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283 Cohort Development for Future HIV-1 Efficacy Vaccine Trials: A Community Cohort, Chon Buri Province, Thailand
M. Benenson*1, N. Sirisopana1, R. Amphaipit2, V. Tungsakul1, K. Pumratana1, S. Santativongchai1, S. Nitayaphan1, and A. Brown1
1AFRIMS, Bangkok, Thailand and 2MOPH, Bangkok, Thailand
Background: Since HIV prevention programs in Thailand have lowered the risk of HIV infection in the general community, a cohort for a phase III efficacy trial will have to be large. There is a need to develop a cohort that can be expanded in a well-defined and established infrastructure. The feasibility of using the MOPH infrastructure for the development of a cohort for an HIV-1 efficacy trial was explored.
Methods: Volunteers were recruited, enrolled, and followed at 3 health centers and a district hospital. Volunteers completed an informed consent and had pre- and post-test HIV counseling and blood drawn for syphilis, hepatitis B, and HIV testing. Demographic and behavioral risk factor data were collected. The volunteers were seen at 6, 12, and 18 months for repeat HIV serologic testing, risk behavior determination, and counseling.
Results: Of the 2,500 persons enrolled in the study, 73% were between the ages of 20 and 30 and 71% were married or in a stable relationship. Eighty-three percent had lived in Chon Buri more than 3 years, and the same proportion planned to remain in the Chon Buri area for at least 5 years. Forty-five percent of the volunteers had no serological evidence of previous hepatitis B infection. Six percent (154) had evidence of acute or chronic hepatitis B infection. Sixty-one percent of the volunteers felt they were at some risk of HIV infection. There were 121 prevalent HIV cases (4.8%). These persons were more likely to have reported the use of IV or recreational drugs, to have had 2 or more sexual partners, to have less education, to be temporary or unskilled laborers, and were, appropriately, much more likely to see themselves at risk of HIV infection. The follow-up rate was 84 and 81%, respectively, at the 6- and 12-month visits. Seventeen volunteers developed new HIV infections, an incidence rate of approximately 0.55/100 PYs (95% CI 0.28 to 0.82/100 PYs). The incidence for those under age 30 is 0.70/100 PYs (95% CI 0.33 to 1.07/100 PYs).
Conclusions: The follow-up and the incidence rate in this cohort is sufficient to carry out an efficacy trial. The MOPH infrastructure provides a well-established expandable base for such studies.
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