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Table 1 Secondary endpoints of PEBRA trial

From: PEBRA trial – effect of a peer-educator coordinated preference-based ART service delivery model on viral suppression among adolescents and young adults living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho

Secondary endpointsDefinitionTime point following enrolmentRemarks
Engagement in careProportion of all participants engaged in care6 months (range 5–8) and 12 months (range 9–15)Definition of “in care”: at least one ART visit in the defined window
I. Including participants who transferred out to any other health facility with known outcome (documented proof of follow-up visit or laboratory test)
All cause mortalityProportion of all participants who died6 months (range 5–8) and 12 months (range 9–15)Verbal autopsy to capture cause of death whenever possible. No death certificate or autopsy report required.
Lost-to-follow-up (LTFU)Proportion of all participants LTFU6 months (range 5–8) and 12 months (range 9–15)We define participants lost to follow-up if they or their treatment buddies were more than 2 months late for a scheduled consultation or medication pick-up and no information was found about the participant
Transfer out (TO)Proportion of all participants who transferred out to any other health facility (than the initially attached one) with known outcome6 months (range 5–8) and 12 months (range 9–15)Definition of “known outcome”: Documented proof of follow-up visit or laboratory test of the new health facility
Viral suppression < 1000 copies/mlProportion of all participants with viral suppression (< 1000 copies/mL)12 months (range: 9–15)Some of the remote health facilities in the study districts face regular challenges in sending the blood to the government hospital. To ensure sufficient VL measurements among study participants, these health facilities will be equipped with dried-blood-spot (DBS) as a backup for VL measurement. According to the WHO the recommended threshold for treatment failure using DBS is 1000 copies/mL
AdherenceAssessed by 3 different setting- and age-validated ART self-reported adherence questions:
1. “When was the last time you missed any medications?” [i) past week, ii) 1–2 weeks ago, iii) 3–4 weeks ago, iv) never]: Dichotomous outcome missed doses vs. no missed doses in the past month
2. “ART missed at two or more consecutive days within last month?”: Dichotomous outcome
3. “How would you rate your adherence over the last month” [i) very poor, ii) poor, iii) fair, iv) good, v) very good, vi) excellent]: Dichotomous outcome adherent vs non-adherent (anything less than ‘excellent’)
3 months (range 2.5–3.5), 6 months (range 5–8) and 12 months (range 9–15) 
Quality of lifeAssessed by SF-12 (Likert-Scale)6 months (range 5–8) and 12 months (range 9–15) 
Satisfaction of careAssessed by a self-reported patient service satisfaction questionnaire partly based on a setting-validated quality of care questionnaire (Likert-Scale)6 months (range 5–8) and 12 months (range 9–15)Assessed by an external data collector, not the PE