Zambia Exclusive Breastfeeding Study

NCT00310726 | Completed DMC

• 1 other identifier: R01HD039611
• Study Type: interventional
• Target: 1,435
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.

Conditions

HIV Infection

Keywords

Mother to Child Transmission of HIV; Postnatal HIV transmission; HIV; Breastfeeding; Perinatal HIV Transmission; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• HIV infection detected by 4 months among children with no evidence of HIV infection at birth.

  24 months of age

• Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.

Study Arms (2)

Abrupt Weaning

EXPERIMENTAL

Women were counseled to abruptly wean their child at 4 months of age.

Other: abrupt weaning at 4 months

Exclusive breastfeeding per WHO guidelines

ACTIVE COMPARATOR

Women were counseled to adhere to the WHO recommendations for duration of exclusive breastfeeding.

Other: Continued exclusive breastfeeding

Interventions

abrupt weaning at 4 months OTHER

abrupt weaning at 4 months

Abrupt Weaning

Continued exclusive breastfeeding OTHER

Continued exclusive breastfeeding

Exclusive breastfeeding per WHO guidelines

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV-positive pregnant women identified through VCT
• After counseling about the risks and benefits of feeding alternatives report that it is their intended decision to breastfeed
• Live within the catchment area of George or Chawama clinic
• Are between 30 - 34 wks gestation. (To insure that opportunity exists to receive a minimum of 2 lactation counseling sessions prior to delivery)
• Do not have any significant presenting illness that requires hospitalization
• Agree to adhere to the requirements of study participation (including exclusive breastfeeding and randomization into one of two infant feeding groups at four months).
• Willing to inform a household member (preferably husband/father) of HIV-status.

You may not qualify if:

• Lives outside of catchment area;
• Have known major illnesses likely to influence pregnancy outcome including diabetes, severe renal or heart disease, or active tuberculosis, prior to randomization;
• Does not intend to breastfeed;
• Prior enrollment in this study or concurrent enrollment in another study

Sponsors & Collaborators

• Boston Medical Center: lead
• United States Agency for International Development (USAID): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

George and Chawama District Health Clinics

Lusaka, Zambia

Location

Related Publications (28)

• Thea DM, Vwalika C, Kasonde P, Kankasa C, Sinkala M, Semrau K, Shutes E, Ayash C, Tsai WY, Aldrovandi G, Kuhn L. Issues in the design of a clinical trial with a behavioral intervention--the Zambia exclusive breast-feeding study. Control Clin Trials. 2004 Aug;25(4):353-65. doi: 10.1016/j.cct.2004.06.005.

  PMID: 15296810 BACKGROUND

• Kuhn L, Aldrovandi GM, Sinkala M, Kankasa C, Mwiya M, Thea DM. Potential impact of new WHO criteria for antiretroviral treatment for prevention of mother-to- child HIV transmission. AIDS. 2010 Jun 1;24(9):1374-7.

  PMID: 20568677 BACKGROUND

• Albrecht S, Semrau K, Kasonde P, Sinkala M, Kankasa C, Vwalika C, Aldrovandi GM, Thea DM, Kuhn L. Predictors of nonadherence to single-dose nevirapine therapy for the prevention of mother-to-child HIV transmission. J Acquir Immune Defic Syndr. 2006 Jan 1;41(1):114-8. doi: 10.1097/01.qai.0000179425.27036.d7.

  PMID: 16340483 RESULT

• Kuhn L, Kasonde P, Sinkala M, Kankasa C, Semrau K, Scott N, Tsai WY, Vermund SH, Aldrovandi GM, Thea DM. Does severity of HIV disease in HIV-infected mothers affect mortality and morbidity among their uninfected infants? Clin Infect Dis. 2005 Dec 1;41(11):1654-61. doi: 10.1086/498029. Epub 2005 Oct 27.

  PMID: 16267740 RESULT

• Kuhn L, Kasonde P, Sinkala M, Kankasa C, Semrau K, Vwalika C, Tsai WY, Aldrovandi GM, Thea DM. Prolonged breast-feeding and mortality up to two years post-partum among HIV-positive women in Zambia. AIDS. 2005 Oct 14;19(15):1677-81. doi: 10.1097/01.aids.0000186817.38112.da.

  PMID: 16184038 RESULT

• Kuhn L, Trabattoni D, Kankasa C, Semrau K, Kasonde P, Lissoni F, Sinkala M, Ghosh M, Vwalika C, Aldrovandi GM, Thea DM, Clerici M. Alpha-defensins in the prevention of HIV transmission among breastfed infants. J Acquir Immune Defic Syndr. 2005 Jun 1;39(2):138-42.

  PMID: 15905728 RESULT

• Semrau K, Kuhn L, Vwalika C, Kasonde P, Sinkala M, Kankasa C, Shutes E, Aldrovandi G, Thea DM. Women in couples antenatal HIV counseling and testing are not more likely to report adverse social events. AIDS. 2005 Mar 24;19(6):603-9. doi: 10.1097/01.aids.0000163937.07026.a0.

