Clinical trial NCT00207493: The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.
Official title: The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chlamydia Infection
Contact Tracing
Keywords: sexually transmitted disease
structural intervention
behavioral intervention
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-21
Enrollment: 494
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: 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.

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 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.

Primary outcomes:
measure: 1. Participant reinfection rates
measure: 2. Participant notification rates
measure: 3. Proportion of partners seeking evaluation
Secondary outcomes:
measure: 1. Experience of violence attributable to notification
measure: 2. Relationship prognosis
measure: 3. Depression levels
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Matthew Hogben, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Guillermo Madico, PhD
role: PRINCIPAL_INVESTIGATOR
References: