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 |