Safety of adult medical male circumcision performed by non-physician clinicians in Kenya: a prospective cohort study.

BACKGROUND: Male circumcision reduces the risk of heterosexually acquired HIV infection in men by approximately 60%. The Government of Kenya is rolling out voluntary medical male circumcision (VMMC) services, but struggles with health worker shortages, particularly with physician shortages. OBJECTIVE: To evaluate the safety of male circumcision performed by non-physician clinicians in Kenya. METHODS: Between December 2009 and December 2010, we conducted a prospective study of VMMC procedures performed by 15 nurses and 11 clinical officers, all trained to competence, in 11 public health facilities in Nyanza Province, Kenya. Providers reported surgical complications and adverse events (AEs), based on standardized definitions, immediately after the procedure and at 7 days and 60 days post-circumcision. We also assessed clients' satisfaction with the circumcision at 60 days. RESULTS: We recruited 2,244 men and boys, ages 13-54. The retention rate was high, with 2,192 participants (98%) returning for the 7-day follow-up visit and 1,845 (82%) for the 60-day visit. There was no difference in rates of moderate and severe AEs between participants whose circumcision was performed by a nurse (2.1%) or a clinical officer (1.9%) at 7 days post-circumcision. The most common AE was excess swelling (1.1%). Risk factors associated with an AE at 7 days post-circumcision included being employed and participant age ≥ 18 years. Participants circumcised by a provider with ≥ 6 years of professional experience were less likely to have an AE. Nearly all participants reported being satisfied with their circumcision at the 60-day follow-up visit. CONCLUSIONS: Trained nurses and clinical officers provided safe VMMC in Nyanza Province, Kenya. AE rates in this study were similar to those reported in typical service-delivery settings. These results add to the current body of evidence suggesting that trained non-physicians can provide safe medical male circumcision, thereby facilitating increased availability and access to circumcision services.

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.

Adult male circumcision in Nyanza, Kenya at scale: the cost and efficiency of alternative service delivery modes.

BACKGROUND: Adult male circumcision (MC) services in Kenya are provided through both horizontal and vertical programs, and via facility-based, mobile and outreach service delivery. This study assesses the costs and composition of unit costs for each program approach and service delivery mode and assess the cost-effectiveness of each. METHODS: This study was conducted on the unit costs of adult MC delivery in 222 purposively-selected MC delivery sites in Nyanza Province, Kenya from November 2008 through April 2010 using program data from the AIDS, Population, and Health Integrated Assistance Project II (APHIA II) and from the Nyanza Reproductive Health Society (NRHS). The former program can be characterized as horizontal or integrated; the latter as 'diagonal'; containing both horizontal and vertical elements. Expenditure and services data were collected from project financial and monitoring documents and via discussions with program officials. In addition, per-case, direct service delivery costs were calculated using time and motion observations of 246 adult MC procedures performed during May and June, 2010. We calculated the cost per HIV infections averted for each of the service delivery modalities. RESULTS: Unit cost per adult MC was $38.62 and $44.24 for APHIA II and NRHS respectively, ranging from $29.32 (APHIA II mobile) to $46.20 (NRHS outreach/mobile). Unit costs at base facilities was similar for the two approaches. Time and motion data revealed that the opportunity cost of the elapsed time between the arrival of the surgical team and the time the first MC procedure begins varies between $2.08 and $6.27 per case. The cost per HIV infection (HIA) averted ranged from $117.29 for mobile service via the horizontal APHIA-II program to $184.84 per HIA for the diagonal NRHS program. CONCLUSIONS: This study provides evidence for the similar efficiency of a horizontal approach (APHIA II) and a combination of horizontal and vertical approaches (NRHS) to support scale-up of adult MC services in Nyanza. Differences in unit cost are modest, not consistently in the same direction, and largely explained by differences in compensation levels.

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.

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.