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.

Background: In Tanzania, disclosure of HIV status to children remains a challenge despite the World Health Organization (WHO) recommendation that children should be informed about their HIV status between the ages of 6 to 12 years. This study aims to determine HIV status disclosure and related factors among children living with HIV in Kilimanjaro, Tanzania. Method: A cross-sectional study using a convergent parallel mixed-methods design was conducted from September 2021 to February 2022 among children aged 6-14 years receiving HIV care. Semi-structured questionnaires were collected from caregivers of undisclosed children, including socio-demographic data and reasons for non-disclosure. Additionally, we interviewed 20 caregivers of children in-depth who had disclosed and not disclosed the status to their children; we also interviewed children whose HIV status had been disclosed, followed by a focus group discussion. Bivariate and multivariate logistic regression analyses identified factors associated with HIV status disclosure. P<0.05 was considered statistically significant. We did thematic content analysis for qualitative data. Results: 121 children and their parents or caregivers were included in the analysis and 51(42%) knew about their HIV status. 31%(n=38) of children were between the ages 6-8 and among them, 33(87%) did not know about their status. Thirty-nine percent (n=47) of children were between the ages of 9-11; 32(68%) did not know about their status. 30% (n=36) of the children were above 12 years old, and 5(14%) did not know their status. 60 children were girls (49.5%); the majority (n=75;62%) lived with their biological parents; 112 children had primary education (93%); and 94 (78%) children attended referral hospitals for ART services. Moreover, 86(71%) of the children had caregivers who had been interviewed. In the final multivariate model, children aged above 12 years (OR= 30; 95%; Cl= 7.2-124); children aged 9-11(OR=2.7;95%; CI= 0.8-9.0) and having a treatment supporter (OR=2.9; 95%CI=1.0-8.2) were significantly associated with HIV status disclosure to their children compared to their counterparts respectively. Through IDI, we revealed the following themes: (1) HIV disclosure challenges and reasons not to disclose the status, (2) the process of the disclosure, and (3) the Importance of disclosure. Conclusion: HIV status disclosure to children living with HIV in Kilimanjaro region was associated with age above 12 years and having a treatment supporter, unlike the WHO recommendation. Therefore, health facilities should introduce new strategies to ensure children know their HIV status.

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

Introduction: In Sub-Saharan Africa, there are knowledge gaps on adverse drug reactions (ADRs) of antiretroviral treatment (ART). Studies have shown that limited training capacity among healthcare workers has affected reporting of ADRs and weakened the pharmacovigilance system in Tanzania. Studies have shown that the use of digital tools, including SMS communication, might be a viable way to increase knowledge and understanding of reporting ADRs. This study aimed to examine the acceptability and feasibility of SMS texts to increase awareness about the importance of reporting ADRs of ART among people living with HIV (PLHIV) in Tanzania. We also explored different ADR profiles that were reported by the participants. Methodology: This was a prospective implementation pilot study. PLHIV who consented to the study received a biweekly message to ask them how they were doing. We programmed keywords in the system that could be used for responding to the presence of ADR. The response to messages generated a flow of SMS that determined the presence of ADRs and informed participants to report. The technical feasibility was calculated based on the percentages of SMS which were sent and delivered about ADR and acceptability was measured based on the percentage of SMS that was replied to by the participants. We also collected data on different types of ADR reported by the participants. We conducted focus group discussions with participants and in-depth interviews with health workers to understand their experiences with and acceptability of the system. Results: Over a 12-month study period, a total of 92 participants were recruited. Sixty-two (67.4%) were women. The mean age of our participants was 42 years (SD 12). Forty (43.5%) participants were on ART for less than 3 months and the other 52 (56.5%) participants were on first-line ART. The system successfully sent and delivered 105 follow-up messages to all participants who consented to receive SMS. Among all the sent SMS 100 (95.2%) were replied to by the participants. Commonly reported ADRs were itching, gastrointestinal discomfort, joint pain, malaise and headache. The themes identified through FGD and IDI were: high motivation to report ADR, well-understood SMS content, the system to remain the same, no concerns about unwanted disclosure, and difficulties in replying to SMS due to network. The latter was mentioned by a few participants. Conclusion: SMS for creating awareness on ADRs reporting is a user-friendly intervention and highly accepted based on qualitative data among PLHIV in Tanzania. Also use of SMS is a low-cost intervention and a simple way to improve public health issues with society. Keywords: Short Message Services; Adverse drug reactions; Awareness; Acceptability

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.