mHealth Monitoring of Treatment of Cutaneous Leishmaniasis Patients: A Community-Based Implementation Study.

Cutaneous leishmaniasis (CL) remains a global health problem. Compelled by the protracted healing process, initial and final outcomes of treatment are determined at 90 and 180 days, respectively, after initiation of treatment. Loss to follow-up during these intervals is substantial. Consequently, the effectiveness of treatment is largely unknown. We conducted an effectiveness-implementation hybrid design study of a community-based mobile health (mHealth) strategy to monitor adherence to anti-leishmanial treatment, adverse drug reactions, and therapeutic response compared with standard of care in two rural communities of Colombia. Three implementation outcomes were evaluated: usability and acceptability by qualitative methods and fidelity using quantitative methods. Fifty-seven patients were prospectively included in the mHealth intervention and 48 in the standard-of-care group. In addition, 24 community health leaders (CHLs), health workers, and patients participated in qualitative evaluations. The intervention significantly increased the proportion of patients having follow-up of therapeutic outcomes 90 and 180 days after initiating treatment from 4.2% (standard of care) to 82.5% (intervention), P < 0.001. The proportion of patients having records of treatment adherence, adverse drug reactions, and therapeutic response also increased significantly (P < 0.001). Fidelity to the intervention (recording of treatment adherence, adverse drug reactions, lesion photographs, and evaluation of therapeutic response) was 70-100%. The app was highly accepted by CHLs, health workers, and patients, who perceived that the app improved case identification and follow-up and met a public health need. Although usability was high, low connectivity affected real-time transmission of data. This community-based mHealth strategy facilitated access to health care for CL in rural areas and knowledge of treatment effectiveness.

Sensitivity and Specificity of the Remote Evaluation of Therapeutic Response in Cutaneous Leishmaniasis Using Photographs from a Mobile Application.

Cutaneous leishmaniasis (CL) primarily affects people in remote settings with limited access to health services. mHealth tools offer an opportunity to overcome knowledge gaps about clinical response to treatment. We evaluated the validity of the Guaral+ST mobile application for the remote assessment of therapeutic response in patients with CL, through photographs of lesions captured with the app by community health volunteers. Patients with confirmed CL were followed at weeks 13 and 26 after completion of treatment to assess therapeutic response in two clinical settings in southwest Colombia. Direct evaluation of lesions performed by an experienced physician was considered the reference standard. Photographs of lesions taken by CHV or nurse assistants with the mobile app, were independently evaluated by three physicians to define clinical response. A summary measure of clinical outcome defined by the three physicians was considered the index test. Sensitivity, specificity, and positive and negative predictive values were estimated. Interrater reliability (kappa) was calculated. Among 53 participants with CL who had at least one follow-up visit, the sensitivity of therapeutic response evaluation through photographs taken with the Guaral+ST app, compared with direct evaluation by an expert physician, had high validity with sensitivity of 100% (95% confidence interval: 80.5-100%) and specificity of 97.2% (95% confidence interval: 85.5-99.9%). The chance-adjusted agreement (κ) was > 0.8, which is conventionally characterized as almost perfect. The high accuracy of the remote evaluation of photographs for the assessment of therapeutic response supports the use of mHealth tools for improving access to treatment follow-up for CL.