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Optimizing Strategies to Improve STD Partner Services

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207454
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
State University of New York - Downstate Medical Center
Information provided by:
Centers for Disease Control and Prevention
  Purpose
This research tests the effectiveness of a social cognitive intervention (with option of patient-delivered medication) geared toward increasing patient referral of partners.

Condition Intervention Phase
Chlamydia Trachomatis Neisseria Gonorrhoeae Behavioral: Social Cognitive Counseling Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Optimizing Strategies to Improve STD Partner Services

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Partner notification 1 month
  • Repeat Infection 6 month

Secondary Outcome Measures:
  • Intent to notify partner baseline post-test
  • Changes in relationship 1 month, 6 month

Estimated Enrollment: 800
Study Start Date: June 2001
Estimated Study Completion Date: August 2005
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207454


Locations
United States, New York
STD Clinic at Kings County Hospital Center (KCHC).
Brooklyn, New York, United States, 11203
Sponsors and Collaborators
Centers for Disease Control and Prevention
State University of New York - Downstate Medical Center
Investigators
Principal Investigator: Tracey Wilson, PhD State University of New York - Downstate Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00207454     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3197
R30/CCR219136-01
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Centers for Disease Control and Prevention:
Partner Referral
Social Cognitive Intervention
Partner Delivered Medication

Additional relevant MeSH terms:
Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female