  PMID: 15802979 RESULT

• Ghosh MK, Kuhn L, West J, Semrau K, Decker D, Thea DM, Aldrovandi GM. Quantitation of human immunodeficiency virus type 1 in breast milk. J Clin Microbiol. 2003 Jun;41(6):2465-70. doi: 10.1128/JCM.41.6.2465-2470.2003.

  PMID: 12791866 RESULT

• Sabbaj S, Edwards BH, Ghosh MK, Semrau K, Cheelo S, Thea DM, Kuhn L, Ritter GD, Mulligan MJ, Goepfert PA, Aldrovandi GM. Human immunodeficiency virus-specific CD8(+) T cells in human breast milk. J Virol. 2002 Aug;76(15):7365-73. doi: 10.1128/jvi.76.15.7365-7373.2002.

  PMID: 12097549 RESULT

• Fawzy A, Arpadi S, Kankasa C, Sinkala M, Mwiya M, Thea DM, Aldrovandi GM, Kuhn L. Early weaning increases diarrhea morbidity and mortality among uninfected children born to HIV-infected mothers in Zambia. J Infect Dis. 2011 May 1;203(9):1222-30. doi: 10.1093/infdis/jir019.

  PMID: 21459815 RESULT

• Gray RR, Salemi M, Lowe A, Nakamura KJ, Decker WD, Sinkala M, Kankasa C, Mulligan CJ, Thea DM, Kuhn L, Aldrovandi G, Goodenow MM. Multiple independent lineages of HIV-1 persist in breast milk and plasma. AIDS. 2011 Jan 14;25(2):143-52. doi: 10.1097/QAD.0b013e328340fdaf.

  PMID: 21173592 RESULT

• Murnane PM, Arpadi SM, Sinkala M, Kankasa C, Mwiya M, Kasonde P, Thea DM, Aldrovandi GM, Kuhn L. Lactation-associated postpartum weight changes among HIV-infected women in Zambia. Int J Epidemiol. 2010 Oct;39(5):1299-310. doi: 10.1093/ije/dyq065. Epub 2010 May 19.

  PMID: 20484334 RESULT

• Heath L, Conway S, Jones L, Semrau K, Nakamura K, Walter J, Decker WD, Hong J, Chen T, Heil M, Sinkala M, Kankasa C, Thea DM, Kuhn L, Mullins JI, Aldrovandi GM. Restriction of HIV-1 genotypes in breast milk does not account for the population transmission genetic bottleneck that occurs following transmission. PLoS One. 2010 Apr 20;5(4):e10213. doi: 10.1371/journal.pone.0010213.

  PMID: 20422033 RESULT

• Kuhn L, Sinkala M, Semrau K, Kankasa C, Kasonde P, Mwiya M, Hu CC, Tsai WY, Thea DM, Aldrovandi GM. Elevations in mortality associated with weaning persist into the second year of life among uninfected children born to HIV-infected mothers. Clin Infect Dis. 2010 Feb 1;50(3):437-44. doi: 10.1086/649886.

  PMID: 20047479 RESULT

• Walter J, Ghosh MK, Kuhn L, Semrau K, Sinkala M, Kankasa C, Thea DM, Aldrovandi GM. High concentrations of interleukin 15 in breast milk are associated with protection against postnatal HIV transmission. J Infect Dis. 2009 Nov 15;200(10):1498-502. doi: 10.1086/644603.

  PMID: 19835475 RESULT

• Walter J, Kuhn L, Semrau K, Decker DW, Sinkala M, Kankasa C, Thea DM, Bulterys M, Ou CY, Aldrovandi GM. Detection of low levels of human immunodeficiency virus (HIV) may be critical for early diagnosis of pediatric HIV infection by use of dried blood spots. J Clin Microbiol. 2009 Sep;47(9):2989-91. doi: 10.1128/JCM.02453-08. Epub 2009 Jul 22.

  PMID: 19625479 RESULT

• Kuhn L, Aldrovandi GM, Sinkala M, Kankasa C, Semrau K, Kasonde P, Mwiya M, Tsai WY, Thea DM; Zambia Exclusive Breastfeeding Study (ZEBS). Differential effects of early weaning for HIV-free survival of children born to HIV-infected mothers by severity of maternal disease. PLoS One. 2009 Jun 26;4(6):e6059. doi: 10.1371/journal.pone.0006059.

  PMID: 19557167 RESULT

• Arpadi S, Fawzy A, Aldrovandi GM, Kankasa C, Sinkala M, Mwiya M, Thea DM, Kuhn L. Growth faltering due to breastfeeding cessation in uninfected children born to HIV-infected mothers in Zambia. Am J Clin Nutr. 2009 Aug;90(2):344-53. doi: 10.3945/ajcn.2009.27745. Epub 2009 Jun 24.

