To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachment ( i.e. , allowing the device to fall off), we conducted a case series of no-flip ShangRing circumcision combined with a randomized controlled trial of removal 7 days postcircumcision versus spontaneous detachment at two health facilities in Kenya. The primary outcome was the safety of the no-flip technique based on moderate and severe adverse events (AEs) during the procedure and through 42-day follow-up. A main secondary outcome was clinical course and safety of spontaneous detachment. Two hundred and thirty males 10 years and older underwent no-flip circumcision; 114 randomized to 7-day removal and 116 to spontaneous detachment. All circumcisions were successfully completed. Overall 5.3% (6/114) of participants in the 7-day group and 1.7% (2/116) in the spontaneous group had an AE; with no differences when compared to the 3% AE rate in historical data from African studies using the original flip technique ( P = 0.07 and P = 0.79, respectively). Overall 72.4% (84/116) of participants in the spontaneous group wore the ShangRing until it detached. Among the remaining (27.6%; 32/116), the ring was removed, primarily at the participants' request, due to pain or discomfort. There was no difference in AE rates ( P = 0.169), visit day declared healed ( P = 0.324), or satisfaction ( P = 0.371) between randomization groups. The median time to detachment was 14.0 (IQR: 7–21, range: 5–35) days. The no-flip technique and spontaneous detachment are safe, effective, and acceptable to boys and men 10 years and older. Phimosis and penile adhesions do not limit successful ShangRing circumcision with the no-flip technique.

The aim of this study was preparation of a liver schinonticide Primaquine phosphate (PQ) directly to the hepatocytes using solid lipid nanoparticles (SLN). The PQloaded solid lipid nanoparticles (PQ-SLNs) were prepared by a modified solvent emulsification evaporation method based on a water-in-oil-in-water (w/o/w) double emulsion and dried freeze drying (PQ-SLNFD) to obtain the nanoparticles. The mean particle size, zeta potential, drug loading, and encapsulation efficiency of the PQ-SLNFD were 236nm, +23 mV, 14%, and 75%, respectively. A spherical morphology of PQ-SLNFD was seen by scanning electron microscope had traces of drug crystals. In vitro, release profile depicted a steady drug release over 400 hours for PQ-SLNFD. Differential scanning calorimeter thermograms demonstrated presence of drug in drug-loaded nanoparticles along with disappearance of decomposition exotherms, suggesting increased physical stability of drug in prepared formulations. The nanoformulated PQ was 20% more effective as compared with conventional oral dose when tested in Plasmodium berghei-infected Swiss albino mice. This study established an effective process of developing a nanomedicine delivery system for PQ.

Background The ShangRing is a disposable, collar clamp circumcision device pre-qualified for use in men and boys 13 years and above. It has been shown to be faster than conventional circumcision with comparable adverse event (AE) rates and high client satisfaction. Voluntary medical male circumcision (VMMC) has been shown to dramatically reduce the risk of HIV acquisition in males. However, the fear of pain during circumcision is an important barrier to uptake. Use of topical anesthesia thus presents an opportunity to address this. Objectives We sought to evaluate the safety, effectiveness and acceptability of the use of topical anaesthesia with ShangRing circumcision of men and boys 10 years of age and above. Methods Participants were randomised 2:1 to receive topical or injectable anaesthesia. All participants underwent no-flip ShangRing circumcision. The primary outcome measure was pain. Secondary outcomes included ease of use of topical versus injectable anaesthesia, AEs and participant satisfaction. Results Compared to the topical group, participants in the injectable group reported significantly more pain on administration of the anesthesia and at approximately 20 minutes after the procedure. In the topical group, sufficient anaesthesia with topical cream was not achieved in 21 (9.3%) cases before the start of the procedure; in another 6 (2.6%), supplementary injectable anaesthesia was required as the circumcision was being carried out. The AE rate was significantly lower (p<0.01) in the topical (0%) vs. the injectable group (4.2%). The most common AE was pain during the post-operative period. All AEs were managed conservatively and resolved without sequeale. 96.7% of participants were satisfied with the appearance of the healed penis and 100% would recommend the ShangRing to others. All seven male circumcision providers involved in the study preferred topical to injectable anaesthesia. Conclusions Our results demonstrate the safety, improved clinical experience, effectiveness, and acceptability of the use of topical anaesthesia in ShangRing circumcision using the no-flip technique. Topical anaesthesia effectively eliminates needlestick pain from the clients’ VMMC experience and thus has the potential to increase demand for the service. Trial registration ClinicalTrials.gov NCT02390310 .

Trained clinical officers—nonphysicians with 3 years of specialized training—conducted the procedure safely and effectively compared with procedures performed by more advanced assistant medical officers. This evidence supports policy change allowing properly trained and supported clinical officers to perform minilaparotomy.

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