Computer-Assisted Tailored Cue-card Health [CATCH] Study - Full Text View

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:

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.

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A

U.S. FDA Resources

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

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

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

National Institute on Drug Abuse (NIDA)

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 March 07, 2013