Effect of a customized digital adherence tool on retention in care and adherence to antiretroviral treatment in breastfeeding women, children and adolescents living with HIV in Tanzania: a mixed-methods study followed by clinical trials.

Autor: Sumari-de Boer IM; Kilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania. m.sumari@kcri.ac.tz.; Amsterdam Institute for Global Health and Development, Amsterdam, the Netherlands. m.sumari@kcri.ac.tz.; Institute of Public Health, Kilimanjaro Christian Medical University College, Moshi, Tanzania. m.sumari@kcri.ac.tz.; Knowledge, Technology & Innovation Group, Wageningen University & Research, Wageningen, the Netherlands. m.sumari@kcri.ac.tz., Ngowi KM; Kilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.; Department of Medial Psychology, Amsterdam UMC, Amsterdam, the Netherlands., Swai IU; Kilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.; Department of Global Health, Amsterdam UMC, Amsterdam, the Netherlands., Masika LV; Institute of Public Health, Kilimanjaro Christian Medical University College, Moshi, Tanzania., Maro RA; Kilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania., Mtenga AE; Kilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania., Mtesha BA; Kilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania., Nieuwkerk PT; Department of Medial Psychology, Amsterdam UMC, Amsterdam, the Netherlands., Reis R; Amsterdam Institute for Global Health and Development, Amsterdam, the Netherlands.; The Children's Institute, University of Cape Town, Cape Town, South Africa., de Wit TFR; Amsterdam Institute for Global Health and Development, Amsterdam, the Netherlands.; Department of Global Health, Amsterdam UMC, Amsterdam, the Netherlands., Aarnoutse RE; Department of Pharmacy, Radboud UMC, Nijmegen, the Netherlands.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Apr 21; Vol. 24 (1), pp. 285. Date of Electronic Publication: 2023 Apr 21.
DOI: 10.1186/s13063-023-07293-1
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
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