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

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ClinicalTrials.gov Identifier: NCT00207493
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

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.

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

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  (Clinical Trial)
Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.
Study Start Date : October 2000
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 1. Participant reinfection rates
  2. 2. Participant notification rates
  3. 3. Proportion of partners seeking evaluation

Secondary Outcome Measures :
  1. 1. Experience of violence attributable to notification
  2. 2. Relationship prognosis
  3. 3. Depression levels


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207493


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
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

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
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

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

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