Computer-Assisted Tailored Cue-card Health [CATCH] Study (CATCH)
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ClinicalTrials.gov Identifier: NCT01170741 |
Recruitment Status
:
Completed
First Posted
: July 27, 2010
Last Update Posted
: October 25, 2012
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Sponsor:
RTI International
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
RTI International
Tracking Information | ||||
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First Submitted Date ICMJE | July 26, 2010 | |||
First Posted Date ICMJE | July 27, 2010 | |||
Last Update Posted Date | October 25, 2012 | |||
Study Start Date ICMJE | June 2010 | |||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Sex risk [ Time Frame: 3 months ] Compared with participants assigned to the control condition, participants assigned to the tailored intervention will report lower rates of unprotected sex at 3-month follow-up.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01170741 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Injection risk [ Time Frame: 3 months ] Compared with IDU participants assigned to the control condition, IDU participants assigned to the tailored intervention will report lower rates of direct and indirect syringe sharing at 3-month follow-up.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Computer-Assisted Tailored Cue-card Health [CATCH] Study | |||
Official Title ICMJE | A Tailored Cue Card HIV/STI Intervention for High Risk Groups Pilot Study | |||
Brief Summary | This study will draw from proven interventions to refine and pilot test a cue card driven computer-assisted intervention, along with HIV/STI testing, that will be tailored to each participant's demographic characteristics, risk behaviors, and biological test results. The specific aims of the proposed study are:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Tailored Cue Cards
The proposed intervention uses education to increase knowledge and skill building to influence behavior-specific self-efficacy and outcome expectations. In addition to providing general information regarding drug use and diseases, the cue-cards include information that is designed to raise awareness regarding perceived threats (perceived susceptibility and perceived severity) related to HIV and other STIs and blood-borne infections, which increases motivation to reduce risk behaviors. The cue-cards also provide information regarding risk reduction strategies. The cue-cards also contain instructions on how to anticipate and avoid risky situations (e.g., using alcohol or drugs prior to sex). This information is augmented with an exercise that involves modeling and guided practice. This combination of information and exercises modifies outcome expectations by increasing confidence (i.e., perceived self-efficacy) that a protective action can be performed |
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Study Arms | No Intervention: Delayed Control Condition
Participants assigned to the delayed treatment control condition will be offered biological testing and the tailored cue-card intervention upon completion of their 3- month follow-up interview. Use of a delayed treatment control group design will permit us to separate intervention effects on HIV risk behaviors from the general effects of participating in the study and completing a detailed HIV risk assessment.
Intervention: Behavioral: Tailored Cue Cards |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
122 | |||
Original Estimated Enrollment ICMJE |
120 | |||
Actual Study Completion Date | June 2012 | |||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: The sample of 120 will be drawn from the Raleigh-Durham, NC metro area with the following targets:
Additional eligibility criteria include the following:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01170741 | |||
Other Study ID Numbers ICMJE | 1R21DA026771( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | RTI International | |||
Study Sponsor ICMJE | RTI International | |||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | |||
Investigators ICMJE |
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PRS Account | RTI International | |||
Verification Date | October 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |