Risk BehaviorNCT00260715
A Community-Based Intervention With Popular Opinion Leaders (C-POL) in Texas
A study testing Community-Popular Opinion Leader Model and Diffusion of Innovations in people with Risk Behavior and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
After exposure to the C-POL intervention: 1) unprotected vaginal or anal sex, sex with casual partners, concurrent sexual relationships, and exchange of sex for drugs or money will decrease significantly; 2) perceived syphilis-risk for self and peer group, knowledge about highly relevant risk-factors, information… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior, Sexually Transmitted Diseases
- What is being tested?
- Community-Popular Opinion Leader Model and Diffusion of Innovations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jul 2005
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community members who live and/or frequent the affected community. The affected community was one that had significant syphilis morbidity at the onset of the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A& M University
College Station, Texas, 77843-4243
About this study
Official title: A Community-Based Intervention With Popular Opinion Leaders (C-POL) in Texas to Achieve Syphilis Elimination
After exposure to the C-POL intervention: 1) unprotected vaginal or anal sex, sex with casual partners, concurrent sexual relationships, and exchange of sex for drugs or money will decrease significantly; 2) perceived syphilis-risk for self and peer group, knowledge about highly relevant risk-factors, information sources and resources will increase significantly; and 3) syphilis morbidity will decrease significantly in the intervention community as compared to the comparison community.
Read the detailed description
The C-POL in Texas project is and intervention study which sought to impact the health behaviors of community residents who live in zip codes that have high syphilis morbidity. The study is being implemented in Texas (Dallas and Houston) with residents of a housing developing and the surrounding community.
The intervention model used for this study is the Popular Opinion Leader (POL) model, which is effective at reducing new HIV infections. The intent of this study was to determine the effectiveness of a diffusion model (e.g. POL) at reducing syphilis infections in affected communities.
For the intervention, community members identified as popular opinion leaders were recruited and trained to share accurate information about syphilis transmission, symptoms, testing, treatment and prevention. Prior to intervention implementation and several times after, community members were given a survey and screened for syphilis as well as 2-3 additional STDs. During each assessment, cross-sections of the community members were sampled.
- Conditions
- Risk Behavior, Sexually Transmitted Diseases
- Being tested
- Community-Popular Opinion Leader Model, Diffusion of Innovations
- Keywords
- Risk behavior, Sexually Transmitted Diseases
- Medical subject headings
- Risk-Taking, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Popular Opinion Leader ModelBehavioural
Diffusion of InnovationsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in syphilis prevalence in affected community.
Secondary outcomes (1)
Change in risk behaviors, and health care seeking.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startOct 2002
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Texas A&M University
- Investigators
- Samantha Williams, Ph.D., Study chair, CDC/NCHSTP/DSTDP/BIRBNilesh Chatterjee, Ph.D., Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260715
- Sponsor's protocol ID
- CDC-NCHSTP-4133
- Other IDs
- U65/CCU622269, U65/CCU622268
- Status last verified
- Dec 2005
- First submitted
- 1 Dec 2005
- Last updated
- 2 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Intervention With Popular Opinion Leaders (C-POL) in Texas to Achieve Syphilis Elimination
- ClinicalTrials.gov ID
- NCT00260715
- Acronym / sponsor ID
- CDC-NCHSTP-4133
- Conditions
- Risk Behavior, Sexually Transmitted Diseases
- Keywords
- Risk behavior, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Texas A&M University
- Study start
- Oct 2002
- Study completion
- Jul 2005
- First posted
- 2 Dec 2005 (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.
After exposure to the C-POL intervention: 1) unprotected vaginal or anal sex, sex with casual partners, concurrent sexual relationships, and exchange of sex for drugs or money will decrease significantly; 2) perceived syphilis-risk for self and peer group, knowledge about highly relevant risk-factors, information sources and resources will increase significantly; and 3) syphilis morbidity will decrease significantly in the intervention community as compared to the comparison community.
Detailed description
The C-POL in Texas project is and intervention study which sought to impact the health behaviors of community residents who live in zip codes that have high syphilis morbidity. The study is being implemented in Texas (Dallas and Houston) with residents of a housing developing and the surrounding community.
The intervention model used for this study is the Popular Opinion Leader (POL) model, which is effective at reducing new HIV infections. The intent of this study was to determine the effectiveness of a diffusion model (e.g. POL) at reducing syphilis infections in affected communities.
For the intervention, community members identified as popular opinion leaders were recruited and trained to share accurate information about syphilis transmission, symptoms, testing, treatment and prevention. Prior to intervention implementation and several times after, community members were given a survey and screened for syphilis as well as 2-3 additional STDs. During each assessment, cross-sections of the community members were sampled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community members who live and/or frequent the affected community. The affected community was one that had significant syphilis morbidity at the onset of the study.
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 |
|---|---|---|
| Community-Popular Opinion Leader Model | Behavioural | – |
| Diffusion of Innovations | Behavioural | – |
Primary outcome
Change in syphilis prevalence in affected community.
1 secondary outcome
Change in risk behaviors, and health care seeking.
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 2 Dec 2005.
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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.
Samantha Williams, Ph.D. study chair
CDC/NCHSTP/DSTDP/BIRB
Nilesh Chatterjee, Ph.D. principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-Popular Opinion Leader Model and Diffusion of Innovations in people with Risk Behavior and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention 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 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 2 Dec 2005. 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.
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?
Change in syphilis prevalence in affected community.. 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 2 Dec 2005; AzTrials last refreshed its copy on 6 Nov 2026.