Clinical trial NCT01170741: Computer-Assisted Tailored Cue-card Health [CATCH] Study
Official title: A Tailored Cue Card HIV/STI Intervention for High Risk Groups Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus
STDs
Hepatitis, Viral, Human
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-07-27
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Sex risk
timeFrame: 3 months
Secondary outcomes:
measure: Injection risk
timeFrame: 3 months
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: RTI International - Wake County Field Site
state: North Carolina
Study officials:
affiliation: RTI International
name: William A Zule, DrPH
role: PRINCIPAL_INVESTIGATOR
References: