You are viewing the site in preview mode

Skip to main content


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