Background: To improve antiretroviral coverage (ART) and help reach the 90-90-90 treatment targets, differentiated approaches to care are necessary, including reduced frequency of clinic visits for stable patients. Given the paucity of data regarding the impact of differentiated care models on pediatric outcomes, BIPAI conducted a retrospective analysis of clinical outcomes, comparing monthly (MS) with multi-monthly (MMS) ART prescription schedules for children and adolescents in Botswana, Lesotho, Swaziland, Malawi, Uganda and Tanzania.
Methods: MMS was introduced in each country in line with national policy. Patients were transferred to MMS when clinically stable and ART adherent, after 6-9 months of monthly prescriptions. For analysis patients were allocated to the MMS group after three consecutive visits at intervals of greater than 56 days. Adherence, lost-to-follow up rates, CD4 counts and viral load were compared between MS and MMS patients by two-sample tests for binomial proportions. Mortality was compared by log rank test. To avoid bias against the MS groups, deaths in the first 6 months of MS therapy were excluded, given the known, high early rates of mortality. To avoid immortal time bias, MMS patients contributed person-time to the MS group between ART initiation and the start of MMS. The analysis was conducted according to an IRB approved protocol.
Results: There were 11,421 MS and 18,137 MMS patients aged between 0 and 19 years. Comparison of clinical outcomes is displayed in table 1.

VariableMS patientsMMS patientsp value
Mean interval between visits (SD)39 days (27.5)61 days (34.9) 
% of patients with good adherence by pill count (95 to 105%)68.7% (7,846/11,421)78.5% (14,238/18,137)< 0.0002
Lost-to-follow up (%)7.1% (811/11,421)1.8% (326/18,137)< 0.0002
Mortality (deaths per 100 patient years)2.90.4< 0.0001
CD4 counts (% reaching > 350 or > 25 % for under age 578.0% (8,312/10,653)92.8% (16,767/18,067)< 0.0002
Viral load (% undetectable)63.3% (2,976/4,703)78.9% (10,787/13,678)< 0.0002
[Table 1: Clinical outcomes of MS and MMS patients]

MMS patients had statistically lower mortality and lost-to-follow up rates, as well as superior ART adherence rates and response to ART by CD4 counts and viral load measurements.
Conclusions: This study, representing data from six African countries, provides reassurance that patients 0-19 years of age who are clinically stable and ART adherent, can do well with reduced clinical visits via MMS. The consequent reduction in visits can yield additional benefits by decreasing the burden on health systems and patient time.