RTMM-based digital adherence tool

The RTMM is a pillbox developed by Wisepill™ containing a SIM card that sends data to a central server through the worldwide general packet radio service (GPRS) network. The pillbox can hold approximately 30 large pills or 60 small pills [14]. In the context of this study, the participants will store their ARV fixed combination tablets in the pillbox.

Data about openings will be immediately sent to and stored on a secure server. The data will include information about the opening time, the dispenser’s identification number, and battery and signal strength specifications. If medication is not taken within one hour of the prescribed time, the participant will receive a text message reminder. The messages will be neutral and unrelated to the HIV status of the recipients.

Participants in the intervention arm will also receive customised adherence feedback based on server-stored adherence data at every scheduled clinic visit. This feedback will be provided by a psychosocial counsellor or an ART nurse or clinician with the help of a research assistant. The feedback sessions will take into consideration the complex interaction of multiple factors unique to the demographic group of YLHIV. During these discussions, participants will go through the stages of precontemplation, contemplation, preparation, action, and evaluation according to the stages of change model. This approach has been adopted from a similar trial conducted by Sumari-de Boer et al. in Tanzania [15]. Participants will be asked about their opinion regarding their self-reported and pharmacy refill adherence since the previous visit (precontemplation), followed by being shown their adherence report from the RTMM server on which participants will be asked to reflect (contemplation). A discussion on possible barriers for adherence and next steps will then be undertaken and a target will be set for the next visit (preparation). After the feedback, participants will be expected to have increased intention to adhere, which should be followed by improved adherence (action). During the next visit, the same process will be repeated, including the evaluation of the preceding period. Lastly, since the intervention is an adherence aid, participants will undergo medical care as prescribed by ART clinic staff and according to Malawi HIV treatment guidelines. Therefore, participants enrolled in this study will not be barred from receiving any concomitant care.