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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Participant retention in clinical trials of candidate HIV vaccines
Journal of Acquired Immune Deficiency Syndromes, Volume 39, No. 4, Year 2005
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Description
Objective: To determine predictors of loss to follow-up (LTFU) in trials of candidate HIV vaccines. Methods: Data were obtained from trials of candidate preventive HIV vaccines conducted by the AIDS Vaccine Evaluation Group (AVEG) and HIV Network for Prevention Trials (HIVNET) that enrolled HIV-negative volunteers. Analytic models included multiple logistic regression and generalized estimating equations. Results: Of 3033 volunteers enrolled in 48 trials, 282 (9.3%) persons did not complete follow-up. In univariate analyses, age, trial duration, and number of immunizations were associated with LTFU. In a multivariate logistic model, age (per year) (adjusted odds ratio [AOR] = 0.96, 95% confidence interval [CI]: 0.95, 0.98) and study duration (per month) (AOR = 1.04, 95% CI: 1.01, 1.08) remained significantly associated with LTFU. Conclusions: Younger age and increasing trial duration predicted LTFU. Limiting enrollment in trials of novel products to those less than 40 years of age may exclude participants shown to have improved retention. Trials should be designed to last only as long as required to address the scientific question. Retention efforts in future trials should especially address younger persons. Copyright © 2005 by Lippincott Williams & Wilkins.
Authors & Co-Authors
De Bruyn, Guy
United States, Seattle
Hiv Vaccine Trials Network
South Africa, Johannesburg
University of the Witwatersrand
Hudgens, Michael G.
United States, Seattle
Fred Hutchinson Cancer Research Center
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Sullivan, Patrick Sean
United States, Seattle
Hiv Vaccine Trials Network
United States, Atlanta
National Center for Hiv, Viral Hepatitis, Std, and tb Prevention
Duerr, Ann C.
United States, Seattle
Hiv Vaccine Trials Network
Statistics
Citations: 4
Authors: 4
Affiliations: 5
Identifiers
Doi:
10.1097/01.qai.0000148532.12329.df
ISSN:
15254135
Research Areas
Infectious Diseases
Study Design
Cohort Study
Case-Control Study