학술논문

Facilitators and barriers to adolescent participation in a TB clinical trial.

Document Type

Academic Journal

Author

Mangan JM; Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA.; Hedges KNC; Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA.; Salerno MM; Bureau of Tuberculosis Control, New York City Department of Health and Mental Hygiene, New York, NY.; Tatum K; Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA.; Bouwkamp B; Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA, Oak Ridge Institute for Science and Education.; Frick MW; Treatment Action Group, New York, NY, USA.; McKenna L; Treatment Action Group, New York, NY, USA.; Muzanyi G; Uganda-Case Western Reserve University Research Collaboration, Kampala, Uganda.; Engle M; UTHSCSA & San Antonio Veterans Administration Medical Center, TX, USA.; Coetzee J; Family Centre for Research with Ubuntu, University of Stellenbosch, Capetown, South Africa.; Yvetot J; Les Centres GHESKIO, Port Au Prince, Haïti.; Elskamp M; Bureau of Tuberculosis Control, New York City Department of Health and Mental Hygiene, New York, NY.; Lamunu D; Uganda National Council for Science and Technology, Kampala, Uganda.; Tizora MET; Family Centre for Research with Ubuntu, University of Stellenbosch, Capetown, South Africa.; Namutamba D; International Community of Women Living with HIV Eastern Africa, Bujumbura, Burundi.; Chaisson RE; Johns Hopkins University, Baltimore, MD.; Swindells S; University of Nebraska Medical Center, Omaha, NE.; Nahid P; UCSF Center for Tuberculosis, University of California, San Francisco, CA.; Dorman SE; Medical University of South Carolina, Charleston, SC, USA.; Kurbatova E; Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA.

Source

Publisher: The Union Country of Publication: France NLM ID: 9706389 Publication Model: Print Cited Medium: Internet ISSN: 1815-7920 (Electronic) Linking ISSN: 10273719 NLM ISO Abbreviation: Int J Tuberc Lung Dis Subsets: MEDLINE

Subject

Language

English

Abstract

BACKGROUNDThe 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.METHODSInterviews 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.RESULTSInvestigators 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.CONCLUSIONProactive partnerships and collaboration with institutions serving adolescents helped identify and reduce barriers to their inclusion in this trial..

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