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      PrePex Male Circumcision: Follow-Up and Outcomes during the First Two Years of Implementation at the Rwanda Military Hospital.

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          Abstract

          PrePex Male Circumcision (MC) has been demonstrated as an effective and scalable strategy to prevent HIV infection in low- and middle-income countries. This study describes the follow-up and outcomes of clients who underwent PrePex MC between January 2011 and December 2012 with weekly follow-up at the Rwanda Military Hospital, the first national hospital in Rwanda to adopt PrePex.

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          Male circumcision for HIV prevention in sub-Saharan Africa: who, what and when?

          Anne Buvé, David J G White, Judith R Glynn … (2008)
          Male circumcision (circumcision) reduces HIV incidence in men by 50-60%. The United Nations Joint Programme on HIV/AIDS (UNAIDS) recommends the provision of safe circumcision services in countries with high HIV and low circumcision prevalence, prioritizing 12-30 years old HIV-uninfected men. We explore how the population-level impact of circumcision varies by target age group, coverage, time-to-scale-up, level of risk compensation and circumcision of HIV infected men. An individual-based model was fitted to the characteristics of a typical high-HIV-prevalence population in sub-Saharan Africa and three scenarios of individual-level impact corresponding to the central and the 95% confidence level estimates from the Kenyan circumcision trial. The simulated intervention increased the prevalence of circumcision from 25 to 75% over 5 years in targeted age groups. The impact and cost-effectiveness of the intervention were calculated over 2-50 years. Future costs and effects were discounted and compared with the present value of lifetime HIV treatment costs (US$ 4043). Initially, targeting men older than the United Nations Joint Programme on HIV/AIDS recommended age group may be the most cost-effective strategy, but targeting any adult age group will be cost-saving. Substantial risk compensation could negate impact, particularly if already circumcised men compensate. If circumcision prevalence in HIV uninfected men increases less because HIV-infected men are also circumcised, this will reduce impact in men but would have little effect on population-level impact in women. Circumcision is a cost-saving intervention in a wide range of scenarios of HIV and initial circumcision prevalence but the United Nations Joint Programme on HIV/AIDS/WHO recommended target age group should be widened to include older HIV-uninfected men and counselling should be targeted at both newly and already circumcised men to minimize risk compensation. To maximize infections-averted, circumcision must be scaled up rapidly while maintaining quality.
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            HIV prevention: male circumcision comparison between a nonsurgical device to a surgical technique in resource-limited settings: a prospective, randomized, nonmasked trial.

            Jean Bitega, S. Kaplan, E Rwamasirabo … (2012)
            Randomized controlled trial studies have shown that male circumcision (MC) can reduce the risk of HIV infection by 53%-60%. The Joint United Nations Program on HIV and AIDS announced a 5-year plan to voluntarily circumcise 20 million men by 2015. There are more than 38 million males in sub-Saharan Africa that could benefit from MC for HIV prevention by 2015. Surgical MC is impractical for nation-wide coverage in resource-limited settings. Rwanda intends to launch a voluntary MC program to reach 2 million adult men in 2 years, an unattainable goal with surgical MC. This study was designed to compare a new nonsurgical device with surgical MC to assess nonsurgical MC suitability for scale-up. Prospective, randomized controlled trial in Rwanda in which the PrePex device was used for nonsurgical MC and the dorsal-slit method for surgical MC (ratio: 2:1). Subjects were healthy adult male volunteers aged 21-54 years. The primary endpoint, set by World Health Organization, was total MC procedure time. Of 217 eligible subjects, 144 were randomized to the PrePex/nonsurgical arm and 73 to the surgical arm. All subjects were circumcised in 10 working days. Nonsurgical MC was bloodless, without anesthesia, sutures, or sterile setting and with mean procedure time of 3.1 minutes (skin to skin), was significantly shorter than mean surgical procedure time (15.4 minutes skin to skin) (P < 0.0001). There were no device-related adverse events. Healing time of the PrePex arm was longer than the surgical arm. PrePex, the nonsurgical MC, takes significantly less time than surgical, is as safe, does not require injections or sterile settings, is bloodless and seems to be suitable for nurses.
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              Safety, Effectiveness and Acceptability of the PrePex Device for Adult Male Circumcision in Kenya

              Paul J. Feldblum, Elijah Odoyo-June, Walter Obiero … (2014)
              Objective To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya. Methods We enrolled 427 men ages 18–49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs) and time to complete healing, and interviewed men about acceptability and pain. Results Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%–8.5%), all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%). Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30–0.58), and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family. Conclusions The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates. Trial Registration ClinicalTrials.gov NCT01711411
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                Author and article information

                Journal
                Journal ID (iso-abbrev): PLoS ONE
                Title: PloS one
                Publisher: Public Library of Science (PLoS)
                ISSN (Electronic): 1932-6203
                ISSN (Print): 1932-6203
                Publication date (Electronic): 2015
                Volume: 10
                Issue: 9
                Affiliations
                [1 ] University of Rwanda College of Medicine and Health Sciences School of Public Health, Kigali, Rwanda.
                [2 ] Rwanda Military Hospital, Kigali, Rwanda.
                [3 ] University of Rwanda College of Medicine and Health Sciences School of Public Health, Kigali, Rwanda; Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, United States of America.
                Article
                Publisher Item ID: PONE-D-15-19307
                DOI: 10.1371/journal.pone.0138287
                PMC ID: 4580619
                PubMed ID: 26398343
                SO-VID: 650533cd-fbd1-4955-914a-36daa658eb95
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