , Nyika Mahachi  6 , Eula Mothibi  7 , Vincent Tukei  8 , Charles Chasela  7   9 , Carl Lombard  1   10 , Geoffrey Fatti  1   2
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Out-of-Facility Multimonth Dispensing of Antiretroviral Treatment: A Pooled Analysis Using Individual Patient Data From Cluster-Randomized Trials in Southern Africa

John Lopes et al. J Acquir Immune Defic Syndr. .

Abstract

Background: Out-of-facility multi-month dispensing (MMD) is a differentiated service delivery model which provides antiretroviral treatment (ART) at intervals of up to 6 monthly in the community. Limited randomized evidence investigating out-of-facility MMD is available. We evaluated participant outcomes and compared out-of-facility MMD models using data from cluster-randomized trials in Southern Africa.

Setting: Eight districts in Zimbabwe and Lesotho.

Methods: Individual-level participant data from 2 cluster-randomized trials that included stable adults receiving ART at 60 facilities were pooled. Both trials had 3 arms: ART collected 3-monthly at healthcare facilities (3MF, control); ART provided three-monthly in community ART groups (CAGs) (3MC); and ART provided 6-monthly in either CAGs or on an individual provider-patient basis (6MC). Participant retention, viral suppression and incidence of unscheduled facility visits were compared.

Results: Ten thousand one hundred thirty-six participants were included, 3817 (37.7%), 2893 (28.5%) and 3426 (33.8%) in arms 3MF, 3MC and 6MC, respectively. After 12 months, retention was non-inferior for 3MC (95.7%) vs. 3MF (95.0%) {adjusted risk difference (aRD) = 0.3 [95% confidence interval (CI): -0.8 to 1.4]}; and 6MC (95.1%) vs. 3MF [aRD = -0.2 (95% CI: -1.4 to 1.0)]. Retention was greater amongst intervention arm participants in CAGs versus 6MC participants not in CAGs, aRD = 1.5% (95% CI: 0.2% to 2.9%). Viral suppression was excellent (≥98%) and unscheduled facility visits were not increased in the intervention arms.

Conclusions: Three and 6-monthly out-of-facility MMD was non-inferior versus facility-based care for stable ART patients. Out-of-facility 6-monthly MMD should incorporate small group peer support whenever possible.

Clinicaltrial registration: ClinicalTrials.gov NCT03238846 and NCT03438370.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

References

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