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EFFECT OF TB SCREENING AND RETENTION INTERVENTIONS ON EARLY ART MORTALITY IN BOTSWANA
Andrew F. Auld1, Tefera Agizew2, Anikie Mathoma2, Rosanna Boyd2, Anand Date1, Sherri Pals1, Christopher Serumola2, Unami Mathebula2, Heather Alexander1, Tedd V. Ellerbrock1, Goabaone Rankgoane-Pono3, Pontsho Pono3, Katherine Fielding4, Alison Grant4, Alyssa Finlay2
1CDC, Atlanta, GA, USA,2CDC Botswana, Gaborone, Botswana,3Ministry of Health, Gaborone, Botswana,4London School of Hygiene & Tropical Medicine, London, UK
In 2012, at 22 antiretroviral therapy (ART) clinics, Botswana implemented a phased rollout of the Xpert package of interventions, with 3 components: (1) additional nurses and mentoring to support intensified tuberculosis (TB) case finding (ICF) activities, (2) intensified tracing for patients missing clinic appointments, and (3) Xpert MTB/RIF (Xpert) replacing smear microscopy. We evaluated effect of the Xpert package on early (6- and 12-month) ART mortality in the XPRES trial (ClinicalTrials.gov: NCT02538952).
At 22 ART clinics, all adult patients (>12 years old) starting ART were enrolled in three phases: (1) a retrospective standard of care (SOC) phase, (2) a prospective enhanced care (EC) phase, and (3) a prospective EC plus Xpert (EC+X) phase. EC and EC+X phases were enrolled as a stepped-wedge trial. Adults enrolled in the EC phase received SOC plus components 1 (TB ICF) and 2 (intensified tracing) of the Xpert package. Adults enrolled in the EC+X phase received SOC plus all 3 components of the Xpert package. All-cause 6-month ART mortality was the primary outcome. An adjusted analysis, appropriate for study design, controlled for baseline differences in individual-level factors and intra-facility correlation. Trial outcome results are final.
14,963 eligible patients were enrolled; 8,980 in the SOC, 1,768 in the EC, and 4,215 in the EC+X phases. Median age of ART enrollees was 35 years, 64% were female, median weight was 58.4 kg, and median hemoglobin 11.7 g/dL. These characteristics were similar across phases. Pregnancy among females was less common in the SOC than subsequent phases (16% in SOC, 23% in EC, and 32% in EC+X). Median CD4 count at ART initiation was lower in SOC than subsequent phases (184/µL in SOC, 241/µL in EC, and 246/µL in EC+X). In adjusted analysis, compared with the SOC phase, 6-month ART mortality was significantly lower in the EC+X phase, while 12-month ART mortality was significantly lower in both the EC and EC+X phases (Table). When compared with the EC phase, 6- and 12-month mortality rates were not significantly different in the EC+X phase.
In Botswana, interventions to strengthen TB ICF and active tracing were associated with lower early ART mortality and should be considered for scale-up. No additional mortality benefit of replacing smear microscopy with Xpert was observed.