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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT01170741
First received: July 26, 2010
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.

Condition Intervention Phase
Human Immunodeficiency Virus
STDs
Hepatitis, Viral, Human
Behavioral: Tailored Cue Cards
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Tailored Cue Card HIV/STI Intervention for High Risk Groups Pilot Study

Resource links provided by NLM:


Further study details as provided by RTI International:

Primary Outcome Measures:
  • Sex risk [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Injection risk [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 122
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170741

Locations
United States, North Carolina
RTI International - Wake County Field Site
Raleigh, North Carolina, United States, 27601
Sponsors and Collaborators
RTI International
Investigators
Principal Investigator: William A Zule, DrPH RTI International
  More Information

No publications provided

Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT01170741     History of Changes
Other Study ID Numbers: 1 R21 DA026771
Study First Received: July 26, 2010
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections

ClinicalTrials.gov processed this record on July 24, 2014