Provision of Extended Nevirapine to Breastfeeding Infants to Reduce Postnatal Transmission of HIV in a Resource-limited Setting: Feasibility, Safety and Effectiveness in a Real world Setting
In recent years the risk of mother-to-child transmission of HIV in developed countries has declined to less than 1%. This success is due to the implementation of a package of interventions including universal HIV screening in pregnancy, provision of highly active antiretroviral therapy (HAART) to HIV-infected pregnant women, antiretroviral (ARV) prophylaxis for the infant during the first 6 weeks of life and avoidance of breastfeeding. In resource-limited countries however, vertical transmission rates can be as high as 35-40% in untreated breastfeeding populations. Although effective interventions have been identified to reduce transmission of HIV in utero and intrapartum in resource-limited settings, breastfeeding attenuates the efficacy of these methods. Therefore a major concern in developing countries is HIV transmission through breastfeeding. Recent clinical trials indicate that provision of ARVs to mothers or infants during breastfeeding can decrease rates of postnatal HIV transmission to less than 5%. We propose an operational research study to evaluate the feasibility, safety and effectiveness during implementation of a program of administering nevirapine (NVP) prophylaxis throughout breastfeeding for HIV-exposed infants enrolled in a program for the prevention of mother- to-child transmission of HIV (PMTCT) in Kenya. To our knowledge, this study will provide the first baseline data on the rate of mother-to-child transmission of HIV during postpartum prophylaxis with extended infant nevirapine at public health clinics in Western Kenya. The aim of our observational study is to provide data from a real-life setting working in public health facilities, as opposed to a clinical trial setting which has fewer logistical constraints in regards to resources. In addition, this study will also provide information about the safety and acceptability of extended infant NVP throughout breastfeeding in this resource-limited setting. We plan to follow 380 women-infant pairs at three Ministry of Health facilities in Kenya supported by Family AIDS Care and Education Services (FACES), an HIV care, treatment and prevention program sponsored by UCSF and the Kenya Medical Research Institute (KEMRI). We expect that this project will help inform the focus of our group's future research to evaluate new strategies and approaches aimed at virtually eliminating vertical HIV transmission. This grant will provide the additional resources necessary to ensure the thorough evaluation of extended NVP during breastfeeding in HIV-exposed infants. Specifically, study specific personnel will train clinic and data management staff to ensure high quality collection and management of these data and develop systems to improve loss to follow-up.