Abstract
Abstract
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.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference45 articles.
1. UNAIDS. AIDSinfo. aidsinfo. 2020.
2. PARTNERS + UNAIDS + PEPFAR. Start free-stay free- aids free a super-fast-track framework for and young women by 2020 on the fast-track to. 2019 [cited 2019 Dec 13]. p. 1–7. Available from: https://free.unaids.org/.
3. Enane LA, Davies M-A, Leroy V, Edmonds A, Apondi E, Adedimeji A, et al. Traversing the cascade: urgent research priorities for implementing the “treat all” strategy for children and adolescents living with HIV in sub-Saharan Africa. J virus Erad. 2018;4(Suppl 2):40–6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/30515313%0A; http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=PMC6248846.
4. UNAIDS. FACT SHEET – World AIDS Day 2019 Global Global HIV statistics. 2019. Available from: https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf.
5. Bangsberg DR, Hecht FM, Charlebois ED, Zolopa a R, Holodniy M, Sheiner L, et al. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS. 2000;14(4):357–66.
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