Chlamydia InfectionPhase 1/2NCT00207493
The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.
A Phase 1/2 study testing Kit enhancement to referral and patient referral versus contract referral in people with Chlamydia Infection and Contact Tracing, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Chlamydia Infection, Contact Tracing
- What is being tested?
- Kit enhancement to referral and patient referral versus contract referral
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Sep 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subsequent lab confirmation of no chlamydial infection OR
- Sex partner of previously enrolled person OR
- Fear of violence from partner during notification.
Trial locations and contacts
1 site in 1 country.
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. 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.
Read the 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
- Conditions
- Chlamydia Infection, Contact Tracing
- Being tested
- Kit enhancement to referral, patient referral versus contract referral
- Keywords
- sexually transmitted disease, structural intervention, behavioral intervention
- Medical subject headings
- Chlamydia Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kit enhancement to referralBehavioural
patient referral versus contract referralProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Participant reinfection rates
2. Participant notification rates
3. Proportion of partners seeking evaluation
Secondary outcomes (3)
1. Experience of violence attributable to notification
2. Relationship prognosis
3. Depression levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2000
- Primary completionSep 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydia InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 494 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew Hogben, PhD, Principal investigator, Centers for Disease Control and PreventionGuillermo Madico, PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207493
- Sponsor's protocol ID
- CDC-NCHSTP-3305
- Other IDs
- R30/CCR 119162
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.
- ClinicalTrials.gov ID
- NCT00207493
- Acronym / sponsor ID
- CDC-NCHSTP-3305
- Conditions
- Chlamydia Infection, Contact Tracing
- Keywords
- sexually transmitted disease, structural intervention, behavioral intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Oct 2000
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Subsequent lab confirmation of no chlamydial infection OR
- Sex partner of previously enrolled person OR
- Fear of violence from partner during notification.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kit enhancement to referral | Behavioural | – |
| patient referral versus contract referral | Procedure or surgery | – |
Primary outcome
1. Participant reinfection rates
2. Participant notification rates
3. Proportion of partners seeking evaluation
3 secondary outcomes
1. Experience of violence attributable to notification
2. Relationship prognosis
3. Depression levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
Related trials for Chlamydia Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Hogben, PhD principal investigator
Centers for Disease Control and Prevention
Guillermo Madico, PhD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Kit enhancement to referral and patient referral versus contract referral in people with Chlamydia Infection and Contact Tracing, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Participant reinfection rates. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.