Evidence map›Paper›PMID 37085913›Full record

Trial reportTrials2023

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.

I Marion Sumari-de Boer, Kennedy M Ngowi, Iraseni U Swai, Lyidia V Masika, Rehema A Maro, Alan E Mtenga, Benson A Mtesha, Pythia T Nieuwkerk, Ria Reis, Tobias F Rinke de Wit and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 3 countries.

I Marion Sumari-de BoerKilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania. m.sumari@kcri.ac.tz.ORCID http://orcid.org/0000-0002-5433-0406
Kennedy M NgowiKilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.
Iraseni U SwaiKilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.
Lyidia V MasikaInstitute of Public Health, Kilimanjaro Christian Medical University College, Moshi, Tanzania.
Rehema A MaroKilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.
Alan E MtengaKilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.
Benson A MteshaKilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.
Pythia T NieuwkerkDepartment of Medial Psychology, Amsterdam UMC, Amsterdam, the Netherlands.
Ria ReisAmsterdam Institute for Global Health and Development, Amsterdam, the Netherlands.
Tobias F Rinke de WitAmsterdam Institute for Global Health and Development, Amsterdam, the Netherlands.
Rob E AarnoutseDepartment of Pharmacy, Radboud UMC, Nijmegen, the Netherlands.
Kilimanjaro Christian Medical Centre · TZAmsterdam Institute for Global Health and Development · NLAmsterdam University Medical Centers · NLCollege of African Wildlife Management · TZRadboud University Nijmegen · NLUniversity of Cape Town · ZA

Funding

EDCTP TMA2818
6 · The paper itself

Abstract

backgroundAdherence 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.

methodsWe 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 registrationPACTR202301844164954, date 27 January 2023.

Indexed as

Anti-HIV AgentsHIV InfectionsRetention in CareAdolescentAnti-Retroviral AgentsBreast FeedingChildFemaleHumansInfantMedication AdherenceTanzaniaAnti-HIV AgentsAnti-Retroviral AgentsAdherenceAdolescentsBreastfeeding womenChildrenDigital HealthHIV

Identifiers

PMID37085913
PMCPMC10120095
OpenAlexW4366687335

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.