Sexually Transmitted DiseasePhase 3SAFENCT00643019
Project Sexual Awareness for Everyone (SAFE)
A Phase 3 study testing SAFE Behavioral Intervention in people with Sexually Transmitted Disease and Secondary Prevention, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Disease, Secondary Prevention, Behavioral Modification
- What is being tested?
- SAFE Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1993to Dec 2012
- Phase
- Phase 3
- 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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mexican American,
- 14 - 45 years old,
- English Speaking,
- non-viral sexually transmitted infection
Who cannot join
- Non-English speaking,
- viral sexually transmitted infection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Sciences Center San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: Preventing Recurrent Sexually Transmitted Infections in Minority Women
This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.
Read the detailed description
Participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as necessary.
- Conditions
- Sexually Transmitted Disease, Secondary Prevention, Behavioral Modification, Public Health
- Being tested
- SAFE Behavioral Intervention, Control
- Keywords
- Sexually Transmitted Infections, Secondary Prevention, Cognitive Behavioral Intervention
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE Behavioral InterventionBehavioural
Group cognitive behavioral intervention sessions
ControlOther
Individual Sexually Transmitted Infection Risk Reduction Counseling
| Study group | Role | What they receive |
|---|---|---|
| SAFE Intervention | Experimental | Behavioral Intervention Receives: Behavioral: SAFE Behavioral Intervention |
| Control | Other | Sexually Transmitted Infection Risk Reduction Counseling Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-infection with a non-viral sexually transmitted infection
Measured: 1 year
Secondary outcomes (1)
Changes in risky sexual behavior
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startJan 1993
- Primary completionJan 1994
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rochelle N Shain, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643019
- Sponsor's protocol ID
- HSC2004415H
- Other IDs
- U01AI040029
- Acronym
- SAFE
- Status last verified
- Apr 2015
- First submitted
- 21 Mar 2008
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thurman AR, Holden AE, Shain RN, Perdue S, Piper JM. Preventing recurrent sexually transmitted diseases in minority adolescents: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1417-25. doi: 10.1097/AOG.0b013e318177143a.
PubMed 18515527
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Recurrent Sexually Transmitted Infections in Minority Women
- ClinicalTrials.gov ID
- NCT00643019
- Acronym / sponsor ID
- SAFE / HSC2004415H
- Conditions
- Sexually Transmitted Disease, Secondary Prevention, Behavioral Modification, Public Health
- Keywords
- Sexually Transmitted Infections, Secondary Prevention, Cognitive Behavioral Intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jan 1993
- Primary completion
- Jan 1994 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Mar 2008 (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.
This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.
Detailed description
Participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as necessary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFE Intervention | Experimental | Behavioral: SAFE Behavioral InterventionBehavioral Intervention |
| Control | Other | Other: ControlSexually Transmitted Infection Risk Reduction Counseling |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Mexican American,
- 14 - 45 years old,
- English Speaking,
- non-viral sexually transmitted infection
Key exclusion criteria (2 listed)
- Non-English speaking,
- viral sexually transmitted infection
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 |
|---|---|---|
| SAFE Behavioral InterventionGroup cognitive behavioral intervention sessions | Behavioural | SAFE Intervention |
| ControlIndividual Sexually Transmitted Infection Risk Reduction Counseling | Other | Control |
Primary outcome
Re-infection with a non-viral sexually transmitted infection
Time frame: 1 year
1 secondary outcome
Changes in risky sexual behavior
Time frame: 2 years
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 15 Apr 2015.
- Derived from this study: PubMed 18515527Thurman AR, Holden AE, Shain RN, Perdue S, Piper JM. Preventing recurrent sexually transmitted diseases in minority adolescents: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1417-25. doi: 10.1097/AOG.0b013e318177143a.
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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.
Rochelle N Shain, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SAFE Behavioral Intervention in people with Sexually Transmitted Disease and Secondary Prevention, run by The University of Texas Health Science Center at San Antonio at 1 site 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 4 inclusion and 2 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Re-infection with a non-viral sexually transmitted infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00643019, which also lists 1 linked publication.
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 15 Apr 2015.