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

BACKGROUND Out-of-facility multi-month dispensing (MMD) is a differentiated service delivery model which provides antiretroviral treatment (ART) at intervals of up to six 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 two cluster-randomized trials that included stable adults receiving ART at 60 facilities were pooled. Both trials had three arms: ART collected three-monthly at healthcare facilities (3MF, control); ART provided three-monthly in community ART groups (CAGs) (3MC); and ART provided six-monthly in either CAGs or on an individual provider-patient basis (6MC). Participant retention, viral suppression (VS) and incidence of unscheduled facility visits were compared. RESULTS 10,136 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% 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%). VS was excellent (≥98%) and unscheduled facility visits were not increased in the intervention arms. CONCLUSIONS Three and six-monthly out-of-facility MMD was non-inferior versus facility-based care for stable ART patients. Out-of-facility six-monthly MMD should incorporate small group peer support whenever possible.