Planning a clinical trial of Flash-heated breast milk to decrease morbidity, impr

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DESCRIPTION (provided by applicant): Planning an efficacy trial of Flash-heated breast milk to decrease morbidity, improve growth, and reduce HIV transmission in HIV-exposed infants The World Health Organization recommends that HIV positive mothers in developing countries exclusively breastfeed for 6 months, and then stop once safe and nutritious foods are available. Many HIV- positive mothers in resource poor areas face a dilemma about how to feed their babies after they cease exclusively breastfeeding. On one hand, breast milk is richer in nutrients than most foods and contains antibodies and other protective components that protect the infant from common illnesses like diarrhea and upper respiratory infections. However, the likelihood of HIV transmission to the infant is higher with mixed feeds, i.e. when breast milk and other foods are both fed to the infant. Flash-heating expressed breast milk kills HIV and maintains most of the milk's nutritional and protective qualities. Previous research has also indicated that it can be acceptable and feasible for many mothers. Thus, heating expressed breast milk could be a safe and healthy way for an HIV-positive mother to feed her baby during this risky time. However, we do not yet know if this technique significantly improves the health of infants when compared to the alternatives of cessation of feeding any breast milk or providing mixed feeds. We propose to plan a clinical trial of heated breast milk to improve infant health in Tanzania. In the study we are planning, the primary aim will be to determine if infants whose mothers receive counseling on heat- treating expressed breast milk once other foods have been introduced are less likely to become infected with HIV and experience better growth and fewer days sick with acute respiratory infection or diarrhea, compared to infants whose mothers do not receive this counseling. Our secondary aim is to determine if local counselors can improve the prevalence and mean duration of exclusive breastfeeding and optimal complementary feeding by visiting HIV-positive mothers in their homes to give them education and support with healthful infant feeding practices. This portion of the study will examine a reduced home visit schedule to ascertain the success rate of the simpler, less expensive approach compared to previous studies of infant feeding counseling. Additionally, we will establish the cost- effectiveness of these two interventions, to determine if they should be implemented on a larger scale. The planning period will allow travel to Tanzania to define collaborative arrangements; finalize study design and sample size; choose study sites; attempt to secure funding; the design, translation and piloting of data collection instruments; application to US and Tanzanian IRBs; and plan staff trainings, among other necessary tasks to plan to conduct a multi-site clinical trial in a developing country. PUBLIC HEALTH RELEVANCE: Safer infant feeding options for HIV+ women in developing countries are needed because mixing complementary foods with breastfeeding after 6 months increases HIV transmission and stopping breastfeeding altogether often results in poor growth, illness and sometimes death. Heat- treating expressed breast milk kills the virus while preserving milk's nutritional and immunological properties, and thus could be a healthier method than other choices. We propose to plan a study to determine if babies of HIV+ mothers would have fewer infections, better growth and less HIV when their mothers are visited by women from the community to counsel them about heat treatment of breast milk and exclusive breastfeeding.