Defining, designing, implementing, and evaluating phase 4 HIV prevention effectiveness trials for vulnerable populations. J Acquir Immune Defic Syndr 2008 Mar 01;47 Suppl 1(Suppl 1):S28-33
Date
04/09/2008Pubmed ID
18301131Pubmed Central ID
PMC2409151DOI
10.1097/QAI.0b013e3181605c77Scopus ID
2-s2.0-40049084616 (requires institutional sign-in at Scopus site) 22 CitationsAbstract
The efficacy of behavioral HIV prevention interventions has been convincingly demonstrated in a large number of randomized controlled phase 3 research outcome trials. Little research attention has been directed toward studying the effectiveness of the same interventions when delivered by providers to their own clients or community members, however. This article argues for the need to conduct phase 4 effectiveness trials of HIV prevention interventions that have been found efficacious in the research arena. Such trials can provide important information concerning the impact of interventions when applied in heterogeneous "real-world" circumstances. This article raises design issues and methodologic questions that need to be addressed in the conduct of phase 4 trials of behavioral interventions. These issues include the selection and training of service providers engaged in such trials, maintenance of fidelity to intervention protocol in provider-delivered interventions, determination of intervention core elements versus aspects that require tailoring, selection of relevant phase 4 study outcomes, interpretation of findings indicative of field effectiveness, sustainability, and other aspects of phase 4 trial design.
Author List
Kelly JA, Spielberg F, McAuliffe TLAuthors
Jeffrey A. Kelly PhD Professor in the Psychiatry and Behavioral Medicine department at Medical College of WisconsinTimothy L. McAuliffe PhD Professor in the Psychiatry and Behavioral Medicine department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
Behavior ControlClinical Trials, Phase IV as Topic
Communicable Disease Control
HIV Infections
Health Services Research
Humans
Vulnerable Populations
