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Completed

NCT Number: NCT01170741

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

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Digestive System Diseases Disease Attributes Genital Diseases HIV Infections Hepatitis Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections STDs Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

RTI International - Wake County Field Site

Raleigh, North Carolina, 27601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Cue Cards

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: CATCH

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 27, 2010
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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