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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