title: Behavioral risk assessment in HIV Vaccine Trials Network (HVTN) clinical trials: a qualitative study exploring HVTN staff perspectives.
abstract: In HIV vaccine trials, the collection and analysis of participant behavior data associated with risk of acquiring HIV-infection is important for a number of reasons. Although the rationale for behavioral risk assessment in HIV vaccine clinical trials is clear, consistent collection of behavioral data over time and across protocols has been challenging for the HIV Vaccine Trials Network (HVTN). Integrating biomedical and behavioral research within the same preventive vaccine clinical trial has proven difficult. The HVTN conducted an internal landscape analysis to: (1) evaluate the challenges of behavioral risk assessment in HIV vaccine trials and observational studies; (2) explore the impact of the Step Study on behavioral risk assessment measures; and (3) identify strategies to overcome existing challenges and improve the quality of data resulting from behavioral risk analysis. These analyses of behavioral risk within the HVTN revealed several challenges and recommendations for improved behavioral risk data collection in future protocols. The recommendations for improvement include: (1) establishment of protocol-specific behavioral risk working groups that include social and behavioral experts; (2) provision of behavioral rationale and objectives to the development team; (3) creation of a template for geographic- and population-specific assessment of low and high risk behaviors; and (4) pilot testing of behavioral risk assessments. Results also underscored the need for routinely conducted analyses of behavioral data.
authors.affiliation: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, HIV Vaccine Trials Network, 1100 Fairview Avenue North, E3-300, PO Box 19024, Seattle, WA 98109, USA. mandrasik@fhcrc.org
authors.forename: Michele Peake
authors.initials: MP
authors.lastname: Andrasik
authors.forename: Shelly T
authors.initials: ST
authors.lastname: Karuna
authors.forename: Michelle
authors.initials: M
authors.lastname: Nebergall
authors.forename: Beryl A
authors.initials: BA
authors.lastname: Koblin
authors.forename: Jim G
authors.initials: JG
authors.lastname: Kublin
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D001291:Attitude of Health Personnel; D001519:Behavior; D040343:Behavioral Risk Factor Surveillance System; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D010349:Patient Compliance; D018570:Risk Assessment; D011795:Surveys and Questionnaires
chemical_list: D016915:AIDS Vaccines
keywords: Biomedical interventions; HIV; Risk behavior; Vaccine clinical trials