GHENT UNIVERSITY Karoline FONCK - International Centre for ...

All studies were approved by the ethical committee of the University of Nairobi. No additional
ethical approval from another institution was sought, except for the randomized placebocontrolled
trial. This trial was executed in collaboration with the University of Manitoba,
Winnipeg, Canada, and received additional approval from the ethical committee of that
University. A drug and safety monitoring board (DSMB) was established to monitor that study
closely. Informed consent was obtained from all study participants.
2.2.2. Data collection
a. Staff
The core staff involved in the research studies consisted of two local physicians, a social
scientist, a nurse, a counselor, a data entry person, one administrator, one clerical staff and
one driver. Whenever necessary, extra staff was hired for temporary assignments. These
persons were mainly recruited among the existing University of Nairobi staff or from the
Nairobi City Council.
Data collection was performed by trained staff using hospital and clinic record cards as well
as standard questionnaires specifically designed for these clinical epidemiological studies.
b. Quality of the data
Substantial consideration was given to the method of data collection. Many of the standard
interview forms also catered for behavioral and sexual data. To avoid incorrect answers on
these sensitive issues, experts in communication have been involved in the preparation of
the questionnaires. Before the start of the studies, the questionnaires were field tested and
adapted. Research assistants were trained in the use of the questionnaires. However, no
quality control for questionnaire administration was done. It can be presumed though that if
systematic errors occurred, they should be similar in HIV positive and negative persons, as in
almost all cases the patients were not aware of their serostatus.
A copy of the study proposals, standard questionnaires and data entry forms are available
upon request.
OBJECTIVES AND METHODS 19