{
  "abstract": "Introduction Male circumcision (MC) has been shown to decrease transmission of HIV and is a critical strategy to decrease its incidence in countries with high rates of heterosexually transmitted HIV. Early infant MC (EIMC), with single-use MC devices, could increase rates of MC in Sub-Saharan Africa. Our objective was to determine the safety, efficacy and satisfaction of ShangRing EIMC in resource-constrained environments.Methods Healthy male infants aged 1–60 days underwent ShangRing EIMC performed by non-physician clinicians in 14 sites in Kenya, Tanzania and Uganda. The primary outcomes were the safety and efficacy of ShangRing EIMC. Secondary outcomes were pain related to the procedure, wound healing and parental satisfaction. Male infants were assessed at discharge and on postoperative days 7 and 28 for wound healing and complications. This trial is registered with Clinical.Trials.gov, NCT03338699, and is complete.Results From the 1697 participants enrolled from February to November 2020, 1691 (99.6%) underwent ShangRing EIMC. Median duration of the procedure was 10 min (IQR 6–13). The mean Neonatal Infant Pain Scale 20 min postprocedure was 0.3 (SD 0.8), indicating no pain. At the time of discharge, 1679 (99.0%) participants had a normal-appearing wound and 1574 (93.1%) demonstrated complete wound healing at 28 days. A total of 17 (1.0%) AEs were reported, most related to bleeding. A total of 1635 (99.1%) of parents were satisfied with the appearance of the circumcised penis at 28 days.Conclusion ShangRing EIMC is a simple and successful MC method that non-physician clinicians can perform safely, with low AE rate, satisfactory wound healing and high satisfaction rate among parents. This indicates that the ShangRing EIMC can be considered a long-term strategic approach to accelerate the scale-up of MC in Sub-Saharan Africa.Trial registration number NCT03338699.",
  "authors": [
    {
      "affiliations": [
        "Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA"
      ],
      "name": "Lina Posada Calderon"
    },
    {
      "affiliations": [
        "Mayo Clinic Minnesota Department of Urology, Rochester, Minnesota, USA"
      ],
      "name": "Spyridon P Basourakos"
    },
    {
      "affiliations": [
        "Department of Population Health Sciences, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA"
      ],
      "name": "Karla V Ballman"
    },
    {
      "affiliations": [
        "Department of Population Health Sciences, Weill Cornell Medicine, New York, New York, USA"
      ],
      "name": "Kaylee Ho"
    },
    {
      "affiliations": [
        "Population Council Center for Biomedical Research, New York, New York, USA",
        "Bill & Melinda Gates Foundation, Seattle, Washington, USA"
      ],
      "name": "Mark A Barone"
    },
    {
      "affiliations": [
        "Population Council Kenya, Nairobi, Kenya"
      ],
      "name": "Quentin Awori"
    },
    {
      "affiliations": [
        "Population Council Kenya, Nairobi, Kenya"
      ],
      "name": "Daniel Ouma"
    },
    {
      "affiliations": [
        "Homa Bay Teaching and Referral Hospital, Homa Bay, Kenya"
      ],
      "name": "Jairus Oketch"
    },
    {
      "affiliations": [
        "Jhpiego Tanzania, Dar es Salaam, Tanzania, United Republic of"
      ],
      "name": "Alice Christensen"
    },
    {
      "affiliations": [
        "Jhpiego Tanzania, Dar es Salaam, Tanzania, United Republic of"
      ],
      "name": "Augustino Hellar"
    },
    {
      "affiliations": [
        "Jhpiego Tanzania, Dar es Salaam, Tanzania, United Republic of"
      ],
      "name": "Maende Makokha"
    },
    {
      "affiliations": [
        "Jhpiego Tanzania, Dar es Salaam, Tanzania, United Republic of"
      ],
      "name": "Alphonce Isangu"
    },
    {
      "affiliations": [
        "Ministry of Health, Dar es Salaam, Tanzania, United Republic of"
      ],
      "name": "Robert Salim"
    },
    {
      "affiliations": [
        "Ministry of Health, Dar es Salaam, Tanzania, United Republic of"
      ],
      "name": "Jackson Lija"
    },
    {
      "affiliations": [
        "Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA"
      ],
      "name": "Ronald Gray"
    },
    {
      "affiliations": [
        "Rakai Health Sciences Program, Kalisizo, Uganda"
      ],
      "name": "Stephen Kiboneka"
    },
    {
      "affiliations": [
        "Rakai Health Sciences Program, Kalisizo, Uganda"
      ],
      "name": "Aggrey Anok"
    },
    {
      "affiliations": [
        "Rakai Health Sciences Program, Kalisizo, Uganda"
      ],
      "name": "Godfrey Kigozi"
    },
    {
      "affiliations": [
        "Rakai Health Sciences Program, Kalisizo, Uganda"
      ],
      "name": "Regina Nakabuye"
    },
    {
      "affiliations": [
        "Rakai Health Sciences Program, Kalisizo, Uganda"
      ],
      "name": "Charles Ddamulira"
    },
    {
      "affiliations": [
        "Rakai Health Sciences Program, Kalisizo, Uganda"
      ],
      "name": "Silas Odiya"
    },
    {
      "affiliations": [
        "Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA"
      ],
      "name": "Marc Goldstein"
    },
    {
      "affiliations": [
        "Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA"
      ],
      "name": "Philip S Li"
    },
    {
      "affiliations": [
        "Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA"
      ],
      "name": "Richard K Lee"
    }
  ],
  "title": "Safety and efficacy of the ShangRing for early infant male circumcision in the routine clinical setting",
  "uid": "d5ad62ad-f69c-5812-8ae4-7ccaf26fcab6"
}