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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00523510
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : February 14, 2012
Sponsor:
Collaborators:
Thrasher Research Fund
University Research Co, LLC
California Department of Health Services
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE August 30, 2007
First Posted Date  ICMJE August 31, 2007
Last Update Posted Date February 14, 2012
Study Start Date  ICMJE March 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
  • To determine the impact of enhanced home-based training on infant feeding outcomes. [ Time Frame: 1 year ]
  • To determine uptake (initiation and duration) of the Flash-heat method and protocol adherence by mothers in their homes. [ Time Frame: 1 year ]
  • To determine the safety of Flash-heated breast milk in a field setting. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00523510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
To pilot an efficacy trial of Flash-heat to improve infant health outcomes. [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility and Pilot Efficacy of Flash-heated Breast Milk to Reduce Maternal-to-Child-Transmission of HIV in Tanzania
Official Title  ICMJE Feasibility and Pilot Efficacy of Flash-heated Breast Milk for Reduction of Maternal-to-Child Transmission of HIV in Tanzania
Brief Summary 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.
Detailed Description

The World Health Organization (WHO) recommends human immunodeficiency virus (HIV) positive mothers in developing countries exclusively breastfeed for the first months of the infant's life followed by early cessation, unless breast milk substitutes are acceptable, feasible, affordable, sustainable, and safe. The weaning period is high risk for such infants due to lack of adequate replacement feeds resulting in malnutrition, growth faltering and susceptibility to diarrheal and respiratory illness from loss of breast milk's immune protection and introduction of contaminated foods and water. In addition, risk of HIV transmission is increased if a mother breastfeeds during weaning due to higher breast milk viral load during this time. Appropriate infant feeding alternatives during and after the high-risk weaning period are urgently needed.

Although heat-treating breast milk is listed by WHO as one method of modifying breast milk, it has not been fully explored. Our preliminary data demonstrate that Flash-heat, a low-technologic home pasteurization method, is capable of inactivating HIV in infected breast milk while maintaining most vitamins and immunoglobulins. This suggests Flash-heating breast milk could be a potential infant feeding option during and after weaning to decrease risk of infant illness and malnutrition.

Clinical staffing shortages in much of Africa, however, limit the ability of doctors, nurses and counselors to provide comprehensive infant feeding counseling to each mother. In light of this, our study will investigate the use of enhanced peer-based infant feeding counseling as a practical approach to improving exclusive breastfeeding durations while we are investigating the feasibility of Flash-heating breast milk. We will collaborate with the US and Tanzania offices of the University Research Co, LLC (URC), who are at the forefront of implementing appropriate infant feeding counseling methods in Africa. We will work with URC, local investigators, and Anna Coutsoudis, who's Safer Breastfeeding Programme in South Africa is considered a model, to provide community health workers with comprehensive infant feeding counseling training. HIV positive mothers (and a small number of HIV negative/status unknown mothers to avoid stigmatizing home-based counseling) who are breastfeeding will be recruited at 1-2 months postpartum at hospitals in Tanzania and provided enhanced counseling to exclusively breastfeed. Trained community health workers will make weekly home visits to support the mothers and collect infant feeding and breast pathology data. When the HIV positive mothers anticipate introduction of complementary foods, the Flash-heat method will be further discussed as an option for during and after transition. Mothers who choose to Flash-heat will be provided home-based support by community health workers and followed for up to 3 months from the time they stop breastfeeding.

This feasibility and pilot efficacy study of Flash-heating breast milk will be used to guide a full-scale efficacy trial in the near future. Specific aims include to: 1) Determine the impact of enhanced home-based training on infant feeding outcomes. Given clinical staffing shortages in Tanzania, the use of community health workers could provide support needed to exclusively breastfeed longer. Rates of initiation and duration of exclusive breastfeeding will be measured. These findings are important to explore effective methods of thoroughly educating the mothers about the risks and benefits of the various infant-feeding alternatives while not increasing the burden facing under-staffed health care workers. 2) Determine uptake of the Flash-heat method and protocol adherence by mothers in their homes. With enhanced support from community health workers, mothers may be able to correctly Flash-heat their milk, suggesting it could be a practical infant feeding method. Uptake of heat treatment and the duration of successful heat treatment will be measured. We will also interview mothers who opt to attempt the method to qualitatively assess the challenges mothers may face in a field setting. 3) Determine safety of Flash-heated breast milk in a field setting. Breast milk samples will be collected and assayed for HIV inactivation and bacterial counts to ensure method safety in field settings. 4) To pilot an efficacy trial of Flash-heat to improve infant health outcomes. Research personnel will monitor infant feeding, growth and morbidity during home visits twice monthly. If infants who receive heat-treated breast milk experience less morbidity and mortality than those fed complementary foods while continuing to breastfeed and those completely weaned to replacement foods, counselors in the future will be better able to inform mothers of risks and benefits of different feeding options.

If this proposed study finds that HIV positive mothers can successfully heat-treat their breast milk, it could be viewed as an HIV-free, safe, nutritious, affordable and available complementary food during and after the weaning phase after EBF.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Infant feeding counseling that includes Flash-heat
  • 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.
    Intervention: Procedure: Infant feeding counseling that includes Flash-heat
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2012)
144
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2007)
666
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00523510
Other Study ID Numbers  ICMJE 200513446
N/A yet
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE
  • Thrasher Research Fund
  • University Research Co, LLC
  • California Department of Health Services
Investigators  ICMJE
Principal Investigator: Caroline J Chantry, MD University of California, Davis
PRS Account University of California, Davis
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP