Community-based differentiated service delivery models incorporating multi-month dispensing of antiretroviral treatment for newly stable people living with HIV receiving single annual clinical visits: a pooled analysis of two cluster-randomized trials in southern Africa.

INTRODUCTION: Differentiated service delivery (DSD) models for HIV treatment decrease health facility visit frequency and limit healthcare facility-based exposure to severe acute respiratory syndrome coronavirus 2. However, two important evidence gaps include understanding DSD effectiveness amongst clients commencing DSD within 12 months of antiretroviral treatment (ART) initiation and amongst clients receiving only single annual clinical consultations. To investigate these, we pooled data from two cluster-randomized trials investigating community-based DSD in Zimbabwe and Lesotho. METHODS: Individual-level participant data of newly stable adults enrolled between 6 and 12 months after ART initiation were pooled. Both trials (conducted between August 2017 and July 2019) had three arms: Standard-of-care three-monthly ART provision at healthcare facilities (SoC, control); ART provided three-monthly in community ART groups (CAGs) (3MC) and ART provided six-monthly in either CAGs or at community-distribution points (6MC). Clinical visits were three-monthly in SoC and annually in intervention arms. The primary outcome was retention in care and secondary outcomes were viral suppression (VS) and number of unscheduled facility visits 12 months after enrolment. Individual-level regression analyses were conducted by intention-to-treat specifying for clustering and adjusted for country. RESULTS AND DISCUSSION: A total of 599 participants were included; 212 (35.4%), 128 (21.4%) and 259 (43.2%) in SoC, 3MC and 6MC, respectively. Few participants aged <25 years were included (n = 32). After 12 months, 198 (93.4%), 123 (96.1%) and 248 (95.8%) were retained in SoC, 3MC and 6MC, respectively. Retention in 3MC was superior versus SoC, adjusted risk difference (aRD) = 4.6% (95% CI: 0.7%-8.5%). Retention in 6MC was non-inferior versus SoC, aRD = 1.7% (95% CI: -2.5%-5.9%) (prespecified non-inferiority aRD margin -3.25%). VS was similar between arms, 99.3, 98.6 and 98.1% in SoC, 3MC and 6MC, respectively. Adjusted risk ratio's for VS were 0.98 (95% CI: 0.92-1.03) for 3MC versus SoC, and 0.98 (CI: 0.95-1.00) for 6MC versus SoC. Unscheduled clinic visits were not increased in intervention arms: incidence rate ratio = 0.53 (CI: 0.16-1.80) for 3MC versus SoC; and 0.82 (CI: 0.25-2.79) for 6MC versus SoC. CONCLUSIONS: Community-based DSD incorporating three- and six-monthly ART refills and single annual clinical visits were at least non-inferior to standard facility-based care amongst newly stable ART clients aged ≥25 years. ClinicalTrials.gov: NCT03238846 & NCT03438370.

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 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.

Assessing the effect of indoor residual spraying (IRS) on malaria morbidity in Northern Uganda: a before and after study.

BACKGROUND: Indoor residual spraying (IRS) is known to reduce malaria transmission. In northern Uganda, a high endemic area, IRS has been implemented since 2006. Limited data however, exists on the effect of IRS on the malaria burden. This study sought to assess the effect of IRS on malaria morbidity in the high intensity area of northern Uganda. Retrospective routine data from ten health facilities in three districts which had received at least five rounds of IRS in northern Uganda was analysed. The primary outcome of interest was malaria morbidity, measured by the slide positivity rate (SPR). Descriptive statistics were used to describe the malaria morbidity stratified by age and sex. The average change in the malaria morbidity, measured by the SPR was assessed according to time, measured as calendar months. A fixed-effects linear regression model was used which included a polynomial function of time and controlled for malaria seasonality and variations between districts/facilities. RESULTS: The total out-patient department attendance in the ten health facilities for the study period was 2,779,246, of which 736,034 (26.5%) malaria cases were diagnosed with 374,826 (50.9%) cases of under 5 years and an overall SPR of 37.5%. The percentage point (p.p.) changes in SPR according to time measured as calendar months following IRS, revealed a decreasing trend in malaria morbidity in the first 3 months following each round of IRS. The highest percentage point decrease in the SPR was observed in the second month following IRS (9.5 p.p., CI -17.85 to -1.16, p = 0.026), among patients above 5 years. The SPR decline however waned by the fourth month following IRS, with an increase in the SPR of 8.4 p.p. at district level by the sixth month, p = 0.510. CONCLUSION: The study results show that IRS was associated with a significant reduction in malaria morbidity in northern Uganda in the first 3 months following IRS. The malaria reduction however waned by the fourth month following IRS.