  PMID: 19553300 RESULT

• Kuhn L, Semrau K, Ramachandran S, Sinkala M, Scott N, Kasonde P, Mwiya M, Kankasa C, Decker D, Thea DM, Aldrovandi GM. Mortality and virologic outcomes after access to antiretroviral therapy among a cohort of HIV-infected women who received single-dose nevirapine in Lusaka, Zambia. J Acquir Immune Defic Syndr. 2009 Sep 1;52(1):132-6. doi: 10.1097/QAI.0b013e3181ab6d5e.

  PMID: 19506483 RESULT

• Walter J, Kuhn L, Kankasa C, Semrau K, Sinkala M, Thea DM, Aldrovandi GM. Reuse of single-dose nevirapine in subsequent pregnancies for the prevention of mother-to-child HIV transmission in Lusaka, Zambia: a cohort study. BMC Infect Dis. 2008 Dec 30;8:172. doi: 10.1186/1471-2334-8-172.

  PMID: 19116004 RESULT

• Fox MP, Brooks DR, Kuhn L, Aldrovandi G, Sinkala M, Kankasa C, Horsburgh R, Thea DM. Role of breastfeeding cessation in mediating the relationship between maternal HIV disease stage and increased child mortality among HIV-exposed uninfected children. Int J Epidemiol. 2009 Apr;38(2):569-76. doi: 10.1093/ije/dyn249. Epub 2008 Nov 30.

  PMID: 19047077 RESULT

• Kuhn L, Aldrovandi GM, Sinkala M, Kankasa C, Semrau K, Mwiya M, Kasonde P, Scott N, Vwalika C, Walter J, Bulterys M, Tsai WY, Thea DM; Zambia Exclusive Breastfeeding Study. Effects of early, abrupt weaning on HIV-free survival of children in Zambia. N Engl J Med. 2008 Jul 10;359(2):130-41. doi: 10.1056/NEJMoa073788. Epub 2008 Jun 4.

  PMID: 18525036 RESULT

• Semrau K, Ghosh M, Kankasa C, Sinkala M, Kasonde P, Mwiya M, Thea DM, Kuhn L, Aldrovandi GM. Temporal and lateral dynamics of HIV shedding and elevated sodium in breast milk among HIV-positive mothers during the first 4 months of breast-feeding. J Acquir Immune Defic Syndr. 2008 Mar 1;47(3):320-8. doi: 10.1097/qai.0b013e31815e7436.

  PMID: 18398972 RESULT

• Fox MP, Brooks D, Kuhn L, Aldrovandi G, Sinkala M, Kankasa C, Mwiya M, Horsburgh R, Thea DM. Reduced mortality associated with breast-feeding-acquired HIV infection and breast-feeding among HIV-infected children in Zambia. J Acquir Immune Defic Syndr. 2008 May 1;48(1):90-6. doi: 10.1097/QAI.0b013e31816e39a3.

  PMID: 18344878 RESULT

• Kuhn L, Sinkala M, Kankasa C, Semrau K, Kasonde P, Scott N, Mwiya M, Vwalika C, Walter J, Tsai WY, Aldrovandi GM, Thea DM. High uptake of exclusive breastfeeding and reduced early post-natal HIV transmission. PLoS One. 2007 Dec 26;2(12):e1363. doi: 10.1371/journal.pone.0001363.

  PMID: 18159246 RESULT

• Castelletti E, Lo Caputo S, Kuhn L, Borelli M, Gajardo J, Sinkala M, Trabattoni D, Kankasa C, Lauri E, Clivio A, Piacentini L, Bray DH, Aldrovandi GM, Thea DM, Veas F, Nebuloni M, Mazzotta F, Clerici M. The mucosae-associated epithelial chemokine (MEC/CCL28) modulates immunity in HIV infection. PLoS One. 2007 Oct 3;2(10):e969. doi: 10.1371/journal.pone.0000969.

  PMID: 17912348 RESULT

• Celerino da Silva R, Segat L, Kuhn L, Chies JAB, Crovella S. Association of SNPs in HLA-C and ZNRD1 Genes With HIV-1 Mother-to-Child Transmission in Zambia Population. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):509-515. doi: 10.1097/QAI.0000000000002584.

  PMID: 33252547 DERIVED

• Bode L, Kuhn L, Kim HY, Hsiao L, Nissan C, Sinkala M, Kankasa C, Mwiya M, Thea DM, Aldrovandi GM. Human milk oligosaccharide concentration and risk of postnatal transmission of HIV through breastfeeding. Am J Clin Nutr. 2012 Oct;96(4):831-9. doi: 10.3945/ajcn.112.039503. Epub 2012 Aug 15.

  PMID: 22894939 DERIVED

MeSH Terms

Conditions

HIV Infections; Breast Feeding

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Feeding Behavior; Behavior

Study Officials

• Louise Kuhn, PhD

  Gertrude H. Sergievsky Center, and Department of Epidemiology, Mailman School of Public Health, Columbia University

  PRINCIPAL INVESTIGATOR

• Donald M Thea, MD, MSc

  Department of International Health, Boston University School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 4, 2006
• Study Start: May 1, 2001
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 27, 2011

Record last verified: 2011-07

Locations

ZA (1)