Evidence map›Paper›PMID 39069626›Full record

ArticleResearch integrity and peer review2024

Perceptions, experiences, and motivation of COVID-19 vaccine trial participants in South Africa: a qualitative study.

Thandeka Nkosi, Chanelle Mulopo, Bey-Marrié Schmidt

Abstract read
In one paragraph

Article in Research integrity and peer review, 2024. 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
–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.

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.

  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

3 authors.

Thandeka NkosiSchool of Public Health, University of the Western Cape, Bellville, Cape Town, South Africa. Thandeka.Nkosi@hiv-research.org.za.ORCID http://orcid.org/0009-0004-1836-3077
Chanelle MulopoSchool of Public Health, University of the Western Cape, Bellville, Cape Town, South Africa.
Bey-Marrié SchmidtSchool of Public Health, University of the Western Cape, Bellville, Cape Town, South Africa.

Funding

EDCTP2 TMA2020CDF-3204 CETH
6 · The paper itself

Abstract

backgroundThe informed consent process is an important step in conducting ethical clinical trials, as it ensures that research participants are aware of their rights and responsibilities in clinical trials. This study explored participants' perceptions, experiences and the factors motivating their participation in a COVID-19 vaccine trial in South Africa.

methodsThis descriptive qualitative study was conducted among twenty-five adult participants (18 to 64 years old) who participated in a COVID-19 vaccine trial in South Africa. Three focus group discussions and fifteen semi-structured interviews were carried out. Data were collected at a Clinical Research Site located in Prince Mshiyeni Memorial Hospital, in Umlazi Township, Durban, South Africa, where the COVID-19 vaccine trial participants were initially enrolled. Data were analysed iteratively using a thematic analysis approach.

resultsFour key findings emerged: 1) Participants who experienced an event (such as tested positive for COVID-19) during the clinical trial were more likely to talk about the informed consent more thoroughly compared to the other participants. 2) Participants understood the purpose of informed consent process better when it was repeated multiple times throughout the course of the trial. 3) Where participants did not recall or understand various elements of the informed consent, participants were likely to create their own interpretations. 4) Factors influencing participations in trials were reimbursement for participation, access to health care, protection of family members, and ability to socialize without fear of COVID-19.

conclusionOverall, the findings show that the informed consent process should be regarded as an ongoing process rather than a once-off event that only happens at the start of a clinical trial. An understanding of participants' perspectives, experiences, and motivations for participating in clinical trials, can help trial staff strengthen the consent documents and processes.

Indexed as

Clinical trialsCOVID-19Informed consentStudy participation

Identifiers

PMID39069626
PMCPMC11285467

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.