AEGiS-13IAC: Preparing for Phase III HIV Vaccine trials: Experiences from rural South Africa.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Preparing for Phase III HIV Vaccine trials: Experiences from rural South Africa.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. ThOrD678)

Gouws E, Abdool Karim Q, Frohlich J, Abdool Karim S
E. Gouws, Medical Research Council, P.O. Box 17120, Congella (Durban), 4013, South Africa, Tel.: +27-31-202 0777, Fax: +27-31-202 0950, E-mail: eleanor.gouws@mrc.ac.za

ISSUES: The feasibility of conducting phase III vaccine trials depends on high HIV sero-prevalence and incidence rates, feasibility of long-term follow-up, and the willingness of a community to participate in research.In preparation for phase III HIV vaccine trials in a rural community in South Africa, we set out to assess these issues.

DESCRIPTION: The study envolves an entire community in a rural area in KwaZulu Natal. HIV prevalence rates, estimated from surveys conducted among prenatal clinic attenders, increased from 4% in 1992 to 30% in 1998. A model was developed to estimate HIV incidence rates from prevalence data. An incidence rate of 9.9% among women aged 15-49 years in 1998 indicates the explosive nature of the epidemic. STD rates, obtained from clinical surveillance, microbiological studies and community-based surveys, show that 25% of women are infected on any given day with at least one STD. As there are no street names and house numbers, the location of every house was digitally captured using GPS, enabling household surveys and follow-up. A locator database exists after completion of a census survey. Clinical facilities have been built to facilitate patient screening and enrolment. Community participation in HIV vaccine trials has been promoted over several months. Series of meetings were held with stakeholders to obtain political support. A Community Advisory Board was established to foster partnerships between researchers, volunteers and the community. An Imbizo, to consult the community on potential involvement in HIV vaccine research, was well attended and served as a mandate to conduct HIV research in the area.

CONCLUSION: Hlabisa is a community at high risk for HIV infection. An infrastructure for conducting vaccine trials is in place, follow-up is feasible, and the community is willing to participate. A community-based survey is underway to assess preparedness of the community for participation in HIV vaccine trials.

Keywords: AEGIS, AIDS Vaccines, Clinical Trials, Prevalence, Incidence, HIV Infections, HIV Seropositivity, Rural Population, Data Collection, South Africa, Human, Female
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