PMID- 27331593
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 Acceptability of the PrePex Device When Used in Routine Male 
      Circumcision Service Delivery During Active Surveillance in Zimbabwe.
PG  - S63-8
LID - 10.1097/QAI.0000000000000721 [doi]
AB  - BACKGROUND: Male circumcision devices have the potential to accelerate voluntary 
      medical male circumcision roll-out, with PrePex being one promising device. Here, 
      we present findings on safety and acceptability from active surveillance of the 
      implementation of PrePex among 1000 males circumcised in Zimbabwe. METHODS: The 
      first 1000 men consecutively circumcised using PrePex during routine service 
      delivery were actively followed up. Outcome measures included PrePex uptake, 
      attendance for postcircumcision visits, and adverse events (AEs). A survey was 
      conducted among 500 consecutive active surveillance clients to assess 
      acceptability and satisfaction with PrePex. RESULTS: A total of 2156 men aged 18 
      years or older were circumcised across the 6 PrePex active surveillance sites. Of 
      these, 1000 (46.4%) were circumcised using PrePex. Among them, 4 (0.4%) 
      self-removals that required surgery (severe AEs) were observed. Six (0.6%) 
      removals by providers (moderate AEs) did not require surgery. A further 280 (28%) 
      AEs were mild or moderate pain during device removal. There were also 12 (1.2%) 
      moderate AEs unrelated to pain. All AEs resolved without sequelae. There was high 
      adherence to follow-up appointments, with 97.7% of clients attending the 
      scheduled day 7 visit. Acceptability of PrePex was high among survey 
      participants, 93% indicated willingness to recommend the device to peers. Of 
      note, 95.8% of respondents reported experiencing pain when the device was being 
      removed. Additionally, 85.2% reported experiencing odor while wearing the device 
      or during removal. CONCLUSIONS: Active surveillance of the first 1000 men 
      circumcised using PrePex suggests that the device is both safe and acceptable 
      when used in routine service delivery.
FAU - Mavhu, Webster
AU  - Mavhu W
AD  - *Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; 
      daggerPopulation Services International, Harare, Zimbabwe; double daggerMinistry of Health and 
      Child Care, Harare, Zimbabwe;  section signUnited States Agency for International 
      Development, Harare, Zimbabwe;  ||University of Zimbabwe College of Health 
      Sciences, Harare, Zimbabwe;  paragraph signUnited States Agency for International Development, 
      Washington, DC; and #University College London, London, United Kingdom.
FAU - Hatzold, Karin
AU  - Hatzold K
FAU - Ncube, Getrude
AU  - Ncube G
FAU - Xaba, Sinokuthemba
AU  - Xaba S
FAU - Madidi, Ngonidzashe
AU  - Madidi N
FAU - Keatinge, Jo
AU  - Keatinge J
FAU - Dhodho, Efison
AU  - Dhodho E
FAU - Samkange, Christopher A
AU  - Samkange CA
FAU - Tshimanga, Mufuta
AU  - Tshimanga M
FAU - Mangwiro, Tonderayi
AU  - Mangwiro T
FAU - Mugurungi, Owen
AU  - Mugurungi O
FAU - Njeuhmeli, Emmanuel
AU  - Njeuhmeli E
FAU - Cowan, Frances M
AU  - Cowan FM
LA  - eng
GR  - PEPFAR/PEPFAR/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, Non-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  - Odorants
MH  - Pain
MH  - *Patient Acceptance of Health Care
MH  - Young Adult
MH  - Zimbabwe
PMC - PMC4936432
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 - 00126334-201606011-00011 [pii]
AID - QAIV15744 [pii]
AID - 10.1097/QAI.0000000000000721 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S63-8. doi: 
      10.1097/QAI.0000000000000721.