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Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision

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ClinicalTrials.gov Identifier: NCT01895556
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : July 10, 2013
Sponsor:
Information provided by (Responsible Party):
Rebecca Thornton, University of Michigan

Study Description
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Brief Summary:
The purpose of this study is to measure the behavioral effects of learning information about male circumcision and HIV risk on sexual behavior and the demand for male circumcision.

Condition or disease Intervention/treatment Phase
Sexual Behavior Dis-inhibition Other: Information Other: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Study of the Effect of Information About the Relationship Between HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision Among Circumcised and Uncircumcised Men in Malawi, Africa.
Study Start Date : August 2008
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Information
Information about male circumcision and HIV risk
 Other: Information
Placebo Comparator: Control
Control
 Other: Control


Outcome Measures
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Primary Outcome Measures :
  1. Condom use [ Time Frame: One year after baseline survey ]
    frequency of reported condom use across all sexual acts (never, sometimes, always)


Secondary Outcome Measures :
  1. Male circumcision [ Time Frame: One year after baseline survey ]
    Circumcision, willingness to circumcise, circumcision of son

  2. Condom purchases [ Time Frame: one year after baseline survey ]
    number of condoms purchased

  3. number of sexual partners [ Time Frame: one year after baseline survey ]
    number of partners over last year with which individual has engaged in vaginal, anal, oral intercourse


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study will involve men between the ages of 25 and 40

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895556


Sponsors and Collaborators
Rebecca Thornton
Investigators
Principal Investigator: Rebecca Thornton, PhD University of Michigan
Study Director: Susan Godlonton, PhD University of Michigan
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Rebecca Thornton, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01895556     History of Changes
Other Study ID Numbers: FSG09-Thornton
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013

Keywords provided by Rebecca Thornton, University of Michigan:
Malawi
Risk Compensation
Male Circumcision
Demand