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OpenTrials
Completed

NCT Number: NCT00207493

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kit enhancement to referral

Behavioral

patient referral versus contract referral

Procedure

Primary outcomes

  1. 1. Participant reinfection rates

  2. 2. Participant notification rates

  3. 3. Proportion of partners seeking evaluation

Secondary outcomes

  1. 1. Experience of violence attributable to notification

  2. 2. Relationship prognosis

  3. 3. Depression levels

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Important dates

Study start
2000
Primary completion
2005
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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