Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe
We aimed to determine if the adverse event (AE) rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits asse...
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| Veröffentlicht in: | PloS one 2017-12, Vol.12 (12), p.e0189146-e0189146 |
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| creator | Tshimanga, Mufuta Makunike-Chikwinya, Batsirai Mangwiro, Tonderayi Tapiwa Gundidza, Patricia Chatikobo, Pesanai Murenje, Vernon Herman-Roloff, Amy Kilmarx, Peter H Holec, Marrianne Gwinji, Gerald Mugurungi, Owen Murwira, Munyaradzi Xaba, Sinokuthemba Barnhart, Scott Feldacker, Caryl |
| description | We aimed to determine if the adverse event (AE) rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision.
Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46); 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459); 337 (85%) on anti-retroviral therapy. Among 385 (96%) observed completely healed, median days to complete healing was 42 (IQR: 35-49). There was no association between time to healing and CD4 (p = 0.66). Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5). This was non-inferior to 2% AEs (p = 0.0003). All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.
Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections. |
| doi_str_mv | 10.1371/journal.pone.0189146 |
| format | Article |
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Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46); 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459); 337 (85%) on anti-retroviral therapy. Among 385 (96%) observed completely healed, median days to complete healing was 42 (IQR: 35-49). There was no association between time to healing and CD4 (p = 0.66). Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5). This was non-inferior to 2% AEs (p = 0.0003). All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.
Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0189146</identifier><identifier>PMID: 29220392</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acquired immune deficiency syndrome ; Adult ; Adults ; AIDS ; Biology and Life Sciences ; CD4 antigen ; Circumcision ; Circumcision, Male - adverse effects ; Circumcision, Male - methods ; Clients ; Clinical trials ; Disease transmission ; Effectiveness ; Health aspects ; HIV ; HIV infections ; HIV Infections - transmission ; Human immunodeficiency virus ; Human papillomavirus ; Humans ; Hygiene ; Infections ; Male ; Medical equipment ; Medicine and Health Sciences ; Men ; People and Places ; Prevention ; Safety ; Sexual behavior ; Sexually transmitted diseases ; STD ; Surgery ; Systematic review ; Wound healing ; Zimbabwe</subject><ispartof>PloS one, 2017-12, Vol.12 (12), p.e0189146-e0189146</ispartof><rights>COPYRIGHT 2017 Public Library of Science</rights><rights>This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication: https://creativecommons.org/publicdomain/zero/1.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c641t-e454096d05f7d8663543643baffbdaee43a5c37fd23c1961576c938b1d170b3e3</cites><orcidid>0000-0002-8152-6754</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5722373/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5722373/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79343,79344</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29220392$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tshimanga, Mufuta</creatorcontrib><creatorcontrib>Makunike-Chikwinya, Batsirai</creatorcontrib><creatorcontrib>Mangwiro, Tonderayi</creatorcontrib><creatorcontrib>Tapiwa Gundidza, Patricia</creatorcontrib><creatorcontrib>Chatikobo, Pesanai</creatorcontrib><creatorcontrib>Murenje, Vernon</creatorcontrib><creatorcontrib>Herman-Roloff, Amy</creatorcontrib><creatorcontrib>Kilmarx, Peter H</creatorcontrib><creatorcontrib>Holec, Marrianne</creatorcontrib><creatorcontrib>Gwinji, Gerald</creatorcontrib><creatorcontrib>Mugurungi, Owen</creatorcontrib><creatorcontrib>Murwira, Munyaradzi</creatorcontrib><creatorcontrib>Xaba, Sinokuthemba</creatorcontrib><creatorcontrib>Barnhart, Scott</creatorcontrib><creatorcontrib>Feldacker, Caryl</creatorcontrib><title>Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>We aimed to determine if the adverse event (AE) rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision.
Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46); 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459); 337 (85%) on anti-retroviral therapy. Among 385 (96%) observed completely healed, median days to complete healing was 42 (IQR: 35-49). There was no association between time to healing and CD4 (p = 0.66). Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5). This was non-inferior to 2% AEs (p = 0.0003). All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.
Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adult</subject><subject>Adults</subject><subject>AIDS</subject><subject>Biology and Life Sciences</subject><subject>CD4 antigen</subject><subject>Circumcision</subject><subject>Circumcision, Male - adverse effects</subject><subject>Circumcision, Male - methods</subject><subject>Clients</subject><subject>Clinical trials</subject><subject>Disease transmission</subject><subject>Effectiveness</subject><subject>Health aspects</subject><subject>HIV</subject><subject>HIV infections</subject><subject>HIV Infections - transmission</subject><subject>Human immunodeficiency virus</subject><subject>Human papillomavirus</subject><subject>Humans</subject><subject>Hygiene</subject><subject>Infections</subject><subject>Male</subject><subject>Medical equipment</subject><subject>Medicine and Health Sciences</subject><subject>Men</subject><subject>People and Places</subject><subject>Prevention</subject><subject>Safety</subject><subject>Sexual behavior</subject><subject>Sexually transmitted diseases</subject><subject>STD</subject><subject>Surgery</subject><subject>Systematic review</subject><subject>Wound 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HIV-positive men: A single-arm study in Zimbabwe</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2017-12-08</date><risdate>2017</risdate><volume>12</volume><issue>12</issue><spage>e0189146</spage><epage>e0189146</epage><pages>e0189146-e0189146</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>We aimed to determine if the adverse event (AE) rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision.
Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46); 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459); 337 (85%) on anti-retroviral therapy. Among 385 (96%) observed completely healed, median days to complete healing was 42 (IQR: 35-49). There was no association between time to healing and CD4 (p = 0.66). Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5). This was non-inferior to 2% AEs (p = 0.0003). All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.
Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>29220392</pmid><doi>10.1371/journal.pone.0189146</doi><tpages>e0189146</tpages><orcidid>https://orcid.org/0000-0002-8152-6754</orcidid><oa>free_for_read</oa></addata></record> |
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| recordid | cdi_plos_journals_1974578146 |
| source | Public Library of Science (PLoS) Journals Open Access; MEDLINE; PubMed Central; Directory of Open Access Journals; Free Full-Text Journals in Chemistry; EZB Electronic Journals Library |
| subjects | Acquired immune deficiency syndrome Adult Adults AIDS Biology and Life Sciences CD4 antigen Circumcision Circumcision, Male - adverse effects Circumcision, Male - methods Clients Clinical trials Disease transmission Effectiveness Health aspects HIV HIV infections HIV Infections - transmission Human immunodeficiency virus Human papillomavirus Humans Hygiene Infections Male Medical equipment Medicine and Health Sciences Men People and Places Prevention Safety Sexual behavior Sexually transmitted diseases STD Surgery Systematic review Wound healing Zimbabwe |
| title | Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-01T10%3A48%3A07IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Safety%20and%20efficacy%20of%20the%20PrePex%20device%20in%20HIV-positive%20men:%20A%20single-arm%20study%20in%20Zimbabwe&rft.jtitle=PloS%20one&rft.au=Tshimanga,%20Mufuta&rft.date=2017-12-08&rft.volume=12&rft.issue=12&rft.spage=e0189146&rft.epage=e0189146&rft.pages=e0189146-e0189146&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0189146&rft_dat=%3Cgale_plos_%3EA517979383%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1974578146&rft_id=info:pmid/29220392&rft_galeid=A517979383&rft_doaj_id=oai_doaj_org_article_1f0d3f4fe2f94ddd9b06d6b94c0b53d5&rfr_iscdi=true |