BACKGROUND:Students attending 'alternative' high schools form relatively small, highly mobile high-risk populations, presenting challenges for the design and implementation of HIV-, other STI-, and pregnancy-prevention interventions. This paper describes the rationale, study design, and baseline results for the Safer Choices 2 program. STUDY DESIGN: Modified group-randomized intervention trial with cross-over of schools but not of students. The study cohort was defined a priori as those who completed the baseline measures and were still enrolled at the time of first follow-up. DESIGN RESULTS: Of 940 students initially enrolled in the study, 711 (76%) formed the study cohort. There were significant demographic differences between those included and those excluded from the study cohort in sex, age, sexual experience, experience with pregnancy, drug use, and some psychosocial measures. There were no significant differences between the intervention and control groups within the study cohort. The only significant difference between those students excluded from the intervention group and those excluded from the control group was reported age at first intercourse. BASELINE DATA RESULTS:Students (n=940) enrolled were predominately African-American (29.7%) and Hispanic (61.3%); 57.3% were female; 66% had ever had sex; and reported drug use in the previous 30 days ran from 4.3% (cocaine) to 26.9% (marijuana). Of the 627 sexually experienced, 41.8% reported their age at first intercourse as 13 years or younger; 28.5% reported ever being or having gotten someone pregnant; 74% reported sex in the past 3 months. Of the 464 sexually active in the last 3 months, 55.4% reported unprotected intercourse and 31.3% reported using drugs beforehand. CONCLUSION: The cross-over design will provide a rigorous test of the intervention; however, loss to follow-up of this population can result in some selection bias. Students attending dropout prevention and recovery schools are at high risk for HIV, STIs, and pregnancy, and are in need of interventions.
RCT Entities:
BACKGROUND: Students attending 'alternative' high schools form relatively small, highly mobile high-risk populations, presenting challenges for the design and implementation of HIV-, other STI-, and pregnancy-prevention interventions. This paper describes the rationale, study design, and baseline results for the Safer Choices 2 program. STUDY DESIGN: Modified group-randomized intervention trial with cross-over of schools but not of students. The study cohort was defined a priori as those who completed the baseline measures and were still enrolled at the time of first follow-up. DESIGN RESULTS: Of 940 students initially enrolled in the study, 711 (76%) formed the study cohort. There were significant demographic differences between those included and those excluded from the study cohort in sex, age, sexual experience, experience with pregnancy, drug use, and some psychosocial measures. There were no significant differences between the intervention and control groups within the study cohort. The only significant difference between those students excluded from the intervention group and those excluded from the control group was reported age at first intercourse. BASELINE DATA RESULTS: Students (n=940) enrolled were predominately African-American (29.7%) and Hispanic (61.3%); 57.3% were female; 66% had ever had sex; and reported drug use in the previous 30 days ran from 4.3% (cocaine) to 26.9% (marijuana). Of the 627 sexually experienced, 41.8% reported their age at first intercourse as 13 years or younger; 28.5% reported ever being or having gotten someone pregnant; 74% reported sex in the past 3 months. Of the 464 sexually active in the last 3 months, 55.4% reported unprotected intercourse and 31.3% reported using drugs beforehand. CONCLUSION: The cross-over design will provide a rigorous test of the intervention; however, loss to follow-up of this population can result in some selection bias. Students attending dropout prevention and recovery schools are at high risk for HIV, STIs, and pregnancy, and are in need of interventions.
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