Population Council | Microbicides | Involving Communities in Clinical Trials

PROJECT
Involving Communities in Clinical Trials

The Population Council's approach to microbicide development is client-focused. Council researchers consult regularly with colleagues in the microbicides field, with women’s health advocates, and with people in the communities in which products are being tested.

Thailand. In the spring of 1998, Council staff members in Bangkok organized a national consultation with women’s health advocates, researchers, provincial and national health officials, and key HIV/AIDS organizations in Thailand. Participants reviewed recent developments in microbicide trial design and research on microbicides and related issues in Thailand and elsewhere. They were also invited to review and comment on specific elements of the planned expanded safety and acceptability trial.

One of the most important outcomes of the consultation was the formation of the Chiang Rai Community Advisory Group (CAG). This group met regularly throughout the trial and was an important source of information about the study for the community in general. The meetings helped the researchers as well, by ensuring that the research was responsive to the needs of the community. Additionally, before beginning the trial, the research team conducted a survey to measure the willingness of women in the community to participate in a microbicide trial. The CAG continued to provide input for two other trials conducted by the Council in Chiang Rai.

South Africa. In the fall of 1998, researchers worked closely with the Women's Health Project in Johannesburg to organize a national consultation with women’s health advocates, researchers, provincial and national health officials, and HIV/AIDS organizations in South Africa to share and review plans for the expanded safety and acceptability trial. Discussions during the meeting ranged from sophisticated debate about ethical challenges to practical suggestions on how to implement the trial.

The consultation had several important outcomes. First, it helped raise awareness of microbicides among key constituencies in South Africa. Second, it fostered a transparent and open research process. Third, it generated a number of practical suggestions that facilitated the implementation of the study. Finally, it served as a sobering reminder of the urgent need to find new means by which women can protect themselves from HIV. A report of the meeting, Informing Research on HIV Prevention, has been widely distributed in South Africa and other countries around the world.

In preparation for the large-scale efficacy trial, the Population Council and two of its local collaborators—the University of Cape Town and the University of Limpopo/Medunsa campus—established community advisory groups to meet with and advise the research teams on a regular basis, prior to and during the trial.

CAGs have clear mandates and are advisory in nature. Members include local researchers, ethicists, representatives from nongovernmental organizations, activists, health authorities, and other interested parties. Involving CAGs in the trial process helps to ensure that study researchers and staff are responsive to local concerns. Additionally, CAGs provide a forum in which to provide information about the trial design and objectives to the community, to solicit input from community members, and to develop a cadre of community members who are knowledgeable about both microbicides in general and the clinical trial in progress.

Broader community meetings also took place before and during the Phase 3 Carraguard® trial at the University of Cape Town and Medunsa, as well as at the South African Medical Research Council in Isipingo. In August 2007, members of the Phase 3 team participated in a meeting on clinical trials held by the African Microbicides Advocacy Group and the South African Gender AIDS Forum. In October 2007, the Population Council and the Microbicide Trials Network (MTN) co-convened a two-day workshop to educate advocates about the recently completed Carraguard trial and an upcoming MTN study. The meeting was an excellent opportunity for advocates and researchers to discuss some of the complicated issues—such as trial design and informed consent—involved in clinical trials and opened a channel for ongoing communication.