The Ethical Involvement of Women in HIV Vaccine Trials in Africa: Discussion Paper Developed for the African AIDS Vaccine Programme

Abstract

HIV disproportionately affects women in developing countries, especially in Southern Africa. Women thus stand to benefit most from a successful HIV vaccine and must participate in trials to test appropriate, gender-specific products. Several HIV vaccine efforts are currently underway in Africa. Participation in HIV vaccine trials requires that participants not only understand the complex nature of trial procedures, but that they also have autonomous decisional capacity to enroll. Given that the risk factors inherent in women's greater vulnerability constitute an intricate mix of biological, economic and social variables, will women's very vulnerability to HIV be an obstacle to ethical participation in vaccine development? This paper addresses some of the challenges underlying the successful recruitment of women into vaccine research and makes research and policy recommendations for the ethical inclusion of women in HIV vaccine trials in Africa.

Gender, sex, and HIV: how well are we addressing the imbalance?

“…Special measures need to be taken to overcome barriers and facilitate enrolment and retention of women in biomedical HIV prevention and treatment trials [51]. The recent darunavir/ritonavir GRACE (gender, race, and clinical experience) study, which was designed to include 70% female participants required the establishment of new community-based research sites beyond the usual academic clinical trial sites (K. Manson, personal communication).…”

Military men and sexual practices: Discourses of ‘othering’ in safer sex in the light of HIV/AIDS

“…For example, the enactment of masculinity and heterosexual men's sexuality is seen to be against condom use (Flood, 2000). Yet, in South Africa and other African countries, HIV/AIDS is more prevalent among women than men, who are reported to be the initiators of unsafe sex (Deacon, 2005;Wassenaar & Barsdorf, 2007). Therefore, a complete examination of current HIV/AIDS interventions requires that we explore constructions of masculinity and sexuality in regard to the constructions and dysfunctions of male identity, sexual identity and cultural and other social factors such as age, race, ethnicity and generation (Dowsett, 2003).…”

“…Young people, especially women, are reported to be at high risk of HIV/AIDS infection (Dowsett, 2003;Gupta, 2005in Wassenaar & Barsdorf, 2007Heinecken, 2003;Shisana, 2004;Shisana & Simbayi, 2002). Even if young women are known to be more at risk, young men too have HIV risk.…”

The Challenges in Enrolment and Retention of African Women in Clinical Trials: A Pilot Study in Nigeria

“…Our study also shows that some of the respondents especially those with low level of education and limited knowledge of the type of clinical trials were concerned about the adverse effect they may encounter during the research process. Wessenaar and Barsdof [8] maintained that women's active informed participation in clinical trials and prevention efforts in general is important, but this participation becomes vital when women are most affected by a given disease. For example, they explained that women's distinct vulnerability to HIV means that HIV vaccine trials must include women, not only because vaccines have to be tested in high-risk groups, but more importantly because HIV vaccine candidates need to be tested for their safety, suitability and efficacy in women.…”