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Recommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies.

dc.contributor.authorEtter, Paige.
dc.contributor.authorLandovitz, Raphael J.
dc.contributor.authorSibeko, Sengeziwe.
dc.contributor.authorSobieszczyk, Magdalena E.
dc.contributor.authorRiddler, Sharon Anne.
dc.contributor.authorKarg, Carissa.
dc.contributor.authorTsibris, Athe.
dc.contributor.authorSchouten, Jeffrey.
dc.date.accessioned2016-10-17T12:15:26Z
dc.date.available2016-10-17T12:15:26Z
dc.date.created2013
dc.date.issued2013
dc.descriptionCAPRISA_2013.en_US
dc.description.abstractObjective: 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.en_US
dc.identifier.citationEtter, P., Landovitz, R., Sibeko, S., Sobieszczyk, M.E., Riddler, S.A., Karg, C., Tsibris, A. and Schouten, J. 2013. Recommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies. AIDS (London, England) 27(7), 1119-1128.en_US
dc.identifier.urihttp://dx.doi.org/10.1097/QAD.0b013e32835dc08e.en_US
dc.identifier.urihttp://hdl.handle.net/10413/13514
dc.language.isoenen_US
dc.publisherWolters Kluwer Health.en_US
dc.subjectClinical trials as topic.en_US
dc.subjectHIV.en_US
dc.subjectHIV seroconversion.en_US
dc.subjectpathogenesis.en_US
dc.subjectPrevention.en_US
dc.titleRecommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies.en_US
dc.typePeer reviewed journal articleen_US

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