Trial reportJournal of acquired immune deficiency syndromes (1999)2015
Implementation and Operational Research: A Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp for Early Infant Male Circumcision in Zimbabwe.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 15 citations in OpenAlex.
- Estimating the Cost of Early Infant Male Circumcision in Zimbabwe: Results From a Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp.Journal of acquired immune deficiency syndromes (1999) · 2015Trial
- Health worker perspectives on, and health system-level facilitators and barriers to early infant male circumcision for HIV prevention in a traditionally non-circumcising community, Northeastern Uganda: a cross-sectional qualitative study.BMC health services research · 2025Article
- Comparison of a modified Mogen clamp and classic dorsal slit circumcision under local anesthesia: A clinical study.Current urology · 2022Article
- Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.Frontiers in medical technology · 2022Review
- How is implementation research applied to advance health in low-income and middle-income countries?BMJ global health · 2019Article
- Evidence-Based Identification of Key Beliefs Explaining Infant Male Circumcision Motivation Among Expectant Parents in Zimbabwe: Targets for Behavior Change Messaging.AIDS and behavior · 2018Article
- Field evaluation of the safety, acceptability, and feasibility of early infant male circumcision using the AccuCirc device.PloS one · 2018Article
- Unpacking early infant male circumcision decision-making using qualitative findings from Zimbabwe.BMC international health and human rights · 2017Article
- Acceptability and feasibility of early infant male circumcision for HIV prevention in Malawi.PloS one · 2017Article
- Article
- Comparative Cost of Early Infant Male Circumcision by Nurse-Midwives and Doctors in Zimbabwe.Global health, science and practice · 2016Article
- Safety, Acceptability, and Feasibility of Early Infant Male Circumcision Conducted by Nurse-Midwives Using the AccuCirc Device: Results of a Field Study in Zimbabwe.Global health, science and practice · 2016Observational
- Perspectives of Parents and Health Care Workers on Early Infant Male Circumcision Conducted Using Devices: Qualitative Findings From Harare, Zimbabwe.Global health, science and practice · 2016Article
- A "Wear and Tear" Hypothesis to Explain Sudden Infant Death Syndrome.Frontiers in neurology · 2016Article
- Safety, Complications, and Procedural Efficiency of Neonatal Circumcision Devices: A Network Meta-Analysis.International braz j urol : official journal of the Brazilian Society of UrologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 3 countries.
Funding
Abstract
backgroundEarly infant male circumcision (EIMC) is a potential key HIV prevention intervention, providing it can be safely and efficiently implemented in sub-Saharan Africa. Here, we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe.
methodsBetween January and June 2013, eligible infants were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor, using a 2:1 allocation ratio. Participants were followed for 14 days post-EIMC. Primary outcomes for the trial were EIMC safety and acceptability.
resultsOne hundred fifty male infants were enrolled in the trial and circumcised between 6 and 54 days postpartum (n = 100 AccuCirc; n = 50 Mogen clamp). Twenty-six infants (17%) were born to HIV-infected mothers. We observed 2 moderate adverse events (AEs) [2%, 95% confidence interval (CI): 0.2 to 7.0] in the AccuCirc arm and none (95% CI: 0.0 to 7.1) in the Mogen clamp arm. The cumulative incident risk of AEs was 2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 to 4.7). As the 95% CI excludes the predefined noninferiority margin of 6%, the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp. Nearly all mothers (99.5%) reported great satisfaction with the outcome. All mothers, regardless of arm said they would recommend EIMC to other parents, and would circumcise their next son.
conclusionsThis first randomized trial of AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices is safe and acceptable to parents. There was no difference in the rate of AEs by device.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.