Feasibility and Pilot Efficacy of Flash-heated Breast Milk to Reduce Maternal-to-Child-Transmission of HIV in Tanzania - Full Text View

Purpose

This study will investigate the feasibility of HIV positive mothers in Tanzania to correctly use the Flash-heat method to pasteurize their breast milk and for how long they are able to do so. The patients will be followed in this study for up to 3 months of Flash-heating their milk. Flash-heated breast milk could be a potential method to reduce mother-to-child transmission of HIV. The investigators will also collect infant health data to pilot a future efficacy trial. The investigators hypothesize that with enhanced home-based infant feeding counseling, mothers will be capable of Flash-heating their breast milk.

Condition	Intervention
HIV Infections	Procedure: Infant feeding counseling that includes Flash-heat

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Feasibility and Pilot Efficacy of Flash-heated Breast Milk for Reduction of Maternal-to-Child Transmission of HIV in Tanzania

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

To determine the impact of enhanced home-based training on infant feeding outcomes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To determine uptake (initiation and duration) of the Flash-heat method and protocol adherence by mothers in their homes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To determine the safety of Flash-heated breast milk in a field setting. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To pilot an efficacy trial of Flash-heat to improve infant health outcomes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	144
Study Start Date:	March 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Feasibility Study 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.	Procedure: Infant feeding counseling that includes Flash-heat Intensive infant feeding counseling which includes description and demonstration of the WHO recommended option for HIV-infected mothers to pasteurize their breastmilk. Flash-heat pasteurization will be described and demonstrated to interested mothers. More intensive counseling and support will be provided home visits.
Experimental: Pilot efficacy 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.	Procedure: Infant feeding counseling that includes Flash-heat Intensive infant feeding counseling which includes description and demonstration of the WHO recommended option for HIV-infected mothers to pasteurize their breastmilk. Flash-heat pasteurization will be described and demonstrated to interested mothers. More intensive counseling and support will be provided home visits.

Arms

Assigned Interventions

Experimental: Feasibility Study

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.

Procedure: Infant feeding counseling that includes Flash-heat

Intensive infant feeding counseling which includes description and demonstration of the WHO recommended option for HIV-infected mothers to pasteurize their breastmilk. Flash-heat pasteurization will be described and demonstrated to interested mothers. More intensive counseling and support will be provided home visits.

Experimental: Pilot efficacy

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.

Procedure: Infant feeding counseling that includes Flash-heat

Intensive infant feeding counseling which includes description and demonstration of the WHO recommended option for HIV-infected mothers to pasteurize their breastmilk. Flash-heat pasteurization will be described and demonstrated to interested mothers. More intensive counseling and support will be provided home visits.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523510

Locations

United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Thrasher Research Fund

University Research Co, LLC (subcontract)

California Department of Health Services

Investigators

Principal Investigator:

Caroline J Chantry, MD

University of California, Davis

More Information

Publications:

Israel-Ballard K, Chantry C, Dewey K, Lonnerdal B, Sheppard H, Donovan R, Carlson J, Sage A, Abrams B. Viral, nutritional, and bacterial safety of flash-heated and pretoria-pasteurized breast milk to prevent mother-to-child transmission of HIV in resource-poor countries: a pilot study. J Acquir Immune Defic Syndr. 2005 Oct 1;40(2):175-81. Erratum in: J Acquir Immune Defic Syndr. 2006 Mar;41(3):396.

Israel-Ballard KA, Maternowska MC, Abrams BF, Morrison P, Chitibura L, Chipato T, Chirenje ZM, Padian NS, Chantry CJ. Acceptability of heat treating breast milk to prevent mother-to-child transmission of human immunodeficiency virus in Zimbabwe: a qualitative study. J Hum Lact. 2006 Feb;22(1):48-60.

Israel-Ballard K, Coutsoudis A, Chantry CJ, Sturm AW, Karim F, Sibeko L, Abrams B. Bacterial safety of flash-heated and unheated expressed breastmilk during storage. J Trop Pediatr. 2006 Dec;52(6):399-405. Epub 2006 Sep 27.

Chantry CJ, Abrams BF, Donovan RM, Israel-Ballard KA, Sheppard HW. Breast milk pasteurization: appropriate assays to detect HIV inactivation. Infect Dis Obstet Gynecol. 2006;2006:95938. No abstract available.

Israel-Ballard K, Donovan R, Chantry C, Coutsoudis A, Sheppard H, Sibeko L, Abrams B. Flash-heat inactivation of HIV-1 in human milk: a potential method to reduce postnatal transmission in developing countries. J Acquir Immune Defic Syndr. 2007 Jul 1;45(3):318-23.

Israel-Ballard KA, Abrams BF, Coutsoudis A, Sibeko LN, Cheryk LA, Chantry CJ. Vitamin content of breast milk from HIV-1-infected mothers before and after flash-heat treatment. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):444-9. Erratum in: J Acquir Immune Defic Syndr. 2008 Oct 1;49(2):235.

Responsible Party:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00523510 History of Changes
Other Study ID Numbers:	200513446, N/A yet
Study First Received:	August 30, 2007
Last Updated:	February 13, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

breastmilk
perinatal HIV
infant feeding
flash heat
pasteurization

pmtct
HIV
HIV Seronegativity
Treatment Naive

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on June 13, 2013