{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T10:48:41Z","timestamp":1761562121894},"reference-count":14,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2016,6,1]],"date-time":"2016-06-01T00:00:00Z","timestamp":1464739200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2016,6,1]]},"abstract":"<jats:sec>\n            <jats:title>Introduction:<\/jats:title>\n            <jats:p>Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited. This study aimed to assess the safety, feasibility, and acceptability of the PrePex device for adult male circumcision in Malawi.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>A prospective single-arm cohort study was conducted at 3 sites (1 urban static, 1 rural static, 1 rural tent) in Malawi. Adverse event (AE) outcomes were stratified to include\/exclude pain, and confidence intervals (CIs) were corrected for clinic-level clustering.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>Among 935 men screened, 131 (14.0%) were not eligible, 13 (1.4%) withdrew before placement, and 791 (84.6%) received the device. Moderate and severe AEs totaled 7.1% including pain [95% CI: 3.4\u201314.7] and 4.0% excluding pain (95% CI: 2.6 to 6.4). Severe AEs included pain (n = 3), insufficient skin removal (n = 4), and early removal (n = 4). Among early removals, 1 had immediate surgical circumcision, 1 had surgery after 48 hours of observation, 1 declined surgery, and 1 did not return to our site although presented at a nearby clinic. More than half of men (51.9%) reported odor; however, few (2.2%) stated they would not recommend the device to others because of odor. Median levels of reported pain (scale, 1\u201310) were 2 (interquartile range, 2\u20134) during application and removal, and 0 (interquartile range, 0\u20132) at all other time points.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>Severe AEs were rare and similar to other programs. Immediate provision of surgical services after displacement or early removal proved a challenge. Cases of insufficient skin removal were linked to poor technique, suggesting provider training requires reinforcement and supervision.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1097\/qai.0000000000000774","type":"journal-article","created":{"date-parts":[[2016,6,23]],"date-time":"2016-06-23T22:34:17Z","timestamp":1466721257000},"page":"S49-S55","source":"Crossref","is-referenced-by-count":6,"title":["Safety, Feasibility, and Acceptability of the PrePex Device for Adult Male Circumcision in Malawi"],"prefix":"10.1097","volume":"72","author":[{"given":"Pamela K.","family":"Kohler","sequence":"first","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle, WA;"},{"name":"Department of Psychosocial and Community Health, University of Washington, Seattle, WA;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beth A.","family":"Tippett Barr","sequence":"additional","affiliation":[{"name":"Health Services, US Centers for Disease Control and Prevention, Lilongwe, Malawi;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anderson","family":"Kang'ombe","sequence":"additional","affiliation":[{"name":"Banja La Mtsogolo, Blantyre, Malawi;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carola","family":"Hofstee","sequence":"additional","affiliation":[{"name":"M\u00e9decin Sans Fronti\u00e8res, Nsanje, Malawi;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Franklin","family":"Kilembe","sequence":"additional","affiliation":[{"name":"International Training and Education Center for Health, Lilongwe, Malawi;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sean","family":"Galagan","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle, WA;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Chilongozi","sequence":"additional","affiliation":[{"name":"International Training and Education Center for Health, Lilongwe, Malawi;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dorothy","family":"Namate","sequence":"additional","affiliation":[{"name":"International Training and Education Center for Health, Lilongwe, Malawi;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Medson","family":"Machaya","sequence":"additional","affiliation":[{"name":"Malawi Ministry of Health, Lilongwe, Malawi;"},{"name":"US Centers for Disease Control and Prevention, Atlanta, Georgia; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khuliena","family":"Kabwere","sequence":"additional","affiliation":[{"name":"Malawi Ministry of Health, Lilongwe, Malawi;"},{"name":"US Centers for Disease Control and Prevention, Atlanta, Georgia; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mwawi","family":"Mwale","sequence":"additional","affiliation":[{"name":"Malawi Ministry of Health, Lilongwe, Malawi;"},{"name":"US Centers for Disease Control and Prevention, Atlanta, Georgia; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wezi","family":"Msunguma","sequence":"additional","affiliation":[{"name":"Health Services, US Centers for Disease Control and Prevention, Lilongwe, Malawi;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Reed","sequence":"additional","affiliation":[{"name":"Jhpiego, An affiliate of Johns Hopkins University, Washington, DC."