Recommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies
Year: 2012
Type: review
Abstract: 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.
Source: AIDS
Institutions: Fred Hutch Cancer Center, University of California, Los Angeles, Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Columbia University Irving Medical Center, Columbia University, University of Pittsburgh, Harvard University, AIDS Clinical Trials Group
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: Microbicide Trials Network, Clinical and Translational Science Award, Leadership and Operations Center (LOC): Microbicide Trials Network, G4607584577, Washington Women's Interagency HIV/AIDS Study, Columbia Collaborative HIV/AIDS Clinical Trials Unit, Clinical and Translational Science Award, Leadership Group for a Global HIV Vaccine Clinical Trials Network, Biomedical Prevention for HIV in High-risk Populations with Comorbidities, Center for HIV Identification, Prevention and Treatment Services, HIV Vaccines Clinical Trials Network Leadership and Operations Center, Pitt-Ohio State Clinical Trials Unit
OpenAlex ID: W2041169972