Perinatal substance abuse and AIDS: subject selection, recruitment, and retention.

Studies that involve subjects who are HIV infected as well as chemically dependent present special challenges to the study team. HIV infection is now so common in many parts of the country and infection can potentially influence so many commonly used endpoints for perinatal chemical dependence studies that HIV must be considered in these studies. Some of the factors that need to be taken into account in the design of studies include the staging of HIV illness, the consequences of HIV-induced CNS disease, the effects of HIV treatment, and the biases in subject selection that arise due to inaccurate information about risk factors and imbalance in sources of subjects and controls. In addition, the study team needs to remember the community and staff fear and bias that are often encountered in the care of HIV-infected patients. Fruitful sources of subjects for perinatal studies include prenatal clinics and delivery rooms, chemical dependence programs, and the network of community social agencies. Retention of this challenging group is strongly aided by the establishment of a seamless system of services that includes all aspects of general medical care, HIV specialty care, access to treatment protocols, and psychosocial care.