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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207493
First received: September 13, 2005
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chlamydia Infection
Contact Tracing
Behavioral: Kit enhancement to referral
Procedure: patient referral versus contract referral
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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

Estimated Enrollment: 494
Study Start Date: October 2000
Study Completion Date: September 2007
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207493

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Investigators
Principal Investigator: Matthew Hogben, PhD Centers for Disease Control and Prevention
Principal Investigator: Guillermo Madico, PhD Boston Medical Center
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00207493     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3305, R30/CCR 119162
Study First Received: September 13, 2005
Last Updated: September 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
sexually transmitted disease
structural intervention
behavioral intervention

Additional relevant MeSH terms:
Chlamydia Infections
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Infection
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial

ClinicalTrials.gov processed this record on October 23, 2014