Epidemiology and Biostatistics

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Browsing Epidemiology and Biostatistics by browse.metadata.advisor "Fatti, Geoffrey"

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    A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa
    (Stellenbosch : Stellenbosch University, 2021-03) Lopes, John; Fatti, Geoffrey; Lombard, Carl J.; Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Global Health. Epidemiology and Biostatistics.
    ENGLISH SUMMARY: Randomized evidence of the effectiveness of community-based multi-month dispensing (MMD) of antiretroviral treatment (ART) is lacking, particularly for 6 months MMD with only annual clinical consultations. Data from two cluster randomized trials (CRTs) were pooled to compare community-based MMD of ART versus non-inferior to standard-of-care facility-based MMD. Methods: Adult people living with HIV (PLHIV) stable on ART for ≥6 months with viral load suppression (VLS) at baseline was included. Community-based 3 monthly (3MC) and 6 monthly (6MC) ART refill dispensing were compared to control facility-based 3 monthly (3MF). Twelve months retention-in-care (primary outcome) was evaluated by intention-to-treat using individual-level regression analyses, with a prespecified non-inferiority margin of -3.25% risk difference (RD). Secondary outcomes evaluated after 12 months were; (1) retention within the study arm (2) VLS, (3) number of unscheduled facility visits, and after 18 months; (4) attrition in ART care. Results: Data pooling yielded a total of 10136 participants with relatively balanced characteristics across the arms, except for age and district. Retention after 12 months was noninferior in the adjusted analysis (3MC: RD=0.3, 95% CI: -0.8 to 1.4 vs 3MF, 6MC: RD=-0.2, 95 % CI: -1.4 to 1.0 vs 3MF). VLS was high (≥97.9%) with no differences between the arms, risk ratio (RR) of 1.0 for 3MC (95 % CI: 1.0 to 1.0, p=0.885) and 6MC (95 % CI: 1.0 to 1.0, p=0.186) compared to 3MF. The incidence rate ratio (IRR) for unscheduled visits showed no difference between 3MC (IRR=0.6, 95 % CI: 0.2 to 2.1, p=0.383) and 6MC (IRR=1.0, 95 % CI: 0.4 to 2.5, p=0.974) compared to 3MF. Participant attrition (0-18 months) for Zimbabwe showed no differences between the arms, facility location or healthcare level. Conclusion: Community-based MMD of ART at 3 and 6 monthly refills for PLHIV stable on ART is safe to scale-up, without increased unscheduled facility visits or compromise in VLS.