The fastest growing HIV epidemic in South Africa involves young people under the age of 19 years.
To this end the DTHF has become involved in adolescent HIV prevention, including the access of adolescents to HIV vaccine clinical trials. It is most important that should a promising HIV vaccine be discovered, it would immediately be available to this vulnerable group. For this reason, the DTHF has conducted a variety of studies aimed at preparing our clinical site, young people and communities for future clinical trials.
A cross-sectional study was conducted amongst South Peninsula community school students aged between 11 and 19 in 2004, funded by SAAVI and Elizabeth Glasier. The HIV prevalence was 10.6% overall, and there was much reported sexual behaviour that would put these adolescents at high risk for HIV. These teens admitted to high risk behaviour and were all very willing to participate in an HIV vaccine trial. The study also compared paper questionnaire to handheld computer or Palm PilotTM. These methods were equivalent in getting answers, except that the data were more complete using the Palm PilotTM.
With funding from the Pediatric AIDS Clinical Trials Group (PACTG), the DTHF completed an HIV vaccine preparedness pilot project in Nyanga District. This study was a series of focus groups with adolescents, their parents and guardians, and other stakeholders. There was overwhelming support for the inclusion of adolescents in HIV vaccine trials, mainly due to the realization from all parties that adolescents are at extreme risk. There was consensus that parental or guardian consent be obtained for participation, however, there were differences in opinion as to whether parents should be allowed access to participants' confidential information. The study also explored other legal and ethical issues, as well as potential recruitment and retention tools, adolescent support systems, operational issues, and counseling and testing.
An adolescent HIV vaccine trial preparedness study was also started in Masiphumelele in 2006. The primary goal of this project was to determine the ability to recruit and retain HIV-negative adolescents from Masiphumelele into a 12-month follow-up cohort study that included HIV and syphilis testing. The study also examined changes in sexual risk behaviour through trial participation, and tested adolescent understanding of HIV vaccine trial concepts with and without a brief education programme. Retention was 85% at 12 months, with most attrition occurring before the 3rd visit. Reasons for withdrawal included relocation, fear of needles, frequency of visits, pregnancy, personal questionnaires and hospitalization. HIV knowledge was found to be high, but there were also high levels of sexual risk behaviour and low perception of HIV risk. Despite high sexual risk behaviour, there were no seroconversions. There was no evidence of sexual disinhibition. Although more adolescents became sexually active, other sexual risk behaviour was unchanged or significantly improved.
We also recognize the need to educate, equip and mobilize adolescents as advocates in the debate about adolescent involvement in HIV vaccine trials and other HIV-related research. An adolescent HIV vaccine trial community advocacy or advisory board - the Future Fighters - meet regularly to learn about HIV vaccines and serve as liaisons between the adolescent community and the researchers.
The research to date has provided a good basis from which to move forward and culminated in a national, multi-site project that aims to further prepare for adolescent HIV vaccine trials through identifying and addressing obstacles to conducting HIV vaccine trials in adolescents, and building national capacity to run such trials. This project is known as SASHA (South African Studies on HIV in Adolescents)
