CompletedNCT00197652Updated Oct 7, 2011

Botswana Diarrheal Diseases Study

An observational study in HIV Infections, sponsored by Harvard School of Public Health (HSPH). Completed at 1 site in Botswana. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2011-10-07.

Sponsored by Harvard School of Public Health (HSPH) · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 1,350
Ages: 18 Years to 55 Years
Sex: Female

Study summary

The goals of this study are to:

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.
link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.

Conditions studied

HIV Infections

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HIV Infections 4,258

Keywords

Prevention of Mother-Infant HIV Transmission

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 1,350 is above the median of 200 across 713 observational studies indexed under HIV Infections.

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Lead sponsor

Harvard School of Public Health (HSPH) is the lead sponsor of 150 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Female
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Primary care clinic

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

Exclusion Criteria:

Subject cannot provide legal independent informed consent.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,350 participants (actual)

Groups and 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.

What researchers measure

Primary outcomes

OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
Time frame: 24 months

Study locations

1 site

Princess Marina Hospital
Gaborone, Botswana

References and documents

Publications

Shapiro RL, Smeaton L, Lockman S, Thior I, Rossenkhan R, Wester C, Stevens L, Moffat C, Arimi P, Ndase P, Asmelash A, Leidner J, Novitsky V, Makhema J, Essex M. Risk factors for early and late transmission of HIV via breast-feeding among infants born to HIV-infected women in a randomized clinical trial in Botswana. J Infect Dis. 2009 Feb 1;199(3):414-8. doi: 10.1086/596034. PubMed 19090775 ↗
Shapiro RL, Lockman S, Kim S, Smeaton L, Rahkola JT, Thior I, Wester C, Moffat C, Arimi P, Ndase P, Asmelash A, Stevens L, Montano M, Makhema J, Essex M, Janoff EN. Infant morbidity, mortality, and breast milk immunologic profiles among breast-feeding HIV-infected and HIV-uninfected women in Botswana. J Infect Dis. 2007 Aug 15;196(4):562-9. doi: 10.1086/519847. Epub 2007 Jul 9. PubMed 17624842 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00197652
Lead sponsor: Harvard School of Public Health (HSPH)
Collaborators: Botswana Ministry of Health
Responsible party: Roger Shapiro (Principal Investigator, Harvard School of Public Health (HSPH)) — Principal investigator
First posted: Sep 20, 2005
Start date: Mar 2001
Primary completion: Oct 2003
Completion: Mar 2008
Last update: Oct 7, 2011

Study contacts

Roger Shapiro, MD

principal investigator · Harvard School of Public Health (HSPH)

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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