Cluster randomized trial of the uptake of a take-home infant dose of nevirapine in Kenya

Objective: To test whether a single take home dose of infant nevirapine increased infant uptake without decreasing institutional deliveries. Design: Cluster randomized post-test only study with control group. Setting: Ten hospitals in urban areas of Coast, Rift Valley, and Western provinces, Kenya. Participants: Pregnant women with HIV, 18 years and older, and at least 32 weeks gestation recruited during antenatal care and followed up at home approximately one week after delivery. Intervention: In the intervention group, women were given a single infant’s dose of nevirapine to take home prior to delivery. In the control group, no changes were made to the standard of care. Main outcome measures: Mothers’ reports of infant uptake of nevirapine and place of delivery. Results: Uptake of the infant’s nevirapine dose was high, 94% in the intervention group and 88% in the control group (p=0.096). Among women who delivered at home, uptake was higher significantly among infants whose mothers got the take home dose compared to women who did not get the dose (93% vs. 53%, p<0.01). The intervention did not influence place of delivery. Providers were positive about the take home dose concept; difficulties were attributed to HIV-related stigma. Conclusions: Making take home infant nevirapine available, either as a single dose administered within 72 hours of birth or as part of a more complex six week postnatal regimen, will increase infant uptake especially among women who deliver at home without affecting place of delivery.