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The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.

Primary Purpose

Chlamydia Infection, Contact Tracing

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Kit enhancement to referral
patient referral versus contract referral
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chlamydia Infection focused on measuring sexually transmitted disease, structural intervention, behavioral intervention

Eligibility Criteria

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

Inclusion Criteria: Sexually active AND 15 years old or older AND at least one of: Individuals with genitourinary symptoms requiring empiric treatment for chlamydia, OR People who self-report that they have had sex with someone who has been diagnosed with an STD within the past 30 days OR Asymptomatic female patients with cervicitis diagnosed via a routine pelvic examination. Exclusion Criteria: Subsequent lab confirmation of no chlamydial infection OR Sex partner of previously enrolled person OR Fear of violence from partner during notification.

Sites / Locations

  • Boston Medical Center

Outcomes

Primary Outcome Measures

1. Participant reinfection rates
2. Participant notification rates
3. Proportion of partners seeking evaluation

Secondary Outcome Measures

1. Experience of violence attributable to notification
2. Relationship prognosis
3. Depression levels

Full Information

First Posted
September 13, 2005
Last Updated
September 26, 2012
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00207493
Brief Title
The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.
Official Title
The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients diagnosed with chlamydial infections (a sexually transmitted disease) are asked to notify their sex partners and tell them to seek medical evaluation. This project tests an enhancement to the materials provided to patients to help convince their partners to seek evaluation against the standard of care, which is a brief notification instruction. The desired outcomes are greater levels of notification by participants of their partners and lower levels of reinfection among participants.
Detailed Description
Patients diagnosed with chlamydial infections (a sexually transmitted disease) are asked to notify their sex partners and tell them to seek medical evaluation: patient referral. Rates of actual referral by patients are unknown, but estimates derived from several evaluations suggest somewhere between 30 - 55% of partners are notified and tested (for chlamydia). Current prevalence and yearly rates of infection suggest this level of partner notification and treatment is insufficient to control the disease. As a program, this project has disseminated notification activities to community health centers that see chlamydial infections, all under the aegis of the awardee (Boston Medical Center). Diagnosis and partner notification can be recorded remotely , but centrally accessed through a secure database. To enhance patient referral effectiveness, this project tests brief instructions to refer (standard of care) against a "kit" containing a specific notification of exposure to chlamydia, an accurate health message about the nature and prognosis of the infection (treated and untreated), options for seeking free or low-cost evaluation and treatment, and a satisfaction survey. A second, crossed condition is pure patient referral against a contract (72 hours to notify, after which study staff will refer cases to public health professionals for notification). Principal outcomes measured are levels of notification by participants of their partners and levels of reinfection among participants. We also measure psychosocial mediating effects, as well as potential unintended consequences of patient referral: incident partner violence against prevalent (baseline rates) violence, depressed affect

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Infection, Contact Tracing
Keywords
sexually transmitted disease, structural intervention, behavioral intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
494 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Kit enhancement to referral
Intervention Type
Procedure
Intervention Name(s)
patient referral versus contract referral
Primary Outcome Measure Information:
Title
1. Participant reinfection rates
Title
2. Participant notification rates
Title
3. Proportion of partners seeking evaluation
Secondary Outcome Measure Information:
Title
1. Experience of violence attributable to notification
Title
2. Relationship prognosis
Title
3. Depression levels

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sexually active AND 15 years old or older AND at least one of: Individuals with genitourinary symptoms requiring empiric treatment for chlamydia, OR People who self-report that they have had sex with someone who has been diagnosed with an STD within the past 30 days OR Asymptomatic female patients with cervicitis diagnosed via a routine pelvic examination. Exclusion Criteria: Subsequent lab confirmation of no chlamydial infection OR Sex partner of previously enrolled person OR Fear of violence from partner during notification.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Hogben, PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillermo Madico, PhD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.

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