Three randomized trials have demonstrated that medical male circumcision (MMC) reduces HIV acquisition in men by 50%–60%,1–3 and UNAIDS/World Health Organization recommended MMC as an integral component of HIV prevention strategies in 2007.4 The agency set a goal of providing MMC to 20.3 million men by 2015 in 14 priority southern and eastern African countries where the prevalence of MMC is low and HIV prevalence is substantial.5 Since 2007, most priority countries have adopted policies promoting MMC, but by the end of 2010, <600,000 MMCs, representing <3% of the UNAIDS goal, had been achieved in the region.
A constraint on service delivery is the time required for conventional surgery, which limits the number of procedures per provider that can be performed in 1 day. There has been an interest in the use of MMC devices such as the Shang Ring6 and PrePex device,7 which do not require suturing or hemostasis, and can reduce the procedure time to approximately 5 minutes, potentially increasing program efficiency. Both devices require removal 7 days after placement.
The Shang Ring has been evaluated in a number of Chinese studies,6 but there is limited experience with this device in sub-Saharan Africa. Two studies reported low rates of adverse events (AEs),8–10 and a safety study showed that the optimum time for ring removal was 7 days.11 A randomized trial of the Shang Ring compared with conventional surgery in Kenya and Zambia reported similar rates of AEs (3.0%), greater cosmetic satisfaction with the Shang Ring than with standard surgery, and all providers preferred the Shang Ring method.12
We assessed the acceptability and safety of the Shang Ring relative to conventional surgery using the dorsal slit method in a service program in Rakai, Uganda.
In a male circumcision program in Rakai, Uganda, men requesting free MMC service were provided with preoperative health education on circumcision and on HIV/sexually transmitted infection prevention, and were offered voluntary HIV counseling and testing using a three rapid test algorithm. Uncircumcised, HIV-negative men aged 18 and older were then provided with basic information on the Shang Ring and dorsal slit MMC procedures and asked to provide written informed consent for participation in a study of acceptability and safety.
Consenting men were provided with detailed information on the Shang Ring and dorsal slit methods of MMC and offered a free choice of procedure. They were then provided with the procedure of their choice unless there were contraindications or complications. MMC was performed by clinical officers in sterile conditions in outpatient operating rooms under dorsal penile nerve block local anesthesia using a mixture of lignocaine 1% and bupivicaine 0.5%. The dorsal slit was performed as described in the WHO Manual for MMC,13 and the Shang Ring was applied as described in the Training Manual for Adult Male Circumcision Using the Shang Ring.14 In brief, the inner Ring was placed around the penis at the coronal sulcus, the foreskin was held with 4 clamps, and drawn over the inner Ring. The outer Ring was then positioned and clamped shut, and the foreskin removed with curved tissue scissors. The wound was cleaned with iodine and dressed with dry gauze.14 Patients were instructed to keep the wound clean and dry and to abstain from intercourse until full wound healing was certified.
The participants were followed up at 7 days postoperatively to remove the Shang Ring and to assess predefined AEs used in the randomized trial with additional items for the Shang Ring (eg, Ring detachment). The Shang Ring was removed under 10% lidocaine spray for pain control. The outer Ring was unlocked and removed, then the inner Ring was cut using the Inner Ring Cutter and removed. The wound was cleaned and dressed with a dry bandage. Men were provided with acetaminophen tablets qid, for postoperative pain control as needed. Pain after surgery or Ring removal was assessed by a visual analog scale of 0–10.
The participants were followed up at 4 weeks postoperatively to ascertain late onset AEs and to assess wound healing. Men with incomplete wound healing at the 4-week visit were followed up at weekly intervals until full wound healing was certified. Men who encountered difficulties were also free to return for unscheduled visits at any time.
The acceptability of the Shang Ring was assessed by the proportion of enrolled men opting for this method of MMC, and the reason for their preference was ascertained. The characteristics of men opting for the Shang Ring or dorsal slit were tabulated and compared using χ2 tests. If the surgeon found difficulty placing the Shang Ring and determined that the participant required dorsal slit, the event was classified as a failure of Ring placement. The frequency of AEs related to surgery was tabulated as the proportion of men with surgery-related AEs and differences in AE rates by MMC method was assessed using χ2 tests. Predefined AEs were categorized as mild requiring no intervention, moderate requiring conservative treatment, or severe requiring surgical intervention or hospitalization. If the foreskin was damaged during Ring placement and sutures were required to repair such damage, the event was considered as a failure of ring placement. The proportion of men with complete wound healing was assessed at the 4-week-scheduled visit. Complete wound healing was defined as an intact scar visualized with a magnifying glass, with no scab formation or stich sinus present. Photographs were used to document wounds deemed to have incomplete healing.
