Table 1 Secondary endpoints of PEBRA trial

Engagement in care

Proportion of all participants engaged in care

6 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 mortality

Proportion of all participants who died

6 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 LTFU

6 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 outcome

6 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/ml

Proportion 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

Adherence

Assessed 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 life

Assessed by SF-12 (Likert-Scale)

6 months (range 5–8) and 12 months (range 9–15)

Satisfaction of care

Assessed 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