Optimizing Strategies to Improve STD Partner Services

Chlamydia Trachomatis Clinical Trial

Official title:

Optimizing Strategies to Improve STD Partner Services

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
• 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

• Chlamydia Trachomatis
• Neisseria Gonorrhoeae

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