Maisha Mabibi: “Life Grandmothers” of Kenya Presented by: Chandice Covington, PhD, RN, PNP (BC), FAAN, Interim Dean, Professor and Florence Thelma Hall Endowed Chair for Nursing Excellence in Women’s Health Texas Tech University Health Sciences Center Anita Thigpen Perry School of Nursing Acknowledgements: Objectives Describe the problem of infant feeding in developing countries where HIV is a significant concern. List possible technologies, including the role of grandmothers, to address infant feeding concerns when the mother is HIV positive. Project the potential efficacy of technologies to address infant feeding and HIV. Problem Globally, 600,000 infants are infected with HIV each year. Less than 100 in US by perinatal transmission. > 80% of new infections are in Africa. 1,600 new pediatric infections every day globally. > 1000 in one ‘county’ of Kenya alone annually. The rate of mother-to-child HIV transmission varies between 10% and 45%. MTCT is responsible for all HIV infections and 10% of all new HIV infections worldwide. http://www.unicef.org/programme/breastfeeding/feeding.htm LIFE GRANDMOTHERS 2010\UNICEF in action.pdf Risk of HIV Transmission Shorter duration of breastfeeding Longer breastfed HIV-positive mother/baby, higher risk of HIV infection. BF 6 months ~ 1/3 risk BF 2 yrs Exclusive breastfeeding in the early months Immunological “war” factors in human milk, of HIV-infected exclusive breastfeeding, 1st 3 months of life resulted in a lower risk of MTCT vs. mixed feeding) SOURCES: http://www.unicef.org/programme/breastfeeding/hiv.htm Associations between breast milk viral load, mastitis, exclusive breastfeeding, and postnatal transmission of HIV. Risk of HIV Transmission Prevention and treatment of breast problems Mastitis & cracked nipples associated with increased risk of HIV-transmission Prevention of HIV-infection during breastfeeding Initial maternal viral load higher subsequent to new infection; increased child risk of infection (2nd infection risk superinfection) Early treatment of infant oral thrush Infant oral sores hasten infectivity SOURCES: http://www.hhmi.org/news/walker.html http://www.medscape.com/viewarticle/718849 Lunney KM, Iliff P, Mutasa K, Ntozini R, Magder LS, Moulton LH, Humphrey JH. Clin Infect Dis. 2010 Mar 1;50(5):762-9. Are there Practical Solutions? 1.Determine feasibility of global practices of surrogate feeding for example by grandmothers? 2.Feasibility of a strategy such as a therapeutic breast shield/filter tailored to the uniqueness of the maternal-child dyad feeding relationship? Presentation Reports: 1. Maisha Mabibi Grandmother Relactation Project, Malindi, Kenya. 2. Phase 1 development of an Anti-HIV Breast Shield, Cupron, Inc., Nairobi, Kenya. MAISHA MABIBI STUDY Funded by the Glaser Pediatric AIDS Foundation and the UCLA School of Nursing Maisha Mabibi Study AIM: Determine if multiparous, non‐pregnant, seronegative [‐] women at the grandmother stage‐of‐life (35 – 70 years of age) could re‐establish a nutritious/adequate milk supply equivalent in essential nutrient bioavailability to mother’s milk through a re-lactation protocol. 11 Maisha Mabibi Study Criteria: BF @ least 1 child 6 mos, weaned 6 mos, not PG, neg for HIV & severe anemia N=35/29, 6 dropped ◦ Age Mean = 49 (Range 35 – 72 years) ◦ Bf Mean = 6.7 children (Range 1-14) ◦ BF duration Mean = 2 years (Range .75 – 4.0 years) 12 Methods: Setting Malindi District of coastal province of Kenya 300,000 population Tribes: Huntersgatherers: BANTUS Mijikenda (Digo, Duruma, Rabai, Ribe, Kambe, Jibana, Chonyi, Giriama, Kauma), Taveta, Pokomo, Taita Religion: Muslim, Prostestant, Indigenous, Mixed Methods: Procedure Informed consent Blood test for baseline hemoglobin and nutritional factors Determination of HIV negative status Urine test to rule out pregnancy Health and reproductive history AIM 1: Re-Lactation TrialProcedure ◦ Participants