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1. A Case Study of A Completed Clinical Trial CPCRA 064: MDR-HIV Study
2. MDR-HIV Study Design 2x2 factorial (equal allocation)
Intervention: experimental (STI) vs. standard of care (control)
Medication adherence self-report form questionnaire: new (3-day recall) vs. standard (7-day recall)
Total sample size: N=480
3. MDR-HIV Study Design
4. MDR-HIV Randomization Schedule Stratified by clinical site:
16 clinical sites, each with its own randomization schedule
Permuted block design to randomly assign to Group A, B, C, or D:
Initial block of size 1
Second block of size 8
Subsequent blocks of size 4 or 8, randomly determined with probability p=0.5
5. MDR-HIV Randomization Process 1. Generation of randomization schedules for each clinical site:
Computer generated at the Statistical and Data Management Center (SDMC) of the Coordinating Center for Biometric Research (CCBR), Division of Biostatistics, University of Minnesota
6. MDR-HIV Randomization Process 2. Signed informed consent (IC). Originals kept at the clinic site (staff at the SDMC are blinded to identifying patient information)
3. Completion of appropriate sections of a paper case report form (CRF), documenting signed IC and eligibility verification.
7. MDR-HIV Randomization Process 4. Obtain randomization group:
Clinical site staff calls SDMC
Phone monitor at the SDMC follows script, documenting that IC has been signed and entering yes or no on a computer for each inclusion and exclusion criteria.
8. MDR-HIV Randomization Process 4. Obtain randomization group (continued):
If questions are answered correctly, the computer program provides the next available randomization assignment for that clinical site
The clinical site staff enters the randomization assignment on the CRF, signs it, and sends it to the SDMC for entry into the database and storage.
9. MDR-HIV Randomization Process: Did It Work?? The study was closed to enrollment early due to safety concerns
When the study was closed, 274 of the expected 480 participants had been enrolled
Was enrollment between the intervention groups (STI and control) balanced?
11. Number of Randomizations By Clinical Site and Intervention Group
12. Did Randomization Balance the Participant Characteristics?
13. STOPPING ENROLLMENT TO A TRIAL BASED ON SAFETY GUIDELINES: Terry Beirn Community Program for Clinical Research on AIDS (CPCRA) MDR-HIV Study Kathy Huppler Hullsiek
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24. AIDS or Death
25. Enrollment
