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Simplifying the Shang Ring Technique for Circumcision of Men and Boys

NCT02390310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2016-08-03

No results posted yet for this study

Summary

This is a research study in Kenya that will examine the outcomes of participants aged 10-15 and 16 and older; and provider acceptability of the Shang Ring technique for male circumcision that would simplify use. The study will be in two phases:

Phase 1 will explore the no-flip technique that has been used in China but will be used for the first time in Africa.

Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.

Conditions

  • Human Immunodeficiency Virus

Interventions

DEVICE

Shang Ring

Comparison of healing times at 7 day and more than 7 days after circumcision.

DRUG

injectable anesthesia (lidocaine 1%)

Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

DRUG

topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)

Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Bon Sante Consulting Limited

    collaborator UNKNOWN

  • Kenya National AIDS & STI Control Programme

    collaborator OTHER

  • Kenya Ministry of Health

    collaborator OTHER_GOV

  • EngenderHealth

    lead OTHER

Principal Investigators

  • Mark A Barone, DVM, MS · EngenderHealth

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02390310 on ClinicalTrials.gov