Evidence map›Paper›PMID 35589351›Full record

ArticleBMJ open2022

Implementation of a peer support intervention to promote the detection, reporting and management of adverse drug reactions in people living with HIV in Uganda: a protocol for a quasi-experimental study.

Ronald Kiguba, Helen Byomire Ndagije, Victoria Nambasa, Cordelia Katureebe, Henry Zakumumpa, Stella Maris Nanyonga, Jacquellyn Nambi Ssanyu, Phil Tregunno, Kendal Harrison, Corinne S Merle and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 44% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

12 authors at 3 institutions in 2 countries.

Ronald KigubaDepartment of Pharmacology and Therapeutics, College of Health Sciences, Makerere University, Kampala, Uganda kiguba@gmail.com.ORCID 0000-0002-2636-4115
Helen Byomire NdagijeDirectorate of Product Safety, National Drug Authority, Kampala, Uganda.
Victoria NambasaDirectorate of Product Safety, National Drug Authority, Kampala, Uganda.
Cordelia KatureebeAIDS Control Programme, Ministry of Health, Kampala, Uganda.
Henry ZakumumpaSchool of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.
Stella Maris NanyongaClinical Epidemiology Unit, College of Health Sciences, Makerere University, Kampala, Uganda.
Jacquellyn Nambi SsanyuDepartment of Pharmacy, College of Health Sciences, Makerere University, Kampala, Uganda.
Phil TregunnoVigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK.
Kendal HarrisonVigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK.
Corinne S MerleSpecial Programme for Research & Training In Tropical Diseases (TDR), World Health Organization, Geneve, Switzerland.
Marie-Eve RaguenaudSpecial Programme for Research & Training In Tropical Diseases (TDR), World Health Organization, Geneve, Switzerland.
Freddy Eric KitutuDepartment of Pharmacy, College of Health Sciences, Makerere University, Kampala, Uganda.ORCID 0000-0003-2277-9572
Makerere University · UGWorld Health Organization · CHMinistry of Health · UG

Funding

World Health Organization 001
6 · The paper itself

Abstract

introductionPatients have contributed <1% of spontaneous adverse drug reaction (ADR) reports in Uganda's pharmacovigilance database. Peer support combined with mobile technologies could empower people living with HIV (PLHIV) to report ADRs and improve ADR management through linkage to care. We seek to test the feasibility and effect of a peer support intervention on ADR reporting by PLHIV receiving combination antiretroviral therapy (cART) in Uganda; identify barriers and facilitators to the intervention; and characterise ADR reporting and management. METHODS AND ANALYSIS: This is a quasi-experimental study to be implemented over 4 months at 12 intervention and 12 comparison cART sites from four geographical regions of Uganda. Per region, two blocks each with a tertiary, secondary and primary care cART site will be selected by simple random sampling. Blocks per region will be randomly assigned to intervention and comparison arms.Study units will include cART sites and PLHIV receiving cART. PLHIV at intervention sites will be assigned to peer supporters to empower them to report ADRs directly to the National Pharmacovigilance Centre (NPC). Peer supporters will be expert clients from among PLHIV and/or recognised community health workers.Direct patient reporting of ADRs to NPC will leverage the Med Safety App and toll-free unstructured supplementary service data interface to augment traditional pharmacovigilance methods.The primary outcomes are attrition rate measured by number of study participants who remain in the study until the end of follow-up at 4 months; and number of ADR reports submitted to NPC by PLHIV as measured by questionnaire and data abstraction from the national pharmacovigilance database at baseline and 4 months. ETHICS AND DISSEMINATION: The study received ethical approval from: School of Health Sciences Research and Ethics Committee at Makerere University (MAKSHSREC-2020-64) and Uganda National Council for Science and Technology (HS1206ES). Results will be shared with PLHIV, policy-makers, the public and academia. TRIAL REGISTRATION NUMBER: ISRCTN75989485.

Indexed as

Drug-Related Side Effects and Adverse ReactionsHIV InfectionsAdverse Drug Reaction Reporting SystemsHumansPharmacovigilanceRandomized Controlled Trials as TopicUgandaAdverse eventsEpidemiologyPharmacologySOCIAL MEDICINE

Identifiers

PMID35589351
PMCPMC9121495
OpenAlexW4280604887

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.