use re-lactation methods 8-weeks ◦ Testing of breast fluids ◦ Nutritional quantity & quality Results Living breast milk cells in GM’s milk Results: Total Protein Mature Human Milk= 8 - 9 mg/ml (LIT) Colostrum=2.95 mg/ml (LIT) GM mean = 27.5 mg/ml, Range=8.96 - 56.72 DA mean = 11.25 mg/ml, Range=7.05 - 14.55 Pooled Protein Comparisons Total Protein mg/ml 60.00 27.26 mg/ml 50.00 20.02 40.00 30.00 20.00 14.76 11.12 10.00 0.00 Daughter GM Protein Protein Milk-like GM Pooled Protein Colostrumlike GM Texas Tech University Health Sciences Center chandice.covington@ttuhsc.edu 20 Lactation Hormones of the PostMenopausal Woman Prolactin – remains stable Oxytocin - increases Estrogen: Levels drop Re-modeling of breast tissue continues, resident stem cells in breast bioactive over lifetime (Russo et al. 2006) Breast developmental research of the last few years support a apocrine, daughter-cell lined breast duct that retains an “process memory” for lactation (Russo & Russo, 2004). Grandmother Hypothesis: Re-visited The data support that grandmothers may serve a "evolutionary loophole" function to circumvent mortality and morbidity in children in AIDSimpacted populations. Breastmilk Shield to Prevent HIV Transmission Phase 1 – Proof of Principle AIM: Anti-HIV Breast Shield Establish proof-of-principle by the examination of breast milk after passing through a copper oxide based filter device. R&D goal to develop an at-the- breast shield to deactivate HIV in breast milk. Anti-HIV Breast Shield Study Design Study Site: Selected City Council Maternity Clinics, Nairobi, Kenya Study Objective: Demonstrate an in vitro reduction of HIV-1 infectivity in whole, skim, cell-free or skim and cell-free breast milk by passage of the milk through copper oxide containing filters. Study Design: Sample 50 HIV-1 seropositive women 18-40 years old HIV positive prenatally Birth to 1 year postpartum No maternal ARV for 2 weeks prior to study entrance Study Design Cont’d Data collection: Blood sample for viral load Women with plasma viral load greater than 50,000 HIV RNA copies per ml donate 1/2 cup of breast milk. Primary Study Goals Demonstrate at least 2 and 3 log reductions in in vitro viral infections in wild type HIV-1 in whole and cell-free breast milk filtered through the copper oxide containing filters. Determine the amounts of copper oxide needed in the filters to successfully achieve the primary outcome. Dr. Gadi Borkow, PI Experiment: Passing thru Filter Next Steps: Phase II Phase 2 of Study Planned if ‘Proof of Principle’ demonstrated: Develop breast shield equipped with copper filter to prevent HIV transmission via breastfeeding drawing upon scientists in medical engineering. Next Steps: Phase II Phase 2 of Study Planned if ‘Proof of Principle’ demonstrated: Safety studies in animal models on copper (regulated naturally in humans). Rare copper disorders. Next Steps: Phase II Confirm that the copper filter does not degrade natural nutritional and antiinfective components of breast milk during filtration process via lab studies on pumped milk that is then passed through filter. Issues: Wilson disease (1:55,000 US births, excess CU) Menkes disease (1:298,000, deficient CU) Inherited disorders of copper transport Future Studies (Phase III) Demonstrate the general, and developmental nontoxicity of the filter. Develop a filter strategy tailored to the uniqueness of the maternal-child dyad feeding relationship within cultural sanctions of resource-poor societies. Progress to Date Milk sample are being analyzed in Kenya Aids Vaccination Initiative (KAVI) laboratory in Nairobi, Kenya. Report due shortly to the Bill & Melinda Gates Foundation. 420,000 new infections + 10 years = 4,200,000 more cases related to MTCT; HIV(-) grandmother ?; Cultural influences on surrogate/shield; Potential Efficacy of Technologies vs. Continuing Questions Human adaptability; Community role