- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01895556
Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision
July 3, 2013 updated by: Rebecca Thornton
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The study will involve men between the ages of 25 and 40
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
|
|
|
Experimental: Information
Information about male circumcision and HIV risk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Condom use
Time Frame: One year after baseline survey
|
frequency of reported condom use across all sexual acts (never, sometimes, always)
|
One year after baseline survey
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Male circumcision
Time Frame: One year after baseline survey
|
Circumcision, willingness to circumcise, circumcision of son
|
One year after baseline survey
|
|
Condom purchases
Time Frame: one year after baseline survey
|
number of condoms purchased
|
one year after baseline survey
|
|
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
|
one year after baseline survey
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebecca Thornton, PhD, University of Michigan
- Study Director: Susan Godlonton, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
June 28, 2013
First Submitted That Met QC Criteria
July 3, 2013
First Posted (Estimate)
July 10, 2013
Study Record Updates
Last Update Posted (Estimate)
July 10, 2013
Last Update Submitted That Met QC Criteria
July 3, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FSG09-Thornton
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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