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Multicenter Study
. 2024 May 1;28(5):243-248.
doi: 10.5588/ijtld.23.0519.

Facilitators and barriers to adolescent participation in a TB clinical trial

J M Mangan  1 , K N C Hedges  1 , M M Salerno  2 , K Tatum  1 , B Bouwkamp  3 , M W Frick  4 , L McKenna  4 , G Muzanyi  5 , M Engle  6 , J Coetzee  7 , J Yvetot  8 , M Elskamp  2 , D Lamunu  9 , M E Theunissen Tizora  7 , D Namutamba  10 , R E Chaisson  11 , S Swindells  12 , P Nahid  13 , S E Dorman  14 , E Kurbatova  1
Affiliations
Multicenter Study

Facilitators and barriers to adolescent participation in a TB clinical trial

J M Mangan et al. Int J Tuberc Lung Dis. .

Abstract

<sec id="st1"><title>BACKGROUND</title>The inclusion of adolescents in TB drug trials is essential for the development of safe, child-friendly regimens for the prevention and treatment of TB. TB Trials Consortium Study 31/AIDS Clinical Trials Group A5349 (S31/A5349) enrolled adolescents as young as 12 years old. We assessed investigator and coordinator described facilitators and barriers to adolescent recruitment, enrollment, and retention.</sec><sec id="st2"><title>METHODS</title>Interviews were conducted with six investigators from sites that enrolled adolescent participants and six investigators from non-enrolling sites. Additionally, two focus groups were conducted with study coordinators from enrolling sites and two focus groups with non-enrolling sites. Discussions were transcribed, analyzed, summarized, and summaries were reviewed by Community Research Advisors Group members and research group representatives for content validity.</sec><sec id="st3"><title>RESULTS</title>Investigators and coordinators attributed the successful enrollment of adolescents to the establishment and cultivation of external partnerships, flexibility to accommodate adolescents' schedules, staff engagement, recruitment from multiple locations, dedicated recruitment staff working onsite to access potential participants, creation of youth-friendly environments, and effective communications. Non-enrolling sites were mainly hindered by regulations. Suggestions for improvement in future trials focused on study planning and site preparations.</sec><sec id="st4"><title>CONCLUSION</title>Proactive partnerships and collaboration with institutions serving adolescents helped identify and reduce barriers to their inclusion in this trial.</sec>.

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Conflict of interest statement

Conflicts of interest: none declared. Sanofi commercial interests did not influence the design of this evaluation; the collection, analysis, or interpretation of data; the preparation of this manuscript; or the decision to submit this manuscript for publication.

Figures

Figure 1.
Figure 1.
Investigator and coordinator-reported “top” reasons for successful enrollment of adolescent participants
Figure 2.
Figure 2.
Potential Partners and Partner Roles
See this image and copyright information in PMC

References

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    1. Dorman SE, et al. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. N Engl J Med 2021;384(18):1705–1718. - PMC - PubMed

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