Botswana Diarrheal Diseases Study

This study has been completed.
Sponsor:
Collaborator:
Botswana Ministry of Health
Information provided by (Responsible Party):
Roger Shapiro, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197652
First received: September 12, 2005
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

The goals of this study are to:

  1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.

    • analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
    • comparison to rates among infants born to HIV uninfected mothers.
  2. link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Botswana Diarrheal Diseases Study

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 1350
Study Start Date: March 2001
Study Completion Date: March 2008
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diarrheal specimens from infants born to HIV infected mothers
400 diarrheal specimens will suffice to determine the prevalence of specific pathogens in the region. Of these, 300 specimens will be collected from infants born to HIV infected mothers, and 100 specimens will be collected from infants born to HIV uninfected mothers.
Breast milk from HIV infected and HIV uninfected women
Breast milk from HIV infected and HIV uninfected women who are breastfeeding is collected at 2 days, 2 weeks, 2 months, and 5 months post-partum. This breast milk will be compared for in vitro functional quality of immunoglobulins to selected diarrheal and respiratory pathogens.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Subject is able to provide independent informed consent.
  • Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly.
  • Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days.

For HIV-infected subjects:

  • Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.

Exclusion Criteria:

  • Subject cannot provide legal independent informed consent.
  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: NCT00197652

Locations
Botswana
Princess Marina Hospital
Gaborone, Botswana
Sponsors and Collaborators
Harvard School of Public Health
Botswana Ministry of Health
Investigators
Principal Investigator: Roger Shapiro, MD Harvard School of Public Health
  More Information

No publications provided by Harvard School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roger Shapiro, Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197652     History of Changes
Other Study ID Numbers: K23 HD001330-05
Study First Received: September 12, 2005
Last Updated: October 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard School of Public Health:
Prevention of Mother-Infant HIV Transmission

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 August 01, 2014