Risk BehaviorNCT00260754
Utilization of the Community Popular Opinion Leader (C-POL) Model in Alabama
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
Community members within the treatment city will report: 1)engaging in fewer sexual risk practices; 2)significantly higher condom use; 3) significantly higher rates of STD care seeking (including STD screening behaviors); 4) fewer having STDs in the past 6 months; 5) significantly higher awareness scores regarding… 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
- 600 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
- Clients who utilized two community homeless shelters in 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
University of Alabama, Birmingham
Birmingham, Alabama, 35294-0022
About this study
Official title: Utilization of the Community Popular Opinion Leader (C-POL) Model to Achieve Syphilis Elimination in Alabama
Community members within the treatment city will report: 1)engaging in fewer sexual risk practices; 2)significantly higher condom use; 3) significantly higher rates of STD care seeking (including STD screening behaviors); 4) fewer having STDs in the past 6 months; 5) significantly higher awareness scores regarding syphilis and other STDs, as compared with those in the comparison city.
Read the detailed description
The C-POL in Alabama 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 Birmingham and Montgomery with shelter clients.
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.
Changes in syphilis morbidity in affected community
Secondary outcomes (1)
Changes in risk behavior and health care seeking behavior
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of Alabama at Birmingham
- Investigators
- Samantha Williams, Ph.D., Study chair, CDC/NCHSTP/DSTDP/BIRBDiane Grimley, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260754
- Sponsor's protocol ID
- CDC-NCHSTP-4087
- Other IDs
- U65/CCU422269
- Status last verified
- Dec 2005
- First submitted
- 1 Dec 2005
- Last updated
- 31 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of the Community Popular Opinion Leader (C-POL) Model to Achieve Syphilis Elimination in Alabama
- ClinicalTrials.gov ID
- NCT00260754
- Acronym / sponsor ID
- CDC-NCHSTP-4087
- Conditions
- Risk Behavior, Sexually Transmitted Diseases
- Keywords
- Risk behavior, Sexually transmitted diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of Alabama at Birmingham
- 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.
Community members within the treatment city will report: 1)engaging in fewer sexual risk practices; 2)significantly higher condom use; 3) significantly higher rates of STD care seeking (including STD screening behaviors); 4) fewer having STDs in the past 6 months; 5) significantly higher awareness scores regarding syphilis and other STDs, as compared with those in the comparison city.
Detailed description
The C-POL in Alabama 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 Birmingham and Montgomery with shelter clients.
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
- Factorial
- 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)
- Clients who utilized two community homeless shelters in 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
Changes in syphilis morbidity in affected community
1 secondary outcome
Changes in risk behavior and health care seeking behavior
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 31 May 2006.
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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
Diane Grimley, Ph.D. principal investigator
University of Alabama at Birmingham
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 31 May 2006. 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?
Changes in syphilis morbidity 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 31 May 2006.