AEGiS-13IAC: Monitoring of social and behavioral harms in the Phase III Trial of AIDSVAX(r) B/B.

13th International AIDS Conference


Durban, South Africa - July 9-July 14, 2000

DonateNow
Print this article

Monitoring of social and behavioral harms in the Phase III Trial of AIDSVAX(r) B/B.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. ThOrD679)

Jermano J
J. Jermano, VaxGen, Inc, 1000 Marina Blvd, 2nd Floor, Brisbane, CA, United States, Tel.: +1 650 624 10 00, Fax: +1 650 624 10 01, E-mail: jjermano@vaxgen.com

ISSUES: Phase II studies suggest that HIV vaccine efficacy trial volunteers may experience stigmatization (through disclosure of high-risk group membership), discrimination (from misinterpretation of HIV serologic tests), and amplification of risk-taking behavior (due to misperceptions of vaccine efficacy). Based on these concerns, a comprehensive program to address study-related social and behavioral harms was integrated into the first HIV vaccine efficacy trial.

DESCRIPTION: The VaxGen Study is a Phase III study 'N = 5415; 94% men who have sex with men (MSM)' to evaluate the safety and efficacy of AIDSVAX(r) B/B. Methods to minimize social impact include pro-active education, detailed informed consent, and confidentiality protection. Client-centered HIV risk reduction counseling is provided based on guidelines that cover key aspects of study design, vaccine protection beliefs, and HIV prevention skills. Outcomes are assessed by questionnaires that collect data on social impact events, risk behavior, non-study HIV testing, and perceived treatment assignment. Through 23-Jan-2000, disturbances in personal relationships were the most frequent social impact (7.5% and 4.1% of reports at mos. 6 and 12, respectively). These often resulted from negative comments about trial participation from family and friends or misperceptions that a volunteer was HIV-infected. Study-related employment and health/life insurance impact was infrequent (>0.4% of reports). Between mos. 0-6, the proportion of MSM with >5 male sex partners declined from 54% to 44%. Unprotected sexual activity between MSM and HIV+ male partners also appeared to be decrease over time.

CONCLUSIONS: This describes the first program implemented to mitigate social and behavioral harms in a Phase III HIV vaccine trial. Vigilance for potential adverse socio-behavioral effects is an essential aspect of safety monitoring in such trials.

Keywords: AEGIS, AIDS Vaccines, Clinical Trials, HIV Infections, Risk-Taking, Acquired Immunodeficiency Syndrome, Sex Behavior, Insurance, Life, Voluntary Workers, Research Design, Employment, AIDSVAX, Human, Male, Psychology, economicsKWDaegis,aidsvaccines,clinicaltrials,hivinfections,risk-taking,acquiredimmunodeficiencysyndrome,sexbehavior,insurance,life,voluntaryworkers,researchdesign,employment,aidsvax,human,male,psychology,economics
000709
ThOrD679

Copyright © 2000 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.