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
South African researcher Ann Strode (University of Kwa Zulu Natal) highlighted the complexities of enrolling adolescents into AIDS vaccine trials. Young women aged 15-24 are particularly vulnerable to HIV infection—in South Africa, for example, 25% of women are HIV-infected by the time they are 22 years old. To prevent HIV infection in this age group it will be important to vaccinate adolescents or, possibly, pre-pubescent girls who have not yet become sexually active. Most licensed vaccines for other diseases have been tested in children (after preliminary safety tests in adults), since children are the primary recipient of these protective vaccinations. But AIDS vaccines will be tested in adults before they are evaluated in adolescents or children. If a vaccine shows efficacy in adults it will be necessary to show that the vaccine has the same immune and safety profile in adolescents and that the effects last for several years.
There are many challenges involved in enrolling young people in trials of AIDS prevention strategies. One overarching issue is that many countries have varied or conflicting regulations regarding young people’s participation in trials. South Africa is one example of a country where “children have limited but evolving legal capacity,” Strode reported. For example, young people can obtain contraceptives at the age of 14 without parental consent, they can have sex at 16, and young women are allowed to terminate a pregnancy at any age. However, Strode noted, South Africa has “no independent age for [children to] consent to research.”
Strode recommended that countries develop national systems to recruit adolescents for AIDS prevention trials and that research and human rights groups work together on advocacy for legal and ethical reform of age of consent laws. She also recommended further research on children’s ability to understand the risks and benefits of trial participation.
~ For more information: “Adolescents: The Missing Cohort” in AIDS Vaccine Advocacy Coalition Annual Report 2004 at www.avac.org
Treatment strategies will not succeed if prevention efforts are failing, as there will always be more people requiring treatment. Prevention strategies will not succeed if treatments are not accessible. Where treatments are accessible, the nexus between AIDS and death is broken. Hope is generated and stigma is reduced. As a result, people are more willing to come forward for testing and more likely to access prevention services.
Statement of Commitment to Building a Comprehensive Global HIV/AIDS Response, released by the coalition for Joint Advocacy on HIV/AIDS, Treatments, Microbicides and Vaccines at Bangkok, 2004.
Failure number one is the lack of political will shared by the North and the South… Currently there is just USD $650 million being spent on AIDS vaccine research each year and close to 60 percent of those funds are coming from the United States. This effort is under-resourced.
Chrispus Kiyonga, Minister without Portfolio, Uganda (former chair of the Global Fund to Fight AIDS, Tuberculosis and Malaria), at Meet the Leaders Session on AIDS Vaccines, July 15 2004.
More doctors leave Ethiopia each year than are being trained in their medical schools; there are more Guyanan nurses working in the UK National Health Service than in Guyana. In easing our own [developed country] capacity constraints, we are adding to theirs. AIDS needs an emergency response, but this response should be complemented by investment in the human and physical needs of the health sectors of the developing country.
Princess Mabel van Oranje, Open Society Institute, plenary speech, July 12 2004.
I cannot help but feel, given the current levels of new infections, that the quest for a vaccine must lie at the heart of this response. The massive assault [of the epidemic] on women has to be one of the ways that leaders are driven to their senses and finance a vaccine with the understanding that…for women this is the ultimate salvation.
Stephen Lewis, UN Special Envoy on HIV/AIDS in Africa at Meet the Leaders Session on AIDS Vaccines, July 15 2004.
The day after tomorrow, the 18th of July, will be the day I turn 86. There could be no better gift than knowing that there is renewed commitment from leaders in every sector of society to take real and urgent action against AIDS. We know what needs to be done—all that is missing is the will to do it. Allow me to enjoy my retirement by showing that you can rise to the challenge.
Nelson Mandela, speech at closing ceremony, July 16 2004.
The three currently available prevention approaches—abstinence, being faithful, and using condoms—while incredibly important are just not enough. Married women or women who do not have control over if they have sex cannot choose abstinence.
Zeda Rosenberg, Chief Executive Officer of the International Partnership for Microbicides, plenary speech, July 15 2004.
When I can work in safe and fair conditions I am free of discrimination, when I am free of labels like: “immoral” or “victim of trafficking”, when I am free from unethical researchers, when I am free to do my job without harassment, violence or breaking the law, when sex work is recognized as work, when we have safety, unity, respect, and our rights, when I am free to choose my own way then I am free to protect myself and others from HIV.
Community Statement, People to People Messages, closing ceremony, July 16 2004.
All articles written by Emily Bass