- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01170741
Computer-Assisted Tailored Cue-card Health [CATCH] Study (CATCH)
A Tailored Cue Card HIV/STI Intervention for High Risk Groups Pilot Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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North Carolina
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Raleigh, North Carolina, United States, 27601
- RTI International - Wake County Field Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sex risk
Time Frame: 3 months
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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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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Injection risk
Time Frame: 3 months
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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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3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William A Zule, DrPH, RTI International
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
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Liver Diseases
- Slow Virus Diseases
- Hepatitis
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Hepatitis, Viral, Human
Other Study ID Numbers
- 1R21DA026771 (U.S. NIH Grant/Contract)
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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