Elsevier

Public Health

Volume 129, Issue 9, September 2015, Pages 1187-1193
Public Health

Original Research
Use of partial least squares path modelling to assess the willingness of Chinese female sex workers to participate in a microbicide trial

https://doi.org/10.1016/j.puhe.2015.06.001Get rights and content

Highlights

  • We investigate willingness to participate (WTP) in a microbicide clinical trial of female sex workers (FSWs) in south-western China.

  • We model WTP with possible motivations/barriers using exploratory factor analysis and partial least squares path modelling.

  • Perceived benefits and hindrances have effects on WTP.

  • FSWs were vulnerable and need more support for participating in a clinical trial.

Abstract

Objectives

To investigate the willingness of Chinese female sex workers (FSWs) to participate (WTP) in a clinical trial of microbicides; to explore the potential hindrances and facilitating factors; and to provide support for future microbicide clinical trials by tailoring their design to better meet the specific needs of FSWs.

Study design

Cross-sectional study.

Methods

In total, 404 FSWs were investigated using structured questionnaires. Exploratory factor analysis and partial least squares path modelling were used to explore the correlations between several influencing factors and WTP.

Results

The WTP of FSWs enrolled in this study was high (53.47%, 216/404). Possible benefits from enrolment in the trial were positively associated with WTP, while concern about a hypothetical microbicide, potential physical harm, economic loss from participation, and fear of family or social isolation were negatively associated with WTP.

Conclusion

FSWs are appropriate participants in microbicide clinical trials, and are likely to benefit from effective microbicides. In a microbicide clinical trial, it is imperative to ensure protection of the rights, dignity, safety, confidentiality and welfare of FSW participants.

Introduction

According to statistics from the World Health Organization and the Joint United Nations Programme on human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), 780,000 adults and children were estimated to be living with HIV/AIDS in China at the end of 2011, with 48,000 new cases of infection in 2011.1 Unprotected heterosexual and homosexual activities have become the primary mode of HIV transmission and infection.

Females accounted for 28.6% of reported HIV-positive cases in China in 2011.1 Women generally lack the power to negotiate use of condoms within sexual relationships,2, 3 thus increasing their vulnerability to HIV and other sexually transmitted infections (STIs). Female-controlled prevention tools, such as female condoms and vaginal microbicides, may better address women's specific prevention needs.4

Microbicides may be able to substantially reduce the risk of transmission of STIs/HIV when applied to the vagina or rectum before intercourse. Several candidate vaginal microbicides are at various stages of laboratorial or clinical development.5, 6, 7, 8, 9, 10, 11 The ideal trial population would consist of sexually active women who perceive themselves to be at some risk of HIV infection. Female sex workers (FSWs) are believed to be at high risk of infection with STIs/HIV and play a critical role in the transmission of STIs/HIV.12, 13 This suggests that FSWs may be appropriate participants in microbicide clinical trials and would be more representative than the general population. As such, their interests and concerns regarding participation should be taken into consideration during the trial design and enrolment process in order to tailor trials to better meet their specific needs.4 A cross-sectional study was undertaken to investigate the willingness of FSWs to participate (WTP) in a clinical trial and to explore possible motivations/barriers.

Section snippets

Study design and population

This study was conducted in the city of Xichang, Sichuan Province, South-west China from April to June 2010. The local STD control centre estimates that there are approximately 2800 FSWs in Xichang. In China, FSWs are difficult to access because of their illegal status and the covert nature of their work.12, 13, 14 A two-stage sampling method was used in this study. Firstly, the sites of sex venues in Xichang were mapped systematically, and three different types of venues (roadside hair salons,

Results

Preliminary analysis showed that 53.47% (216/404) of FSWs were definitely WTP, 26.98% (109/404) might participate, 7.92% (32/404) might not participate, and 11.63% (47/404) were definitely non-WTP. The outcome variables were dichotomized into WTP (if the answer was ‘definitely WTP’) and non-WTP (for other answers) to better compare each category with plenty of subjects.

Discussion

To the authors' knowledge, this is the first study to conduct research among FSWs in south-western China, and it found that FSWs were very positive about the idea of vaginal microbicides. The participants expressed interests and concerns, and a high percentage (53.47%, 216/404) reported definite WTP in a microbicide trial. The high and increasing infection rates of HIV and other STDs12, 13 among FSWs may be a compelling reason for their great support. Research regarding HIV vaccine trials in

Ethical approval

All research activities were reviewed and approved by the Ethical Review Committee of Chongqing Medical University and the Institutional Review Board of the Centre for Disease Control and Prevention of China for acceptable protection of human subjects.

Funding

National Natural Science Foundation of China (30972548), the Ministry of Science and Technology of China (2008ZX10001-015, 2012ZX10001-002).

Competing interests

None declared.

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