title: Recommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
authors.forename: Paige
authors.initials: P
authors.lastname: Etter
authors.forename: Raphael
authors.initials: R
authors.lastname: Landovitz
authors.forename: Sengeziwe
authors.initials: S
authors.lastname: Sibeko
authors.forename: Magdalena E
authors.initials: ME
authors.lastname: Sobieszczyk
authors.forename: Sharon A
authors.initials: SA
authors.lastname: Riddler
authors.forename: Carissa
authors.initials: C
authors.lastname: Karg
authors.forename: Athe
authors.initials: A
authors.lastname: Tsibris
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Schouten
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000453:epidemiology* / Q000517:prevention & control; D018791:CD4 Lymphocyte Count; D002986:Clinical Trials as Topic; D003625:Data Collection; D003695:Delivery of Health Care / Q000458:organization & administration*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D017408:Guidelines as Topic; D006679:HIV Seropositivity / Q000453:epidemiology*; D006801:Humans; D008297:Male; D012725:Sexual Behavior / Q000706:statistics & numerical data*; D014481:United States / Q000453:epidemiology; D019562:Viral Load