Computer-Assisted Tailored Cue-card Health [CATCH] Study (CATCH)

Tracking Information
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; (submitted: July 26, 2010)	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.
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; (submitted: July 26, 2010)	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.
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: To refine a cue card driven computer-assisted risk reduction intervention that will be tailored to each participant's demographic characteristics (e.g., gender, ethnicity), risk behaviors, and biological test results (HIV, hepatitis B and C, syphilis and herpes).; To pilot test the tailored intervention's effects on sexual risk behaviors (e.g., frequency of unprotected sex, condom use), drug use during sex and injection risk behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group randomized design that compares the tailored intervention with a delayed treatment control condition.; To assess the feasibility and acceptability of the tailored intervention in a rural setting.
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
Condition ICMJE	Human Immunodeficiency Virus; STDs; Hepatitis, Viral, Human
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
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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 24, 2012)	122
Original Estimated Enrollment ICMJE; (submitted: July 26, 2010)	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: 40 MSM (at least 12 African American, 12 non-Hispanic white and 12 Hispanic) - eligibility includes unprotected sex with another male in the past 30 days; 40 sex workers (at least 6 male and 6 female of each race/ethnicity) - eligibility includes unprotected sex within the last 30 days and exchange of sex for money or drugs within the past 30 days; 40 drug users who are not sex workers or MSM (at least 2 males and 2 females of each race/ethnicity) - eligibility includes use of methamphetamine, crack or powder cocaine, or heroin in the past 30 days and unprotected intercourse and/or syringe sharing in the past 30 days. Additional eligibility criteria include the following: be 18 years of age or older; self-identify as male or female; self-identify as African American, non-Hispanic white or Hispanic; not currently be in or seeking substance use treatment; speak and understand written English proficiently; be a resident of Wake, Durham, Orange, Johnston or Chatham counties, with no plans to move in the next 3 months
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Principal Investigator: William A Zule, DrPH RTI International
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