This study was approved by Institutional Review Boards in Uganda and at Johns Hopkins University, and was overseen by a Safety Monitoring Committee that comprised a Urologist, statistician, ethicist, and program scientist. The Uganda National Drug Authority reviewed the study protocol and approved the use of this new device for research purposes. The US Food and Drug Administration cleared the Shang Ring for marketing in the United States (August 2012).
Figure 1 shows the study flow diagram. One thousand four hundred twenty-seven men were eligible for the study of whom 1322 (92.6%) came for a prescheduled surgical visit and 621 (47.0%) of these latter men consented to study enrollment. Of the 701 eligible men not enrolled, the majority (638 or 91.0%) declined enrollment before receiving full information on the Shang Ring because they did not want to adhere to the study follow-up schedule or were not interested in the study. There were 17 nonenrolled men (2.4%) who had medical contraindications including phimosis, tight foreskins, abnormalities of the genitalia, or anemia.
Among the 621 enrolled men, 508 (81.8%) chose the Shang Ring, and 113 preferred to have the dorsal slit procedure. Men were asked the reasons for their preferences and could give multiple responses. The reasons men cited for preferring the Shang Ring were the shorter time required for surgery (51.9%), a belief that it is safer (52.7%), would cause less pain (41.4%) and that wound healing would be faster (25.3%). The predominant reasons for opting for the dorsal slit procedure were that this is the standard method (42.0%), that it would be safer (48.2%), did not require removal (29.5%), and that healing would be faster (33.9%).
In 4 (0.8%) of the 508 men who opted for the Shang Ring, the Ring placement failed either because the Ring slipped off after removal of the prepuce (n = 3) or there was damage to the prepuce after placement (n = 1), and the surgeon secured hemostasis and skin closure using sutures. These cases of Ring placement failure are likely to be due to provider inexperience rather than to the presence of preputial abnormalities. These cases were considered failures of Ring placement. Another 4 men who chose the Shang Ring could not receive this method of MMC due to stock outs of the appropriate Ring size and were offered and accepted dorsal slit surgery. Thus, 500 men received the Shang Ring, 117 men received the dorsal slit, and 4 men had failed Ring placement and received MMC after repair. Retention at the 7-day visit was 99.4% (497/500) for the Shang Ring recipients, 96.6% (113/117) for the dorsal slit and 75% (3/4) for the 4 Ring placement failures. Follow-up at the scheduled 4-week visit was 97.2% (486/500) for the Shang Ring recipients, 96.6% (113/117) for the dorsal slit, and 100% for the 4 Ring failures.
As shown in Table 1, the characteristics and behaviors of men who received the Shang Ring or dorsal slit procedures were generally comparable, except that a higher proportion of dorsal slit recipients (30.8%) than Shang Ring recipients (20.2%) were not sexually active, and this was of borderline statistical significance (P = 0.07).
The mean duration of surgery for the Shang Ring was 6.1 minutes (SD ± 2.7), compared with 17.7 minutes (SD ± 7.3) with the dorsal slit method. The time required for removal of the Shang Ring was 2.2 minutes (SD ± 1.3).
There was 1 severe AE unrelated to surgery involving hospitalization for dislocation of the ankle due to trauma. The frequencies of intraoperative Ring failures and postoperative AEs are given in Table 2, and the specific postoperative AEs summarized in Table 3. The rates of moderate/severe AEs, including Ring placement failures, were 1.8% with the Shang Ring (9/504) and 0.8% with the dorsal slit (1/117). This difference was not statistically significant (Fisher exact P = 0.697). Excluding the 4 Ring failures, the frequency of surgery-related postoperative moderate/severe AEs was 1.0% with the Shang Ring (5/500) and 0.8% (1/117) with the dorsal slit. Nine men in the Shang Ring arm had mild AEs (Table 3).
