Optimizing Strategies to Improve STD Partner Services - Full Text View

Sponsors and Collaborators:	Centers for Disease Control and Prevention State University of New York - Downstate Medical Center
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00207454

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 I

MedlinePlus related topics: Gonorrhea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	CDC-NCHSTP-3197, R30/CCR219136-01
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00207454
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

Partner Referral
Social Cognitive Intervention
Partner Delivered Medication

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Sexually Transmitted Diseases
Chlamydia Infections

Gonorrhea
Genital Diseases, Male
Gram-Negative Bacterial Infections
Neisseriaceae Infections

Additional relevant MeSH terms:

Sexually Transmitted Diseases, Bacterial
Infection

ClinicalTrials.gov processed this record on January 16, 2009