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.

journal_name

Vaccine

journal_title

Vaccine

authors

Andrasik MP,Karuna ST,Nebergall M,Koblin BA,Kublin JG,NIAID HIV Vaccine Trials Network.

doi

10.1016/j.vaccine.2013.07.003

subject

Has Abstract

pub_date

2013-09-13 00:00:00

pages

4398-405

issue

40

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(13)00924-9

journal_volume

31

pub_type

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