Figure 1.
Approximately 800 women at each CRC were tested for HIV infection at screening as indicated. Those confirmed as seronegative and who met the entry criteria (299 at each CRC) were enrolled into the prospective cohort study and retested at 3, 6, 9, and 12 months after enrollment using the same algorithm. Participants who became HIV-positive while on study were referred to available sources of psychosocial and medical care and support. HIV-positive participants could continue on study for scheduled examinations per protocol with the exception of any further HIV testing and genital assessment, unless clinically indicated.
Table 1.
Baseline Characteristics of Study Participants.
Table 2.
Determinants of Prevalent HIV Infection in the Cross-Sectional Studies1.
Figure 2.
HIV incidence in the prospective cohort studies.
Women enrolled in the 12-month cohort studies visited the CRC at 3, 6, 9, and 12 months after enrollment for HIV testing according to the algorithm presented in Figure 1. HIV incidence rates were calculated based on a Poisson distribution with PY at risk in the denominator. They are expressed as number of cases per 100 PY, with 95% confidence intervals (CI). HIV infection was assumed to have occurred at the mid-point between the last available negative test and first positive test.
Figure 3.
Pregnancy rates in the prospective cohort studies.
Urine pregnancy tests were done at each study visit (screening, enrollment, and 3, 6, 9, and 12 months after enrollment in the cohort study). If test result was positive, the participant was to continue on study for follow-up per protocol. Estimated date of conception and estimated due date were to be recorded. If possible, follow-up was to continue for pregnancy outcome. Contraceptive counseling was provided and condoms were dispensed at each study visit.