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 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: 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.
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.
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