Sexual BehaviorNCT02054026
Impact Evaluation of the Reducing the Risk Program
A study testing Reducing the Risk in people with Sexual Behavior, run by Mathematica Policy Research, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of an eight-hour version of Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number of sexual partners, and pregnancy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior
- What is being tested?
- Reducing the Risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,220 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2013to Dec 2016
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 9th grader
- Attends participating school
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Bardstown High School
Bardstown, Kentucky, 40004
Warren Central High School
Bowling Green, Kentucky, 42101
Warren East High School
Bowling Green, Kentucky, 42101
Greenwood High School
Bowling Green, Kentucky, 42104
Central Hardin High School
Cecilia, Kentucky, 42724
Metcalfe County High School
Edmonton, Kentucky, 42129
Elizabethtown High School
Elizabethtown, Kentucky, 42701
Franklin-Simpson High School
Franklin, Kentucky, 42134
LaRue High School
Hodgenville, Kentucky, 42748
Marion County High School
Lebanon, Kentucky, 40033
North Hardin High School
Radcliff, Kentucky, 40160
Logan County High School
Russellville, Kentucky, 42276
Russellville Junior/Senior High School
Russellville, Kentucky, 42276
About this study
The purpose of this study is to evaluate the effectiveness of an eight-hour version of Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number of sexual partners, and pregnancy.
- Conditions
- Sexual Behavior
- Being tested
- Reducing the Risk
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing the RiskBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Reducing the Risk | Experimental | An eight-lesson (approximately eight-hour) version of Reducing the Risk Receives: Behavioral: Reducing the Risk |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Initiation
Measured: 2-years post intervention
Secondary outcomes (5)
Sexual Initiation
Measured: 1-year post intervention
Contraceptive use
Measured: 1-year post intervention
Contraceptive use
Measured: 2-years post intervention
Number of sexual partners
Measured: 1-year post intervention
Number of sexual partners
Measured: 2-years post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completionDec 2016
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
- 2,220 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
- NCT02054026
- Sponsor's protocol ID
- PRP699102
- Status last verified
- Apr 2017
- First submitted
- 31 Jan 2014
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Reducing the Risk Program
- ClinicalTrials.gov ID
- NCT02054026
- Acronym / sponsor ID
- PRP699102
- Conditions
- Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,220 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 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 effectiveness of an eight-hour version of Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number of sexual partners, and pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reducing the Risk | Experimental | Behavioral: Reducing the RiskAn eight-lesson (approximately eight-hour) version of Reducing the Risk |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 9th grader
- Attends participating school
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 |
|---|---|---|
| Reducing the Risk | Behavioural | Reducing the Risk |
Primary outcome
Sexual Initiation
Time frame: 2-years post intervention
5 secondary outcomes
Sexual Initiation
Time frame: 1-year post intervention
Contraceptive use
Time frame: 1-year post intervention
Contraceptive use
Time frame: 2-years post intervention
Number of sexual partners
Time frame: 1-year post intervention
Number of sexual partners
Time frame: 2-years post intervention
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 17 Apr 2017.
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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.
Robert Wood, PhD study director
Mathematica Policy Research
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing the Risk in people with Sexual Behavior, run by Mathematica Policy Research, Inc. at 13 sites in United States.
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: finished, 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.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Sexual Initiation (time frame: 2-years 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.