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

Human Immunodeficiency Virus Clinical Trial

— CATCH  

Official title:

A Tailored Cue Card HIV/STI Intervention for High Risk Groups Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170741
• Other study ID #: 1R21DA026771
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2010
• Last updated: October 24, 2012
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

1. 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).

2. 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.

3. To assess the feasibility and acceptability of the tailored intervention in a rural setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis, Viral, Human
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• STDs

Intervention

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

Locations

Country	Name	City	State
United States	RTI International - Wake County Field Site	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex risk	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.	3 months	No
Secondary	Injection risk	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.	3 months	No