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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Recommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies
AIDS, Volume 27, No. 7, Year 2013
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Description
Objective: To facilitate collection of cumulative data on longitudinal HIV disease outcomes during HIV prevention studies by developing recommendations for follow-up of the relatively few study participants with breakthrough infections. Design: We formed a working group to compare and contrast the various approaches taken in recent HIV prevention trials, to summarize the advantages and disadvantages associated with each, and to explore the feasibility of developing protocols for the long-term follow-up of seroconverters. Methods: We reviewed study designs, objectives, and assessments in 15 interventional studies that followed HIV seroconverters. Protocol team members joined discussions of the various approaches and developed recommendations. Results: Most HIV prevention clinical trials share a core set of objectives, including the description/comparison of virological, immunological, and clinical course of HIV, and sometimes a comparison of preseroconversion and postseroconversion behavior. Long-term follow-up of seroconverters can be conducted in separate studies if the transition from parent protocol is effectively managed. Conclusion: We recommend the development of harmonized seroconverter protocols. Although specific research questions in the postseroconversion period may differ depending on prevention modality, harmonizing key evaluations would create an opportunity to ask overarching questions that inform the prevention field with respect to design and implementation of future combination prevention studies. Follow-up immediately postseroconversion should be conducted in the parent protocol before roll over into a follow-up protocol. Development of specimen repositories with ample volumes for future assays, standardized definitions of infection, diagnosis and seroconversion dates, and harmonization of study objectives and sample collections at key time points are important. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Authors & Co-Authors
Etter, Paige
United States, Seattle
Fred Hutchinson Cancer Research Center
Landovitz, Raphael J.
United States, Los Angeles
University of California, Los Angeles
Sibeko, Sengeziwe Sibongile
South Africa, Congella
Centre for the Aids Programme of Research in South Africa
Sobieszczyk, Magdalena E.
United States, New York
Vagelos College of Physicians and Surgeons
Riddler, Sharon A.
United States, Pittsburgh
University of Pittsburgh
Karg, Carissa
United States, Seattle
Fred Hutchinson Cancer Research Center
Tsibris, Athe M.
United States, Boston
Harvard Medical School
Schouten, Jeffrey T.
United States, Seattle
Fred Hutchinson Cancer Research Center
Statistics
Citations: 8
Authors: 8
Affiliations: 6
Identifiers
Doi:
10.1097/QAD.0b013e32835dc08e
e-ISSN:
14735571
Research Areas
Infectious Diseases
Study Design
Cohort Study