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Optimizing Strategies to Improve STD Partner Services

Primary Purpose

Chlamydia Trachomatis, Neisseria Gonorrhoeae

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Social Cognitive Counseling
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Chlamydia Trachomatis focused on measuring Partner Referral, Social Cognitive Intervention, Partner Delivered Medication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • STD Clinic at Kings County Hospital Center (KCHC).

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
State University of New York - Downstate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00207454
Brief Title
Optimizing Strategies to Improve STD Partner Services
Official Title
Optimizing Strategies to Improve STD Partner Services
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
State University of New York - Downstate Medical Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis, Neisseria Gonorrhoeae
Keywords
Partner Referral, Social Cognitive Intervention, Partner Delivered Medication

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Social Cognitive Counseling
Primary Outcome Measure Information:
Title
Partner notification 1 month
Title
Repeat Infection 6 month
Secondary Outcome Measure Information:
Title
Intent to notify partner baseline post-test
Title
Changes in relationship 1 month, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracey Wilson, PhD
Organizational Affiliation
State University of New York - Downstate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
STD Clinic at Kings County Hospital Center (KCHC).
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States

12. IPD Sharing Statement

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Optimizing Strategies to Improve STD Partner Services

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