Background Adherence to antiretroviral (ARV) treatment for HIV infection is challenging because of many factors. The World Health Organization (WHO) has recommended using digital adherence technologies (DATs). However, there is limited evidence on how DATs improve adherence. Wisepill® is an internet-enabled medication dispenser found feasible and acceptable in several studies. However, limited evidence is available on its effectiveness in improving ART adherence, specifically among children and adolescents. Furthermore, DATs are often developed without involving the target groups. We propose a two-stage project consisting of a formative study to customize an existing Wisepill DAT intervention and a randomized clinical trial to investigate the effectiveness of DAT combined with reminder cues and tailored feedback on adherence to ARV treatment among children and adolescents living with HIV and retention in care among breastfeeding women living with HIV in Kilimanjaro and Arusha Region, Tanzania. Methods We will conduct a formative mixed-methods study and three sub-trials in Kilimanjaro and Arusha Regions among (1) children aged 0–14 years and their caregivers, (2) adolescents aged 15–19 years and (3) breastfeeding women and their HIV-negative infants. In the formative study, we will collect and analyse data on needs and contents for DATs, including the contents of short message service (SMS) texts and tailored feedback. The results will inform the customization of the DAT to be tested in the sub-trials. In the trials, participants will be randomized in the intervention arm, where the DAT will be implemented or the control arm, where standard care will be followed. Participants in the intervention arm will take their medication from the Wisepill box and receive daily reminder texts and tailored feedback during clinic visits. Discussion If the intervention improves adherence to ART and the devices are acceptable, accurate and sustainable, the intervention can be scaled up within the National Aids Control Programmes. Trial registration PACTR202301844164954, date 27 January 2023.

Children and adolescents living with HIV (CALHIV) form a significant proportion of people living with HIV (PLHIV). Optimal adherence (>95%) to medication is needed to achieve viral suppression. However, optimal adherence remains a challenge among CALHIV. Digital adherence tools (DAT) like the Wisepill® device have proven feasible among adult PLHIV. Still, there are concerns about unwanted disclosure of HIV status due to content in short message service (SMS) that serve as reminders. We assessed the needs, contents, and acceptability of a DAT intervention among CALHIV. We conducted a mixed-methods study among CALHIV with their parents/guardians. We performed a survey and then purposively selected participants who used the intervention for one month. They received SMS text reminders that differed over time from asking if the medication was taken to more neutral SMS like “take care”. After one month, participants received tailored feedback based on automatically generated adherence reports. Afterwards, we completed exit interviews, in-depth interviews, and focus-group discussions. We analysed quantitative findings descriptively and used thematic content analysis for qualitative data. We included 284 participants in the survey and 40 used the intervention. Among participants who often forgot medication intakes, 93% of adolescents and 83% of children's parents/guardians were interested in receiving reminders. Among participants who used DAT, 90% had good experience receiving reminders and agreed that SMS made them take medication. However, 25% experienced network problems. Participants were happy to use the device. Further, they preferred neutral reminder SMSs that did not mention the word ‘medication’, but preserved confidentiality. Adherence reports inspired good adherence. None of the participants experienced unwanted disclosure or stigmatisation due to DAT. However, 5% of adolescents were concerned about being monitored daily. This study provided insights on how to customise DAT. We will implement this in a clinical trial to assess effectiveness in improving adherence.

Background Adherence to antiretroviral (ARV) treatment for HIV infection is challenging because of many factors. The World Health Organization (WHO) has recommended using digital adherence technologies (DATs). However, there is limited evidence on how DATs improve adherence. Wisepill® is an internet enable medication dispenser found feasible and acceptable in several studies. However, limited evidence is available on its effectiveness in improving ART adherence, specifically among children and adolescents. Furthermore, DATs are often developed without involving the target groups. We propose a two-stage project consisting of a formative study to customize an existing Wisepill DAT intervention and a randomized clinical trial, to investigate the effectiveness of DAT combined with reminder cues and tailored feedback on adherence to ARV treatment among children and adolescents living with HIV and retention in care among breastfeeding women living with HIV in Kilimanjaro and Arusha Region, Tanzania. Methods We will conduct a formative study mixed-methods study and three sub-trials in Kilimanjaro and Arusha Regions among (1) children aged 0–14 years and their caregivers, (2) adolescents aged 15–19 years and (3) breastfeeding women and their HIV-negative infants. In the formative study, we will collect and analyse data on needs and contents for DATs, including the contents of short message service (SMS) texts and tailored feedback. The results will inform the customization of the DAT to be tested in the sub-trials. In the trials, participants will be randomized in the intervention arm, where the DAT will be implemented or the control arm, where standard care will be followed. Participants in the intervention arm will take their medication from the Wisepill-box and receive daily reminder texts and tailored feedback during clinic visits. Discussion If the intervention improves adherence to ART and the devices are acceptable, accurate and sustainable, the intervention can be scaled up within the National Aids Control Programmes. Trial registration: PACTR202301844164954, date 27 January 2023

Background Retention in care and adherence to medication among pregnant and breastfeeding women living with HIV (PBWLH) are crucial for the prevention of mother-to-child transmission (PMTCT) of HIV. Wide coverage of mobile phones, digital tools, including the use of internet-enabled medication dispensers and short message service (SMS), have been recommended as potential interventions to improve adherence to medication by PBWLH. The main objective of the study was to understand the needs and contents for a customized digital tool for retention in care and medication adherence among PBWLH. Method A mixed-methods study was conducted from September 2021 to March 2022 at five health facilities in Kilimanjaro region. Pregnant and breastfeeding women receiving PMTCT services were included in a survey using a semi-structured questionnaire. Among the interviewed, twenty breastfeeding women were purposively selected and enrolled to use an internet-enabled Wisepill medication dispenser for one month. They received different types of SMS reminders for a period of one month and feedback on their adherence patterns was received after one month using adherence graph from the Wisepill digital tool. Later, exit interviews and in-depth interviews were conducted to explore the needs and contents for a future customized digital adherence tool. Descriptive analyses for quantitative data and thematic content analyses for qualitative data were also done. Results Among 142 women interviewed, 42(30%) were pregnant and 100 (70%) were breastfeeding. A majority of 136 (95%) had access to mobile phones and used SMS daily, while 90% were interested in receiving reminder messages. Qualitative findings revealed more insights on reminders’ content and educational SMS. Most people preferred neutral SMS which does not contain the word “medication”. Health educational SMS content was preferred to be on breastfeeding, opportunistic diseases, nutrition and entrepreneurship education. Overall, SMSs were regarded helpful to remind clients of medication time and the medication dispenser provided them with privacy and safe storage for their medication. Conclusions Findings from this study will help to construct useful content for future digital adherence tools to support the health of pregnant and breastfeeding women living with HIV.