Enrolling Women into HIV Preventive Vaccine Trials: An Ethical Imperative but a Logistical Challenge

Abstract

Mills and colleagues argue that the challenge of enrolling women into HIV vaccine trials must be overcome in order for trials to be considered ethical, valid, and generalizable.

Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries

“…In this context, all study-related procedures should be presented in the local language and addressed to varying levels of age, sex and education, both orally and in writing, thus enabling participants to fully comprehend the design, risks and potential benefits of the clinical study (Mills et al, 2006). Flexibility in the documentation and securing of such consent, both on the individual and community level, is demanded (Hyder & Wali, 2006).…”

“…Enrolling women in HIV/AIDS clinical trials represents another, equally daunting, challenge that needs to be addressed (De Bruyn & Paxton, 2005;Homsy et al, 2007;Karamagi et al, 2006;Mills et al, 2006;Pettifor et al, 2005;Salvi & Damania, 2006). Mills et al (2006) when examining patients' recruitment and enrollment in HIV vaccine trials reported that women in poorer countries often lacked formal education and could not fully understand the uncertainty that existed within clinical trials; known as the 'therapeutic fallacy' in the medical ethics literature.…”

“…Mills et al (2006) when examining patients' recruitment and enrollment in HIV vaccine trials reported that women in poorer countries often lacked formal education and could not fully understand the uncertainty that existed within clinical trials; known as the 'therapeutic fallacy' in the medical ethics literature. Furthermore, women's decision-making was often subject to parental or husband control, religious coercion or social hierarchy, conditions under which free informed consent was unfeasible to obtain (De Bruyn & Paxton, 2005;Homsy et al, 2007;Karamagi et al, 2006;Salvi & Damania, 2006;Shaibu, 2007;UNAIDS, 2004).…”

The Utility of Non-proportional Quota Sampling for Recruiting At-risk Women for Microbicide Research

“…Enrolling women in HIV prevention research may raise issues not present when enrolling men. Some women may lack the power to freely choose to enroll in sexual behavior studies (Mills et al, 2006), researchers may not offer flexibility to work around participants' schedules (Dilworth-Anderson & Williams, 2004) or may create barriers to participation by not offering transportation and child care (Morrow & Costello, 2004), and some women and minorities face illiteracy and/or limited education (Mills et al, 2006), potentially challenging informed consent processes and privacy protections via selfadministered questionnaires. These issues, together with cultural and language barriers and a historical lack of trust in health research (Dunn & Chadwick, 2004;Killien et al, 2000;Yancey, Ortega, & Kumanyika, 2006), may contribute to nonparticipation among racial/ethnic minorities.…”

A model for community representation and participation in HIV prevention trials among women who engage in transactional sex in Africa

“…These include female sex workers (Page-Shafer et al, 2005); prisoners (Moser et al, 2004); intravenous drug users (Meyers et al, 1995); the homeless (Nyamathi et al, 2004); and men that have sex with men (Sherr, Bolding, & Elford, 2004). In many resource-limited settings, such populations are often marginalised within the broader community and considered vulnerable both in terms of increased risk of HIV and sexually transmitted infections (STIs), and due to stigma, poverty, social exclusion and lack of access to education, health care and other essential services (Gysels, Pool, & Nnalusiba, 2002;Mills et al, 2006). Traditional concepts of 'community', 'participation' and 'representation' can be difficult to apply in such environments (Busza & Schunter, 2001;Vallely, Shagi et al, 2007 specific setting (MacQueen et al, 2001;Nyamathi et al, 2004).…”