Motivations and barriers for healthy participants to participate in herbal remedy clinical trial in Tanzania: A qualitative study based on the theory of planned behaviour

Kamaka R Kassimu; Florence A Milando; Justin J Omolo; Gloria Nyaulingo; Hussein Mbarak; Latipha Mohamed; Ramla Rashid; Saumu Ahmed; Mohammed Rashid; Gumi Abdallah; Thabit Mbaga; Fatuma Issa; Omar Lweno; Neema Balige; Bakari Mwalimu; Ali Hamad; Ally Olotu; Said Jongo; Billy Ngasala; Salim Abdulla

doi:10.1371/journal.pone.0271828

Motivations and barriers for healthy participants to participate in herbal remedy clinical trial in Tanzania: A qualitative study based on the theory of planned behaviour

PLoS One. 2022 Jul 21;17(7):e0271828. doi: 10.1371/journal.pone.0271828. eCollection 2022.

Authors

Kamaka R Kassimu^{1

2}, Florence A Milando¹, Justin J Omolo³, Gloria Nyaulingo¹, Hussein Mbarak¹, Latipha Mohamed¹, Ramla Rashid¹, Saumu Ahmed¹, Mohammed Rashid¹, Gumi Abdallah¹, Thabit Mbaga¹, Fatuma Issa¹, Omar Lweno¹, Neema Balige¹, Bakari Mwalimu¹, Ali Hamad¹, Ally Olotu¹, Said Jongo¹, Billy Ngasala², Salim Abdulla¹

Affiliations

¹ Bagamoyo Clinical Trial Facility, Ifakara Health Institute, Bagamoyo, Tanzania.
² Department of Parasitology, Muhimbili University of Health and Allied Sciences, Dar es salaam, Tanzania.
³ Department of traditional medicine, National Institute for Medical Research, Dar es salaam, Tanzania.

Abstract

Background: The success of any randomized clinical trial relies on the willingness of people to be recruited in the trial. However, 90% of all clinical trials worldwide have been reported to have failed to recruit the required number of trial participants within the scheduled time. This study aimed to qualitatively explore the motivations and barriers for healthy participants to participate in herbal remedy clinical trials in Tanzania.

Materials and methods: This study used a qualitative descriptive research design based on the theory of planned behaviour. A total of five Focus Group Discussions (FGD) were conducted at Bagamoyo Clinical Trial Facility from 29 to 30 May 2021. Each group consisted of 5 to 10 participants. The participants of the study were 30 healthy males aged 18 to 45 male who participated in the clinical trial that evaluated the safety, tolerability, and efficacy of Maytenus Senegalensis. The focus group discussions were recorded audio-recorded. Verbatim transcription and thematic analysis were performed on the data.

Results: The prominent motivations mentioned were the opportunity for self-development, altruism, flexible study visit schedule, and financial compensation. Furthermore, the Participants' mothers and friends were reported as those most likely to approve of participation in an herbal remedy. The most mentioned barriers were inconvenience related to time commitment requirements, possible side effects, inflexible study visit schedule, and having other commitments. Moreover, the participants' father was reported to be more likely to disapprove of participation in a clinical trial of herbal remedy clinical trial.

Conclusions: The results of this study showed that the motivations and barriers of healthy participants to participate in clinical trials of herbal remedies are varied and that participants are motivated by more than financial gains. The identified motivations and barriers can be used as a guideline to improve the design of recruitment and retention strategies for herbal remedy clinical trials.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Focus Groups
Healthy Volunteers
Humans
Male
Motivation*
Qualitative Research
Tanzania

Grants and funding

This work was supported by the R. Geigy Foundation. The funder had no role in study design, data collection, and analysis, decision to publish, or preparation of the manuscript.