PMID- 27331587
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  - Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: 
      Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes.
PG  - S30-5
LID - 10.1097/QAI.0000000000001015 [doi]
AB  - OBJECTIVES: To assess the safety, effectiveness, and acceptability of providing a 
      reduced number of ShangRing sizes for adult voluntary medical male circumcision 
      (VMMC) within routine service delivery in Lusaka, Zambia. METHODS: We conducted a 
      randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 
      3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm 
      vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm 
      inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; 
      the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm 
      inner diameter). Each participant was scheduled for 2 follow-up visits: the 
      removal visit (day 7 after placement) and the healing check visit (day 42 after 
      placement), when they were evaluated for adverse events (AEs), pain, and healing. 
      RESULTS: Four hundred and ninety-six men comprised the analysis population, with 
      255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men 
      experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing 
      arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were 
      completely healed at the scheduled day 42 healing check visit, with similar 
      percentages across study arms. Virtually all (99.6%) men, regardless of study 
      arm, stated that they were very satisfied or satisfied with the appearance of 
      their circumcised penis, and 98.6% stated that they would recommend ShangRing 
      circumcision to family/friends. CONCLUSIONS: The moderate/severe AE rate was low 
      and similar in the 2 study arms, suggesting that provision of one-half the number 
      of adult device sizes is sufficient for safe service delivery. Effectiveness, 
      time to healing, and acceptability were similar in the study arms. The simplicity 
      of the ShangRing technique, and its relative speed, could facilitate VMMC program 
      goals. In addition, sufficiency of fewer device sizes would simplify logistics 
      and inventory.
FAU - Feldblum, Paul J
AU  - Feldblum PJ
AD  - *Global Health Department, FHI 360, Durham, NC; daggerDepartment of Surgery, 
      University Teaching Hospital, Lusaka, Zambia; double daggerFHI 360, Lusaka, Zambia; and  section signFHI 
      360, Nairobi, Kenya.
FAU - Zulu, Robert
AU  - Zulu R
FAU - Linyama, David
AU  - Linyama D
FAU - Long, Sarah
AU  - Long S
FAU - Nonde, Thikazi Jere
AU  - Nonde TJ
FAU - Lai, Jaim Jou
AU  - Lai JJ
FAU - Kashitala, Joshua
AU  - Kashitala J
FAU - Veena, Valentine
AU  - Veena V
FAU - Kasonde, Prisca
AU  - Kasonde P
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
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  - Young Adult
PMC - PMC4936423
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 - 00126334-201606011-00006 [pii]
AID - QAIV16735 [pii]
AID - 10.1097/QAI.0000000000001015 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S30-5. doi: 
      10.1097/QAI.0000000000001015.