Randomized controlled trial of the shang ring versus conventional surgical techniques for adult male circumcision: safety and acceptability.

OBJECTIVE: To compare clinical profiles of Shang Ring versus conventional circumcisions. DESIGN: Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites. METHODS: We enrolled HIV-negative men aged 18-54 years in Homa Bay, Kenya, and Lusaka, Zambia and followed them at 2, 7, 14, 21, 28, 42, and 60 days after Shang Ring versus conventional circumcision. We compared the duration of surgery, postoperative pain using a visual analog scale, adverse events rates, time to complete wound healing by clinical assessment, participant acceptability, and provider preferences between circumcision groups. RESULTS: We randomized 200 men to each group; 197 and 201 contributed to the Shang Ring and conventional surgery analyses, respectively. Adverse event rates were similar between groups. Pain scores at most time points were similar, however, the Shang Ring group reported higher scores for worst pain during erections (3.5 ± 1.9 vs. 2.3 ± 1.7; P < 0.001). Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision (MC), 95.7% versus 85.9% (P = 0.02) in Kenya, and 96.8% versus 71.3% (P < 0.01) in Zambia. Although median time to complete wound healing was 43 days in both groups, conventional circumcisions healed on average 5.2 days sooner (P < 0.001). Shang Ring procedures took one-third the time of conventional MC, 7 versus 20 minutes. All circumcision providers preferred the Shang Ring. CONCLUSIONS: Safety profiles of the 2 techniques were similar, all MC providers preferred the Shang Ring technique, and study participants preferred the Shang Ring's cosmetic results. The Shang Ring should be considered for adult MC as programs scale-up.

Pharmacokinetics of subcutaneous depot medroxyprogesterone acetate injected in the upper arm.

BACKGROUND: The abdomen and thigh are recommended injection sites in the label for Depo-SubQ Provera 104™. We evaluated the pharmacokinetic profile of medroxyprogesterone acetate (MPA) following injection of Depo-SubQ Provera 104 in the upper arm, a preferred injection site in developing countries. STUDY DESIGN: Twenty-six women in Norfolk, VA, received a single injection of Depo-SubQ Provera 104 in the upper arm in this prospective noncomparative study. We measured MPA serum concentrations prior to injection (day 1) and 11 times postinjection (days 2, 4, 8, 14, 30, 44, 60, 74, 91, 104 and 120). RESULTS: Serum MPA levels peaked at 0.953 ng/mL 2-14 days (interquartile range; median=8) after dosing. Mean AUC0-91 was 45.1 ng·day/mL. Mean MPA levels at days 91, 104 and 120 were 0.427, 0.367 and 0.327 ng/mL, respectively. A total of 15 individual measurements of MPA were below 0.2 ng/mL. All women but one had MPA levels above 0.1 ng/mL on day 91. CONCLUSIONS: Injection of Depo-SubQ Provera 104™ in the upper arm provided sufficient MPA levels for contraceptive protection for 3 months (13 weeks). The uptake and metabolism of MPA when injected in the upper arm may be different from the abdomen and thigh.

HIV prevalence and incidence among women at higher risk of infection in Addis Ababa, Ethiopia.

This study aimed to estimate HIV incidence among women at higher HIV risk in Addis Ababa, Ethiopia using cross-sectional data. To refine the estimate, we sought to determine a local correction factor by estimating a false recent rate for the BED assay. The overall study had two parallel phases: cross-sectional incidence and BED false recent (BED FR). A total of 1856 women at higher HIV risk were enrolled into the cross-sectional phase. For the BED FR, 500 women and 70 men with known HIV infection of greater than 12 months were enrolled. Rapid HIV tests were used to assess participant HIV status. Samples from women with positive results on HIV rapid testing were then analyzed using the BED assay to determine incident HIV infections. The overall HIV prevalence was 11.3%, with women greater than 25 years old having a higher prevalence (26.5% vs. 7.9% for younger women). The overall unadjusted HIV incidence was 3.3%. The estimated HIV incidence was 2.6% when adjusted using the locally derived false recent rate of 3.5%. Similar incidence rates were found between the younger and older age groups. This is one of the first field-based studies of HIV incidence in Ethiopia; it demonstrates that there is sufficient incidence to warrant further HIV prevention efforts among women at higher risk of HIV infection.