Therapeutic response
ADVERSE EVENTS, INDURATION
In the intervention (app) arm, the study physician evaluated the therapeutic response via photographs taken by the CHV using the phone app at four time points. In-person assessment by the study physician was only undertaken if the app photos were not clear or if it was required for patient management, e.g. for adverse events or concomitant medication. Evaluation of clinical response was performed at the end of treatment, and at target study weeks 7, 13 and 26 after starting treatment, whether in-person or via assessment of lesion photographs taken with the Guaral +ST app by the CHV. Due to a technical error, the exact dates of visits were not retained in the app dataset, but rather only as the target study week.In the control (standard of care) groups, evaluation of therapeutic response was conducted in-person by a physician at the CIDEIM clinic. The therapeutic response was evaluated at week 13 as failure, improvement, or apparent cure, and at week 26 as cure or failure [In the intervention (app) arm, it was not possible to evaluate the induration of lesions via photographs, only their epithelization, but induration is not considered an absolute criterion of cure [In case of treatment failure, standard procedures based on national guidelines were followed for the administration of a second round of treatment with a different recommended drug. The responses to retreatment were outside of the study protocol and hence not reported here.