NCT00523510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Mar 2008

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

1.3 years

First QC Date

August 30, 2007

Last Update Submit

February 13, 2012

Conditions

HIV Infections

Keywords

breastmilkperinatal HIVinfant feedingflash heatpasteurizationpmtctHIVHIV SeronegativityTreatment Naive

Outcome Measures

Primary Outcomes (3)

  • To determine the impact of enhanced home-based training on infant feeding outcomes.

    1 year

  • To determine uptake (initiation and duration) of the Flash-heat method and protocol adherence by mothers in their homes.

    1 year

  • To determine the safety of Flash-heated breast milk in a field setting.

    1 year

Secondary Outcomes (1)

  • To pilot an efficacy trial of Flash-heat to improve infant health outcomes.

    1 year

Study Arms (2)

Feasibility Study

EXPERIMENTAL

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

Pilot efficacy

EXPERIMENTAL

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

Interventions

Infant feeding counseling that includes Flash-heatPROCEDURE

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.

Feasibility StudyPilot efficacy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women over the age of 18, with permanent local residence
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (6)

  • 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. doi: 10.1097/01.qai.0000178929.15904.95.

    PMID: 16186735BACKGROUND

  • 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. doi: 10.1177/0890334405283621.

    PMID: 16467287BACKGROUND

  • 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. doi: 10.1093/tropej/fml043. Epub 2006 Sep 27.

    PMID: 17005732BACKGROUND

  • 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. doi: 10.1155/IDOG/2006/95938. No abstract available.

    PMID: 17093357BACKGROUND

  • 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. doi: 10.1097/QAI.0b013e318074eeca.

    PMID: 17514015BACKGROUND

  • 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. doi: 10.1097/QAI.0b013e31817beb8d.

    PMID: 18614920BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Caroline J Chantry, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Study Start

March 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

US(1)