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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00260754
Other study ID # CDC-NCHSTP-4087
Secondary ID U65/CCU422269
Status Completed
Phase N/A
First received December 1, 2005
Last updated May 30, 2006
Start date October 2002
Est. completion date July 2005

Study information

Verified date December 2005
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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 syphilis and other STDs, as compared with those in the comparison city.


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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Community-Popular Opinion Leader Model

Diffusion of Innovations


Locations

Country Name City State
United States University of Alabama, Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in syphilis morbidity in affected community
Secondary Changes in risk behavior and health care seeking behavior
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