Sexual BehaviorNCT02052830
Impact Evaluation of the Wise Guys Program
A study testing Wise Guys in people with Sexual Behavior and Sexually Transmitted Infections, run by Mathematica Policy Research, Inc..
Trial summary
The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying sexual initiation on adolescent males in Eastern Iowa. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Sexually Transmitted Infections
- What is being tested?
- Wise Guys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 737 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Jan 2018
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 7th grade student in participating schools
- Male
Who cannot join
None listed.
About this study
The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying sexual initiation on adolescent males in Eastern Iowa.
Read the detailed description
This study uses a randomized controlled design to compare the impacts of the Wise Guys Program to the "business-as-usual" school curriculum. The Wise Guys multi-session curriculum is delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections. Study participants are 7th grade boys attending a participating school in either the Davenport Iowa or North Scott Community school districts. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.
- Conditions
- Sexual Behavior, Sexually Transmitted Infections
- Being tested
- Wise Guys
- Medical subject headings
- Sexual Behavior, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wise GuysBehavioural
Multi-session curriculum delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections.
| Study group | Role | What they receive |
|---|---|---|
| Wise Guys | Experimental | A sexual health and male responsibility program for adolescent males Receives: Behavioral: Wise Guys |
| Control | No intervention | Business as usual sexual education in schools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual initiation
Measured: 24 months post-intervention
Secondary outcomes (1)
Sexual initiation
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wood, PhD, Study director, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052830
- Sponsor's protocol ID
- PRP699101
- Status last verified
- Sep 2015
- First submitted
- 30 Jan 2014
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the Wise Guys Program
- ClinicalTrials.gov ID
- NCT02052830
- Acronym / sponsor ID
- PRP699101
- Conditions
- Sexual Behavior, Sexually Transmitted Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 3 Feb 2014 (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 evaluate the impact of the Wise Guys program on the delaying sexual initiation on adolescent males in Eastern Iowa.
Detailed description
This study uses a randomized controlled design to compare the impacts of the Wise Guys Program to the "business-as-usual" school curriculum. The Wise Guys multi-session curriculum is delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections. Study participants are 7th grade boys attending a participating school in either the Davenport Iowa or North Scott Community school districts. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wise Guys | Experimental | Behavioral: Wise GuysA sexual health and male responsibility program for adolescent males |
| Control | No intervention | –Business as usual sexual education in schools |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 7th grade student in participating schools
- Male
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Wise GuysMulti-session curriculum delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections. | Behavioural | Wise Guys |
Primary outcome
Sexual initiation
Time frame: 24 months post-intervention
1 secondary outcome
Sexual initiation
Time frame: 6 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
Related trials for Sexual Behavior
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
Recruiting
Sex Differences in BDNF Study
Exercise, BDNF
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
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.
Robert Wood, PhD study director
Mathematica Policy Research
Questions about this trial
What is this clinical trial studying?
A study testing Wise Guys in people with Sexual Behavior and Sexually Transmitted Infections, run by Mathematica Policy Research, Inc..
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 17 Apr 2017. 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. 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?
Results are not available in the source record.
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?
Sexual initiation (time frame: 24 months post-intervention). 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 17 Apr 2017.