A series of qualitative studies were undertaken on issues related to AIDS vaccine trials in India to understand some of these key concerns and perspectives. Probe Qualitative Research (PQR), studied the opinions among experts within community organisations active in the fields of HIV/AIDS and reproductive health. Issues such as why India had been chosen for trials as well as those around compensation, informed consent, human rights of people involved in the trials and ethical issues were raised. Findings in this report have informed various communication efforts and community mobilisation plans. A report is available. (Please click here to read the report)

Efforts to Engage Women: IAVI's challenge when conducting AIDS vaccine trials in India is to address issues related to communities at higher risk, including women. An AIDS vaccine is rarely viewed through the lens of women's vulnerability, yet it holds tremendous promise for women, who often lack the power to negotiate the terms and conditions of sexual relations.

IAVI has been engaged in identifying and addressing critical issues related to women's and men's participation in AIDS vaccine trials and eventual acceptability and use of an AIDS vaccine in India. IAVI recognises that gender-specific issues are one facet of a larger programmatic focus on ethics, community preparedness, access and eventual use of the vaccine.

While the need to include equitable numbers of women and men in clinical trials is well-recognised, enrolling significant numbers of women in AIDS vaccine clinical trials is a challenge. Considerable effort and planning is required to take care of the cultural and logistical barriers to women's participation. The challenge lies in investing the time and effort needed to explain the process and trial requirements to women, communities and families.

During 2002-2003, IAVI held a series of consultations in India with individuals and organisations working on issues of gender, women’s health, ethics and rights. These consultations provided useful guidance on key gender concerns and issues when conducting trials in India. Critical gender issues include informed consent, confidentiality, stigma and discrimination that could arise from disclosing participation, and prevention of social harm of any kind to all volunteers, particularly women. Read Programe Brief - Women in AIDS Vaccine Clinical Research: Applying a Gender Lens in India

In May 2003, IAVI set up a Gender Advisory Board to help oversee and guide IAVI's efforts to incorporate gender issues in the planned trials. The mandate of this advisory board is to provide guidance in developing gender-sensitive trial protocols, building a gender perspective in the trial team and setting up accountability mechanisms to review and monitor all aspects of the trial.

IAVI facilitated gender sensitisation training for trial teams at the two vaccine trial centres as plans for starting Phase I trials of AIDS vaccines in India were underway. In August 2004, training was conducted with the National AIDS Research Centre (NARI) in Pune, and in July 2005, with the Tuberculosis Research Centre (TRC) in Chennai. A range of gender issues were covered, including the limited autonomy in decision-making that women often face; the potential consequences for women of breaches of confidentiality, including stigma, blame, loss of economic support or even violence; and what the trial team could do individually and effectively to address these barriers to improve recruitment and retention.

Thus far, both Phase I trials in Pune and Chennai have enrolled fifty per cent women and men. Whether these equal enrolment figures can be attributed to a higher awareness of gender issues and a more gender-sensitive approach, or a combination of other factors, can only be determined once an assessment is conducted of the gender training.

The proactive steps taken to incorporate gender concerns in AIDS vaccine trials in India might hold important lessons for other AIDS vaccine trials. Meanwhile, the gender work initiated in India has served as a foundation for IAVI’s gender efforts in its other programme countries in East Africa (Kenya and Uganda) and Southern Africa.

IAVI has been engaged with MSM and TG populations as potential high risk groups that could be involved in future AIDS vaccine research. In 2006, numerous consultations were held with NGOs and CBOs working with MSM and TG populations, experts, and community members to seek insights into and understanding of the community regarding their concerns and issues in participating in clinical research studies.

In 2007, IAVI conducted a formative research study to assess the group dynamics of this population in terms of their sub-groups, hierarchies, and stability; understand the risk profile of this population in terms of their sexual behaviour, mobility, and substance use; and identify the health care-seeking patterns and quality of available health services, including VCT services. The study was conducted in four sites in three high-prevalence states: Chennai and Madurai in Tamilnadu, Hyderabad in Andhra Pradesh, and Mumbai in Maharashtra. A mix of qualitative and quantitative methods were used, including a participatory ethnographic evaluation and research (PEER) methodology for in-depth interviews of the MSM and TG population. Data from this study is under analysis and findings will be made available by early March.

Involving community representatives and key stakeholder groups in meaningful dialogue early on can contribute to the success of AIDS vaccine research.

Trust must be built with communities and in country stakeholders so that they may become allies. It is their right to know about the research and to be involved.

Communities in which trials are conducted should experience benefits beyond their contribution to the trial and should be better off after the trial is completed.

In sub-saharan Africa, HIV infection rates among women surpassed those among men: women now account for 57% of all infections in the region. Young women in particular seem to be more vulnerable than men of their same age.