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Chimbwandira","sequence":"additional","affiliation":[{"name":"Malawi Ministry of Health, Lilongwe, Malawi;"},{"name":"US Centers for Disease Control and Prevention, Atlanta, Georgia; and"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"R1-20230927","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1016\/S0140-6736(07)60313-4","article-title":"Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial","volume":"369","author":"Gray","year":"2007","journal-title":"Lancet"},{"key":"R2-20230927","doi-asserted-by":"crossref","first-page":"e298","DOI":"10.1371\/journal.pmed.0020298","article-title":"Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial","volume":"2","author":"Auvert","year":"2005","journal-title":"PLoS Med."},{"key":"R3-20230927","doi-asserted-by":"crossref","first-page":"643","DOI":"10.1016\/S0140-6736(07)60312-2","article-title":"Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial","volume":"369","author":"Bailey","year":"2007","journal-title":"Lancet"},{"key":"R5-20230927","doi-asserted-by":"crossref","first-page":"e1001132","DOI":"10.1371\/journal.pmed.1001132","article-title":"Voluntary medical male circumcision: modeling the impact and cost of expanding male circumcision for HIV prevention in eastern and southern Africa","volume":"8","author":"Njeuhmeli","year":"2011","journal-title":"PLoS Med."},{"key":"R7-20230927","doi-asserted-by":"crossref","first-page":"e1001129","DOI":"10.1371\/journal.pmed.1001129","article-title":"Voluntary medical male circumcision: strategies for meeting the human resource needs of scale-up in southern and eastern Africa","volume":"8","author":"Curran","year":"2011","journal-title":"PLoS Med."},{"key":"R8-20230927","doi-asserted-by":"crossref","first-page":"506","DOI":"10.1097\/QAI.0b013e318237af5d","article-title":"Can devices for adult male circumcision help bridge the implementation gap for HIV prevention services?","volume":"58","author":"McIntyre","year":"2011","journal-title":"J Acquir Immune Defic Syndr."},{"key":"R9-20230927","first-page":"61","article-title":"Non-surgical adult male circumcision using the PrePex device: task-shifting from physicians to nurses","volume":"18","author":"Mutabazi","year":"2014","journal-title":"Afr J Reprod Health."},{"key":"R10-20230927","doi-asserted-by":"crossref","first-page":"e127","DOI":"10.1097\/QAI.0b013e3182354e65","article-title":"Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings","volume":"58","author":"Bitega","year":"2011","journal-title":"J Acquir Immune Defic Syndr."},{"key":"R11-20230927","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1097\/QAI.0b013e3182631d69","article-title":"HIV prevention: male circumcision comparison between a nonsurgical device to a surgical technique in resource-limited settings: a prospective, randomized, nonmasked trial","volume":"61","author":"Mutabazi","year":"2012","journal-title":"J Acquir Immune Defic Syndr."},{"key":"R12-20230927","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1097\/QAI.0b013e31828e6412","article-title":"One-arm, open-label, prospective, cohort field study to assess the safety and efficacy of the PrePex device for scale-up of nonsurgical circumcision when performed by nurses in resource-limited settings for HIV prevention","volume":"63","author":"Mutabazi","year":"2013","journal-title":"J Acquir Immune Defic Syndr."},{"key":"R14-20230927","doi-asserted-by":"crossref","first-page":"1109","DOI":"10.1111\/j.1464-410X.2005.05810.x","article-title":"Adult male circumcision: results of a standardized procedure in Kisumu District, Kenya","volume":"96","author":"Krieger","year":"2005","journal-title":"BJU Int."},{"key":"R15-20230927","doi-asserted-by":"crossref","first-page":"e86631","DOI":"10.1371\/journal.pone.0086631","article-title":"Adverse events profile of PrePex a non-surgical device for adult male circumcision in a Ugandan urban setting","volume":"9","author":"Galukande","year":"2014","journal-title":"PLoS One"},{"key":"R16-20230927","doi-asserted-by":"crossref","first-page":"e100008","DOI":"10.1371\/journal.pone.0100008","article-title":"The safety and acceptance of the PrePex device for non-surgical adult male circumcision in Rakai, Uganda. A non-randomized observational study","volume":"9","author":"Kigozi","year":"2014","journal-title":"PLoS One"},{"key":"R17-20230927","doi-asserted-by":"crossref","first-page":"e95357","DOI":"10.1371\/journal.pone.0095357","article-title":"Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya","volume":"9","author":"Feldblum","year":"2014","journal-title":"PLoS One"}],"container-title":["JAIDS Journal of Acquired Immune Deficiency Syndromes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.lww.com\/00126334-201606011-00009","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,27]],"date-time":"2023-09-27T15:13:06Z","timestamp":1695827586000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.lww.com\/00126334-201606011-00009"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,6,1]]},"references-count":14,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2016]]}},"URL":"https:\/\/doi.org\/10.1097\/qai.0000000000000774","relation":{},"ISSN":["1525-4135"],"issn-type":[{"value":"1525-4135","type":"print"}],"subject":[],"published":{"date-parts":[[2016,6,1]]}}}