THE SAFER CHOICES PROJECT - METHODOLOGICAL ISSUES IN SCHOOL-BASED HEALTH PROMOTION INTERVENTION RESEARCH

Randomized trials of school-based health promotion programs present un ique design and analytical issues not widely discussed in the research literature. This article describes the Safer Choices study - a school -based program for prevention of HIV, other sexually transmitted disea ses, and pregnancy - to illustrate critical methodological issues invo lved in large-scale, school-based intervention trials, particularly th ose evaluating interventions with a school-wide focus. The issues pres ented are: I) comparability of the intervention and control groups eve n when few units are randomized; 2) factors that affect the decision t o use a cohort or cross-sectional design; and 3) appropriate analysis strategy when the unit of randomization and intervention is at the sch ool level, bur observations are at the student level.