CONFERENCE HIGHLIGHTS - Recruitment reports from around the world
Bangkok brought frontline reports from many sites that have recently launched AIDS vaccine trials and are using innovative approaches to enrollment. But it was also clear that recruitment is a time-consuming process that often does not proceed as rapidly as planned and can require trial teams to revise original recruitment strategies.
Perhaps the most dramatic example comes from the ongoing Phase III “Prime-Boost” trial in Thailand. Principal Investigator Supachai Rerks-Ngarm gave an update on enrollment for the study, which aims to recruit 16,000 volunteers in the provinces of Rayong and Chon Buri. The trial is enrolling a “community-based” cohort, meaning that all trial activities are integrated into existing health facilities and that all adult residents of these provinces are eligible to enroll.
Recruitment began in late September 2003 and, as of June 2004, 2,571 volunteers had enrolled in the trial, fewer than originally anticipated. The enrollment will be extended by another year. “We are confident that we will achieve enough volunteers after this extension,” said Dr. Rerks-Ngarm.
Another report came from the vaccine trials unit in Soweto, South Africa, where the country’s first two AIDS vaccine trials began in 2003. The site used community-based voluntary counseling and testing (VCT) centers as the “entry point” for recruitment. All HIV-uninfected adults were invited to join monthly “vaccine discussion groups” and individuals who attended more than two sessions were then invited to be screened for trial participation. This approach led to a 10:1 ratio of screening to enrollment, a typical ratio that illustrates the effort and resources required for trial recruitment, even at experienced sites.
Other posters also described recruitment, retention and media outreach strategies in settings like Botswana, Brazil, Kenya and the UK, and examined key issues such as the enrollment of women into trials and the level of health care that should be provided to volunteers and surrounding communities.
Trial preparation also starts long before the first volunteers are screened. IAVI Medical Director-India, Jean-Louis Excler, discussed ongoing efforts to prepare for India’s first AIDS vaccine trials, which could start as soon as late 2004. Excler described intensive coalition-building work on a national level and in six of India’s high-prevalence states, including outreach to AIDS NGOs, women’s groups and political leaders.
~ For more information: A searchable database of conference abstracts can be found online at www.aids2004.org