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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Chlamydia Infection, Contact Tracing

Intervention / Treatment
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* Behavioral: Kit enhancement to referral
* Procedure: patient referral versus contract referral


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Kit enhancement to referral|nan|
|Procedure: patient referral versus contract referral|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Participant reinfection rates |  |  | 
| 2. Participant notification rates |  |  | 
| 3. Proportion of partners seeking evaluation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Experience of violence attributable to notification |  |  | 
| 2. Relationship prognosis |  |  | 
| 3. Depression levels |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexually transmitted disease, structural intervention, behavioral intervention