Willingness to participate in HIV therapeutic vaccine trials among HIV-infected patients on ART in China

Yuan Dong; Xiaoxing Shen; Ruizhang Guo; Baochi Liu; Lingyan Zhu; Jing Wang; Linxia Zhang; Jun Sun; Xiaoyan Zhang; Jianqing Xu

doi:10.1371/journal.pone.0111321

Willingness to participate in HIV therapeutic vaccine trials among HIV-infected patients on ART in China

PLoS One. 2014 Nov 5;9(11):e111321. doi: 10.1371/journal.pone.0111321. eCollection 2014.

Authors

Affiliations

¹ Shanghai Public Health Clinical Center and Institutes of Biomedical Sciences, Key Laboratory of Medical Molecular Virology of Ministry of Education/Health, Shanghai Medical College, Fudan University, Shanghai, China.
² Bloomberg School of Public Health, John Hopkins University, Baltimore, Maryland, United States of America.
³ Shanghai Public Health Clinical Center and Institutes of Biomedical Sciences, Key Laboratory of Medical Molecular Virology of Ministry of Education/Health, Shanghai Medical College, Fudan University, Shanghai, China; State Key Laboratory for Infectious Disease Prevention and Control, China CDC, Beijing, China.

Abstract

Background: More and more HIV therapeutic vaccines will enter clinical trials; however, little is known about the willingness to participate (WTP) in HIV therapeutic vaccine trials among HIV-positive individuals.

Objective: To investigate the WTP in HIV therapeutic vaccine trials among Chinese HIV-infected patients.

Methods: We conducted a cross-sectional survey on HIV-positive inpatients and outpatients at Shanghai Public Health Center. A total of 447 participants were recruited into this study. Following an introduction with general information on HIV therapeutic vaccine and its potential effectiveness and side effects, each participant completed a questionnaire in a self-administered form. The questionnaires covered demographics, high-risk behaviors, clinical characteristics and willingness to participate in HIV therapeutic vaccine trial.

Results: The overall willingness to participate in HIV therapeutic vaccine trials was 91.5%. Interestingly, multivariate logistic regression analyses demonstrated that the willingness was higher for those sexually infected by HIV (odds ratio [OR]: 4.36; 95% confidence interval [CI]: 1.53-12.41), diagnosed as HIV-1 infection for greater than 5 years (OR: 7.12, 95% CI: 1.83-27.76), and with the presence of infectious complications (OR: 2.75; 95% CI: 1.02-7.45). The primary reason for participation was to delay or reduce antiretroviral treatment (ART) and to avoid ART side effects (76.6%), and then followed by delaying disease progression (74.9%), increasing immune response to suppress opportunistic infections (57.7%) and preventing the development of drug resistance (37.1%). Reasons for unwillingness to participate mainly included concern for safety (37.0%), lack of knowledge on therapeutic vaccine (33.3%), and satisfaction with ART effectiveness (22.2%).

Conclusions: The WTP in HIV therapeutic vaccine trials was high among HIV-infected Chinese patients. HIV+ subjects who acquired infection through sexual contact and who were diagnosed for more than 5 years may represent a good candidate population for enrollment in therapeutic vaccine trials.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

AIDS Vaccines* / immunology
AIDS Vaccines* / therapeutic use
Adult
Aged
Antiretroviral Therapy, Highly Active
China
Clinical Trials as Topic
Cross-Sectional Studies
Female
HIV Infections / prevention & control
HIV Infections / psychology*
HIV Infections / therapy
Humans
Male
Middle Aged
Motivation*
Patient Participation*
Risk Factors
Young Adult

Substances

AIDS Vaccines

Grants and funding

This work was supported by National Grand Program on Key Infectious Disease Control and Prevention (2013ZX10001-002) of China. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.