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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01844102 |
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Date of registration:
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29/04/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia
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Scientific title:
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Evaluation of the Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01844102 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Zambia
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Zimbabwe
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Contacts
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Name:
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Namwinga Chintu, MBChB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Society for Family Health |
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Name:
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Karin Hatzold, MD, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Population Services International |
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Name:
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Bruce Bvulani, MBChB, MMed |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ministry of Health, Zambia |
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Name:
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Paul Hewett, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Population Council |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must be aged 18 to 49 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must agree to voluntary counseling and testing for HIV, or have documentation of
testing no more than one week before the MC visit;
- Must be HIV-uninfected;
- Must be free of genital ulcerations or other visible signs of STI (on examination);
- Must be able to understand study procedures and the requirements of study
participation;
- Must agree to return to the healthcare facility for the full schedule of follow-up
visits after his circumcision or be willing to receive a home visit;
- Must freely consent to participate in the study and sign a written informed consent
form;
- Must have a cell phone or access to a cell phone; and,
- Must agree to provide the study staff with an address, phone number, or other locator
information while participating in the research study.
Exclusion Criteria:
- Penis does not fit any of the five PrePex sizes;
- Takes a medication that would be a contraindication for elective surgery, such as an
anticoagulant or steroid;
- Has known bleeding/clotting disorder (e.g. hemophilia);
- Has an active genital infection, anatomic abnormality (e.g. phimosis or hypospadias)
or other disease or condition (e.g. extreme obesity, poorly controlled diabetes,
sickle cell anemia, AIDS-like signs or symptoms) which in the investigator's opinion
contraindicates MC or participation in the study; and,
- Is participating in another longitudinal biomedical research study.
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Device: PrePex
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Primary Outcome(s)
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Adverse Events
[Time Frame: 42 days]
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Secondary Outcome(s)
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Proportion of men ineligible for circumcision with PrePex
[Time Frame: 42 days]
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Acceptability of PrePex procedures among Zambian clients
[Time Frame: 42 days]
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Costs of PrePex training and service delivery
[Time Frame: 42 days]
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Acceptability of PrePex procedures among male circumcision providers
[Time Frame: 42 days]
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Follow-up outcomes
[Time Frame: 42 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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