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

NCT00207493 | Completed Phase 1

• 2 other identifiers: CDC-NCHSTP-3305R30/CCR 119162
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

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.

Conditions

Chlamydia Infection; Contact Tracing

Keywords

sexually transmitted disease; structural intervention; behavioral intervention

Outcome Measures

Primary Outcomes (3)

• 1. Participant reinfection rates

• 2. Participant notification rates

• 3. Proportion of partners seeking evaluation

Secondary Outcomes (3)

• 1. Experience of violence attributable to notification

• 2. Relationship prognosis

• 3. Depression levels

Interventions

Kit enhancement to referral BEHAVIORAL

patient referral versus contract referral PROCEDURE

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sexually active AND
• 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.

You may not qualify if:

• Subsequent lab confirmation of no chlamydial infection OR
• Sex partner of previously enrolled person OR
• Fear of violence from partner during notification.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Chlamydia Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Hogben, PhD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Guillermo Madico, PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2000
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2007
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

US (1)