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

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.

Study Overview

• Status: Completed
• Conditions: Contact Tracing; Chlamydia Infection
• Intervention / Treatment: Behavioral: Kit enhancement to referral; Procedure: patient referral versus contract referral

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

• Study Type: Interventional
• Enrollment: 494
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Matthew Hogben, PhD, Centers for Disease Control and Prevention; Principal Investigator: Guillermo Madico, PhD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: behavioral intervention; sexually transmitted disease; structural intervention
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections
• Other Study ID Numbers: CDC-NCHSTP-3305; R30/CCR 119162