NCT00207454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

First QC Date

September 13, 2005

Last Update Submit

April 14, 2025

Conditions

Chlamydia TrachomatisNeisseria Gonorrhoeae

Keywords

Partner ReferralSocial Cognitive InterventionPartner Delivered Medication

Outcome Measures

Primary Outcomes (2)

  • Partner notification 1 month

  • Repeat Infection 6 month

Secondary Outcomes (2)

  • Intent to notify partner baseline post-test

  • Changes in relationship 1 month, 6 month

Interventions

Social Cognitive CounselingBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

STD Clinic at Kings County Hospital Center (KCHC).

Brooklyn, New York, 11203, United States

Location

Study Officials

  • Tracey Wilson, PhD

    State University of New York - Downstate Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2001

Study Completion

August 1, 2005

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations

US(1)