ArticleJournal of acquired immune deficiency syndromes (1999)2016
Safety Profile of PrePex Male Circumcision Device and Client Satisfaction With Adolescent Males Aged 13-17 Years in Zimbabwe.
Article in Journal of acquired immune deficiency syndromes (1999), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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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.
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Who cites it
8 citing papers in PubMed, 8 citations in OpenAlex.
- Trial
- Use of the ShangRing circumcision device in boys below 18 years old in Kenya: results from a pilot study.Journal of the International AIDS Society · 2017Trial
- Simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment.Asian journal of andrologyTrial
- Article
- Article
- VMMC Devices-Introducing a New Innovation to a Public Health Intervention.Journal of acquired immune deficiency syndromes (1999) · 2016Article
- Innovative Methods of Male Circumcision for HIV Prevention-Getting the Right Evidence.Journal of acquired immune deficiency syndromes (1999) · 2016Article
- Safety and Efficacy of the PrePex Male Circumcision Device: Results From Pilot Implementation Studies in Mozambique, South Africa, and Zambia.Journal of acquired immune deficiency syndromes (1999) · 2016Article
Corrections and comments
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Authors and funding
12 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe safety and efficacy of the PrePex device for voluntary medical male circumcision (VMMC) has been demonstrated in studies in Rwanda, Uganda, and Zimbabwe, leading to the conditional prequalification of the device for use in adults. Because the majority of VMMC clients in the 14 priority countries are adolescents under 18 years, research to establish the safety and efficacy of the device for males <18 years is required.
methodsOne-arm, prospective study included 402 adolescents, aged 13-17 years, using PrePex device between August 2013 and January 2014 at a VMMC centre in Harare. Endpoints are number and grade of adverse events associated with device circumcision, time to complete wound healing, client satisfaction with the procedure, and outcome.
resultsThe rate of medical ineligibility among adolescent males was high; 237/402 (35.9%) of study participants had to be excluded based on medical reasons. The severe/moderate adverse event rate was low at 2/402 (0.5%). No device displacements/self-removals were observed. Time to complete wound healing was shorter than in adults; 367/398 (92.2%) adolescents had completed wound healing by day 35, whereas 90% of adults had completed wound healing by day 56 as demonstrated in previous studies. Overall, adolescents were highly satisfied with the results of their circumcision.
conclusionsThe study demonstrates that the PrePex device can be safely used in adolescents aged 13-17 years. The significant proportion of males opting for surgical circumcision and the high medical ineligibility suggest that surgical circumcision needs to be provided alongside PrePex services in programs targeting young age groups.
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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.