- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207493
The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
1. Participant reinfection rates
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2. Participant notification rates
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3. Proportion of partners seeking evaluation
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Secondary Outcome Measures
Outcome Measure |
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1. Experience of violence attributable to notification
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2. Relationship prognosis
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3. Depression levels
|
Collaborators and Investigators
Investigators
- Principal Investigator: Matthew Hogben, PhD, Centers for Disease Control and Prevention
- Principal Investigator: Guillermo Madico, PhD, Boston Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCHSTP-3305
- R30/CCR 119162
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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