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Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons
Olamide Ojo-Fati1,2, Anne M Joseph3,4, Jed Ig-Izevbekhai5,3
1Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA. oojofati@umn.edu.
Trials
|July 7, 2017
Summary
Conducting clinical trials with homeless populations requires addressing unique challenges. This research shares lessons learned from two NIH-funded smoking cessation trials to improve future study feasibility and data quality.
Area of Science:
- Public Health
- Clinical Research Methodology
- Health Disparities
Background:
- Homeless populations are often excluded from clinical trials due to practical research challenges.
- Effective health promotion and care for homeless individuals necessitate objective research data.
- Previous research has not adequately addressed the specific methodological issues in studying this population.
Purpose of the Study:
- To report on experiences and lessons learned from conducting two randomized controlled trials targeting smoking cessation in homeless individuals.
- To identify and discuss challenges encountered during clinical trials with homeless populations.
- To offer potential solutions and strategies for improving the feasibility and data quality of research involving homeless individuals.
Main Methods:
- The study draws upon practical experience from two large National Institutes of Health (NIH)-funded randomized controlled trials.
- Focuses on identifying and analyzing common obstacles in recruiting and retaining participants experiencing homelessness.
- Examines issues such as cognitive impairment, mental health and substance use disorders, logistical challenges, and participant compensation.
Main Results:
- Recruitment and retention are significant hurdles, compounded by daily survival needs of homeless individuals.
- Cognitive impairments, mental health, and substance use disorders present additional complexities in trial conduct.
- Logistical issues including transportation, scheduling, and appropriate participant compensation require careful consideration.
- Ensuring staff safety and participant well-being are paramount when working with vulnerable homeless populations.
Conclusions:
- Anticipating and addressing the unique challenges faced by homeless populations is crucial for designing feasible clinical trial protocols.
- Implementing tailored strategies can improve the quality of data collected from these studies.
- This experience provides valuable insights for investigators aiming to conduct effective health research with individuals experiencing homelessness.
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