Practical issues regarding implementing a randomized clinical trial in a homeless population: Strategies and lessons learned

Olamide Ojo-Fati, Anne M Joseph, Jed Ig-Izevbekhai, Janet L Thomas, Susan Everson-Rose, Rebekah J Pratt, Nancy C Raymond, Ned L. Cooney, Xianghua Luo, Kola Okuyemi

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons learned while conducting two large NIH-funded randomized controlled trials targeting smoking cessation among persons who are homeless. The current report also addresses challenges when conducting clinical trials among homeless populations and offers potential solutions. Homeless individuals face several challenges including the need to negotiate daily access to food, clothing, and shelter. Some of the critical issues investigators encounter include recruitment and retention obstacles; cognitive impairment, mental health and substance abuse disorders; transportation and scheduling challenges; issues pertaining to adequate study compensation; the need for safety protocols for study staff; and issues related to protecting the wellbeing of these potentially vulnerable adults. Anticipating realistic conditions in which to conduct studies with participants who are homeless will help investigators to design efficient protocols and may improve the feasibility of conducting clinical trials involving homeless populations and the quality of the data collected by the researchers. Trial registration: ClinicalTrials.gov, ID: NCT00786149. Registered on 5 November 2008; ClinicalTrials.gov, ID: NCT01932996. Registered on 20 November 2014.

Original languageEnglish (US)
Article number305
JournalTrials
Volume18
Issue number1
DOIs
StatePublished - Jul 5 2017

Bibliographical note

Funding Information:
This work was supported by a grant from the National Heart Lung and Blood Institute (R01HL081522), along with the diversity supplement (R01HL081522-07S1) and National Cancer Institute of the National Institutes of Health (NIH) under Award Number R25CA163184.

Funding Information:
The authors would like to thank the directors and staff of the participating shelters and express gratitude to the members of the Community Advisory Board and the study participants. Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number 2T32CA163184 (Michele Allen, MD, MS; PI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Funding Information:
Both PTQI and PTQII were approved and monitored by the University of Minnesota Institutional Review Board. The objective of this paper is to describe several practical lessons learned while conducting two large RCTs targeting smoking cessation among persons who are homeless. Our intention is to provide information that may assist other investigators who are interested in developing and testing the efficacy of interventions designed for homeless populations. Both studies were funded by the National Institutes of Health (USA).

Publisher Copyright:
© 2017 The Author(s).

Keywords

  • Attrition
  • Clinical trials
  • Community-based
  • Homeless adults
  • Retention
  • Smoking cessation

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