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

RTI International1 site in 1 country122 target enrollmentJune 2010

ConditionsHuman Immunodeficiency Virus STDs Hepatitis, Viral, Human

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Human Immunodeficiency Virus
Sponsor: RTI International
Enrollment: 122
Locations: 1
Primary Endpoint: Sex risk
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

June 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

RTI International

Responsible Party

Sponsor

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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.