Table 3 Secondary and exploratory endpoints of the VIBRA trial

Viral suppression < 20 copies/mL

Proportion of all participants with viral suppression (< 20 copies/mL)

6 (range: 5–8) months

Viral suppression < 1000 copies/mL

Proportion of all participants with viral suppression (< 1000 copies/mL)

6 (range: 5–8) and 12 (range: 10–15) months

Some of the remote health facilities in our study districts face regular challenges in sending blood samples to a government hospital. To ensure there are sufficient VL measurements among our study participants, these health facilities will be equipped with dried-blood-spot kits as a backup for VL measurements. According to WHO, the recommended threshold for treatment failure using a dried blood spot is 1000 copies/mL

Linkage to care

Proportion of all participants attending their first clinic- or VHW-based ART visit at least once within the given period

a) Within 1 month

b) Within 3 months

Engagement in and retention in care

Proportion of all participants active in care at a health facility or with a VHW

6 (range: 5–8) and 12 (range: 10–15) months

Active in care is defined as at least one ART visit in the defined window. Patients who have stopped ART and those who have transferred to another health facility with a known outcome (documented proof of a follow-up visit or laboratory test) are included. Participants who have died, are lost to follow-up, who have transferred to another facility without a known outcome (no documented proof of a follow-up visit or laboratory test), or are more than 2 months late for a scheduled consultation or medication pick-up with a reason (e.g. currently no money for a clinic visit, busy working in South Africa, etc.) are not counted as being active in care

All-cause mortality

Proportion of participants dead for any reason

12 (range: 10–15) months

Verbal autopsy to determine cause of death whenever possible; death certificates and autopsy reports are not required

Lost to follow-up

Proportion of all participants lost to follow-up

12 (range: 10–15) months

We define participants lost to follow-up if they or their treatment buddies are more than 2 months late for a scheduled consultation or medication pick-up and we have no recent information about the participant

Transfer out

Proportion of all participants who transferred to another health facility (other than the one they were initially attached to) with a known outcome

12 (range: 10–15) months

As above, a known outcome is documented proof of a follow-up visit or laboratory test at the new health facility

Serious adverse event

Proportion of patients with a serious adverse event

Within 12 months

Serious adverse events graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November 2014

Compliance with the protocol procedure

Proportion of ART refills and ART visits per participant according to the protocol schedule, at the VHW and the health facility

12 (range: 10–15) months

Overall effect of HOSENG + VIBRA

Overall effect of the combined interventions HOSENG and VIBRA (arm 4 vs arm 1) on viral suppression (< 20 copies/mL)

12 (range: 10–15) months

Assessment of acceptance of interventions

a) Acceptance of same-day ART initiation

b) Acceptance of VIBRA model

Within 1 month

Long-term follow-up

Proportion of participants who are active in care and virologically suppressed (< 20 copies/mL)

24 (range: 22–28) months