Making the cut: evidence-based lessons for improving the informed consent process for voluntary medical male circumcision in Swaziland and Zambia.

The informed consent (IC) process for voluntary medical male circumcision (VMMC) was evaluated in Zambia and Swaziland as VMMC programs scaled up. In-depth interviews (IDIs) were conducted with clients 1 week after surgery to explore understanding of IC and gauge how expectations of MC surgery compared to actual experiences. In Zambia, key opinion leaders (KOLs) were also interviewed. Some clients equated written IC with releasing the clinic from liability. Most clients felt well prepared for the procedure, although many were surprised by the level of pain experienced during anesthesia and postsurgery. Clients were highly motivated to adhere to wound care, but some were overwhelmed by extensive instructions. Adolescents described barriers to accessing follow-up care and the need for support in overcoming adult gatekeepers. KOLs indicated that IC is not well understood in poorly educated communities. Results led to concrete programmatic changes, including revised patient education materials and more effective anesthesia for longer-lasting pain relief.

An overview of adverse events reported by participants in CDC's anthrax vaccine and antimicrobial availability program.

PURPOSE: The CDC's Anthrax Vaccine and Antibiotic Availability Program was implemented under an Investigational New Drug (IND) application to provide additional post-exposure prophylaxis for individuals potentially exposed to Bacillus anthracis in the fall of 2001. Participants were provided with two options: (1) 40 additional days of antimicrobial prophylaxis (i.e., ciprofloxacin, doxycycline, or amoxicillin); or (2) 40 additional days of antimicrobial prophylaxis plus three doses of anthrax vaccine adsorbed (AVA). METHODS: Participants were monitored for adverse events (AEs). Participants were asked to complete 2-week AE diaries for 6 weeks post-enrollment, and approximately 2 months after enrollment, active surveillance was conducted through telephone interviews with 1113 (64%) participants. RESULTS: A total of 1727 of approximately 10 000 previously prophylaxed persons enrolled to receive 40 additional days of antibiotics. Of these, 199 opted at enrollment to receive three doses of AVA in addition to the additional 40 days of antibiotic. Overall, 28% of participants reported at least one AE on their diaries. Results varied by surveillance mechanism, the diary data indicated differences in the proportion reporting AEs between participants receiving antibiotic only and participants receiving antibiotic and AVA. However, during the active 2-month telephone follow-up, the rates of AEs reported for both the antibiotic only and antibiotic plus AVA treatment regimens were similar. Additionally, ciprofloxacin and doxycycline had similar AE profiles, with only rigors reported significantly more often among ciprofloxacin recipients. CONCLUSIONS: Overall, the rates of AEs experienced by all participants were acceptable given the seriousness of potential B. anthracis exposure.