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Table 1 Eligibility criteria for the SESOTHO trial

From: SESOTHO trial (“Switch Either near Suppression Or THOusand”) – switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa

Inclusion Criteria

Exclusion Criteria

a) On non-nucleoside reverse transcriptase inhibitor (NNRTI) based ART (standard first-line regimen in Lesotho) for at least 6 months

b) Two consecutive VL ≥100 copies/mL, with the latest VL between 100 and 999 copies/mL

c) Participant lives and/or works in the district of Butha-Buthe and declares to seek follow-up at one of the study-facilities

d) Signed written informed consent. For children aged < 18 years and illiterate patients, a literate caregiver or witness, respectively, must provide written informed consent (see Ethical considerations).

a) On ART less than 6 months

b) On protease inhibitor (PI) or integrase inhibitor containing ART regimen

c) Poor adherence (self-reported at least 1 dose of a once-daily regimen missed in the last 4 weeks, respectively two doses of a twice-daily-regimen)

d) Clinical WHO stage 3 or 4 at enrolment