Quentin Awori

The Shang Ring device for adult male circumcision: a proof of concept study in Kenya.

Objective:To assess safety, preliminary efficacy, and acceptability of the Shang Ring, a novel disposable device for adult male circumcision in Kenya. Methods:Forty HIV-negative men were recruited in Homa Bay, Kenya. Circumcisions were performed by a trained physician or nurse working with 1 assistant. Follow-up was conducted at 2, 7, 9, 14, 21, 28, 35, and 42 days after circumcision. Rings were removed on day 7. Pain was assessed using a visual analog scale (VAS) (0 = no pain, 10 = worst possible). Men were interviewed at enrollment and on days 7 and 42. Results:All 40 procedures were completed successfully. Mean procedure and device removal times were 4.8 (SD ± 2.0) and 3.9 (SD ± 2.6) minutes, respectively. There were 6 mild adverse events, including 3 penile skin injuries, 2 cases of edema, and 1 infection; all resolved with conservative management. In addition, there were 3 partial ring detachments between days 2-7. None required treatment or early ring removal. Erections with the ring were well tolerated, with a mean pain score of 3.5 (SD ± 2.3). By day 2, 80% of men were back to work. At 42 days, all participants were very satisfied with their circumcision and would recommend the procedure to others. Conclusions:Our results demonstrate that the Shang Ring is safe for further study in Africa. Acceptability of the Shang Ring among participants was excellent. With short procedure times, less surgical skill required, and the ease with which it can be used by nonphysicians, the Shang Ring could facilitate rapid roll-out of male circumcision in sub-Saharan Africa.

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 Rings cosmetic results. The Shang Ring should be considered for adult MC as programs scale-up.

Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment.

Objectives:To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers. Methods:Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal. Results:Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8–14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was “very easy” compared with the forceps-guided procedure. Conclusion:The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.

Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia.

Background:Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. Methods:We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18–54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35–42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. Results:We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35–42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. Conclusions:The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.

Clinical trials using the Shang Ring device for male circumcision in Africa: a review

Male circumcision (MC) reduces the risk of HIV and other sexually transmitted infections (STIs), including human papillomavirus (HPV) and herpes simplex virus type 2 (HSV-2), and is recommended as an important component of a comprehensive package of HIV prevention interventions. While computer modeling has demonstrated that substantial reductions in HIV could be achieved with rapid scale-up of MC services in sub-Saharan Africa, scale-up has lagged due to scarcity of trained providers coupled with relative technical difficulty of recommended surgical MC techniques. Simplified techniques, such as devices, have the potential to allow for a more rapid roll-out of MC. One such device is the Shang Ring, a novel disposable MC device that eliminates the need for suturing and has been on the Chinese market since 2005. Results from Chinese studies have demonstrated that the Shang Ring is both safe and easy to use. Since 2008, a series of studies using the Shang Ring for adult MC have been carried out in Kenya, Uganda and Zambia, according to guidelines established by World Health Organization (WHO) for clinical evaluation of new devices for adult MC. These include a proof of concept study, a study of delayed removal of the Shang Ring, two studies comparing Shang Ring circumcision to conventional surgical approaches, and a large field trial to evaluate safety of Shang Ring circumcision during routine service delivery. Results from these studies demonstrate that the Shang Ring has an excellent safety profile and that Shang Ring circumcision is relatively easy to teach and learn, making Shang Ring MC an appealing technique for use in sub-Saharan Africa where doctors are in short supply and non-physician providers such as nurses and clinical officers are playing a major role in providing MC through task shifting. Shang Ring MC and device removals were uneventfully performed by trained nurses and clinical officers, who preferred the Shang Ring to conventional surgical techniques. Adverse event rates were similar to those observed with conventional surgical circumcision and were managed with, at most, minor interventions, resolving with no long-term sequale. Perhaps one of the biggest advantages of the Shang Ring is the relatively short 3-6 minutes procedure time. Importantly, men also preferred the Shang Ring compared to conventional circumcision and satisfaction with cosmetic appearance of their circumcised penis was very high. The vast majority of participants in studies in Africa as well as China have reported few problems and little disruption to daily life while wearing the device. The Shang Ring holds great promise as an innovative technology that has the potential to facilitate the safe and effective scale-up of circumcision services in settings where MC is not widely used and where the burden of HIV-disease is high.

