Feasibility and Pilot Efficacy of Flash-heated Breast Milk to Reduce Maternal-to-Child-Transmission of HIV in Tanzania (Flash-heat)
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring breastmilk, perinatal HIV, infant feeding, flash heat, pasteurization, pmtct, HIV, HIV Seronegativity, Treatment Naive
Eligibility Criteria
Inclusion Criteria:
- Women over the age of 18, with permanent local residence
- 1-2 months post-partum
- Breastfeeding
- HIV-negative or unknown in 1:3 ratio with HIV-positive
- If HIV positive: having CD4+ > 200, not currently on Antiretroviral Therapy (ART)
Exclusion Criteria:
- Males, females under the age of 18
- Women not 1-2 most postpartum
- Women not breastfeeding
- Women with HIV and CD4+ < 200 OR on Antiretroviral Therapy (ART); And
- Women without permanent local residence
Sites / Locations
- University of California Davis Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Feasibility Study
Pilot efficacy
HIV positive women [and a smaller number of HIV negative/unknown status (1 for every 3 infected women)] to avoid stigmatizing home-based counseling will be recruited at 1-2 postpartum and provided enhanced home-based infant feeding counseling by community health workers to exclusively breastfeed for 6 months. Mothers will also be told about the option to Flash-heat breastmilk during and after the transition from exclusive breastfeeding. Mothers who choose to Flash-heat will be provided continued home-based counseling and support. Feasibility data will be collected during the time mothers Flash-heat.
We will collect infant health data to monitor and compare health outcomes among 3 groups of infants who had exclusive breast feeding (EBF) for the first months and then either: 1) fed Flash-heated breast milk and complementary foods (n=30), or 2) weaned to replacement foods and NO breast milk (n=15; per standard WHO recommendation for rapid cessation), or 3) continued feeding at the breast and providing other foods and/or fluids, i.e. mixed feeds (n=15; per WHO consensus that breastfeeding continue if replacement feeding is not AFASS94). We will collect infant growth and morbidity data. Infant health outcomes will be compared for the 3 groups noted above. These data will be collected primarily to pilot an efficacy trial.