Optimizing Strategies to Improve STD Partner Services

Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00207454
Collaborator
State University of New York - Downstate Medical Center (Other)
800
1
50
16

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social Cognitive Counseling
Phase 1

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Educational/Counseling/Training
Official Title:
Optimizing Strategies to Improve STD Partner Services
Study Start Date :
Jun 1, 2001
Study Completion Date :
Aug 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Partner notification 1 month []

  2. Repeat Infection 6 month []

Secondary Outcome Measures

  1. Intent to notify partner baseline post-test []

  2. Changes in relationship 1 month, 6 month []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00207454
Other Study ID Numbers:
  • CDC-NCHSTP-3197
  • R30/CCR219136-01
First Posted:
Sep 21, 2005
Last Update Posted:
Sep 21, 2005
Last Verified:
Sep 1, 2005
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2005