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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00207454
Other study ID # CDC-NCHSTP-3197
Secondary ID R30/CCR219136-01
Status Completed
Phase Phase 1
First received September 13, 2005
Last updated September 13, 2005
Start date June 2001
Est. completion date August 2005

Study information

Verified date September 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

This research tests the effectiveness of a social cognitive intervention (with option of patient-delivered medication) geared toward increasing patient referral of partners.


Description:

This is a four-year study involving longitudinal data collection for 800 men and women recruited from four clinics in Brooklyn, NY. Participants were eligible for enrollment at any of the study sites if diagnosed as having C trachomatis or N gonorrhoeae genital infection or if they have an STD syndrome likely to be related to either of these pathogens (i.e., males with NGU). Consenting patients were randomly assigned to receive either standard-of-care patient referral for partner notification (N = 350), a social-cognitive intervention geared toward increasing patient referral (N = 350), or the social-cognitive intervention with an option of patient-delivered medication (N = 100). Evaluation activities include an interviewer administered measure provided at baseline, one month, and six months, a screen for N gonorrhoeae and C trachomatis using urine-based ligase chain reaction screening (Abbott LCx) at baseline and six months, and medical chart abstraction at one and six months.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Any individual presenting at study sites with STD-related symptoms who receives a microbiologic diagnosis with N gonorrhoeae and/or C trachomatis will be eligible for study participation if they meet the following criteria: 1) are 18 years of age or older; 2) have been sexually active in the previous two months; 3) are able to understand English or Spanish; 4) have resided within the catchment area for at least one year prior to enrollment; 5) plan to remain in the area through the course of the study period. .

Exclusion Criteria:

- Any potential participant deemed by a provider or member of the study staff to have psychological impairment, brought on by drug use or some other illness, to an extent that it would affect the ability to understand or provide informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


Intervention

Behavioral:
Social Cognitive Counseling


Locations

Country Name City State
United States STD Clinic at Kings County Hospital Center (KCHC). Brooklyn New York

Sponsors (2)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Partner notification 1 month
Primary Repeat Infection 6 month
Secondary Intent to notify partner baseline post-test
Secondary Changes in relationship 1 month, 6 month
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