Sexual BehaviorNCT01895556
Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision
A study testing Information in people with Sexual Behavior and Dis-inhibition, run by Rebecca Thornton.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Sexual Behavior, Dis-inhibition
- What is being tested?
- Information
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The study will involve men between the ages of 25 and 40
Who cannot join
- None
About this study
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.
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.
- Conditions
- Sexual Behavior, Dis-inhibition
- Being tested
- Information, Control
- Keywords
- Malawi, Risk Compensation, Male Circumcision, Demand
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationOther
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Information | Experimental | Information about male circumcision and HIV risk Receives: Other: Information |
| Control | Placebo comparator | Control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom use
frequency of reported condom use across all sexual acts (never, sometimes, always)
Measured: One year after baseline survey
Secondary outcomes (3)
Male circumcision
Circumcision, willingness to circumcise, circumcision of son
Measured: One year after baseline survey
Condom purchases
number of condoms purchased
Measured: one year after baseline survey
number of sexual partners
number of partners over last year with which individual has engaged in vaginal, anal, oral intercourse
Measured: one year after baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startAug 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Thornton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rebecca Thornton, University of Michigan
- Investigators
- Rebecca Thornton, PhD, Principal investigator, University of MichiganSusan Godlonton, PhD, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895556
- Sponsor's protocol ID
- FSG09-Thornton
- Status last verified
- Jul 2013
- First submitted
- 28 Jun 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01895556
- Acronym / sponsor ID
- FSG09-Thornton
- Conditions
- Sexual Behavior, Dis-inhibition
- Keywords
- Malawi, Risk Compensation, Male Circumcision, Demand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Rebecca ThorntonUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information | Experimental | Other: InformationInformation about male circumcision and HIV risk |
| Control | Placebo comparator | Other: ControlControl |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study will involve men between the ages of 25 and 40
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information | Other | Information |
| Control | Other | Control |
Primary outcome
Condom use
Time frame: One year after baseline survey
frequency of reported condom use across all sexual acts (never, sometimes, always)
3 secondary outcomes
Male circumcision
Time frame: One year after baseline survey
Condom purchases
Time frame: one year after baseline survey
number of sexual partners
Time frame: one year after baseline survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Thornton, PhD principal investigator
University of Michigan
Susan Godlonton, PhD study director
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing Information in people with Sexual Behavior and Dis-inhibition, run by Rebecca Thornton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condom use (time frame: One year after baseline survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.