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

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
University Research Co, LLC (subcontract)
California Department of Health Services
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00523510
First received: August 30, 2007
Last updated: February 13, 2012
Last verified: February 2012
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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 July 26, 2014