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Challenges in recruiting children to a multidrug-resistant TB prevention trial

S Purchase1, E Batist1, N Mmile2

  • 1Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg.

The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease
|October 7, 2021
PubMed

Insights

Recruiting young children for multidrug-resistant tuberculosis (MDR-TB) prevention trials is challenging. Key success factors include thorough planning, dedicated teams, and strong collaboration with TB services.

Area of Science:

  • Clinical Trials
  • Pediatric Infectious Diseases
  • Public Health

Background:

  • Recruitment for randomized clinical trials is often slow and presents significant challenges.
  • Slow patient recruitment can have severe implications for trial outcomes and public health initiatives.
  • Enrolling young children into clinical trials, particularly for complex conditions like multidrug-resistant tuberculosis (MDR-TB), poses unique difficulties.

Purpose of the Study:

  • To summarize and analyze the challenges encountered during the enrollment of young children into a multidrug-resistant tuberculosis (MDR-TB) prevention trial in South Africa.
  • To identify specific barriers and facilitators for recruiting pediatric participants into the Tuberculosis Child Multidrug-resistant Preventive Therapy Trial (TB-CHAMP).

Main Methods:

  • Utilized an electronic recruitment platform to track participant enrollment and generate a recruitment flow diagram for the TB-CHAMP trial.
  • Conducted thematic analysis of structured personnel questionnaires, meeting minutes, and workshop notes to identify recruitment barriers and potential solutions.
  • Pre-screened adult index cases to assess eligibility for pediatric enrollment in the MDR-TB prevention trial.

Main Results:

  • Over 3,682 adult index cases were pre-screened, with a significant proportion having no eligible children under five or having rifampicin-monoresistant tuberculosis.
  • More than nine index cases required pre-screening for each child successfully enrolled in the trial, highlighting recruitment inefficiency.
  • Identified numerous barriers to recruitment, emphasizing the need for comprehensive planning, dedicated teams, and strong relationships with existing TB services.

Conclusions:

  • Recruiting children into multidrug-resistant tuberculosis (MDR-TB) prevention trials is a complex and demanding process.
  • Lessons learned from the TB-CHAMP trial underscore the importance of meticulous planning, robust data tracking, and effective collaboration for successful pediatric trial recruitment.
  • Findings are relevant for ongoing and future MDR-TB prevention trials and other pediatric tuberculosis studies.

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