Evidence map›Paper›PMID 39122788›Full record

ArticleCommunications medicine2024

Hydroxyurea mobile directly observed therapy versus standard monitoring in patients with sickle cell anemia: a phase 2 randomized trial.

Philip Sasi, Abel Makubi, Raphael Z Sangeda, Mariam Y Ngaeje, Bruno P Mmbando, Joseph Soka, Caterina Rosano, Alex S Magesa, Sharon E Cox, Julie Makani and 1 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Communications medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02844673 (Effect of Mobile-Directly Observed Therapy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT02844673 phase2completednot on this map

Effect of Mobile-Directly Observed Therapy (DOT) on Adherence to Hydroxyurea Treatment in Adult HbSS Patients at Muhimbili National Hospital (MNH) in Tanzania: a Pilot Study

TypeinterventionalSponsorMuhimbili University of Health and Allied SciencesRan2017 to 2018Enrolled98ConditionsSickle Cell AnaemiaArmsHydroxyurea, Mobile Directly Observed Therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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.

Philip SasiSickle Cell Programme, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. philip.sasi@muhas.ac.tz.ORCID http://orcid.org/0000-0002-9911-8302
Abel MakubiSickle Cell Programme, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Raphael Z SangedaSickle Cell Programme, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.ORCID http://orcid.org/0000-0002-6574-5308
Mariam Y NgaejeSickle Cell Programme, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Bruno P MmbandoNational Institute for Medical Research, Tanga Cente, Tanga, Tanzania.
Joseph SokaSickle Cell Programme, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Caterina RosanoGraduate School of Public Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh, USA.
Alex S MagesaMuhimbili National Hospital, Central Pathology Laboratory, Dar es Salaam, Tanzania.
Sharon E CoxSchool of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan.
Julie MakaniSickle Cell Programme, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Enrico M NovelliSchool of Medicine, Department of Medicine, Division of Classical Hematology, University of Pittsburgh, Pittsburgh, USA.

Funding

Pitt | Vascular Medicine Institute, University of Pittsburgh (VMI) 9011142 (710111 - 1).
6 · The paper itself

Abstract

backgroundSickle cell anemia (SCA) prevalence remains high in sub-Saharan Africa. Long-term treatment with hydroxyurea (HU) increases survival, however, poor adherence to treatment could limit effectiveness. Whilst HU treatment adherence is currently high, this might decrease over time.

methodsWe conducted a single-center, randomized, open-label, parallel group phase 2 controlled clinical trial to determine whether mobile Directly Observed Therapy (m-DOT) increases HU treatment adherence (NCT02844673). Eligible participants were adults with homozygous SCA. People on a chronic blood transfusion program, with hemoglobin (Hb) A levels greater than 20% of the total Hb, total Hb less than 4 g/dL, pregnant or HIV positive were excluded. After a 3-month pre-treatment period participants were randomized to either m-DOT or standard monitoring arm. All participants received smart mobile phones and were treated with HU (15 mg/kg) daily for three months. In the m-DOT arm, drug intake was video recorded on cell phone by the participant and the video sent to the study team. The primary objective was to evaluate the effect of m-DOT on adherence to HU treatment by medication possession ratio (MPR).

resultsOf the 86 participants randomized, 76 completed the trial (26.13 ± 6.97 years, 63.5 % female). Adherence was high (MPR > 95 %) in both groups, 29 (80.6 %) in m-DOT versus 37 (94.9 %) in the standard monitoring arm (P = 0.079). No HU treatment was withheld from participants due to safety concerns.

conclusionsm-DOT did not increase adherence to HU treatment. We recommend that further testing in larger trials with a longer follow up period be undertaken.

Identifiers

PMID39122788
PMCPMC11315961

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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.