PMID- 27331589
OWN - NLM
STAT- MEDLINE
DCOM- 20170523
LR  - 20200930
IS  - 1944-7884 (Electronic)
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 72 Suppl 1
IP  - Suppl 1
DP  - 2016 Jun 1
TI  - Safety and Efficacy of the PrePex Male Circumcision Device: Results From Pilot 
      Implementation Studies in Mozambique, South Africa, and Zambia.
PG  - S43-8
LID - 10.1097/QAI.0000000000000742 [doi]
AB  - BACKGROUND: Fourteen countries in East and Southern Africa have engaged in 
      national programs to accelerate the provision of voluntary medical male 
      circumcision (VMMC) since 2007. Devices have the potential to accelerate VMMC 
      programs by making the procedure easier, quicker, more efficient, and widely 
      accessible. METHODS: Pilot Implementation studies were conducted in Mozambique, 
      South Africa, and Zambia. The primary objective of the studies was to assess the 
      safety of PrePex device procedures when conducted by nurses and clinical officers 
      in adults and adolescent males (13-17 years, South Africa only) with the 
      following end points: number and grade of adverse events (AEs); pain-related AEs 
      measured using visual analog score; device displacements/self-removals; time to 
      complete wound healing; and procedure times for device placement and removal. 
      RESULTS: A total of 1401 participants (1318 adult and 83 adolescent males) were 
      circumcised using the PrePex device across the 3 studies. Rates of 
      moderate/severe AEs were low (1.0%; 2.0%; and 2.8%) in the studies in Mozambique, 
      Zambia, and South Africa, respectively. Eight early self-removals of 1401 (0.6%) 
      were observed, all required corrective surgery. High rates of moderate/severe 
      pain-related AEs were recorded especially at device removal in South Africa 
      (34.9%) and Mozambique (59.5%). Ninety percent of participants were healed at day 
      56 postplacement. DISCUSSION: The study results from the 3 countries suggest that 
      the implementation of the PrePex device using nonphysician health care workers is 
      both safe and feasible, but better pain control at device removal needs to be put 
      in place to increase the comfort of VMMC clients using the PrePex device.
FAU - Feldblum, Paul
AU  - Feldblum P
AD  - *Global Health Department, FHI 360, Durham, NC; daggerPeri-natal HIV Research Unit, 
      Faculty of Health Sciences, University of Witswatersrand, Johannesburg, South 
      Africa;  section signUniversity Teaching Hospital, Lusaka, Zambia;  ||Population Services 
      International, Washington, DC;  paragraph signJhpiego, Maputo Mocambique; #Society for Family 
      Health, Lusaka, Zambia; **Population Services International Lusaka, Zambia; 
      double daggerdouble daggerSociety for Family Health, Johannesburg, South Africa;  section sign section signJhpiego, Baltimore, 
      MD;  || ||Population Services International, Maputo, Mozambique;  paragraph sign paragraph signFHI 360, Nairobi, 
      Kenya; and ##Population Services International, Harare, Zimbabwe.
FAU - Martinson, Neil
AU  - Martinson N
FAU - Bvulani, Bruce
AU  - Bvulani B
FAU - Taruberekera, Noah
AU  - Taruberekera N
FAU - Mahomed, Mehebub
AU  - Mahomed M
FAU - Chintu, Namwinga
AU  - Chintu N
FAU - Milovanovic, Minja
AU  - Milovanovic M
FAU - Hart, Catherine
AU  - Hart C
FAU - Billy, Scott
AU  - Billy S
FAU - Necochea, Edgar
AU  - Necochea E
FAU - Samona, Alick
AU  - Samona A
FAU - Mhazo, Miriam
AU  - Mhazo M
FAU - Bossemeyer, Debora
AU  - Bossemeyer D
FAU - Lai, Jaim Jou
AU  - Lai JJ
FAU - Lebinai, Limakatso
AU  - Lebinai L
FAU - Ashengo, Tigistu A
AU  - Ashengo TA
FAU - Macaringue, Lucinda
AU  - Macaringue L
FAU - Veena, Valentine
AU  - Veena V
FAU - Hatzold, Karin
AU  - Hatzold K
LA  - eng
GR  - U2G PS001542/PS/NCHHSTP CDC HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Circumcision, Male/adverse effects/*instrumentation
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mozambique
MH  - Pain Measurement
MH  - Prospective Studies
MH  - South Africa
MH  - Wound Healing
MH  - Young Adult
MH  - Zambia
PMC - PMC4936427
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2016/06/23 06:00
MHDA- 2017/05/24 06:00
PMCR- 2016/07/07
CRDT- 2016/06/23 06:00
PHST- 2016/06/23 06:00 [entrez]
PHST- 2016/06/23 06:00 [pubmed]
PHST- 2017/05/24 06:00 [medline]
PHST- 2016/07/07 00:00 [pmc-release]
AID - 00126334-201606011-00008 [pii]
AID - QAIV15822 [pii]
AID - 10.1097/QAI.0000000000000742 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S43-8. doi: 
      10.1097/QAI.0000000000000742.