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.
Behavioral: Kit enhancement to referral
Procedure: patient referral versus contract referral
|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.|
- 1. Participant reinfection rates
- 2. Participant notification rates
- 3. Proportion of partners seeking evaluation
- 1. Experience of violence attributable to notification
- 2. Relationship prognosis
- 3. Depression levels
|Study Start Date:||October 2000|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207493
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Matthew Hogben, PhD||Centers for Disease Control and Prevention|
|Principal Investigator:||Guillermo Madico, PhD||Boston Medical Center|