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Table 1 Secondary outcomes

From: Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho – a randomized controlled trial (CASCADE trial)

Secondary outcome Definition Time-frame Remarks
ART-initiation Participant started ART 3 months after the enrolment  
1-year retention in care Proportion confirmed dead (death record at clinic or confirmed by a first-grade relative), lost to follow-up (not attending the clinic 11–14 months after HIV-test and not confirmed dead), and retained in care (on ART, attends the clinic) 12 months (11–14 months) after enrolment Participants with transfer out to another clinic are excluded from analysis. Participants are considered as transferred out if the facility where they were enrolled in care issued a transfer letter.
Viral suppression under ART VL<100 copies/mL among those who started ART 6 months (5–7) months) after ART initiation  
Change in body weight Delta between body weight (kg) at baseline and 12 months after enrolment At baseline and 12 months (11–14 months) after enrolment  
Change in CD4 cell count Delta between CD4 cell count (cells/mL) at baseline and 12 months after enrolment At baseline and 12 months (11–14 months) after enrolment  
Change in haemoglobin Delta haemoglobin (g/dL) at baseline and 12 months after enrolment At baseline and 12 months (11–14 months) after enrolment  
New clinical WHO stage 3 or 4 events Diagnosis of a new clinical WHO stage 3 or 4 event confirmed by study-physician 12 months (11–14 months) after enrolment in the trial WHO 3 or 4 events occurring within 3 months after ART-initiation and judged as immune reconstitution inflammatory syndrome by the study physician will not be classified as a new WHO stage 3 or 4 event