Surgical Outcomes of Newly Trained ShangRing Circumcision Providers

Background:Devices can potentially accelerate scale-up of voluntary medical male circumcision in sub-Saharan Africa. Studies have demonstrated advantages of the ShangRing device over conventional circumcision. With the need to train providers rapidly for scale-up, concerns arise about the transferability of techniques and the expertise of new trainees. Methods:We compared outcomes of ShangRing circumcisions conducted in Kenya by experienced providers (experience with more than 100 ShangRing circumcisions) and newly trained providers (trained in Kenya by the experienced providers before the study began). During training, trainees performed at least 7 ShangRing circumcisions and 3 removals. Newly trained providers received intermittent clinical mentoring initially during the study but otherwise conducted circumcisions on their own. Results:Four hundred six and 115 ShangRing procedures were performed by the new trainees and the experienced providers, respectively. The mean duration of circumcisions was 6.2 minutes for both trained and experienced provider groups (P = 0.45), whereas the mean pain score (on an 11-point scale) was 2.5 and 3.2, respectively (P = 0.65). There was no difference in the proportion of participants healed by the day 42 visit (P = 0.13) nor in the incidence of moderate and severe adverse events observed (P = 0.16). Participants in both groups were equally satisfied with final wound cosmesis. Discussion:Results demonstrate that the ShangRing circumcision technique is easy to learn and master. Newly trained providers can safely conduct ShangRing circumcisions in routine service settings. The ShangRing can facilitate rapid rollout of voluntary medical male circumcision for HIV prevention in sub-Saharan Africa.

Minimally invasive male circumcision.

1. Sayana S, Javanbakht M, Weinstein M, Khanlou H. Clinical impact and cost of laboratory monitoring need review even in resource-rich setting. J Acquir Immune Defic Syndr. 2011;56:e97–e98. 2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Department of Health and Human Services; 2011:1–167 Available at: http: //www.aidsinfo.nih.gov/ContentFiles/Adultand AdolescentGL.pdf. Accessed January 11, 2011.

V9-03 RANDOMIZED CLINICAL TRIAL OF THE NO-FLIP SHANGRING CIRCUMCISION FOR ADOLESCENTS AND ADULTS IN AFRICA

INTRODUCTION AND OBJECTIVES: Non-curvature penile deformities are prevalent and bothersome manifestations of Peyronie’s disease (PD) that can result in functional impairment and psychological distress. The quantitative metrics that are currently used to describe these deformities are inadequate and non-standardized, which has historically been a barrier to clinical research and patient care. Our aim is to introduce three-dimensional photography as a technique to improve the evaluation of patients with PD, partially by the measurement of erect penile volume (EPV) and percent erect penile volume loss (EPVL), and to assess the reliability of measurements acquired by 3D photography. METHODS: Six penis models were constructed using computer-assisted design software, and physical models were produced using a 3D printer. 3D photographs of each model were captured in triplicate by 4 observers using an inexpensive 3D camera (Structure Sensor, Occipital, San Francisco, CA). Computer software (Blender, Amsterdam, Netherlands) was used to generate automated measurements of EPV, penile length, minimum circumference, and maximum circumference. 3D images were then digitally reconstructed to restore each image to a non-deformed shape. Percent EPVL was calculated for each model as the percent difference between the EPV of the original model and the EPV after digital reconstruction. The automated measurements were then statistically compared to measurements obtained using water displacement experiments and a tape measure. RESULTS: On average, 3D photography was accurate to within 0.1% for measurement of penile length. It overestimated maximum and minimum circumference by averages of 5.0% and 1.8%, respectively; overestimated EPV by an average of 8.6%; and underestimated percent EPVL by an average of 1.9%. All inter-test, inter-observer, and intraobserver ICC values were greater than 0.75, reflective of excellent methodological reliability. CONCLUSIONS: Erect penile volume and percent EPVL are novel, highly descriptive metrics that may be useful in describing all variants of non-curvature, volume-loss deformities resulting from PD. These metrics can be quickly, accurately, and reliably determined using computational analysis of 3D photographs. Clinical research using 3D photography for assessment of EPV and percent EPVL will empower clinicians and researchers to better understand the clinical impact of penile volume-loss deformities and to study how these deformities respond to therapy.

Use of the ShangRing circumcision device in boys below 18 years old in Kenya: results from a pilot study

Introduction: Male circumcision is a proven prevention strategy against the spread of HIV. The World Health Organizations new 2016–2021 strategic framework on voluntary medical male circumcision (VMMC) targets 90% of males aged 10–29 years to receive circumcision by 2021 in 14 priority sub‐Saharan countries while anticipating an increase in the demand for infant circumcision. It also states that the use of circumcision devices is a safe and efficient innovation to accelerate attainment of these goals. The primary objective of this pilot study was to evaluate the safety and acceptability of the ShangRing, a novel circumcision device, in boys below 18 years of age.