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Table 3 Secondary and exploratory endpoints of the VIBRA trial

From: VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho

  Definition Time point following enrolment Remarks
Secondary endpoints
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
Exploratory endpoints
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
Long-term follow-up Proportion of participants who are active in care and virologically suppressed (< 20 copies/mL) 24 (range: 22–28) months  
  1. The denominator of all proportions is the total number of study participants enrolled. Although this is a cluster-randomized trial, these endpoints will be analyzed at the individual level with binary outcomes
  2. ART antiretroviral therapy, VHW village health worker, VL viral load