Optimizing Strategies to Improve STD Partner Services

This study has been completed.
Sponsor:
Collaborator:
State University of New York - Downstate Medical Center
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207454
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
State University of New York - Downstate Medical Center
Investigators
Principal Investigator: Tracey Wilson, PhD State University of New York - Downstate Medical Center
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on September 18, 2014