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

Chlamydia Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207493
• Other study ID #: CDC-NCHSTP-3305
• Secondary ID: R30/CCR 119162
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: September 26, 2012
• Start date: October 2000
• Est. completion date: September 2007

Study information

• Verified date: September 2012
• 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

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: September 2007
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia Infection
• Chlamydia Infections
• Contact Tracing

Intervention

Behavioral:
• Kit enhancement to referral

Procedure:
• patient referral versus contract referral

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Participant reinfection rates
Primary	2. Participant notification rates
Primary	3. Proportion of partners seeking evaluation
Secondary	1. Experience of violence attributable to notification
Secondary	2. Relationship prognosis
Secondary	3. Depression levels