Contact TracingPhase 1/2NCT00207571
Partner Notification Intervention for STD Clinics.
A Phase 1/2 study testing Computer in people with Contact Tracing, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
To help public health professionals (DIS) in interviews of patients infected with STD for the names of their sex partners, this project used a computer-based partner elicitation program before the actual DIS interview. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Tracing
- What is being tested?
- Computer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Oct 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older AND
- Anglo, Hispanic, or Black AND
- STD diagnosis positive
Who cannot join
- Non-English speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-assisted STD Partner Notification
To help public health professionals (DIS) in interviews of patients infected with STD for the names of their sex partners, this project used a computer-based partner elicitation program before the actual DIS interview. The main outcome was the mean number of partners named by those who had the intervention versus those those who did not.
Read the detailed description
The primary goal of this project is to develop and evaluate an intervention that will increase the number of people who, having been exposed to a sexual partner with chlamydia, gonorrhea or syphilis, (a) are notified and (b) receive evaluation and treatment. The intervention program will be presented entirely by an automated multimedia computer system with touch screen interface. The intervention will be tailored to user, based on demographic and recent sexual history factors. The intervention is designed to (a) motivate and prompt STD clinic clients to recall and identify sexual partners, (b) teach clinic clients a set of social skills for minimizing negative reactions while informing partners that they may be infected with an STD; (c) increase client's self-efficacy relative to disclosing partners names and informing them of their STD exposure, and (d) provide clients with tools for motivating their partners to seek treatment.
- Conditions
- Contact Tracing
- Being tested
- Computer
- Keywords
- computer, video, partner notification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComputerBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Numbers of partner named.
2. Amount and quality of identifying information.
Secondary outcomes (1)
1. Willingness to name partners.
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 startApr 2001
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact TracingStudies 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
- Parallel groups
- Masking
- Single blind
- Enrolment
- 150 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 PreventionChristy Sherman, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207571
- Sponsor's protocol ID
- CDC-NCHSTP-3590
- Other IDs
- R30/CCR 019151
- 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
- Computer-assisted STD Partner Notification
- ClinicalTrials.gov ID
- NCT00207571
- Acronym / sponsor ID
- CDC-NCHSTP-3590
- Conditions
- Contact Tracing
- Keywords
- computer, video, partner notification
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Apr 2001
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (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.
To help public health professionals (DIS) in interviews of patients infected with STD for the names of their sex partners, this project used a computer-based partner elicitation program before the actual DIS interview. The main outcome was the mean number of partners named by those who had the intervention versus those those who did not.
Detailed description
The primary goal of this project is to develop and evaluate an intervention that will increase the number of people who, having been exposed to a sexual partner with chlamydia, gonorrhea or syphilis, (a) are notified and (b) receive evaluation and treatment. The intervention program will be presented entirely by an automated multimedia computer system with touch screen interface. The intervention will be tailored to user, based on demographic and recent sexual history factors. The intervention is designed to (a) motivate and prompt STD clinic clients to recall and identify sexual partners, (b) teach clinic clients a set of social skills for minimizing negative reactions while informing partners that they may be infected with an STD; (c) increase client's self-efficacy relative to disclosing partners names and informing them of their STD exposure, and (d) provide clients with tools for motivating their partners to seek treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 or older AND
- Anglo, Hispanic, or Black AND
- STD diagnosis positive
Key exclusion criteria (1 listed)
- Non-English speaker
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 |
|---|---|---|
| Computer | Behavioural | – |
Primary outcome
1. Numbers of partner named.
2. Amount and quality of identifying information.
1 secondary outcome
1. Willingness to name partners.
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.
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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
Christy Sherman, PhD principal investigator
Oregon Research Institute
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 Computer in people with 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 3 inclusion and 1 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. Numbers of partner named.. The study lists 2 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.