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Preparing for and executing a randomised controlled trial of podoconiosis treatment in Northern Ethiopia: the utility of rapid ethical assessment

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posted on 2023-06-09, 00:58 authored by Henok Negussie, Thomas Addissie, Adamu Addissie, Gail DaveyGail Davey
Background Community-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis treatment in northern Ethiopia. Methods A qualitative study was carried out in Aneded woreda, East Gojjam Zone, Amhara Regional State from August to September, 2013. A total of 14 In-depth Interviews (IDIs) with researchers, experts, and leaders, and 8 Focus Group Discussions (FGDs) involving 80 participants (people of both gender, with and without podoconiosis), were conducted. Interviews were carried out in Amharic. Data analysis was started alongside collection. Final data analysis used a thematic approach based on themes identified a priori and those that emerged during the analysis. Results Respondents made a range of specific suggestions, including that sensitisation meetings were called by woreda or kebele leaders or the police; that Health Extension Workers were asked to accompany the research team to patients’ houses; that detailed trial information was explained by someone with deep local knowledge; that analogies from agriculture and local social organisations be used to explain randomisation; that participants in the ‘delayed’ intervention arm be given small incentives to continue in the trial; and that key community members be asked to quell rumours arising in the course of the trial. Conclusion Many of these recommendations were incorporated into the preparatory phases of the trial, or were used during the course of the trial itself. This demonstrates the utility of rapid ethical assessment preceding a complex piece of research in a relatively research-naive setting.

Funding

Gene-environment studies in podoconiosis; G0033; WELLCOME TRUST; 091956/Z/10/Z

Randomised Control Trial of Podoconiosis Treatment in Northern Ethiopia; G1043; MRC-MEDICAL RESEARCH COUNCIL; MR/K007211/1

History

Publication status

  • Published

File Version

  • Published version

Journal

PLoS Neglected Tropical Diseases

ISSN

1935-2735

Publisher

PLoS

Issue

3

Volume

10

Department affiliated with

  • Global Health and Infection Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2016-04-20

First Open Access (FOA) Date

2016-04-20

First Compliant Deposit (FCD) Date

2016-04-20

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