Facilitators and barriers to adolescent participation in a TB clinical trial-Reference-Cited by-同舟云学术

Facilitators and barriers to adolescent participation in a TB clinical trial

Published:2024-05-01 Issue:5 Volume:28 Page:243-248
ISSN:1027-3719
Container-title:The International Journal of Tuberculosis and Lung Disease
language:en
Short-container-title:int j tuberc lung dis

Author:

Mangan J.M.¹,Hedges K.N.C.¹,Salerno M.M.²,Tatum K.¹,Bouwkamp B.³,Frick M.W.⁴,McKenna L.⁴,Muzanyi G.⁵,Engle M.⁶,Coetzee J.⁷,Yvetot J.⁸,Elskamp M.²,Lamunu D.⁹,Tizora M.E. Theunissen⁷,Namutamba D.¹⁰,Chaisson R.E.¹¹,Swindells S.¹²,Nahid P.¹³,Dorman S.E.¹⁴,Kurbatova E.¹

Affiliation:

1. Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA,

2. Bureau of Tuberculosis Control, New York City Department of Health and Mental Hygiene, New York, NY,

3. Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA, Oak Ridge Institute for Science and Education,

4. Treatment Action Group, New York, NY, USA;

5. Uganda-Case Western Reserve University Research Collaboration, Kampala, Uganda;

6. UTHSCSA & San Antonio Veterans Administration Medical Center, TX, USA;

7. Family Centre for Research with Ubuntu, University of Stellenbosch, Capetown, South Africa;

8. Les Centres GHESKIO, Port Au Prince, Haïti;

9. Uganda National Council for Science and Technology, Kampala, Uganda;

10. International Community of Women Living with HIV Eastern Africa, Bujumbura, Burundi;

11. Johns Hopkins University, Baltimore, MD,

12. University of Nebraska Medical Center, Omaha, NE,

13. UCSF Center for Tuberculosis, University of California, San Francisco, CA,

14. Medical University of South Carolina, Charleston, SC, USA

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>

Publisher

International Union Against Tuberculosis and Lung Disease