Three men removed the Shang Ring themselves (0.6%). One man who experienced postoperative pain removed the Ring himself on the fifth postoperative day, but when seen, the wound was in good condition. Two men were absent for the scheduled seventh postoperative day visit and both removed the Rings themselves on the eighth postoperative day. Both reported pain at the time of removal and 1 reported mild bleeding from the wound, but when seen at the 4 weeks’ scheduled visit, both men had satisfactory wound healing.
The proportions of men with certified wound healing at the 4-week follow-up were 84.0% (408/486) for Shang Ring recipients and 100% (113/113) among dorsal slit recipients (Fisher exact P < 0.001). Resumption of intercourse before the fourth week visit was reported by 7.0% of Shang ring recipients and 15.0% of dorsal slit recipients (P = 0.01). Three Shang ring recipients reported that they resumed intercourse before self-perceived wound healing (0.6%). The proportions of men reporting that they were satisfied or very satisfied with their chosen procedure were 99.1% with the Shang Ring and 100% with the dorsal slit. The Shang Ring recipients (99.8%) and dorsal slit recipients (100%) reported that they were satisfied or very satisfied with the cosmetic appearance.
The Shang Ring was highly acceptable in this rural adult Ugandan population where after receiving full information on both methods of circumcision, 82% of men chose the Ring in preference to the dorsal slit method of MMC. However, 4 men (0.8%) who opted for the Shang Ring had failures of Ring placement requiring surgical repair of the wound. These failures were attributed to inexperience of the surgeons and occurred early in the study after training, but this finding emphasizes the need for back up surgical facilities. The postoperative rates of AE with the Shang Ring were low and comparable with those with the dorsal slit method in this study. Also, the AEs were similar to rates observed with the dorsal slit or sleeve methods of MMC in a general programmatic setting in Rakai.15 Substantially less time was required for Shang Ring placement than for the dorsal slit MMCs. Therefore, we conclude that the Shang Ring is highly acceptable and safe in rural Uganda, and potentially could increase efficiency/throughput of circumcision surgeries in this setting. However, the need to return for the removal of the Shang Ring adds to the programmatic burden of this method of MMC. The finding that Shang Ring recipients were less likely than dorsal slit recipients to resume intercourse (7% vs 15%, respectively) may be an advantage because early resumption of sex is associated with increased risks of AEs,16 and in HIV-infected men, it is also associated with increased risk of transmission of HIV to female partners.16
There are limitations to this study. In this implementation science study, men self-selected their preferred method of circumcision because we wished to ascertain the acceptability of the Shang Ring device because if acceptability was low, introduction of this method may not be culturally appropriate. Therefore, the study lacked the benefits of randomization. It is possible that 638 men who declined study enrollment may have done so because they only wanted to receive standard surgery using the dorsal slit method. These men had been informed of the availability of the Shang Ring, and if these 638 men who declined enrollment plus the 113 men who elected for dorsal slit (total 1446) are considered to have rejected the Shang Ring, then the minimum acceptability of the Ring in this population was 35.1%. However, the men who declined study enrollment did not cite rejection of the Ring as their reason for nonenrollment. There were minor differences in the characteristics of enrolled men who selected the Shang Ring vs those choosing the dorsal slit method, but none of these differences affected the comparisons between surgical methods in terms of AEs or rates of complete wound healing. At follow-up, the only difference between the 2 procedures was that fewer Shang Ring recipients had complete wound healing and had resumed intercourse by the fourth postoperative week than the dorsal slit recipients did. An additional limitation is that only men aged 18 and older were enrolled because they had reached the age of majority and could consent to the procedures; thus, we cannot generalize the findings to adolescents and we will shortly conduct a further study of the Shang Ring in adolescent boys aged 13–17 years.
In summary, the Shang Ring seems to be an acceptable and safe method of MMC in rural Africa, and its introduction into MMC programs could markedly reduce the time required for surgery and increase the efficiency of MMC services. However, back-up surgical facilities are needed in the case of failures of Ring placement.
The authors wish to express their gratitude to study participants and the Safety Monitoring Committee (Drs Stephen Watya, Frederick Makumbi, Ben Kikaire, and Mr. Robert Ssekubugu).
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Keywords:© 2013 by Lippincott Williams & Wilkins
male circumcision; Shang ring; Rakai; Uganda