Botswana Diarrheal Diseases Study

Botswana Diarrheal Diseases Study

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.

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.